An­drew Cheng spent close to 20 years at Gilead, end­ing as its chief med­ical of­fi­cer af­ter play­ing a key role in de­vel­op­ing a string of block­busters. Now, af­ter mak­ing a re­cent ex­it at Gilead in an ex­o­dus of top ex­ecs, he’s sur­faced at the helm of an up­start biotech with plans to play a dis­rup­tive role in the bur­geon­ing NASH field.

Jonathan Young

Cheng is the new CEO of Akero Ther­a­peu­tics, and his re­cruit­ment was im­por­tant enough for the still-small com­pa­ny to de­cide to switch its head­quar­ters from the hot hub in Cam­bridge, MA to trendy San Fran­cis­co. And start­up CEO Jonathon Young will now switch to the COO’s job.

With ven­ture cash surg­ing and IPOs still hot, start­up biotech has been an ap­peal­ing field for top re­searchers at the big play­ers look­ing for new chal­lenges — and an eq­ui­ty stake. Gilead in par­tic­u­lar has seen the re­volv­ing door to the ex­ec­u­tive suite spin in re­cent months, with CEO John Mil­li­gan join­ing Chair­man John Mar­tin and R&D chief Nor­bert Bischof­berg­er as they head out in search of new ca­reer chap­ters.

Tim Rolph

Akero CSO Tim Rolph has been en­thu­si­as­tic about the biotech’s chances in the crowd­ed NASH field. A Pfiz­er vet, Rolph is work­ing on an FGF21 drug that’s al­ready been through ear­ly-stage work at Am­gen. Now the com­pa­ny plans to jump in­to Phase II next year.

“My ex­pe­ri­ence with FGF21 goes back 8 years,” Rolph told me in June, when Akero land­ed its $65 mil­lion launch round. And the sci­ence around FGF21, he added, has grown ex­po­nen­tial­ly in the last 3 to 4 years. “It’s a mech­a­nism that us­es the whole body to get to a bet­ter place,” not­ed Rolph. “It plays an es­sen­tial role restor­ing cells un­der stress — that’s what drove my in­ter­est.”

I asked Cheng via email what prompt­ed him to jump from a lead­ing R&D role at a com­pa­ny with a multi­bil­lion-dol­lar re­search bud­get to a start­up. His re­ply:

I’ve spent most of my pro­fes­sion­al ca­reer at Gilead. I had the tremen­dous op­por­tu­ni­ty to shape and build a re­al­ly ex­cit­ing clin­i­cal pro­gram in HIV and be part of the growth and tra­jec­to­ry of the com­pa­ny from an ear­ly stage. Our ther­a­pies have ben­e­fit­ed mil­lions of peo­ple around the world. When I was ap­proached with the Akero op­por­tu­ni­ty, I was moved to once again build some­thing — to work with a great team, and be close to the sci­ence and clin­i­cal de­vel­op­ment. Our lead can­di­date is a com­pelling as­set with strong po­ten­tial in NASH and oth­er meta­bol­ic dis­eases, one that I’m con­fi­dent we can build a com­pa­ny around.

Ap­ple Tree Part­ners, where Young has been a part­ner, seed­ed the project. At­las Ven­ture, ven­Bio Part­ners and Ver­sant Ven­tures all joined as co-leads, mak­ing an im­pres­sive group of deep-pock­et in­vestors, which no doubt played a big role in woo­ing Cheng. The in­vestors are rep­re­sent­ed on the board by Aaron Kantoff, Kevin Bit­ter­man, Aaron Roys­ton and Gra­ham Walm­s­ley.

Im­age: An­drew Cheng. AKERO

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.