Robert Langer. Cred­it: Chem­i­cal Her­itage Foun­da­tion

Bob Langer has an­oth­er biotech start­up to add to his lengthy ros­ter.

Lyn­dra has gath­ered $23 mil­lion to­geth­er to work on a new de­liv­ery tech plat­form de­vel­oped by Langer, Gio­van­ni Tra­ver­so and An­drew Bellinger at MIT.

Lyn­dra’s big idea is that it can de­vel­op plat­form tech that can pro­vide “ul­tra” long act­ing sus­tained re­lease of oral drugs. And it says this new ap­proach could al­so re­duce the side ef­fects as­so­ci­at­ed with some drugs while vast­ly im­prov­ing com­pli­ance. Po­laris part­ner and co-founder Amy Schul­man is lead­ing the ef­fort.

Langer has been pro­lif­ic over the years, help­ing a num­ber of his stu­dents launch their own com­pa­nies. The last time we talked, Langer count­ed more than 30 biotech star­tups, and they keep com­ing.

Amy Schul­man, Po­laris

Po­laris Part­ners led the round for the Wa­ter­town, MA-based biotech with par­tic­i­pa­tion from Quark Ven­ture and GF Se­cu­ri­ties, Yonghua Cap­i­tal, Health­link Cap­i­tal, Part­ners Health­care, Suf­folk Eq­ui­ty and oth­ers.

“Lyn­dra’s ul­tra-long act­ing plat­form, orig­i­nal­ly de­vel­oped for mass drug ad­min­is­tra­tion cam­paigns in the de­vel­op­ing world, is par­tic­u­lar­ly pow­er­ful be­cause of the breadth of in­di­ca­tions and com­pounds that the com­pa­ny can tar­get and bring to pa­tients,” Langer said in a state­ment. “The num­ber of lives we could touch with this tech­nol­o­gy is near­ly lim­it­less. Since the com­pa­ny’s found­ing, 5 mem­bers of the [Langer] Lab have joined Lyn­dra due to their com­mit­ment to bring this tech­nol­o­gy to pa­tients. This mix of pas­sion and po­ten­tial pa­tient im­pact is tru­ly some­thing spe­cial.”

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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.

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.

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.