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Harnessing the Potential of Digital Quality: Transforming Manufacturing Outcomes for Long-Term Success

Harnessing the Potential of Digital Quality: Transforming Manufacturing Outcomes for Long-Term Success     Automation and digitization of quality processes are becoming integral to advanced manufacturing operations. Medical manufacturers are using it more often to improve efficiency, reduce costs, and enhance product quality. MTI recently discussed how this digital transformation is improving MedTech manufacturing quality with …

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Sanofi cuts staff in Belgium as early-stage research dwindles

Sanofi’s global restructuring and downsizing is now fully underway, with layoffs stretching to the company’s Belgian offices.
Belgian newspaper De Tijd reports that 67 employees have been laid off at a site in Ghent and 32 jobs are on the chopping block at Sanofi’s Belgium HQ in Diegem. A spokesperson for the company confirmed the figures are correct. 

“Based on the re-prioritization of our pipeline we will shift some of our investments in early research programs to clinical development programmes and some early-stage research activities in Ghent including in oncology will be discontinued,” the spokesperson said. They added that Ghent “remains a strategic site for Sanofi,” after the €3.9 billion acquisition of Ablynx back in 2018. 

Then-CEO Olivier Brandicourt said in a release at the time that the purchase teed up growth in treating “rare blood disorders.” 
“We are also pleased to reaffirm our commitment to Belgium, where we have invested significantly over the years in our state-of-the-art biologics manufacturing facility in Geel,” Brandicourt wrote. “We intend to maintain and support the Ablynx science center in Ghent.” Brandicourt was replaced by current CEO Paul Hudson in September 2019. 

Belgian staffers are the latest to be impacted by Sanofi’s global restructuring, which was first hinted at by leadership at the tail end of 2023 during Sanofi’s third-quarter earnings call. Executives described plans to increase R&D spending by doubling down on clinical-stage immunology candidates while diverting resources away from other parts of the pipeline.
Employees were told at the beginning of this month that the restructuring was going into effect. An April 4 email from R&D chief Houman Ashrafian, Ph.D., described a “full pipeline reprioritization” was in effect, and that the workforce would be downsized as a result. Sanofi’s goal, Ashrafian wrote, is to be “an immunoscience powerhouse.” 
Now, the divestments are coming into clearer view. Sanofi has axed, divested or pulled back from at least three oncology deals with Amunix, Kiadis and IGM Biosciences, respectively. In October 2023, executives specifically listed oncology as a therapeutic area where resources could be diverted. The company also laid off employees at a U.K. site acquired from Kymab and has trimmed its US commercial vaccine operations. 
In his email to staff, Ashrafian said there would be “fewer projects in research to fund the required increase in investment in our development portfolio.”

How Vir found the one: CEO Marianne De Backer

Vir Biotechnology conducted a world-wide search to find the perfect CEO. In the end, the board picked Bayer’s Marianne De Backer, Ph.D., because of her three decades of experience in the pharmaceutical industry and her “deep and thorough understanding of the evolving healthcare landscape.”
Details of De Backer’s hiring were laid out in Vir’s April 19 proxy statement, as well as her executive compensation, which totaled $40 million for 2023 altogether. That package is likely to shrink significantly after De Backer’s initial year, which included stock awards of $13 million, option awards of $21.6 million and a $2.5 million sign-on bonus.

De Backer arrived at Vir during a transitional time. The company saw a significant decrease in revenues from, COVID antibody treatment sotrovimab, which was developed with GSK and used under emergency authorization. But that has since been revoked as the virus mutated and the SARS-CoV-2 omicron BA.2 sub-variant became dominant. GSK walked away from the collaboration. 

Then in July 2023, Vir’s phase 2 PENINSULA trial of VIR-2482 in influenza A failed. This occurred “all while responding to the general strong headwinds facing the biotechnology sector,” according to the proxy statement.
Founding CEO George Scangos, Ph.D., then decided to retire, setting off the search for a new leader.

“The search focused on identifying experienced candidates who could manage rapidly growing global biotherapeutic operations, drive innovation, and deliver value during a period of key business initiatives and events,” the document said.
After considering many candidates, De Backer was chosen.
“Dr. De Backer brings over three decades of executive management experience and is recognized for her leadership and contributions to the biopharma industry,” the statement said. “Through her tenure at Bayer and Johnson & Johnson, she has a demonstrated track record of accelerating the growth and impact of companies to bring new and important therapeutics to patients around the world.”
She came to Vir from Bayer, where she was executive vice president and head of pharmaceuticals strategy, business development and licensing/open innovation. Prior to that, she served at J&J from 1991 to 2019.

Her appointment was effective April 3, 2023. Her new hire package included a $900,000 base salary, target annual bonus of 80% of base salary, a sign-on equity award of 576,452 restricted stock units (RSUs) and an option to purchase 1,152,904 shares of common stock. De Backer was also paid a $5 million sign-on bonus, with $2.5 million paid out at sign-on and another $2.5 million due on her one-year anniversary.

“Following her appointment, Dr. De Backer immediately focused her efforts on building on the strength of our core capabilities and strong balance sheet to position Vir for continued success, including rolling out a new corporate strategy to drive future growth,” the proxy statement said.
This included releasing data for two key hepatitis trials of tobevibart and elebsiran. In the phase 2 SOLSTICE trial, five out of six patients with chronic hepatitis delta achieved undetectable HDV RNA, while all had HDV RNA less than the lower limit of quantification.
In the MARCH trial, patients with chronic hepatitis B had a three-fold higher response rate when tobevibart was added to elebsiran after 24 weeks of treatment.
Vir also submitted an investigational new drug application and advanced three early research programs.
All this was done while achieving the biotech’s financial objectives of reducing cash spend and “implementing financial rigor,” too. Vir secured $75 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) and the Bill & Melinda Gates Foundation.
But tough decisions also had to be made, with 12% of roles eliminated, or 75 positions. Most of this was done through the discontinuation of Vir’s small molecule group, which began in the third quarter of the year.

For 2024, De Backer will receive a base salary of $925,000 with the same bonus plan and an equity award of 175,000 RSUs and 350,000 stock options.
Besides De Backer, Vir also had five other executive changes, including former CEO Scangos, who retained a role as director of the board. The company’s CFO Howard Horn, Chief Administrative Officer Steven Rice, Chief Medical Officer Phillip Pang, M.D., Ph.D., and Chief Operating Officer Johanna Friedl-Naderer also left.
“Over the course of the year, Dr. De Backer assembled her executive management team composed of executives with significant immunology, infectious disease, and commercialization experience, including a proven track record of progressing product candidates from early-stage research through clinical development, and through worldwide regulatory approval,” the statement said.
Sung Lee is now CFO and Jeffrey Calcagno became chief business officer. Vir is still looking for a replacement for Pang.

Barinthus' HPV-related cancer therapy proves safety, but not efficacy

Barinthus Biotherapeutics has hit the primary endpoint of a phase 1b/2 trial by showing its treatment for high-risk human papillomavirus (hrHPV)-associated cervical cancer is safe. But the failure to prove the therapy actually works has left the biotech mulling how to take the candidate further.
The trial involved 108 women across the U.K. and the EU aged 25 to 55 with persistent hrHPV infection and low-grade cervical lesions who received either the therapy, dubbed VTP-200, or placebo. VTP-200 is an immunotherapeutic combo regimen that involves patients receiving an initial dose using the ChAdOx vector and a second dose using the MVA vector. Both doses encode the same HPV antigens, with the aim of producing an antigen-specific T-cell immune response to HPV.

The U.K.-based company—formerly known as Vaccitech—said the trial hit its primary endpoint of demonstrating VTP-200 was generally safe and well tolerated. No treatment-related adverse events of grade 3 or above were recorded.

However, when it came to whether the vaccine actually works, things weren’t as straightforward. Barinthus was keen to zoom down into the five groups who had received different variations of the VTP-200 combo regimen to try to salvage some success.
For example, in group 2—which included the highest dose of ChAdOx—there was a hrPV clearance rate of 60% at 12 months, compared to 33% for the placebo cohort. But the other four groups received either little additional benefit or actually fared worse, with clearance rates ranging from just 11% to 36%.

It was a similar story when it came to clearing cervical lesions. The highest clearance rate of 67% was observed in two of the groups—both of which received the highest dose of ChAdOx—compared to 39% in the placebo cohort. But the other three groups saw rates of just 20%, 33% and 40%.
Ultimately, when the data from all five groups were pooled, they didn’t demonstrate a significant improvement in hrHPV clearance or cervical lesion clearance, the biotech acknowledged.
For now, the company is evaluating “future development options for the VTP-200 program.”
“We were pleased to see that VTP-200 was generally well-tolerated, meeting the primary safety endpoint in this study,” Barinthus Chief Scientific Officer Nadege Pelletier, Ph.D., said in the release.

“The most promising hrHPV and cervical lesion clearance data were observed in the highest ChAdOx-HPV dosing groups which is informative for future development,” Pelletier added. “However, these differences compared to placebo were not statistically significant given that the trial was not powered for individual dose group comparisons.”
“Further analyses are ongoing, mostly focusing on immunological responses and we plan to share the detailed results in due course,” she said.

Chutes & Ladders—Recursion makes big executive splash, nabs J&J's chief data science officer

 Welcome to this week’s Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  

Recursion makes big executive splash, plucking J&J’s chief data science officer

Recursion Pharmaceuticals
AI-infused drug developer Recursion Pharmaceuticals has hired Najat Khan, Ph.D., as chief commercial officer and head of R&D. She joins from Johnson & Johnson where she was chief data science officer and head of strategy and portfolio within the pharma R&D team. 

Najat Khan, Ph.D.
(Najat Khan)

It’s a major hire for the Utah-based biotech, indicative of the rising influence of artificial intelligence and machine learning in drug development efforts along with Recursion’s standing in that field. Few biotechs—or even pharmas for the matter—have invested as much as Recursion in making machine learning a foundation of its R&D. Recursion CEO Chris Gibson, Ph.D., said Khan “has a vision and passion for transforming drug discovery and development” that complements Recursion’s. 
Khan chaired J&J’s data science council and helped scale the technology across the R&D organization. She is also a board member for the Alliance for Artificial Intelligence in Healthcare. Release 

Canaan adds former Pfizer R&D leader as new venture partner

Canaan Partners
Some week for Canaan Partners! The venture capital firm that splits its investments between healthcare and tech has hired Uwe Schoenbeck, Ph.D., as a new venture partner.
Schoenbeck has two decades of pharma experience, first at Boehringer Ingelheim before clocking his last 15 years at Pfizer. There, he led an early science wing of the R&D team, often working with academics and early-stage biotechs on collaborations and partnerships. Under his purview was the Centers for Therapeutic Innovation, a specific subunit that offered resources to physician-scientists working on possible therapeutic breakthroughs while still treating patients. But the CTI could not survive Pfizer’s recent multibillion-dollar cost-cutting effort, with existing projects being folded into other R&D teams.
Schoenbeck will be tasked with similar work at Canaan, this time offering private capital instead of pharma prowess. And the firm got a boost on that front as well, adding $100 million earmarked specifically for biotech bets. Fierce Biotech

Obesity-focused Metsera unveils all-star leadership team
Metsera
Obesity- and metabolic-disease-focused Metsera has emerged from stealth with one of 2024’s largest biotech fundraises thus far—$290 million—and a stacked team of industry veterans.
The clinical-stage company is led by Clive Meanwell, M.D., a British oncologist with an extensive industry track record that includes founding and leading The Medicines Company, a biotech that was acquired by Novartis for $9.7 billion in 2019. Meanwell has also held roles at Roche and MPM Capital, among others.
“The ‘dream team’ terminology is overused, but in this case, between the investors—led by Arch—and the management, we’re as close as you can get to that definition, honestly,” CEO Meanwell told Fierce Biotech. 
Meanwell is joined by Stephen R. Bloom—a professor and head of diabetes, endocrinology and metabolism at Imperial College London—who serves as the senior vice president of R&D for Metsera. Previously, Bloom served as the executive chairman for Zihipp, a London-based diabetes and obesity biotech Metsera snapped up while in stealth.
Other team members include Brian Hubbard, Ph.D., a metabolic disease translational researcher who has worked at both Merck and Novartis and helms Anji Pharma; John Amatruda, M.D., who previously ran Merck’s diabetes and obesity franchise; and Whit Bernard, a co-founder and managing partner of Population Health Partners, a firm that helped launch Metsera.  
Steven Marso, M.D., the principal author of the two The New England Journal of Medicine papers that put semaglutide (Novo Nordisk’s Wegovy) on the map, is also part of the leadership team at Metsera. Fierce Biotech

> Javier San Martin, M.D., has left his role as Arrowhead Pharmaceuticals’ chief medical officer for the same title at neurodegenerative-disorders-focused Athira Pharma. Before Arrowhead, San Martin held roles across Ultragenyx Pharmaceutical, Alder Biopharmaceuticals, Amgen and Eli Lilly. Release
> Viatris has tapped Corinne Le Goff to serve as the pharma’s chief commercial officer. Prior to Viatris, Le Goff helmed clinical-stage biotech Imunon and served as Moderna’s chief commercial officer before that, where she helped build out capabilities for creating global access to Spikevax, the company’s COVID-19 vaccine. Release
> Innovent Biologics has chosen Nageatte Ibrahim, M.D., to serve as the biopharma’s oncology chief medical officer. Ibrahim left her role at Merck & Co. as VP of oncology and global clinical development for Innovent, where she will lead the oncology global clinical development program. Release
> Poseida’s former president of gene therapy Brent Warner has moved on to helm Protego Biopharma, a preclinical company aiming to develop small-molecule therapeutics for various systemic amyloid diseases. Before Poseida, Warner served as Novartis’ VP of gene therapy and rare diseases. Release
> Ocular Therapeutix President and CEO Antony Mattessich has stepped down, with Executive Chair Pravin Dugel, M.D., taking on the two leadership titles. One day after the CEO shake-up was announced, Ocular brought on a slew of new team members, tapping Nadia Waheed, M.D., to serve as chief medical officer, though Rabia Gurses Ozden, M.D., is still listed on the company’s website as CMO as of April 18. Meanwhile, Peter Kaiser, M.D., has been tapped to become chief development officer, while Chief Business Officer Chris White has been removed from the company’s leadership page. Release 
> KBI Biopharma has chosen Jean-Baptiste Agnus to serve as the CDMO’s chief business officer. Before joining KBI, Agnus held leadership roles across AGC Biologics, Ajinomoto Bio-Pharma Services, Novasep and Isochem. Release
> Stoke Therapeutics has hired Jason Hoitt to step on as the company’s chief commercial officer. Hoitt joins from Provention Bio, where he held the same title and led all commercial activities for Tzield (teplizumab-mzwv), the first FDA-approved drug designed to address the underlying autoimmune cause of Type 1 diabetes. Release
> Clinical-stage cell therapy company Vittoria Biotherapeutics has tapped Keith Westby to be its inaugural chief operating officer. Before Vittoria, Westby held the same title at Astellas’ Iveric Bio. Release
> Morphoceuticals has hired Jim Jenson, Ph.D., as CEO. He was most recently the co-founder and CEO of CytoSite Biopharma after founding Novo Nordisk-bought Dicerna. Release
> Chris Krueger is taking on a new Endeavour as CCO. He joins Endeavour BioSciences following executive roles at other biotechs, including Ventyx Biosciences, Oppilan Pharma and Zomagen Bioscience. Release
> LEO Pharma’s head of U.S. commercial operations is leaving for Chiesi, the Italian pharma announced. Richard Smith will be VP and business leader for U.S. AIR. Release
> BrainStorm Cell Therapeutics is rejigging its executive team after pulling its approval application in October 2023. The company is hiring Bob Dagher as its new chief medical officer, and Stacy Lindborg is stepping down as co-CEO. Release
> Markus Rothmaier is joining Polaroid Therapeutics as its first head of R&D. He last was at IVF Hartmann AG designing bandages and wound dressings. Release
> Catherine Miller is sprinting toward Jaguar Health, taking a new gig as SVP of growth strategy. Miller was chief commercial officer at Vibrant Gastro before the new job. Release
> The START Center for Cancer Research has brought aboard Nick Slack as its CEO. The organization helps run preclinical and phase 1 studies for new cancer treatments. Release

Vertex inches closer to acute pain market with FDA application acceptance

Vertex Pharmaceuticals has inched closer to bringing a new, non-opioid med to the blockbuster pain market, with the FDA accepting a rolling new drug application for the company’s NaV1.8 inhibitor VX-548 in moderate-to-severe acute pain.
Vertex is slated to complete the submission for VX-548, now dubbed suzetrigine, in the second quarter of this year, according to an April 18 company release.   

The Boston-based biopharma believes suzetrigine, which has snagged both FDA fast track and breakthrough therapy tags in the indication, could be the first new medicine class for acute and neuropathic pain in more than two decades. The opportunity is huge, with more than 80 million Americans prescribed medicine for acute pain each year, according to Vertex.

The rolling FDA submission follows a pair of phase 3 trial results shared this January. The late-stage trials found suzetrigine, which is aimed at the sodium channel, beat placebo in improving pain intensity. However, while the primary endpoints compared VX-548 to placebo, the oral drug failed to hit key secondary endpoints designed to show the non-opioid medicine is more effective than the existing, widely-used painkiller Vicodin, opening up the biotech to skepticism that suzetrigine is a better option than established, relatively cheap alternatives.

Vertex’s push to get suzetrigine over the finish line in acute pain is part of a broader program. The company also announced the planned launch of a phase 3 pivotal program testing suzetrigine among patients with painful diabetic peripheral neuropathy (DPN) in the second half of 2024, according to the April 18 release. The late-stage program is set to include two identical 12-week double-blind, placebo-controlled studies evaluating the efficacy and safety of 70 mg daily suzetrigine, with about 1,100 patients expected to enroll in each phase 3 study.  

In December 2023, Vertex shared phase 2 results assessing the NaV1.8 inhibitor among people with DPN, linking the pain candidate to statistically significant improvements in pain intensity. Suzetrigine has also landed breakthrough therapy status for treating pain associated with DPN.
The company is also studying suzetrigine in a phase 2 trial for patients with pain tied to lumbosacral radiculopathy, which is caused by inflammation or irritation of nerve roots in the lower back. Enrollment for the study is slated to wrap by the end of this year. 
The new Vertex updates crossed the wire at 8 a.m. ET, coinciding with a share price spike from $393 at market close yesterday to $408 directly after market open today. However, the stock has slipped down to $394 per share as of 10:45 a.m. ET today.

AACR: Biotechs emerge frostbitten from 'nuclear winter,' ready to show why they fought for survival

The trees have been trimmed, branches pruned, underbrush cleared away. A thinner, leaner biotech forest arrived at the American Association for Cancer Research (AACR) conference in San Diego ready to showcase the budding data that have sprouted as a result of difficult decisions made during the sector’s so-called “nuclear winter.”
It’s a show-me year for these companies, which rode waves of layoffs throughout 2023 and cut programs in order to stay afloat amid an extremely challenging fundraising environment. Many kept just the highest priority programs going.

Reflecting on the tough times past, biotech executives told Fierce Biotech in interviews on the sidelines of the AACR conference that they are ready to show what all those gut-wrenching decisions were for.

“It was devastating. It was really tough,” said Raquel Izumi, Ph.D., chief operations officer for Vincerx. The company cut 33% of staff in June 2022 and trimmed its pipeline to focus on just three cancer indications. Lead asset VIP152 (now known as enitociclib) took on an even bigger role, with trials continuing in three indications in lymphoma and leukemia.
Click here for more AACR 2024 coverage from the Fierce Biotech team. 
Mythic Therapeutics launched in December 2021 with a $103 million series A to develop new antibody-drug conjugates (ADCs). But the initial enthusiasm from the nine-figure raise quickly changed, and Mythic’s leadership had to revert back to its scrappy early days to survive.

“We saw the hatches shut,” said Chief Scientific Officer Brian Fiske, Ph.D., on the funding environment in the past two years.
And so the company battened down its own hatches, demonstrating the ability to stretch that cash as long as possible. But Fiske said it was still important to spend some money to ensure a stream of data would arrive to secure the next round.
“You’re looking at Mythic’s first investor,” he said with a laugh. “We rented six feet of lab space in basically a converted warehouse in a strip mall in order to start, so we had to be fuel efficient from the very beginning.”
Meanwhile, Foghorn Therapeutics was sent into a spiral in 2022 when the FDA placed a clinical hold on blood cancer candidate FHD-286 after a patient death in a phase 1 trial. A second drug was partially halted by the FDA in April 2023 and then in June 2023, the company was forced to drop uveal melanoma as an indication for FHD-286. This all, of course, happened amid the larger market challenges for all biotechs.

It’s been a whirlwind, but CEO Adrian Gottschalk says they’re on the other side now.
“I think we’ve sort of weathered the valley of death, if you will, of biotech that everyone was going through for the last few years as best as one can,” Gottschalk said in an interview. “Obviously, when you’re doing completely novel biology targets, some things are gonna work, some things aren’t, and that’s just the business we’re in.”

Trimming the sails

The workforce reduction at Vincerx was personal for Izumi, who says she has long brought along colleagues from previous companies she had worked at to her next gig.
“It was a difficult decision to make. But it was necessary because—as the term goes—we needed to trim sails to really focus,” she said.
The drastic move was meant to extend Vincerx’s cash runway into late 2024. As of the biotech’s latest earnings report on March 29, the runway remains at the third quarter of 2024 with $12.8 million in cash and cash equivalents as of Dec. 31, 2023. This compares to $52.5 million a year prior.
So the showing at AACR couldn’t be more important, Izumi said.
“We have a great candidate in an enitociclib, and we’re still developing it,” she said.

What has changed is how the phase 1 study is funded. Instead of running it as a sponsored trial, Vincerx is now relying on the National Institutes of Health in an effort to reduce costs.
That allowed the company to move two other candidates, VIP236 for advanced solid tumors and the ADC VIP943 in relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia.
“Focusing our resources allowed us to get to where we are today with these two drugs with early phase 1 data,” Izumi said.
Izumi could not speak to Vincerx’s fundraising needs, saying the company intends to present its case in the form of data and “take it from there.”
“Last year, we call that one of the biotech nuclear winters, for sure. And there’s a lot of companies in our position, but I don’t know. I am an optimist. I’m seeing signs of change. And we think the future is bright,” Izumi said.

At AACR, Vincerx presented early data for the two candidates behind enitociclib. Preliminary data for VIP236 as a monotherapy showed tumor reductions in patients with metastatic tumors who had tried all other standard options for treatment.
The small, open-label dose escalation study has seen 15 patients receive the drug so far, every three weeks. VIP236 is a small-molecule drug conjugate, a modality that plays off of the ever-popular ADC that has been the apple of pharma’s eye the past few quarters.
Just two doses into the cycle, seven patients achieved objective stable disease, including tumor reduction, Vincerx said.
“Obviously, everybody in the industry does this, you’re benchmarking against other drugs at this stage of development, and we’re really happy because we’re seeing results that we feel are on target and on track for this stage of development,” Izumi said.
“We look at other drugs like [Gilead Sciences’ breast cancer drug] Trodelvy and look at what they were like in their first-in-human trial, and we’re seeing very similar results—and that’s an approved drug. So we’re really excited about what we’re showing here.”
The company said the every-three-week dosing schedule was well tolerated with no dose-limiting toxicities and no discontinuations due to adverse events. There were also no reports of life-threatening diarrhea, which is a common issue in this patient population, according to Izumi.

“I’d like to remind people that phase 1 trials are ‘Last Chance Saloon’ for these patients. They’ve seen everything. They’ve failed everything. And this is the last thing for many of them. It’s either that or hospice for many of them,” Izumi said.
As for VIP943, a very early readout of seven patients across two cohorts provided some details on dose-limiting toxicities.
Vincerx is lucky to be playing in an arena of great interest to Big Pharma with its ADC technology. The company has even funded its own efforts to showcase how the VersAptx bioconjugation platform can boost the efficacy of approved ADC like Gilead’s Trodelvy and AstraZeneca-Daiichi Sankyo’s Enhertu. While at AACR the biotech is showcasing its lead molecules, Izumi hopes the platform can attract some big-time partnerships.

Don’t be arrogant

While Vincerx’s CEO Ahmed Hamdy, M.D., blamed the markets for the workforce reduction, over at Foghorn Therapeutics, similar decisions were driven by data and regulatory hurdles.
In the middle of 2023, Foghorn had about 165 people on staff and was running about three clinical trials. Then the melanoma indication for FHD-286 was dropped, and FHD-609 was paused in synovial sarcoma and SMARCB1-deleted tumors after the FDA’s partial hold in April 2023.
“We knew at that point that we would need to reduce the footprint of our clinical organization,” Gottschalk said.
The company conducted a round of layoffs initially, then a larger round in October 2023, while also taking a hard look at the pipeline. Ultimately about 35 to 40 people lost their jobs, while the total reduction was about 50 when resignations were accounted for. Gottschalk estimates the total head count is now around 115.
“There’s never a great way to do that stuff. We try to do it with as much dignity and grace and respect for all our colleagues,” the CEO said.

After a tough year, Gottschalk and his Chief Scientific Officer Steve Bellon, Ph.D., are trying to take lessons from the clinical ups and downs.
“What Steve and I talk a lot about is really learning from some of the challenges or the setbacks and then improving on the next generation of molecules we’re bringing forward,” Gottschalk said.
At AACR, Foghorn previewed preclinical data, including for BRM (SMARCA2) selective inhibitor FHD-909 in BRG1 mutated cancers, showing tumor growth inhibition and regression. The program is being developed with Eli Lilly’s Loxo Oncology unit, and the pharma plans to file for an investigational new drug application in BRG1-mutated non-small cell lung cancers this quarter.
Bellon said the collaboration with Loxo has “clearly helped us drive to the sort of finish line in this challenging target. That collaboration is super important for helping us achieve this success.”
Foghorn has emerged from the “valley of death” with a cash runway extending into 2026. Gottschalk said they entered the year with about $244 million and do not have any debt.

“We’re certainly not in an existential position or state. At the same time, biotech companies do spend a lot of money,” he cautioned. So Foghorn will likely look for fundraising opportunities or business development in the next six to 12 months, he said.
While Foghorn survived, Gottschalk knows of many companies, made up of fellow biotech leaders and friends, who did not make it through. They have great scientists and physicians, and, through funding challenges or trial failures, they had to pack up and call it quits.
“It comes back to, don’t be arrogant in this business, because there’s a lot of serendipity,” he said. “Everyone works really hard in this sector, I think. So it’s not about the hard work. It’s like, did you get the results? And sometimes that’s a lot of luck. You try and be as smart as you can, but sometimes the science just doesn’t work. So it was painful to see. It was painful to see people go through all of that. So, you know, hopefully we’re in a brighter spot as a sector. It feels that way.”

Biopharma M&A more than doubled in the first quarter compared to the year prior: report

The number of biopharma M&A deals more than doubled in the first quarter of 2024 compared to the same period a year ago, exemplifying a top exit route for pre-commercial companies vying for validation and attention.
A new report from Leerink Partners released this week tallied 13 biopharma M&A deals in the first quarter of 2024 compared to six in the first quarter of 2023. There were 47 deals in the last twelve months through March 2024, compared to 42 through March 2023. 

The Leerink M&A team described persistent Big Pharma interest specifically in biotechs focusing on new cancer drugs, namely radiopharmaceutical and antibody-drug conjugate (ADC) makers. AstraZeneca made two deals in the oncology sphere while Merck offered bait to T-cell engager company, Harpoon Therapeutics. The report’s authors conclude that they expect M&A activity to stay hot through the rest of the year. 

Elsewhere, public companies that struggled to produce stellar data were able to find reverse merger partners, including Tectonic’s deal with AvroBio and LENZ’s merger with Graphite Bio. The report notes that among 10 public-private mergers that have closed since the beginning of 2023, stock prices are up 29%. 

It was a record quarter for public companies looking to fluff their fiscal pillow with 54 registered offerings and 17 PIPEs raking in a combined $17 billion in proceeds.

Seven companies raised IPOs, bringing in roughly $1.5 billion, most of which occurred during a four-week period from the middle of January through the middle of February. More than half of that total amount raised however came from just two biotechs, namely CG Oncology and Kyverna Therapeutics, which combined brought in around $800 million. 
“Further, as potential IPOs continue to test the market, we expect high quality companies to actively evaluate sale transactions as an alternative exit for investors,” the report’s authors said. 
The M&A landscape paints a rosier picture than some of the biotech indexes, namely the XBI, which is down more than 6% for the year and down nearly 18% since a high point at the end of February. Stubborn inflation figures have delayed a much-anticipated interest rate cut from the Federal Reserve, leaving investors slightly skittish. 
And don’t expect a mega deal anytime soon to rejuvenate morale, Leerink cautions. Challenges from regulators in 2023 mean another behemoth buyout—like Pfizer’s purchase of Seagen—isn’t likely. 

AbbVie-bound Cerevel reports phase 3 Parkinson's victory in early win for $8.7B deal

The backing singer in AbbVie’s $8.7 billion takeover of Cerevel Therapeutics is having its moment in the spotlight. Cerevel thrust tavapadon to the fore Thursday, reporting the success of a phase 3 Parkinson’s disease trial and providing a small boost to AbbVie as it works to close a deal focused on another asset. 
Emraclidine, Cerevel’s midphase schizophrenia prospect, was the headline act when AbbVie disclosed the deal to buy the biotech late last year but tavapadon represents the first chance to start generating a return on the outlay. Tavapadon is a once-daily oral dopamine D1/D5 receptor partial agonist that is designed to balance meaningful motor control activity with a favorable tolerability profile.

On Thursday, Cerevel provided the strongest evidence yet that the molecule strikes that balance. The data come from a phase 3 trial that randomized 507 adults with Parkinson’s and motor fluctuations. Subjects had to be on a stable dose of levodopa for at least four weeks prior to screening and continued to take the drug in combination with tavapadon or placebo once the trial began.

Over the 27-week trial, patients who took tavapadon spent significantly more time without troublesome uncontrolled, involuntary movements, known medically as dyskinesia, than their peers on placebo. The study, which collected data using a self-completed home diary for motor function status, showed people on the drug spent 1.7 hours without troublesome dyskinesia, compared to 0.6 hours in the control arm.

Cerevel also reported a significant reduction in the time patients had symptoms but is yet to share data on that secondary endpoint. Similarly, the biotech said the molecule was generally well tolerated, with no surprises and most adverse events being mild or moderate, but is holding off on providing a closer look at the safety data until medical meetings. 

The meetings are part of a roadmap of updates on tavapadon that includes regulatory submissions and topline results from a pair of phase 3 studies that are testing the molecule as a monotherapy. Cerevel expects to share data from the other phase 3 trials in the second half of the year, by when AbbVie intends to close the acquisition. 
Jeffrey Stewart, chief commercial officer at AbbVie, discussed tavapadon on a call with investors when the drugmaker announced the Cerevel takeover. AbbVie already has a presence in advanced Parkinson’s, with Duopa and is developing ABBV-951, but is absent from the earlier, oral segment targeted by tavapadon. 

“Tavapadon … could be a nice complementary product up in the more early phases of the condition, so distinct from where we play now, but also complementary in terms of our commercial infrastructure. We believe it’s relatively modest—the bulk of the value does sit on emraclidine—but nonetheless a nice fit to where we can slot that in with our global teams across the world,” Stewart said.

Mizuho Securities analysts model peak annual U.S. sales of $532 million, making it a “relatively small revenue contributor” in the context of Cerevel’s wider pipeline. That fact, coupled with the fact AbbVie is already set to buy the biotech, led the analysts to predict the data will have “very little material impact to the current [Cerevel] investment narrative” in a note to investors.

With $290M in hand, newly emerged biotech Metsera thinks customizable combos are the future of obesity treatments

Clinical-stage Metsera has emerged from stealth with $290 million in hand and the bold vision of ushering in the next generation of obesity and metabolic disease medicines.
“It’s an almost limitless market opportunity,” Metsera CEO Clive Meanwell, M.D., told Fierce Biotech in an interview. The leader is a British oncologist with an extensive industry track record that includes founding and leading The Medicines Company, a biotech that homed cardiovascular medicine inclisiran (Leqvio) and was acquired by Novartis in 2019 for $9.7 billion. “I think we have a real shot here of making some major products.”

MetseraCEO Clive Meanwell, M.D.
(Metsera)

Meanwell also helped form and is a partner of private equity firm Population Health Partners. The firm, alongside Arch Venture Partners, launched Metsera during biotech’s “nuclear winter” in early 2022, the CEO explained.
However, the company was able to stay warm in stealth with the help of several other investors such as F-Prime Capital, GV, Mubadala Capital, Newpath Partners and SoftBank Vision Fund 2, alongside other undisclosed investors.
The $290 million financing was led by founder Arch and is a series A round that includes a “little seed” money, according to Meanwell.

“There was emerging evidence that diabetes and weight loss was going to become a big category,” he said, explaining how Metsera came to be.    
“Initially, we had discussions with Big Pharma about their appetite for investing—I’d say in 2020, it was sort of lukewarm,” Meanwell said. “Nobody had quite seen the juggernaut that was coming.” 

After Eli Lilly and Novo Nordisk started publishing “great data” for the diabetes and obesity franchises-in-a-drug semaglutide and tirzepatide, respectively, Meanwell and the Arch crew decided to abandon the Big Pharma aspirations and start something of their own.

“We went out and said, let’s go shopping among the 200-plus companies that are already working in this space, and let’s see if we can pick up some great technology and create a new company that could develop these technologies for commercial use,’” he explained.
And that’s exactly what happened. While in stealth mode, New York-based Metsera snapped up Zihipp, a diabetes and obesity biotech in London. Researcher and Zihipp Chair Stephen R. Bloom now serves as the senior vice president of R&D for Metsera.
From Zihipp, Metsera picked up a proprietary library of more than 20,000 gut hormone peptides that can be mixed and matched “a bit like a Lego kit,” Meanwell described.

Then, Metsera hunted down oral absorption technology from an unnamed company that is designed to allow oral administration for injectable peptides.
“Metsera’s portfolio is designed to unlock new treatment strategies through scalable, sustainable and personalized interventions for weight loss, weight maintenance and disease prevention,” Metsera R&D lead Bloom—who is also the head of drug development, metabolism, digestion and reproduction at Imperial College London—said in an April 18 release. “Through optimized combinations of injectable and oral peptides, we aim to establish a cycle of continuous and responsive innovation to address a growing worldwide obesity crisis.”  
Metsera’s injectable and oral development programs are made up of peptides and peptide-antibody conjugates, two of which are clinical-stage assets. One of those programs is an undisclosed molecule, while the other is an injectable, fully biased GLP-1 receptor agonist being assessed in a phase 1 clinical trial. The asset is designed to trounce competitors in duration of effect and is currently being tested out among non-diabetic patients. The U.S. trial is currently enrolling participants, Meanwell said.
The biotech’s preclinical pipeline also includes a dual amylin/calcitonin receptor agonist (DACRA) designed to be combined with the GLP-1 receptor agonist, a unimolecular GGG (GLP-1, GIP, glucagon) engineered for combo use with DACRA and two IND-ready candidates sourced from the company’s oral peptide delivery platform.  

“The aim is to develop a suite of molecules that are miscible, or multi-target, molecules that give you the advantages of increased effect with less side effects,” Meanwell said. “We think the future is combinations, and we want to be there.”
“Most people would agree that a GLP-1 backbone or core is at the center of most people’s strategies. And then the rest is: What do you add to that?” the leader continued. “Novo went down the amylin pathway successfully. Lilly went down the GIP glucagon pathway. And we think you should do both because, ultimately, those two pathways are coming together.”
Metsera’s programs are designed to address multiple therapeutic targets and tackle upcoming needs in the quickly evolving weight loss treatment landscape through more effective weight maintenance, muscle preservation, less frequent dosing and improved tolerability, according to the company release.
While Meanwell couldn’t disclose the specific size of Metsera’s team, he said “it’s not small.” He noted that a biotech of 70 people is an optimal size. Beyond R&D head Bloom, Metsara’s leaders include Brian Hubbard, Ph.D.; John Amatruda, M.D.; Whit Bernard; Christopher Cox; and Steven Marso, M.D., who is the principal author of two The New England Journal of Medicine papers that put semaglutide on the map.

“The ‘dream team’ terminology is overused, but in this case, between the investors—led by Arch—and the management, we’re as close as you can get to that definition, honestly,” Meanwell said.
As for other big-name company partners, Meanwell said Metsera hasn’t made any outreach efforts and doesn’t plan on it right now.
“In a way, we’re meeting Lilly and Novo at the corner—they themselves are very ambitiously seeking new combinations and new ways of improving risk benefit, ease of use, maintenance, dosing, tolerability,” Meanwell said. “And we’re doing the same now. And we’d hope to be a player alongside them when we all get there.”