→ According to an SEC filing, Aurinia’s EVP of research Robert Huizinga and CMO Neil Solomons are both walking away by Halloween, and while no explanations are given, details of their severance packages were provided. Huizinga had spent the last nine years at Aurinia after the Isotechnika merger: first as VP, clinical affairs, then as EVP, corporate development before his latest promotion in 2020. Solomons co-founded Aurinia a decade ago and used to be VP of R&D with Vifor Pharma. The Peter Greenleaf-led Aurinia just launched its “Get Uncomfortable” ad campaign, urging lupus nephritis patients to schedule checkups with their doctor.
→ CRISPR Therapeutics COO Lawrence Klein will not return next year “to pursue external opportunities,” but he’ll stay until this year draws to a close. Klein was originally appointed VP, strategy in February 2016, eventually receiving promotions to CBO in 2019 and COO a year later. The search begins for a replacement as CRISPR and Vertex make their case to the FDA for exa-cel, a once-and-done treatment for sickle cell disease and transfusion-dependent beta-thalassemia, after getting lapped by bluebird bio with Zynteglo.
→ Pairing up with Eli Lilly on AMPK activators a couple of weeks ago in a deal that almost reaches the $500 million mark, Nimbus Therapeutics has poached Nathalie Franchimont from Biogen, naming her CMO. Franchimont had recently led the multiple sclerosis and immunology development unit and she held a cornucopia of other positions in her 10 years with Biogen, which is pinning its Alzheimer’s hopes on lecanemab after the Aduhelm debacle. At Amgen, she worked in medical affairs and clinical development, specifically with the bone drug denosumab (now marketed as Xgeva and Prolia).
→ Serge Stankovic is set to retire as president of Acadia Pharmaceuticals at the end of the year. A former clinical development exec with Teva and Alkermes, Stankovic was named head of R&D at Acadia in 2015 and president in 2018, helping guide the San Diego biotech to its only approved drug in April 2016. The FDA gave the OK to Nuplazid for Parkinson’s disease psychosis, but Acadia’s been shooting bricks lately in other indications, with CRLs in back-to-back years for dementia- and Alzheimer’s-related psychosis. Upon his retirement, Stankovic will move into a part-time advisory role.
→ Arturo Molina’s time is winding down as CMO of antibody-drug conjugate developer Sutro Biopharma, and Peer Review will keep its eyes peeled for his next destination after he leaves on Nov. 4. Sutro CEO Bill Newell will stand in for him until a permanent successor is found. Molina was VP of oncology scientific innovation at J&J’s California Innovation Center before he joined Sutro, which struck an ADC deal with Astellas for $90 million upfront in late June.
→ As biotech stocks were going subterranean, it dawned on Sagimet Biosciences that an IPO wasn’t prudent for them in March. This week there’s a new sheriff in town at the NASH-centered biotech, with Dave Happel taking over for George Kemble as chief executive. Since 2020, Happel had been president and CEO of Cognoa, and in an earlier role, he was EVP of commercial development and strategy for Horizon. With Happel in place, Kemble is sliding into the role of executive chairman, succeeding Westlake Village BioPartners managing director Beth Seidenberg.
→ It didn’t take long for ex-Biotheryx chief Robert Williamson to find his next gig, landing at T cell-focused Triumvira Immunologics as president and CBO. Williamson was at the controls for Biotheryx when the protein degradation squad garnered a $92 million Series E round in May 2021, and as we told you, he then became chief business and financial officer at OncoMyx in March. Triumvira says it’s constructing a new cell therapy manufacturing facility in South San Francisco for its lead program, TAC01-HER2, that should open by next year.
→ Let’s Twist again: Patrick Finn has been promoted to president and COO of DNA synthesis heavyweight Twist Bioscience, which inked a $710 million antibody discovery deal with Boehringer Ingelheim last year. Finn signed on as Twist’s SVP, commercial operations in February 2015 and was elevated to chief commercial officer in 2019. He’s also been VP of sales and marketing for Enzymatics, now known as Qiagen.
→ Positions are getting filled left and right at antibody radiation-conjugate (ARC) player Actinium: Jenny Hsieh (chief strategy officer) was head of corporate strategy and operations with Immunomedics as it was being sold to Gilead for $21 billion. In March, the large pharma handed out pink slips to 114 staffers that worked out of Immunomedics’ old HQ in Morris Plains, NJ; Sunitha Lakshminarayanan (head of CMC and product development) previously took on the role of executive director, cell therapy process engineering at Bristol Myers Squibb; Stephen Dressel (VP, strategic finance and analysis) had a 10-year career at Regeneron and just spent a year and a half with Dewpoint Therapeutics as senior director, financial planning & analysis; Peter Baker (director, drug substance/drug products operations) helped manufacture Lutathera and Pluvicto as head of production at Novartis’ Advanced Accelerator Applications; and Micah Riskin (director, product steward, manufacturing sciences & technology) has Bristol Myers ties and recently led process development and MSAT for Imvax.
But wait, there’s more: Actinium has plucked Akash Nahar (VP, clinical development) from Merck, where he served as global product development lead for hematology; Elaina Haeuber (VP, head of clinical operations) is a veteran of Syneos Health who had been VP of operations at WCG until May; finally, Madhuri Vusirikala (VP, clinical development, bone marrow transplant and cellular therapy) and Patrik Brodin (VP, head of radiation sciences) round out the hiring bonanza.
→ Cameron Durrant will be on the lookout for another COO and CFO as Tim Morris decamps from both posts at Humanigen and becomes finance chief at Opthea, a retinal disease biotech that will be all set financially for the time being with $170 million in funding through Carlyle and Abingworth’s Launch Therapeutics and an additional $90 million private placement. The ex-CFO of Iovance and AcelRx just took another board seat at Aquestive Therapeutics over the summer.
→ As they build a plan around WHIM syndrome drug mavorixafor, X4 Pharmaceuticals has recruited Mark Baldry as chief commercial officer. A former commercial exec at Shire, Biogen and Amicus, Baldry has held this same post at Wave Life Sciences and Freeline Therapeutics. The highs haven’t outweighed the lows this year at X4, scoring a $55 million PIPE but cutting 20% of its staff and pruning the pipeline.
→ There’s a batch of new execs at Anokion, while the Swiss autoimmune biotech also says that Stephan Kontos will relinquish his CSO duties to chair the scientific advisory board. Alison Long (CMO) once led clinical R&D at Spark and had been the medical chief with now-defunct Kaleido BioSciences; Glenn Booma (chief strategy officer) is a Genzyme alum who had worked as a life sciences consultant for the past nine years; and Stephanie Haller (SVP, clinical operations) only needs to replace three letters on her business card after parting ways with Alexion, where she was senior director, clinical operations, therapeutic area lead, nephrology. Additionally, Anokion promoted Kristie Grebe from VP, clinical & translational development to SVP, immunology & translational medicine. Pfizer invested $35 million into Anokion’s celiac disease therapy KAN-101 last week.
→ The glycoproteomics specialists at InterVenn Biosciences have promoted Erwin Estigarribia to president and COO. Estigarribia brought plenty of diagnostics experience before coming to InterVenn in 2019, with stints as an operations exec at CardioDx and Applied Proteomics — and further back, he had a series of leadership roles with Chiron, Novartis and Geron.
→ We have all sorts of other CMO appointments to discuss, and Edward Kim is first up at Swedish mental illness and addiction disorder biotech Orexo. Kim steps away from Biohaven, where he was head of medical affairs, and he’s a Novartis neuro alum who has further Big Pharma connections as the former schizophrenia therapeutic area leader at J&J’s Janssen.
→ PaxMedica’s modest IPO may have been under the radar a couple months ago, but the New York biotech has added some gravitas to the staff with Big Pharma alum Stefan Schwabe as CMO. Schwabe spent more than a decade in neuro roles at J&J, Novartis and Sanofi, and since 2012 he had been CMO and EVP of R&D at Supernus, getting out of Dodge not long after the FDA threw cold water on the latest pitch for its Parkinson’s drug SPN-830 earlier this month. PaxMedica is advancing its lead asset PAX-101 (intravenous suramin) in autism spectrum disorder, with a preclinical study of the drug in the works for Fragile X-associated tremor/ataxia syndrome (FXTAS).
→ Mark Deeg has been named medical chief at Enveda Biosciences, a Boulder, CO startup that chalked up the cash with a $51 million Series A in June 2021. Deeg was once the chief medical and safety officer for Eli Lilly’s Chorus in his 10 years with the Indianapolis pharma, and the ex-Regulus CMO recently oversaw global clinical development at Cullgen. Elsewhere, Deeg earned a promotion to VP of R&D at Pear Therapeutics before taking the Cullgen job last year.
→ As Rob Thomson shed the interim label this season and is now bound for the World Series as manager of the Philadelphia Phillies, will we say the same someday for interim CMO Richard Graydon’s job status at Seattle breast cancer biotech Atossa Therapeutics? Graydon worked on such drugs as Carvykti (cilta-cel) and Imbruvica as the senior director of clinical development for Janssen, and he has served as director of clinical development at Daiichi Sankyo.
→ Jens Würthner has jumped on board as CMO of Amsterdam’s Scenic Biotech, which allied with Roche two years ago in a development deal involving genetic modifiers and raised $31 million in March. Würthner’s Big Pharma background includes stops at AstraZeneca, GSK and as a clinical program leader at Novartis before pivoting to ADC Therapeutics in 2016. He had led global clinical development at ADC since January 2020.
→ To close this CMO loop, antimicrobial developer Adaptive Phage Therapeutics has tapped Edward Fang for the position. Fang has held this post before at Adenium Biotech and US-China outfit MicuRx Pharmaceuticals. In April, Adaptive Phage topped off the cash tank from its Series B from May 2021 to bring the total to $61 million, and the following month it began the Phase I/II trial for its diabetic foot osteomyelitis treatment.
→ Ex-Antios chief Greg Mayes is shoring up his leadership at Toronto psychedelics player Reunion Neuroscience with Edward Smith as CFO and Aviva Asnis-Alibozek as VP, medical affairs. Smith has held a string of CFO posts at Lava Therapeutics, Marinus Pharmaceuticals and PolyMedix, and he’s a board member at Benitec Biopharma. A one-time medical affairs director at AstraZeneca, Asnis-Alibozek was EVP of medical affairs during her six years at TRM Oncology.
→ Travis May’s healthcare information upstart Datavant — a relative in the Vivek Ramaswamy family of “vants” — has crunched the numbers and selected Marla Kessler as chief marketing officer. The Pfizer marketing vet followed up her 13 years at IQVIA with a recent yearlong stay at Aetion as chief customer officer.
→ Things can only get Better: J&J alum Diane Gomez-Thinnes has joined San Francisco-based Better Therapeutics as chief commercial officer. Last year, Gomez-Thinnes finished her 17-year tenure at J&J as the worldwide president of its medtech Mentor, and from there she became the president of US operations for Galderma.
→ Kleanthis Xanthopoulos’ cell therapy crew at Shoreline Biosciences has welcomed Charles Calderaro III as chief technical officer. Calderaro knows his way around the space from his days at Kite, where he was in charge of CAR-T manufacturing as global head of technical operations. After several leadership positions in a 14-year period at Genentech, Calderaro moved on to BioMarin as SVP, global manufacturing from 2016-19.
→ CRO Sannova Analytical has saddled up Jason Apter as CEO and Stephen Unger as CFO. This isn’t Apter’s first time running things in the CEO seat, having called the shots previously as CEO at Johnson Matthey’s health division. Apter also has experience under his belt from Millipore Sigma and Sigma-Aldrich. Meanwhile, Unger hops aboard after a stint as CFO at Quotient and Circulogene Theranostics.
→ Genuv has named Jenny Choih president of its new Cambridge, MA-based subsidiary Genuv US. Choih joined Genuv in 2016, most recently serving as director of development. Earlier in her career, Choih was a consultant at McKinsey.
→ Intellia CEO John Leonard is joining the likes of Sean Parker and John Connolly on the board of directors at 3T Biosciences, a TCR startup that pulled together a $40 million Series A led by chairman Sean Harper and the folks at Westlake Village BioPartners. The Abbott and AbbVie alum is also a board member at IQVIA.
→ As Redonda Miller exits from the board of directors at Invivyd, Christine Lindenboom will step in during a time of tumult marked by last week’s layoffs and executive departures after Tillman Gerngross bailed as CEO in February. An Amgen and Pfizer vet, Lindenboom is Alnylam’s SVP of investor relations & corporate communications.
→ Fred Hutch’s Tom Lynch has sewn up a spot on the board of directors at Flagship’s Foghorn Therapeutics. Lynch’s appointment comes after the FDA threw down the stop sticks with a full clinical hold on Foghorn’s blood cancer drug FHD-286 in August. A partial hold was handed out a few months before.
→ Expansion Therapeutics has elected Raymond Kelleher to the board of directors at a time when drugging RNA continues to attract interest. Kelleher, a faculty member at Massachusetts General Hospital and Harvard Medical School, is managing director of Cormorant Asset Management.
→ Ubiquigent has announced that the company’s CSO Sheelagh Frame has joined its board of directors. Frame began her career at Ubiquigent in 2018 as head of biology before being promoted to her current position last year. Prior to this role, Frame was with Cyclacel and Onyx Pharmaceuticals.
→ TC Biopharm has finished setting up its scientific advisory board, which now consists of: Blythe Sather (VP and head of research at Tune Therapeutics), Erin Adams (professor at the University of Chicago), Chris Bond (experience from Genentech, OncoMed, Juno, Celgene and Kite), Isabelle Riviere (director of the cell therapy and cell engineering laboratory at Memorial Sloan Kettering Cancer Center), Daniel Olive (researcher at the Cancer Research Center of Institut Paoli-Calmettes), and Uma Lakshmipathy (head of patheon translation services and cell therapy R&D pharma services group at Thermo Fisher).
→ Trinity Biotech is adding a fresh face to its board of directors as two others hit the exit. Tom Lindsay joins as non-executive director, having served previously as president of Alere’s (now a part of Abbott) business in Africa and currently serves as a board member at Genedrive. At the same time, directors Seon Kyu Jeon and Michael Sung Soo Kim are heading out the door.
Illustration: Kim Ryu for Endpoints News
Digital medicine has become a major component in an ever-evolving healthcare environment. You’re likely already familiar with digital technologies such as telehealth platforms and electronic health records. Plus, there are hundreds of thousands of wellness apps available to anyone on smartphone app stores.
But there’s a reason digital medicine and even more specifically, digital therapeutics exist in a subcategory of their own. A digital therapeutic is typically described as an evidenced-based software solution, which are held to the same standards of regulatory oversight as more traditional medical devices. Digital Therapeutics can positively impact the trajectory of a patient’s disease and are approved to deliver specific clinical outcomes. In other words, Digital Therapeutics are viewed as clinically validated software solutions used by clinicians to treat, manage, and prevent a broad spectrum of diseases and disorders. This differs significantly from consumer health apps that track health or aid in the care process in some way.
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The vaccine R&D revolution has gone global. How will the lessons from Covid-19 reshape the way we study, test, produce and distribute vaccines around the world? Join me on Wednesday for a panel discussion. You can sign up at no cost here.
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On Friday afternoon, the FDA’s oncology drug advisory committee unanimously voted 16-0 against the approval of Y-mAbs’ experimental drug for CNS metastases in pediatric neuroblastoma patients. The key issue the FDA pointed to was that the external control group for Y-mAbs’ pivotal study was very different from the treatment group at baseline, an issue it highlighted in briefing docs released yesterday.
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One of the key programs that inspired Sanofi’s $2.5 billion buyout of Synthorx in late 2019 is now the subject of a $1.6 billion writedown.
Sanofi disclosed in its Q3 earnings that it’s closing down Phase II platform trials for SAR444245, an IL-2 candidate that it had hoped would serve as a next-gen foundation of the oncology franchise. An early look at the data, it said, suggests efficacy that’s “lower than projected.”
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As third quarter numbers rolled in, Sanofi CEO Paul Hudson alluded to the French pharma’s objectives moving forward.
Kicking off a call Friday morning with investors and analysts, Hudson wasted little time when it came to discussing President Biden’s Inflation Reduction Act and its impact on drug prices. Among other things, the Sanofi chief said from his perspective, the implementation of the Act’s drug policies will likely “create significant uncertainties across our industry with regards to sustainable investment in science and innovation, and artificially influence future R&D decisions.” Additionally, he said the bill does not address what he called “core concerns,” specifically around access to certain medicines and affordability.
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Only a few weeks after the FDA recognized a shortage of Adderall, another crucial drug is in low supply, this time the antibiotic amoxicillin.
According to the American Society of Health System Pharmacists’ (AHSP) drug shortage list, three manufacturers are posting shortages of the oral version of the drug. The list includes Hikma Pharmaceuticals, Teva and Sandoz, which are reporting low supplies of multiple dosage amounts. The companies did not post a reason for the shortages.
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Following the US’ lead, the EMA is cutting back on the use of JAK inhibitors for some patients over a suite of safety concerns.
The EMA’s safety committee issued new guidance on Friday, recommending that a group of JAK inhibitors used for chronic inflammatory disorders are only used in certain at-risk patients if no alternatives are available.
That includes patients 65 years and older, those at risk of major heart problems, those who smoke or who have extensively in the past and those at risk of cancer. Patients at risk of blood clots in the lungs and deep veins (VTE) should take caution, the committee says, while recommending lower doses for some patients at risk of VTE, cancer or major heart problems.
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The FDA is changing up its marketing rules for emergency use Covid treatments. Six drugmakers can now more broadly promote their Covid therapies, including Pfizer’s Paxlovid and AstraZeneca’s Evusheld.
However, that doesn’t mean the companies are ready to roll out new ads. Pfizer and AstraZeneca declined comment, and a spokesperson for Eli Lilly — both baricitinib and bebtelovimab were included in the FDA memo — said in an email simply that “Lilly has and will continue to comply with all FDA rules regarding the advertising and promotion of EUA treatments.”
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Alnylam Pharmaceuticals, the pharma market’s leader in RNAi therapies, reported its third quarter earnings Thursday, updating shareholders on its pipeline progress and initial sales figures for the recently approved vutrisiran (marketed as Amvuttra).
But tucked away near the bottom of its report, the company revealed it would scrap plans to launch a Phase III trial for vutrisiran in the rare Stargardt disease, appearing to blame President Joe Biden’s Inflation Reduction Act in the process.
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