Imagine if H.R. 3 — the drug price-control bill that has significant support in the House of Representatives — were to become law.

What would it look like if some of the bill’s provisions, like indexing US prices to 120 percent of prices in Europe, were enacted?

How would entrepreneurs adapt? What types of drug discovery programs might be prioritized, and which ones cast aside as impractical? How would management teams have to adjust their strategy, and pitches, to successfully attract investors? How would certain patient groups be affected? What would it mean for the sector?

There are many questions. It’s fascinating, when you dig in, to think through the implications of this thought experiment.

Students at the University of Texas Southwestern Medical Center were challenged to think along these lines through a business plan competition on Mar. 20. Small teams of postdocs, grad students and MBAs were asked to think of a product profile, a relevant disease indication, and — assuming success in clinical development and regulatory approval — a price that could withstand the hard calculations of Incremental Cost-Effectiveness Ratios (ICER) and Quality-Adjusted Life Years (QALY).

The goal was to come out with an investment pitch that investors might buy into.

RA Capital Management, the Office for Technology Development at UTSW, Biotech+ Hub at Pegasus Park and McKinsey supported the competition. RA Capital managing partner Peter Kolchinsky served as a judge with Jeb Keiper, CEO of Nimbus Therapeutics, and Sara Nayeem, partner at Avoro Ventures. I observed.

The students clearly did their homework.

The results were eye-opening.

One group imagined it had an antibody-drug conjugate for lung cancer that delivered an 85 percent Complete Response rate, few side effects, and an average improvement in life expectancy of 10-11 years. Such a drug could be administered for about two years on average, and priced at $210,000 a year in Europe and $250,000 a year in the US, they figured. At that price, the fictional company would beat existing PD-1 inhibitors from Merck and Bristol Myers Squibb on a QALY-based comparison.

Kolchinsky shook his head. Sure, payers would pay for that. But there is no such drug on the market, or in R&D.

“We never see this kind of efficacy,” Kolchinsky told the students. Turning to his fellow judges, he said: “What they are asking us to do is stop investing in plausible, realistic science and start investing in fantasy.”

Another group sized up a new treatment for irritable bowel syndrome with constipation or diarrhea, and imagined generating three times as much sales volume in Europe to make up for an anticipated shortfall in the US.

Next came a team with an mRNA vaccine for HIV that elicits broadly neutralizing antibodies. The students thought the vaccine could be given to everyone in the US. They considered a low price for a national population and a higher price for a subpopulation deemed to be “high risk.”

The team concluded that it didn’t make sense to develop such a product as a low-volume/high-priced ($9,000) product for the high risk population. Forget about it.

A few days later, I asked the judges to reflect. How were students forced to adapt to the new environment? What did it tell us?

Kolchinsky wrote:

“The participants made an admirable effort, but every single team was forced to make unrealistic assumptions to try to make their business pitches seem fundable despite the limitations of price controls.

“A lot of the submissions were based on actual drugs in development by real companies. But the actual programs are funded because those companies and investors have an expectation that, if successful, those drugs will get reimbursed at prices close to those drugs we have on the market now, which are all higher than prices that HR-3 would allow. And when these teams tried to win funding for these programs but asked investors to accept a much lower price, they couldn’t. Some teams resorted to asking the judges to imagine that these drugs were better than they actually were, had a higher chance of succeeding that they actually have, or would treat more patients than could possibly be true. Bottom line, price controls killed investment in the R&D that is actually possible and forced teams to resort to making promises they couldn’t keep…”

If health economists who run conventional cost-effectiveness are put in charge of setting price, innovators probably won’t be able to win funding from any knowledgeable investors. There may some investors who fall for a pitch claiming a high probability of success and larger market than is real, but in time they will lose enough money to realize the price controls set rewards too low for the risks involved in making new medicines.”

Jeb Keiper of Nimbus said the pressures would cause entrepreneurs to overpromise. “Like snake oil salesmen, [they] promise a cure in every bottle,” he said. “The constraints forced business plan competitors’ strategies to subvert price-control legislation by promising miracles.” 

That was one survival strategy. The winning team had a different plan. It pitched a reformulation of a proven drug. But in a hostile pricing environment, the students said they would need to accept a lower valuation in the next funding round — crushing the ownership stakes of earlier investors.

Keiper ruefully asked the team who was the CEO. That person would likely be fired.

“The implications are chilling,” Keiper wrote. “Existing biotech investors (including large scale mutual funds and pensions which many Americans have their savings in) get gutted, new medicines stop being developed for patients that need them, and the public only gets incremental improvements that industry watchdogs rightly hound against.”

Pain would be spread among entrepreneurs, investors, and patients. The patients most likely to bear the brunt, though, would be ones with the greatest needs.

Sara Nayeem of Avoro Ventures wrote:

“Drug development for diseases where there have been many historic failures would be especially hard to fund.  For instance, pancreatic cancer is a devastating diagnosis for which we need breakthrough drugs; but because the historical probability of success is much lower than in other areas of oncology (per BIO, a drug for pancreatic cancer entering Phase 1 trials has only a 1.1% chance of approval), investors would need to know that a drug that shows needle-moving efficacy would be reimbursed at a higher price than the average cancer drug…groups like ICER don’t take into account the low success rates in certain diseases; nor do they quantify the value to society into perpetuity of branded drugs going generic.”

Some readers might think this boils down to the same old industry talking points about price controls causing investment to dry up.

But the students weren’t trying to score political points. They were imagining a future drug pricing environment, and trying to prepare.

It was a useful and humbling exercise. Lawmakers would be wise to think a few steps ahead, like this, when considering big changes to a complex market like this with so much at stake.

That’s not to say we should slavishly stick with the status quo. Biotech as an industry is creative and resilient under pressure. Management teams were forced to cut expenses and operate in more lean ways in the Great Recession years of 2008-2012. People in Congress warned the Affordable Care Act would crush incentives for innovation. That didn’t happen.

Instead, a crop of battle-tested, productive companies emerged. We have reaped the harvest of those innovations from the early 2010s. Year by year, the FDA approvals tell the story.

Markets have their vicissitudes. But the secular trend in biomedicine is upward. There’s a lot here in academia, government and industry that’s worth preserving and building upon.

Our elected leaders ought to guide regulations and set guardrails that keep companies honest, with an eye toward preserving a dynamic environment where startups can come along and knock off incumbents.

Kolchinsky, in his book “The Great American Drug Deal,” advocates for contractual genericization as one way to provide balance to pharmaceutical markets that are too often dominated by companies with incentives to primarily protect aging franchises. Many of these aging franchises should have gone generic years ago. Too many drugs, because of patenting games or other perverse incentives that involve middlemen, command sky-high prices that can’t be justified. All of these shenanigans end up wasting money, harming patients and discouraging entrepreneurs.

This publication believes in standing up for the proverbial little guy. Policymakers, health economists, and industry leaders should take action to rein in the excesses of the big guys, without forgetting that little guy (or gal) with a startup dream. That person should have an incentive, and a chance. That person shouldn’t become collateral damage.

If we want to create an environment where scientific entrepreneurs can flourish, we can do it. With scalpels, not sledgehammers.

 

Damaged Public Trust

If you missed Tuesday’s Frontpoints, it predicted this week’s AstraZeneca vaccine debacle. The NIH statement of Mar. 23 pointed out the company’s press release claiming 79 percent efficacy was based on outdated data. The NYT and Washington Post got ahold of a seething letter from the Data Safety Monitoring Board. AZ tried to do some damage control in a revised press release on Mar. 25, which dragged efficacy down to 76 percent. Given the company’s recent pattern of bad behavior and incompetence, I plan to read every line of the FDA briefing documents, and listen to every minute of the FDA advisory committee hearing for this vaccine candidate.

This is a test. Regulators, doing their jobs, will go over everything with a fine-toothed comb and review the application with full transparency. Then we can make informed decisions.

A lot of leeway has been granted to companies in this emergency, born from necessity and a generous spirit of “we’re all in this together.” Some standards about not doing science by press release, and not accepting company statements at face value, have gone out the window in the name of expediency. We put a lot of trust in companies and they have mostly delivered the past year.

But when a company abuses trust repeatedly, the credibility of science and industry itself gets called into question. AstraZeneca needs to make things right. This isn’t one of those cases where PR window dressing or a carpet-bombing of advertisements will make controversy go away. They need to fix things.

This Week in Drug Pricing

Are you a biopharma executive who breathed a sigh of relief about how the drug pricing pit bulls snarling at the industry have been neutered during the glory days of vaccine development?

Not so fast. Public opinion can be fickle.

The AZ imbroglio (see above) feeds into the confirmation bias of the industry’s harshest critics. While a majority are grateful for the vaccines, we still have perverse incentives in our health insurance system, healthcare profiteering, millions of our most vulnerable are being left in the cold, and we still have an information commons that downgrades fact-based discourse and amplifies conspiracy mongering.

Without systemic fixes to how we pay for healthcare — and how we provide fair access to healthcare for everyone — we could easily fall back into the brain-dead rhetorical rut about sticking it to those evil price-gouging drugmakers.

See this NYT op-ed, headlined “Taxpayers Fund Research and Drug Companies Make a Fortune” in which a patient advocate imagines a day when COVID-19 vaccines might cost money (the horror!).

I agree individuals shouldn’t be paying out of pocket for this most valuable preventive medicine. We should be paying for it with our tax dollars. We should be grateful about it because we’re getting an amazing bargain from vaccines that will get the global economy moving again and bring tremendous peace of mind.

Science Policy

President Biden is showing vision and guts. Who says we can’t solve problems, so why bother trying? Biden isn’t buying that nihilistic garbage. He’s acting like a young man in a hurry. Let’s ask serious questions that citizens in a serious participatory democracy ought to ask. Like whether we invest enough in science as a country. What more could we be doing to advance cures, fight climate change, and create meaningful career opportunities for younger generations?

A big investment like the one suggested below inspire a new generation to be drawn to science, and to value science.

Science Features

• Pandemic whistle-blower: we need a non-political way to track viruses. Interview with Rick Bright. Nature. Mar. 19. (Amy Maxmen)
• What scientists do and don’t know about the Oxford–AstraZeneca COVID vaccine. Nature. Mar. 24. (Smriti Mallapaty and Ewen Callaway)
• Unlocking the COVID Code. NYT Magazine. Mar. 25. (Jon Gertner)

Science of SARS-CoV-2

• Dynamics of SARS-CoV-2 neutralising antibody responses and duration of immunity: a longitudinal study. The Lancet Microbe. Mar. 23. (Wan Chia et al Duke-NUS Medical School, Singapore)
• Early Evidence of the Effect of SARS-CoV-2 Vaccine at One Medical Center. NEJM. Mar. 23. (William Daniel et al UT Southwestern)

Data That Mattered

Bristol Myers Squibb said it met the primary endpoint – progression free survival — in a Phase III clinical trial with its LAG-3 targeting antibody, relatlimab, in combination with nivolumab (Opdivo), the PD-1 directed antibody. The study looked at patients newly diagnosed with metastatic or unresectable melanoma. Overall survival data aren’t yet available. It’s the first time a checkpoint inhibitor for LAG-3 has passed a pivotal study.

Financings

Eric Schmidt, the former Google CEO, donated $150 million to establish a new center at the Broad Institute to support machine learning analysis of emerging biological datasets, including next-generation DNA sequencing, single-cell genomics, and advanced medical imaging. The Schmidt Center will be co-directed by Caroline Uhler, Associate Professor of Electrical Engineering and Computer Science and the Institute for Data, Systems, and Society at MIT and an associate member of the Broad Institute; and Anthony Philippakis, Broad’s chief data officer. 

Rivervest Venture Partners, with offices in St. Louis and San Diego, said it raised $275 million for Fund V to invest in early stage biopharma and medical device companies.

Seattle-based Eliem Therapeutics raised $80 million in a Series A financing led by RA Capital Management to develop treatments for chronic pain and depression. (TR coverage).

Emeryville, Calif.-based Zymergen, an industrial biotech company, filed an IPO prospectus to raise up to $100 million.

Cambridge, Mass.-based Apnimed raised $25 million in a Series B financing to develop a once-daily oral pill for obstructive sleep apnea. Morningside Ventures led.

San Francisco-based Ginger said it raised $100 million in a Series E financing led by Blackstone to improve mental healthcare offerings for employers, health plans, and strategic partners. (TR Frontpoints column on mental health, Mar. 4, 2021)

Cambridge, Mass.-based 1910 Genetics said it raised $26 million to advance its technology to design small molecules and protein drugs with AI and automated tools. M12 – Microsoft’s Venture Fund and Playground Global co-led.

Personnel File

Moncef Slaoui, the former head of R&D at GSK and leader of the Operation Warp Speed program for COVID-19 vaccines, was fired from the board of a GSK / Verily entity (Galvani Bioelectronics), and stepped down immediately from a new job as chief scientific officer of Centessa Pharmaceuticals, after GSK said it had learned of sexual harassment allegations and an outside law firm investigated the claim.

Amy Abernethy, the principal deputy commissioner of the FDA, will step down from her position next month. She has overseen a push to modernize the agency’s data practices.

Novartis said it’s closing down a factory in Colorado where it was planning to manufacture Zolgensma, the gene therapy for spinal muscular atrophy type 1. The company plans to shut down the plant in July, and lay off 400 workers. It apparently overestimated demand for the therapy, which it obtained through the acquisition of AveXis for $8.7 billion. (FiercePharma coverage).

Atul Dandekar joined South San Francisco-based Maze Therapeutics, a precision medicine company, as chief strategy officer. (TR coverage of Maze, Feb. 2019)

Josh Makower was named the new director of the Stanford Byers Center for Biodesign. He replaces the legendary founder of the center, Paul Yock, a medical device innovator. Makower will retain a relationship with NEA, in keeping with the center’s longstanding focus on academic-industry partnerships.

Merck promoted Caroline Litchfield from treasurer to CFO. She replaces Robert Davis, who is being promoted to president on Apr. 1 as part of a succession plan for him to take over from Ken Frazier as CEO on July 1.

Regulatory Action

Takeda Pharmaceuticals said its submitted an application for its dengue vaccine to regulators in Europe, and in dengue-endemic countries.

Our Shared Humanity

Bruce Booth of Atlas Venture wrote an unusually personal piece on his LifeSciVC blog Mar. 16. I let some time pass before asking him about the feedback from this article about divorce.

It was a rare example of a powerful business leader showing vulnerability.

If you missed it, this is a message that bears repeating. We should all try to be a little more empathetic to friends and colleagues at work who may be stressed by personal issues just beneath the surface. By listening a little more, and extending some understanding and grace, we do ourselves a favor and everyone around us.

I was really happy to hear Booth tell me yesterday that the feedback has been “uniformly positive.”

Hundreds of emails poured in. These weren’t the usual “Hey, nice article” notes that writers sometimes get.

Many of these correspondents got specific and personal, Booth said.

“They went on for paragraphs about a sick kid, a sick spouse, feeling unable to talk about it at work. There were other people who went through divorces, and talked about making it through. They were just sharing their stories. I got very emotional reading all the responses. It was really powerful.”

It took courage to write the article.

We men are taught to be brave from an early age, in a gladiatorial, competitive sense. Never let ‘em see you sweat. Bullies on the playground will bury you at the slightest hint of “weakness.” But at some point in life, we realize that “putting on your game face” at work, as Booth put it, isn’t always a show of strength.

Showing some vulnerability, and allowing people to be human beings with each other in your midst, can be a source of leadership strength.

The positive reaction to Booth’s article lifts my spirits. It reminds me that people in this industry are capable of many good things, in science and beyond.

Credibility can be lost in a heartbeat.

It can take years to rebuild.

That maxim kept running through the back of my mind when reading the press release on the AstraZeneca Phase III clinical trial conducted with 32,449 participants in the US, Peru and Chile, in partnership with the NIH’s COVID-19 Prevention Network.

The top line was encouraging — 79 percent efficacy at preventing COVID-19 and 100 percent efficacy at preventing severe illness and hospitalization.

The company, following a rough couple weeks of rumors and innuendo, said independent data monitors found no increased risk of blood clots in people who got the vaccine.

“I’m thrilled,” said Ashish Jha, dean of Brown University’s School of Public Health, in reacting to the breaking news in Science. “This is the vaccine that I had always assumed would vaccinate a large chunk of the world.”

It’s a view rooted in practical reality. AZ’s is an adenoviral vector vaccine, given in two doses four weeks apart (or potentially further apart, according to UK officials). It’s manufacturable at global scale, easy to ship in refrigerators, and cheap — $2 to $6 a dose.

So far, so good.

I hope that everything in the company statement is right, and that there are no serious flies in the ointment. But despite our yearning for positive vaccine news, we have reason to withhold judgment until we get a good, hard look at the data.

This company has shot itself in the foot multiple times, damaging its credibility in the past year.

Consider the sequence of vaccine events:

May 21—company says it’s getting $1 billion from the Biomedical Advanced Research and Development Authority (BARDA) to develop, produce and deliver its COVID-19 vaccine in the US. Plan is to run a 30,000-participant Phase III trial, and deliver at least 400 million doses in 2020 and 2021. This was an assuring sign of a major league pharma company with a major league academic partner (Oxford), getting a major league vote of confidence from the richest and most scientifically powerful country in the world. At a time when mRNA was still seen as fairly speculative, this looked like a safe bet.

Sept. 6—company receives a report of an adverse event — transverse myelitis, an inflammation of the spine — in a vaccine participant in Britain. The company halts enrollment while investigating the adverse event, looking to see if its vaccine might have played a causative role.

Sept. 8—company has conference call with FDA officials, seeking clarity on what’s necessary for US regulatory approval. Company neglects to mention the transverse myelitis adverse event in the UK, and the decision to halt trial enrollment. The FDA was blindsided a few hours later when it heard about the revelations on the news. (The only reason we know this is because of a New York Times report from four months later). This confirms the absolute worst impressions critics have of the pharmaceutical industry. Not only that, but if you were working for the FDA and in the room that day, wouldn’t you be fuming that the company didn’t disclose the event, and didn’t discuss how to get to the bottom of the issue in partnership?

Sept. 9—As reports of the adverse event swirl, AstraZeneca CEO Pascal Soriot goes into a private conference call organized by J.P. Morgan for clients of the investment bank. From this well-controlled safe space, he assures everyone that the woman who suffered the severe spinal inflammation was improving and likely to be discharged from the hospital soon. We only learned this because STAT broke the story that day. Again, this was news of international biomedical significance, given in private to wealthy clients of JP Morgan — before the public.

Sept. 9—All AstraZeneca COVID-19 vaccine trials go on clinical hold as researchers seek to suss out what happened with the woman who got transverse myelitis.

Sept. 12—AstraZeneca vaccine trial resumes enrollment in the UK. Importantly, the big 30,000-participant study in the US, the one designed to yield the most rigorous evidence, remains on hold.

Oct. 23—the US FDA lifts the clinical hold, allowing AZ to resume enrollment of the 30,000-participant vaccine study. The clinical hold lasted more than six weeks – an eternity in a fast-moving pandemic. Pfizer/BioNTech, Moderna and J&J leaped ahead.

Nov. 23—AZ reports on a pooled analysis of 23,000 participants who got the vaccine in the UK and Brazil. Because of a dosing screw-up, a half-dose appeared to be 90 percent effective in a subpopulation of 2,100 subjects, while the full dose appeared to be 62 percent effective. The dataset, on its own, was a mess. Regulators here, in the best-resourced drug regulatory agency, already had good reason to be suspicious at the company for hiding a crucial piece of information. Now AZ is telling the world that its trial was bungled? There was no realistic path forward for the company to seek FDA Emergency Use Authorization on the basis of this unconvincing dataset.

Dec. 8—The NYT publishes its expose on AstraZeneca’s failure to disclose the adverse event to the FDA in September. Days later, the FDA approved the first two COVID-19 vaccines – one from Pfizer/BioNTech, the other from Moderna.  

Feb. 8.—South Africa health officials halt administration of the AZ vaccine, saying it was offering “minimal protection” against the B.1.351 variant of SARS-CoV-2 that was in wide circulation by then.

Feb.15—the World Health Organization authorizes the AZ vaccine for use in low and middle-income countries.

Mar. 15—European countries temporarily halt administration of the AZ vaccine amid anecdotal scary reports of blood clots in people who received the vaccine. Despite no compelling evidence to point to the vaccine causing those adverse events, health authorities in multiple countries, fearing the worst, shut down mass vaccinations with the AZ product, partly to allay public fears.

Mar. 22—AZ reports the long-awaited results from the US, Peru and Chile, in 32,000 participants. The top-line efficacy of 79 percent looks solid, if not spectacular. Some public health experts, like Ashish Jha at Brown University, cheer this development as a step toward vaccinating the world.  

For sure, 79 percent is solid efficacy. The more vaccines we have, the better. But before getting too excited, I want to see some more details on how the vaccine is performing against the variants and in subpopulations and what the immunogenicity data look like.

Part of me really prefers to withhold judgment for now, wondering if there’s another shoe to drop. Given the track record, it makes sense to wait and see for what the FDA staff come up with when they comb through the dataset with a kind of rigor that makes peer-review look like a stroll in the park.

Not only is the FDA rigorous, it has a long institutional memory. It can really put the screws to companies behind the scenes in multiple ways.

That’s one of the important lessons I learned many years ago in an FDA law class at Harvard Law School taught by Peter Barton Hutt, the attorney at Covington and a legendary former FDA counsel. (I’m not a Harvard Law graduate, but was able to audit classes at MIT and Harvard during the 2005-2006 academic year via the Knight Science Journalism Fellowship at MIT).

I practically heard shades of Peter Barton Hutt and FDA staff sharpening their pencils this morning when I watched a TV appearance by Anthony Fauci.

“The FDA is going to very, very carefully go over all of these data,” Fauci said, “You can rest assured, that the FDA will apply a great deal of scrutiny in every aspect of these data.”

Fauci is surely aware that while the US public may have forgotten some of AZ’s missteps, the FDA has not.

Even if the company turns in a thorough and squeaky-clean application and regulators agree that it deserves an Emergency Use Authorization (the most likely outcome), that will be just one step in building back public trust.

Yesterday morning, on cue with the company press release, the NYT published an op-ed from Heidi Larson, the preeminent voice on vaccine hesitancy.  

There’s a lot of work to do in building vaccine trust, she wrote.

Indeed.

[Update 6:45 am PT, Mar. 23: After this column was published, the National Institute of Allergy and Infectious Disease issued the following statement: “AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.” AstraZeneca responded with its own statement, saying it would provide more updated data within 48 hours.

Financings

Taicang, China and San Diego-based Connect Biopharma raised $191 million in an IPO at $17 a share. The company is working on T-cell driven inflammatory diseases. Qiming Venture Partners, RA Capital Management, and Advantech Capital were among the principal shareholders heading into the liquidity event. Shares inched up to $18.61 at yesterday’s close.

Dallas, Texas-based Instil Bio, the developer of T-infiltrating lymphocyte therapies for cancer, raised $320 million in an IPO at $20 a share. It climbed to $26.80 at yesterday’s close, with a market valuation of $3.3 billion. CEO Bronson Crouch controls the Curative Ventures entity that holds 29.7 percent ownership in the company after the IPO. The other big stakeholders in the company include Venrock, CPMG and Vivo Capital.

Somerville, Mass.-based Finch Therapeutics, a microbiome therapeutics developer, raised $128 million in an IPO at $17 a share. A member of the Walton family, heirs to the Walmart fortune, is among the big winners in this IPO. Shares traded up to $19.15 at yesterday’s close.

Boston Immune Technologies and Therapeutics (BITT) said it completed a $10 million Series A/A1 financing to develop novel antibodies against members of the TNF superfamily. BeiGene participated, along with Hatteras Venture Partners and EGP Investments.

Malvern, Penn.-based Xylocor Therapeutics said it completed a $41.9 million Series A round to advance its gene therapy for coronary artery disease. Fountain Healthcare Partners led and was joined by new investors Longwood Fund and Lumira Ventures.

Seattle-based Dexcare, a new digital health startup, said it raised $20 million in investment led by Define Ventures. The round included Frist Cressey Ventures, Kaiser Permanente Ventures, SpringRock Ventures and Providence Ventures. DexCare describes itself in a statement as “an intelligent digital care operating system that manages health system capacity and demand across all lines of care.” It was developed internally at Providence, a large hospital chain on the West Coast, in 2016 and is now being spun out aas a business with a half-dozen customers.

Cambridge, Mass.-based Aura Biosciences said it raised $80 million in financing to advance virus-like drug conjugate therapies for cancer. Matrix Capital Management and Surveyor Capital led.

Legal Corner

The SEC brought charges against uBiome for allegedly defrauding investors out of $60 million. The complaint was brought in the US District Court in Northern California.

Science Policy

• Put this one in the ‘Never Forget’ Folder: Tom Frieden on the ‘Mind-Boggling’ Interference of the Trump Administration in COVID-19. The BMJ. Mar. 17. (Joanne Silberner)
• Where’s the Science Behind CDC’s 6-Foot Decree and Transmissability? WSJ. Mar. 21. (Scott Gottlieb)
• The Pandemic Year: The Hyper-Acceleration of the Life Sciences. WSJ. Mar. 19. (Eric Topol)
• Five Myths About Coronavirus Vaccines. Washington Post. Mar. 19. (Peter Hotez and Maria Elena Bottazzi)

Science of SARS-CoV-2

• Post-acute COVID-19 syndrome. Nature Medicine. Mar. 22. (Ani Nalbandian et al New York-Presbyterian/Columbia University Irving Medical Center)
• Neutralizing Antibodies Against SARS-CoV-2 Variants After Infection and Vaccination. JAMA. Mar. 19 (Venkata Viswanadh Edara et al Emory University).
• Infection and vaccine-induced antibody binding and neutralization of the B.1.351 SARS-CoV-2 variant. Cell. Mar. 20. (Venkata Viswanadh Edara et al Emory University).
• SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies. Cell. Mar. 20. (Markus Hoffmann et al University Gottingen)
• Difference in SARS-CoV-2 attack rate between children and adults may reflect bias. Oxford Clinical Infectious Diseases preprint. Feb. 26. (Zoe Hyde et al University of Western Australia)
• Transmissibility and transmission of respiratory viruses. Nature Reviews Microbiology. Mar. 22. (Nancy Leung)
• Single-component, self-assembling, protein nanoparticles presenting the receptor binding domain and stabilized spike as SARS-CoV-2 vaccine candidates. Science Advances. Mar. 19. (Linling He et al The Scripps Research Institute)

Data That Mattered

Roche/Genentech said its PD-L1 directed antibody atezolizumab (Tecentriq), hit the primary endpoint of extending disease-free survival in the Phase III Impower010 study. The trial looked at patients getting adjuvant therapy after surgery and chemotherapy for Stage II-IIIA populations with non-small cell lung cancer. Participants were randomized to the drug group, or best supportive care. The company said the magnitude of disease-free survival benefit “was particularly pronounced in the PD-L1-positive population.” The company said it doesn’t yet have mature data on Overall Survival.

Roche/Genentech also said it shut down a Phase III clinical trial for tominersen, an antisense oligonucleotide for Huntington’s disease in-licensed from Ionis Pharmaceuticals. The drug was designed to reduce production of huntingtin protein (HTT), including its mutated variant, mHTT. An independent data monitoring committee made the recommendation. See Sek Kathiresan’s succinct summary of this head-scratcher below. (Phase I results in NEJM, 2019).

Exton, Penn.-based Idera Pharmaceuticals failed in a pivotal trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma. The drug is a Toll-like receptor 9 agonist, being combined with the CTLA-4 inhibitor in this case. Shares lost two-thirds of their value.

Our Broken US Healthcare System

Major donors to South Florida hospital foundation got early vaccine access. Politico. Mar. 19. (Arek Sarkissian and Matt Dixon)

RIP

Jose Baselga, the prominent cancer researcher and leader of oncology R&D at AstraZeneca, died at age 61. (STAT obituary).

Personnel File

Diana Brainard was hired as CEO at Cambridge, Mass.-based AlloVir, a cell therapy company focused on viral diseases patients with weakened immune systems. She starts May 17. Brainard is currently senior vice president of virology therapeutics at Gilead Sciences. She oversaw teams that developed curative therapies for hepatitis C and remdesivir for COVID-19, among other areas. She replaces David Hallal, who is moving upstairs to be executive chairman. Hallal is also CEO of ElevateBio, the largest shareholder in AlloVir. (Disclosure: Brainard is married to TR healthtech columnist David Shaywitz.)

Jean-Frédéric Viret was hired as chief financial officer at South San Francisco-based Blade Therapeutics, a developer of treatments for fibrotic diseases. He was previously CFO at Coherus Biosciences.

South San Francisco-based Sutro Biopharma, the developer of treatments for cancer and autoimmunity, promoted David Pauling to General Counsel and Robert Kiss was promoted to senior vice president of process and analytical development.

South San Francisco-based Veracyte, a molecular diagnostics company, added Muna Bhanji to its board of directors.

Chart of the Day

The data out of Brazil are a concern.

Source: Outbreak.info, based on data from Johns Hopkins University Center for Systems Science and Engineering, New York Times, COVID Tracking Project, GISAID Initiative

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Please subscribe and tell your friends why it’s worthwhile. Quality journalism costs money. When you subscribe to Timmerman Report at $169 per year, you reward quality independent biotech reporting, and encourage more.

Please subscribe and tell your friends why it’s worthwhile. Quality journalism costs money. When you subscribe to Timmerman Report at $169 per year, you reward quality independent biotech reporting, and encourage more.

Please subscribe and tell your friends why it’s worthwhile. Quality journalism costs money. When you subscribe to Timmerman Report at $169 per year, you reward quality independent biotech reporting, and encourage more.

Mental health problems were mounting heading into this pandemic.

Now, the challenges are bigger and coming in waves.

There’s the grief. Think about all the family and friends of the more than 520,000 people who have died.

There’s anxiety about getting infected. There’s depression, and loneliness, that stems from social distancing. Addictions to alcohol and drugs are on the rise as people seek ways to cope. Post-traumatic stress disorder is a concern among our healthcare workers. The social media platforms are designed to maximize engagement — they keep us angry and outraged and ultimately exhausted by efforts to sell us stuff.

Data are starting to tell a story.

Depression rates have tripled during the pandemic, according to one study published in JAMA in September. Suicidal thinking among young people was rising before 2020, and surged last year to the point where one in four young adults in the US contemplated suicide, according to the CDC. Heavy drinking episodes shot up 41 percent among women, according to a RAND Corp. study.

Biotech has sprung into action like never before against the virus. Incredible progress has been made there.

What can industry do about mental health?

This week, some of you may have heard my interview with Bob Nelsen of ARCH Venture Partners on The Long Run podcast. The longtime VC, known for being ahead of the curve, spoke of increasing investment in mental health. This isn’t exactly new for him. Nelsen previously invested in schizophrenia drug developer Karuna Therapeutics and depression drug developer Sage Therapeutics.

What struck me most was that Nelsen wasn’t speaking exclusively about the next Karuna and other “hard science” approaches. He also spoke of the “soft” kind of interventions that incorporate some combination of other elements like, presumably, talk therapy, cognitive behavioral therapy, more convenient access, maybe some passive data collection from smartphones equipped with useful analytical capabilities, and maybe some pharmacologic therapy. He didn’t specifically mention the term “digital therapeutics” but there’s a lot of room to re-think mental health treatment in a broader way.

Thinking about those comments, I called a friend.

D.A. Wallach is a general partner at Time BioVentures, a biotech investment firm in the Los Angeles area. He’s curious about science and startups, and a longtime TR subscriber. He’s a successful recording artist. He kindly gave me one of his unpublished songs to start The Long Run podcast in 2017.

That music still fills me with joy each episode.

I wanted to check in with D.A. partly for his thoughts on mental health investing, but moreso for his personal experience with the system.

He suffered a death in the family last year and has sought grief counseling.

Grief, like death, is something our society doesn’t like to talk about. “Nobody knows what to say to you,” D.A. told me.

“Grief isn’t a mental illness, but it’s sort of the equivalent of a mental injury,” he added. “I’d think of it almost like rehab. If you have an injury to your leg, you go to rehab. If you have an injury to your brain, you should go to rehab.”

Like so many people in America, he discovered that it’s a lot easier to get rehab for a leg injury.

First off, it was hard to find someone qualified to talk to. It didn’t take long to figure out why. A market failure was staring him in the face.

Healthcare insurance reimbursement rates are so low in greater Los Angeles that all the best providers refuse to take insurance, D.A. said. They take cash only. Some of the best charge up to $400 an hour.

That means they end up serving primarily wealthy clientele, leaving the average and the below-average practitioners for everyone else with insurance. “You’d have to be a saint to be an incredibly talented therapist and take insurance. You’re choosing to make less money,” D.A. said.

D.A. ended up finding a counselor. He said he’s satisfied with the quality of care he’s been getting via telemedicine.

What’s gnawing him now is the broken system. Los Angeles has developed what amounts to a two-tiered system – high-quality cash-only mental healthcare for the wealthy and lower-quality, insurance-based mental healthcare for everyone else.

That might be too generous of a description. It assumes people who aren’t wealthy can even get access to mental health services at all.

Limited access is the downstream manifestation of deeper ills. Our social-cultural stigma around mental health issues feeds directly into a political system that, as a result, provides only the most parsimonious support for mental healthcare. Naturally, we are left with this narrow funnel of qualified professionals attempting to grapple with millions of people in need.

The gap is enormous. One pre-pandemic study, conducted by the Cohen Veterans Network, a national nonprofit, and National Council for Behavioral Health, attempted to get its arms around this access problem with its inaugural “America’s Mental Health” report in 2018. (Full report).

According to the report:

• 42 percent of the population considers cost and inadequate insurance coverage as a barrier to accessing mental healthcare.
• Nearly one in five Americans, 17%, said they have had to choose between getting treatment for a physical health condition and a mental health condition because of their insurance.
• Almost two-thirds of Americans, 64%, who have sought mental health treatment believe the U.S. government needs to do more to improve mental health services.
• More than one-third of Americans, 38%, have had to wait longer than one week for mental health treatments.
• Almost half of Americans, 46%, have had to or know someone who has had to drive more than an hour roundtrip to seek treatment.

These numbers were disturbing in 2018. One year into the COVID-19 pandemic, we need an update.

Jonathan Shaywitz, a board-certified psychiatrist in Los Angeles with a medical degree from Harvard Medical School, said the demand for mental health services is “the highest it has been for some time.” (If the name’s familiar, he’s the younger brother of TR healthtech columnist David Shaywitz.)

Jon Shaywitz currently handles outpatient services, as well as inpatient services at five facilities. He’s busy. Despite efficiency gains that make it easier to accommodate new patients through telemedicine, Shaywitz said the waiting list for new patients extends out for three months.

Even with increasing awareness of the need, mental healthcare still doesn’t get reimbursed at the same level as physical healthcare. As Jon Shaywitz said:

“This is an area that still needs work — while the law has attempted to create parity between physical and mental health — we are still lacking regarding parity of reimbursement for mental health. Due to the lack of procedures in mental health, our currency is time and talking and unfortunately insurance companies don’t reimburse for time/talking as they do for procedures or imaging. While some of my colleagues still do private practice, the majority are leaving practice and joining large organizations/companies (community psychiatry/Kaiser) where they are salaried and who take insurance.”

With 520,000 dead from COVID-19, how many family members and friends of the deceased out there could use some help coping with their grief? How many people could use help for depression and anxiety?

What can biotech do that might make a difference?

D.A. hasn’t yet invested in mental health, but he’s been studying the opportunities. It’s an area that can’t simply be addressed with pharmacologic solutionism, where the pill is everything, he says.

A more integrated approach that might involve some combination of tech-enabled diagnostic data, behavioral coaching, new treatments, and the empathetic touch from skilled professionals is more likely to succeed. Smoking cessation is one potential model, where the drug is just one tool. Psychedelic therapies for mood disorders are another potential arena for integrated investigation (see in-depth TR coverage of psychedelic drug R&D, September 2020).

Those of us who aren’t neuroscientists or psychiatrists or venture capitalists can do a few things, too.

We can create situations in our companies when it’s OK for people to take a break when they need it. We can lean on our health insurance providers to improve access to mental health services. We can pressure elected officials to raise awareness and provide more funding for reimbursement.

We can support more basic research, from people like Harmit Malik, a member of the National Academy of Sciences. He bravely admitted in a public forum — see below — that many scientists are struggling.  

We can make ourselves aware of the suffering of our friends and colleagues that’s often buried beneath the surface. We can choose to uplift. We can be kind.

We can do more for mental health.

TR readers can continue on for a roundup of the deals and financings and other major developments of the week in biotech.

Vaccines

Delayed Large Local Reactions to mRNA-1273 Vaccine against SARS-CoV-2. NEJM. Mar. 3. (Kimberly G. Blumenthal et al Mass General Brigham)

Fauci: U.S. must stick with two-shot strategy for Pfizer-BioNTech, Moderna vaccines. Washington Post. Mar. 1. (Dan Diamond)

India-based Bharat Biotech reports vaccine trial results from 25,800-volunteer study with 81 percent efficacy against COVID-19. (Bharat Biotech statement)

Science of SARS-CoV-2

High resolution profiling of MHC-II peptide presentation capacity, by Mammalian Epitope Display, reveals SARS-CoV-2 targets for CD4 T cells and mechanisms of immune-escape. BioRxiv. Mar. 2. (Jan Kisielow et al Repertoire Immune Medicines in Cambridge, Mass.)

Estimated transmissibility and impact of SARS-CoV-2 lineage B.1.1.7 in England. Science. Mar. 3. (Nicholas Davies et al London School of Hygiene and Tropical Medicine)

Science Features

• When Will It End? How a Changing Virus is Reshaping Scientists’ Views on COVID-19. Reuters. Mar. 3. (Julie Steenhuysen and Kate Kelland)
• COVID-19 Can Derange the Immune System in Strange Ways. Kaiser Health News. Mar. 2. (Liz Szabo)
• The short-term, middle-term, and long-term future of the coronavirus. STAT. Mar. 4. (Drew Joseph and Helen Branswell)

Data That Mattered

San Francisco-based VIR Biotechnology and GSK had some bad news from the NIH-sponsored ACTIV-3 clinical trial that evaluated its therapeutic neutralizing antibody against COVID-19 in hospitalized patients. The Data Safety Monitoring Board recommended enrollment in the drug arm be closed after seeing data “that raised concerns about the magnitude of the benefit.” There were no reported safety signals, the companies said. VIR shares fell 28 percent on the news. (NIH Statement on ACTIV-3, which includes antibodies from VIR and Durham, NC and Beijing-based Brii Biosciences.)

Financings

Cambridge, Mass.-based eGenesis said it raised $125 million in a Series C financing. The company uses CRISPR to engineer animal tissues for transplant into humans – starting with kidneys for kidney failure and islet cells for type 1 diabetes.

Foresite Capital raised $969 million in its Fund V and Opportunity Fund.

Paris-based Sofinnova Partners, a European-focused life science fund, raised a new $540 million late-stage crossover fund.

Berkeley, Calif.-based Caribou Biosciences raised $115 million in a Series C financing to use its CRISPR technology to further advance work on allogeneic, off-the-shelf engineered immune cell therapies for cancer. Farallon Capital Management, PFM Health Sciences, and Ridgeback Capital Investments co-led.

Philadelphia-based Century Therapeutics raised $160 million in a Series C financing. The company is developing induced pluripotent stem cell-derived therapies for cancer. Casdin Capital led. (Listen to Century chief strategy officer Janelle Anderson on The Long Run podcast, Aug. 2019).

Waltham, Mass.-based Morphic Therapeutic seized upon its surging stock price to put together a new offering of shares at $70 apiece. The company, the developer of oral small molecule integrin inhibitors, took home a fresh $245 million from the offering. (See Tuesday’s TR coverage of Morphic’s proof-of-concept clinical data).

San Diego-based Janux Therapeutics raised $56 million in a Series A financing led by Avalon Ventures. The company is developing “Tumor Activated T Cell Engager” technology.

South San Francisco-based Amunix Pharmaceuticals said it raised $117 million in a Series B financing led by Viking Global Investors. The company is developing protease-activated T cell engagers and cytokines for the treatment of solid tumors.

UK-based Exscientia, an AI drug discovery company, said it raised $100 million in a Series C financing that included Blackrock funds, Novo, Bristol Myers Squibb and others.

MassBio released a report this week finding that Massachusetts biotech companies raised a record-breaking $5.8 billion combined in venture capital in 2020. That shattered the previous record of $4.8 billion from 2018. A remarkable 21 biotech companies from Massachusetts alone went public last year, raising another $3.9 billion, the trade group said. (Summary and link to full report).

Access and Manufacturing

Merck, likely suffering from a bruised corporate ego after its COVID-19 vaccine candidates failed, agreed to help Johnson & Johnson manufacture its adenoviral vaccine that was just authorized for distribution by the FDA. The Biomedical Advanced Research and Development Authority (BARDA) agreed to provide $269 million to Merck to set up the necessary processes to make the J&J vaccine. President Biden later said the plan is to make enough vaccine to vaccinate all American adults by May 31. Previously, Novartis and Sanofi said they would help produce the Pfizer / BioNTech vaccine.

WuXi Apptec completed its acquisition of Oxgene, a UK-based contract manufacturer of cell and gene therapies.

San Diego and Boston-based Resilience acquired two new biotech drug manufacturing facilities. One is the 310,000-square foot landmark along the Charles River in Boston, originally developed by Genzyme and now part of Sanofi. The other is a 136,000-square foot facility in Mississauga, Ontario. Resilience said it has now assembled a network of factories with 750,000 square feet in North America. It will continue to invest in upgrading and adapting the facilities for production. (Bob Nelsen of ARCH Venture Partners, co-founder of Resilience, discussed the company in my latest Long Run podcast).

Cambridge, Mass.-based Biogen said it plans to build a new gene therapy manufacturing plant in Research Triangle Park, North Carolina. It’s planning to scale up future gene therapies for neurological disorders. Biogen plans to hire 90 new workers there, and invest $200 million.

Germany-based CureVac, a less-known mRNA vaccine and therapeutics developer, agreed to work with Novartis to help scale up production of its mRNA vaccine candidates in the second quarter of 2021. The companies said they expect to be able to make 50 million doses at a Novartis facility in Austria in 2021, and another 200 million in 2022.

Deals

Amgen agreed to pay $1.9 billion to acquire South San Francisco-based Five Prime Therapeutics, a company that’s been on a 20-year odyssey in biologic drug discovery and development. Amgen pointed to its interest in bemarituzumab, an anti-FGFR2b antibody being prepped for Phase III study in gastric cancer. (Five Prime founder Lewis T. “Rusty” Williams is a member of my Everest Base Camp trekking expedition to benefit Fred Hutch. It’s been on hold because of the pandemic, and now looks like a Spring 2022 event. Can’t wait to ask him about Five Prime on the trails of Nepal).

Takeda Pharmaceuticals took back full rights to soticlestat (TAK-935/OV935) for developmental and epileptic encephalopathies, including Dravet syndrome and Lennox-Gastaut syndrome. New York-based Ovid Therapeutics had been its development partner since 2017, and helped drive the asset through Phase II testing. To get back full global rights, Takeda agreed to pay Ovid $196 million at closing and another $660 million in milestones, plus royalties. Ovid stock, beaten down after a clinical failure with its candidate for Angelman syndrome, jumped back up 37 percent on the news that it was getting the cash infusion.

AbbVie obtained an exclusive option to acquire San Francisco-based Mitokinin once it completes IND-enabling studies. Mitokinin is developing drugs to increase the activity of PINK1 a master regulator of mitochondria. The company, spun out of work at UCSF by Nicholas Hertz and Kevan Shokat, is betting that by increasing the activity of PINK1, it can address one of the underlying problems that contributes to Parkinson’s disease. Terms weren’t disclosed. The startup was backed by Mission Bay Capital.

Santa Clara, Calif.-based Agilent Technologies agreed to pay $550 million in cash at closing, plus $145 million in milestones, to acquire Kirkland, Wash.-based Resolution Bioscience, which uses liquid biopsies and next-gen sequencing technology for the diagnosis of cancer.

The Defense Advanced Research Projects Agency (DARPA), the government agency that made a visionary investment in mRNA vaccines for pandemic preparedness in 2013, awarded a grant to Georgia Tech Research Institute to develop technology to detect SARS-CoV-2 in the air in real-time. San Diego-based Cardea Bio is a subcontractor on the deal. If successful, the detectors could conceivably be used in schools, offices, restaurants and other indoor environments where people might wonder about whether the virus is circulating.

Seattle-based Presage Biosciences said it raised $13 million in a round that included $7 million from new investors LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners Ltd. Presage also said it established new research agreements with Merck and Maverick Therapeutics. The company uses intratumoral microdosing to evaluate several cancer drugs simultaneously in Phase O trials.

Grail, the Menlo Park, Calif.-based developer of next-gen sequencing enabled tests for early detection of cancer, said it struck an agreement with Providence, a major West Coast hospital network, to offer Grail’s Galleri test that’s scheduled to become available in the second quarter of 2021. It’s not a surprise that Providence would be an early adopter of this next-gen sequencing enabled healthcare application – it acquired the Institute for Systems Biology, led by DNA sequencing pioneer Leroy Hood, in Mar. 2016. (Read “Hood: Trailblazer of the Genomics Age”).

Our Shared Humanity

The California Life Sciences Association (CLSA) published a Racial & Social Equity Plan, which includes specific actions and a $1 million commitment over three years to get the ball rolling.

Regulatory Action

The FDA released its Data Modernization Action Plan, about 18 months in the making. There are three main elements – identifying valuable demonstration projects, developing consistent and repeatable data practices across the agency, and build up and sustain a stronger talent network (internally and with external partners). (Executive Summary)

Merck said it’s voluntarily withdrawing one of its approved indications for the PD-1 inhibitor pembrolizumab (Keytruda). It’s for metastatic small cell lung cancer. The drug was granted accelerated approval by the FDA in 2019 on a surrogate endpoint – tumor response – but full approval was supposed to be contingent on demonstrating an Overall Survival benefit. The drug failed to clear that higher bar of evidence in January 2020, and now the indication is being taken out of the prescribing label.

The FDA, in an unusual public statement, waded into a mess around Brainstorm Cell Therapeutics and its experimental NurOwn treatment for amyotrophic lateral sclerosis. The company announced Feb. 22 what looked like unequivocal bad news – that the FDA said it doesn’t have enough evidence of efficacy to submit a Biologics License Application. The company, however, appeared to muddy the waters and perhaps stir some false hope by adding that “FDA advised that this recommendation does not preclude Brainstorm from proceeding with a BLA submission.”

The FDA — under pressure for years to release full Complete Response Letters to investors, doctors and patients so that companies can’t engage in one-sided and misleading communications about new drug applications – decided to clear things up. The agency said:

Although FDA generally cannot provide confidential information about unapproved products, given the tremendous public interest in this product, we have concluded that it is important to provide high-level information about the status of the NurOwn development program.

With the recent completion of a randomized phase 3 controlled clinical trial comparing NurOwn to placebo, it has become clear that data do not support the proposed clinical benefit of this therapy. Data indicated that none of the primary or secondary endpoints were met in the group of patients who were randomized.

The agency got into some more specifics in case anyone is wondering if this is a close call, or the agency is being wishy-washy. The take-home lesson: the FDA has to step up its communications game in the age of transparency, especially with companies who are leaving people with misleading impressions.

The FDA granted a label expansion to Pfizer to start marketing lorlatinib (Lorbrena) as a treatment for patients with newly diagnosed ALK-positive non-small cell lung cancer. The FDA also converted an accelerated approval from 2018 into a full approval, based on results from the CROWN study which showed a 72 percent reduced risk of disease worsening or death for ALK-positive patients on the medicine.

Personnel File

Cambridge, Mass.-based Fulcrum Therapeutics said CEO Robert Gould is retiring at the end of March, and will remain on the board of directors and function as an advisor. The rare disease drug developer is promoting chief operating officer Bryan Stuart to president and CEO. (TR coverage of Fulcrum, Sept. 2018).

Cambridge, Mass.-based Solid Biosciences, the developer of gene therapy for Duchenne Muscular Dystrophy, said Erin Powers Brennan was hired as chief legal officer and Joel Schneider was promoted to chief operating officer.

Dilawar Syed was nominated by President Biden to be the deputy administrator of the Small Business Administration. He’s currently CEO at Lumiata, an AI-for-healthcare company.

Waltham, Mass.-based Dyne Therapeutics, the developer of treatments for muscle diseases, said it hired Wildon Farwell as chief medical officer. He was VP of neuromuscular at Biogen.

Cambridge, Mass.-based eGenesis, the CRISPR for xenotransplantation company that recently raised $125 million in a Series C financing and is almost surely getting dressed up for an IPO, hired Sapna Srivastava as chief financial officer. She previously worked as chief financial and strategy officer at Abide Therapeutics, and before that had a similar job at Intellia Therapeutics.

Chicago-based OMX Ventures, a new fund that says it’s investing in companies “at the intersection of biology, big data and engineering,” hired Jamie Kasuboski as a vice president on its team of investing professionals. Jamie previously worked at RA Capital, and Boehringer Ingelheim Venture Fund. Kevin Ness, former CEO of Inscripta, also agreed to become an advisor to OMX.

San Diego-based Viracta Therapeutics, a company working on treatment for viral-associated cancer, added Stephen Rubino and Barry Simon to its board of directors. The company also announced a series of promotions in operating roles.