Stephen Hahn’s cancer-testing biotech hires a new CMO; Former Iovance exec named CEO of Obsidian

May Orfali

Flagship Pioneering’s blood cancer testing startup Harbinger Health has brought in drug industry veteran May Orfali as its new chief medical officer.

Orfali will be charged with wrapping up a key clinical trial for Harbinger’s test, working closely with ex-FDA head Stephen Hahn, who became the biotech’s CEO in 2021 after leaving the agency.

Orfali has spent more than 25 years working in the industry, including nearly a decade at various roles at Pfizer and most recently as CMO of Sigilon Therapeutics, another Flagship company.

“May brings a wealth of experience in clinical product development and oncological care that will be invaluable to the advancement of our cancer origin epigenetics clinical trials,” Hahn said in a statement.

In an email interview with Endpoints News, Orfali said she’s been fascinated by biology since she was a kid. She graduated with a medical degree from the University of Baghdad in 1991, then moved to Boston to complete her training in pediatric hematologic oncology while studying brain cancer.

“It was the 1990s — we had no cures, no treatment,” she said. “It was then and still is a really tough field. After a few years, I didn’t feel that I was doing what I was supposed to do.”

Her lab head recommended biotech, and Orfali said she never looked back, working at a range of drug developers both large and small.

Orfali said she’s particularly excited by a development timeline that can be far shorter with diagnostics than drugs. And while there are formidable competitors like Illumina’s Grail and Exact Sciences’ Thrive Earlier Detection that have more clinically advanced programs and have raised more cash, Harbinger pitches itself winning with accuracy and pricing.

Orfali said Harbinger is focused on detecting cancer at the earliest possible stages with enough specificity and sensitivity to be clinically meaningful. Par for the course for Flagship startups, Harbinger has an audacious vision of revolutionizing cancer detection and changing cancer diagnoses from a life-changing moment to more routine part of standard checkups.

Hahn has said he hopes to price Harbinger’s test below $100 and be able to detect “precancer” in seemingly healthy people, or cases where malignant cells have yet to even start spreading invasively in the body. The ongoing clinical trial that Orfali is charged with leading is a critical first step in reaching those broader aims.

“My primary focus, at least initially, is on our 10,000-subject clinical trial called CORE-HH that is well underway,” Orfali said. “We expect to have results to share from that trial next year.”

— Andrew Dunn

Madan Jagasia

→ Cell and gene therapy developer Obsidian Therapeutics has tapped Madan Jagasia as CEO and Parameswaran Hari as chief development officer. Paul Wotton, who replaced Arrakis chief Michael Gilman four years ago, stepped aside as chief executive in December with very little fanfare — Obsidian never divulged the news in a release. Iovance connections abound here: Obsidian chair Maria Fardis and Jagasia worked together at Iovance when she was CEO and he was SVP of medical affairs. After Fardis’ 2021 departure, Iovance elevated Jagasia to EVP. Likewise, Hari had filled the role of SVP, clinical science at Iovance since November 2021. One more Obsidian nugget: The Vertex gene editing partner has welcomed Generation Bio CFO Matthew Norkunas to the board of directors.

Jami Rubin

→ ARCH has gained two venture partners in consecutive days, as ex-Goldman Sachs analyst Jami Rubin starts the next phase of her career with Bob Nelsen’s crew. Rubin was previously the finance chief at EQRx, but jumped ship in March before the company gave up on its drug-disruptor goals and dismissed half of its employees. Another ARCH newbie is Kevin Hrusovsky, the chairman of 908 Devices and former president and CEO of Quanterix.

→ US-China genome editing player HuidaGene Therapeutics has installed co-founder Alvin Luk as CEO. Luk’s extensive résumé includes stints at Amgen and Bayer, and he was senior director, global medical affairs with Biogen. From 2014-17, Luk was in charge of clinical research and operations at Spark Therapeutics, and he then became a CEO for the first time at China-based gene therapy biotech Neurophth Therapeutics in 2020.

Catherine Sabatos-Peyton

→ Making a $35.5 million debut this week, cancer upstart Larkspur Biosciences has appointed Catherine Sabatos-Peyton as CEO. Sabatos-Payton had a seven-year career at Novartis, where she ascended to executive director and head of immune modulation at the Novartis Institutes for Biomedical Research. Polaris-backed Larkspur — co-founded by Lewis Cantley, who also helped create Agios and Volastra — has two other execs on its leadership team so far: CSO Krista Goodman and biology & translation EVP Emily Corse.

→ CytoDyn president Cyrus Arman is taking a medical leave of absence from the company, while CFO Antonio Migliarese takes over until Arman returns. That isn’t the only personnel item from a company that’s drawn the ire of the FDA: Melissa Palmer, the former head of liver disease clinical development at Takeda and one-time CMO of Gannex, has joined CytoDyn as interim medical chief. And the Vancouver, WA-based biotech has named Merck vet Salah Kivlighn as a clinical and strategic advisor. CytoDyn still doesn’t have a CEO, or even an interim one, after the firing of Nader Pourhassan in January 2022.

Ayisha Jeter

→ Less than a year into the launch of its roflumilast cream Zoryve for plaque psoriasis, Arcutis chief commercial officer Ken Lock has decided to walk away “to attend to personal matters.” VP of market access Ayisha Jeter will fill in on an interim basis until Arcutis finds a permanent successor. Lock had led commercial operations since 2019 and is set to leave June 2 as Arcutis also seeks an approval for Zoryve in atopic dermatitis.

Jeremy Chadwick

→ Shire and Takeda alum Jeremy Chadwick has signed on as COO of Nello Mainolfi’s protein degradation crew at Kymera Therapeutics as its alliance with Sanofi gains steam after a positive Phase I readout. Chadwick oversaw clinical development operations at Shire, and when he switched over to Takeda, he was the head of the Japanese pharma’s global development office and also led global regulatory affairs.

→ While Biogen and Eisai’s Leqembi awaits a decision on a full approval, Athira Pharma is making its case for an accelerated nod with its Alzheimer’s drug fosgonimeton as a monotherapy. As it does so, finance chief Glenna Mileson is retiring after more than eight years, and the Seattle-area biotech has lined up Andrew Gengos as CFO and CBO. Gengos just completed three years as CBO of Cyteir Therapeutics and is the ex-VP of strategy and corporate development at Amgen. He’s also held the top spots at ImmunoCellular Therapeutics and Neuraltus Pharmaceuticals.

Emily Hill

→ “You’re riding high in April, shot down in May”: PTC Therapeutics experienced a reversal of fortune in less time than what Frank Sinatra sang about in “That’s Life,” posting a Phase III win in phenylketonuria last week but missing the mark this week on the primary endpoint with vatiquinone for Friedreich’s ataxia. PTC then announced a significant pipeline reorg that will jettison gene therapy programs in not just Friedreich’s ataxia, but Angelman syndrome and other conditions. In the pipeline maelstrom, CFO Emily Hill “has been relieved of her responsibilities,” the New Jersey biotech said. It’ll take some work for PTC to, in Sinatra’s words, go “back on top in June.”

Jay Feingold

→ Jay Feingold will bolt from Pyxis Oncology on June 15, according to a release that outlined the Apexigen buyout at a bargain price. Feingold, the former head of US medical affairs at Daiichi Sankyo, has been CMO at Pyxis since September 2021 after seven years in the same position at ADC Therapeutics.

Terry Coelho

→ Terry Coelho popped up recently in Peer Review when she was added to the board of directors at Hookipa Pharma. This week the Novartis finance vet has been named CFO at Gamida Cell, which just earned an FDA approval last month with Omisirge (omidubicel-onlv). “Omisirge has great commercial potential and the opportunity to fill a critical need for patients in need of stem cell transplant,” Coelho said in a statement. “I’m excited to work with the team to help support Omisirge’s launch and find a partner that can help it fulfill its promise.” Coelho held this same post at CinCor Pharma and replaces Shai Lankry with immediate effect, but Lankry will stay with Gamida Cell until June 2.

→ From the company behind the robo-pill, Rani Therapeutics has now named former Elevar Therapeutics CEO Kate McKinley as CBO. McKinley hops aboard after a stint as CEO of Spark Outcomes. Currently, McKinley has a board seat at Maxwell Biosciences.

Burkhard Blank

→ United Therapeutics partner MannKind has enlisted Burkhard Blank as EVP of R&D and CMO. For nearly a year and a half, the 20-year Boehringer Ingelheim vet tackled these responsibilities at Pharnext, an appointment that Peer Review covered in November 2021. The role of medical chief is also a familiar one to Blank from his previous stops at a number of other companies, including Mersana Therapeutics, Finland’s Herantis Pharma and Acorda Therapeutics. In October 2021, manufacturing difficulties resulted in an FDA rejection of MannKind and United’s pulmonary arterial hypertension drug Tyvaso DPI.

BJ Sullivan

→ Anti-aging player BioAge Labs has promoted BJ Sullivan to chief strategy officer. Sullivan started out at BioAge as chief of staff in 2021 and became VP of strategy & business operations in short order. Competing against the likes of 2022 Endpoints 11 honoree Altos Labs in this space, Andreessen Horowitz-backed BioAge rummaged through the Amgen scrapheap and renamed its lead candidate BGE-105 for acute and chronic muscle indications.

Star Seyedkazemi

→ Only a few days remain until Richard Beckman steps aside as CMO of Adverum Biotechnologies. But he’ll stay at the eye disease gene therapy outfit as a senior medical advisor, while chief development officer Star Seyedkazemi will be “expanding her responsibilities to lead Adverum’s clinical development, medical affairs and pharmacovigilance teams,” the press release states. We told you about Seyedkazemi’s appointment at Adverum in January 2022 after a year as VP, portfolio management for R&D at Pliant Therapeutics.

Alexandra Joseph

→ Co-founded by Prime Medicine’s David Liu and pinning down a lead candidate, Exo Therapeutics has picked up Alexandra Joseph as EVP of biology. Joseph had served as VP of research at ImmuneID for almost two years. Earlier, Joseph held a series of roles from 2003-20 at Sanofi, where she was promoted to head of scientific portfolio management and operations before she joined Kiniksa as head of translational research. Exo’s lead program is “an exosite-targeted compound that selectively reprograms the activity of TBK1 in the STING pathway,” according to president and COO Dorothy Lou Bailey.

→ Cartography Biosciences has mapped out a new hire with Blaine Templeman as chief administrative and legal officer. Templeman was promoted to these positions during his five-year tenure with Aduro Biotech (now Sairopa). With 20(+2) under 40 selection Kevin Parker at the controls, Cartography launched in July 2022 with a $57 million Series A.

Monica Thomas

→ Back in 2018 when Amber Tong would toil on Peer Reviews, Stillman Hanson was named general counsel at G1 Therapeutics. Now that Hanson has taken a similar role with Labcorp spinoff Fortrea, G1 has selected Monica Thomas as general counsel and chief compliance officer. Thomas was head of corporate legal and assistant corporate secretary at Tymlos maker Radius Health, which was sold to two VCs — Gurnet Point Capital and Patient Square Capital — for $890 million last summer. The 12-year GSK vet has also been UCB’s associate general counsel.

→ After merging with Graybug Vision in March, inflammatory disease biotech CalciMedica has onboarded a pair of new execs. Raven Jaeger (chief regulatory officer) owned the same title at Diffusion Pharmaceuticals, a company that went through a merger of its own with EIP Pharma. Up next, Andrew Cunningham (SVP of clinical development) led the neurodegenerative franchise at Taysha Gene Therapies and had a stint with Reata Pharmaceuticals as associate VP of clinical development.

Megan Yung

→ Eterna Therapeutics, once known as Brooklyn ImmunoTherapeutics, has brought in Megan Yung as chief strategy officer and general counsel. At SQZ Biotechnologies, Yung took on the roles of deputy general counsel and VP, head of intellectual property. Eterna purchased Exacis Biotherapeutics — a biotech in the same office building as Eterna in Cambridge, MA — and its off-the-shelf immuno-oncology platform earlier this month “for as much as $50 million,” according to the Boston Business Journal.

Robert Werner

→ Astellas–partnered Twist Bioscience is bringing a new exec on board with Robert Werner as chief accounting officer. Werner formerly served in the same role at Invitae and has prior gigs at Proteus Digital Health, CardioDx and Bloom Energy.

→ Swedish biotech BioInvent has recruited Ingunn Munch Lindvig as SVP regulatory affairs. Lindvig joins from Circio, where she was VP and head of regulatory affairs. Before that, she was head of regulatory affairs at Nordic Nanovector.

Jay Bradner

→ Ex-Novartis Institutes for Biomedical Research president Jay Bradner now has a seat on the board of directors at The Foundation for the National Institutes of Health. He joins another new member, Real Chemistry chairman and founder Jim Weiss, on a board chaired by Karuna Therapeutics CSO and R&D chief Steve Paul.

Catherine Owen

→ John Maraganore has concluded a 12-year run on the board of directors at Agios, but he does have just a few other board appointments and advisory roles to occupy his time. Catherine Owen, Bristol Myers Squibb’s SVP and general manager, US commercialization, will become a member of Agios’ board on June 13, and former Onyx global human resources exec Kaye Foster is now lead independent director.

Cristian Massacesi

→ AstraZeneca CMO and oncology chief development officer Cristian Massacesi has carved out a spot on the board of directors at Replay, co-founded by Adrian Woolfson and another one of this week’s featured 20(+2) under 40 leaders, Lachlan MacKinnon. Last week, Replay spoke to Endpoints exclusively when the cell and gene therapy incubator named Arun Balakumaran as CMO, poaching him from Allogene.

→ Focused on endocrine disorders, Spruce Biosciences has made room for Plexium president and CEO Percival Barretto-Ko on the board of directors. Barretto-Ko had been elevated to CBO at Astellas before he ended his 16-year association with the Japanese pharma to lead Plexium in November 2021. Both Spruce and Plexium are chaired by Mike Grey.

Pamela Klein

→ Former Olema Oncology CMO Pamela Klein has clinched a spot on the board of directors at Spanish cancer player ONA Therapeutics. Klein left the Sean Bohen-led company in January before it laid off a quarter of its workforce a couple months later. Klein, a Genentech clinical development vet, has board seats at argenx, Patrys and I-Mab.

→ Swiss T cell receptor (TCR) biotech Engimmunne Therapeutics has elected Longwood Fund venture partner Annalisa D’Andrea to the board of directors. Formerly the president and CSO of ImmuneID, D’Andrea was also the global head of discovery for immunology and inflammation during her four years with Roche.

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