The ‘don’t eat me’ an­ti­dote: Glax­o­SmithK­line, Roche and No­vo back $86M start­up in high-stakes CD47 show­down

CD47 is a hot prospect in the im­muno-on­col­o­gy world. And Wash­ing­ton Uni­ver­si­ty spin­out Tioma Ther­a­peu­tics plans to be a play­er in that boom­ing R&D game.

It’s an old­er start­up, seed­ed for years to cov­er pre­clin­i­cal work but now prep­ping for a turn in the clin­i­cal spot­light. To­day the com­pa­ny land­ed an $86 mil­lion launch round and an ex­pe­ri­enced biotech hand who is now at the helm. River­Vest Ven­ture Part­ners co-led the round along with a trio of phar­ma heavy­weights: No­vo Ven­tures, Roche Ven­ture Fund and Glax­o­SmithK­line’s S.R. One.

John Dono­van, a co-founder of Alios, ac­quired by J&J, has tak­en over as CEO.

Dono­van will use the cash to ad­vance a port­fo­lio of an­ti­bod­ies de­signed to tar­get CD47, based on work from a group of sci­en­tif­ic founders that in­cludes William A. Fra­zier, PhD, pro­fes­sor of Bio­chem­istry, Mol­e­c­u­lar Bio­physics, Cell Bi­ol­o­gy, and Bio­med­ical En­gi­neer­ing at Wash­ing­ton Uni­ver­si­ty School of Med­i­cine. The com­pa­ny was orig­i­nal­ly found­ed as Vas­cu­lox and now has a cor­po­rate of­fice in the Bay Area and its re­search work close to its uni­ver­si­ty home in St. Louis.

The big idea here is that block­ing CD47 will help a T cell at­tack over­come tu­mor cells, mak­ing it an ide­al com­bi­na­tion to the com­bi­na­tion ther­a­pies tak­ing shape in the clin­ic.

“We’ve got three or four years of life now,” Dono­van tells me. He plans to use that time, and the cash, to ze­ro in on a proof-of-con­cept study that can start in H1 2017–look­ing to demon­strate that tar­get­ing CD47 can ben­e­fit pa­tients with blood can­cers as well as sol­id tu­mors. The plan is to build a sus­tain­able com­pa­ny, adds the CEO, who got start­ed with Tioma 6 months ago. And re­searchers will be ex­am­in­ing which of a num­ber of CD47 mech­a­nisms will work best, and which sub­sets of pa­tients will ben­e­fit the most.

Up to this point, says Dono­van, John McK­earn at River­Vest has been seed­ing the com­pa­ny, build­ing the syn­di­cate and es­tab­lish­ing the com­pa­ny foun­da­tion. In the next seg­ment of its ex­is­tence, Tioma can start con­sid­er­ing how it can best pair its drug with oth­ers in the on­col­o­gy field.

It’s not alone. Just a few months ago, Stan­ford spin­out Forty Sev­en gained a $75 mil­lion round to back the de­vel­op­ment of its own an­ti­bod­ies in the field, look­ing to si­lence a set of mol­e­cules on the sur­face of tu­mor cells that broad­cast a sim­ple “don’t eat me” sig­nal. That work was head­ed by Stan­ford’s leg­endary Irv Weiss­man. And Cana­da’s Tril­li­um Ther­a­peu­tics $TRIL has a lead ther­a­py, SIR­PαFc, that al­so tar­gets CD47.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Kaile Zagger, Infinant Health CEO

UC Davis mi­cro­bio­me spin­out re­brands in­fant sup­ple­ment busi­ness with na­ture fo­cus

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.

FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Bob Azelby, Eliem Therapeutics CEO

Eliem says ear­li­er drug ex­po­sure is­sues have been re­solved, drops one epilep­sy in­di­ca­tion

After being forced to delay two Phase IIa trials and blaming CMC issues on a Phase Ib miss, Eliem Therapeutics believes it’s now in the clear.

The Seattle and UK-based biotech put out word Wednesday morning about how it conducted new early-stage studies to confirm why low exposure issues arose during the Phase Ib. After researchers compared the results of the studies, Eliem found “no meaningful difference” between them and ruled out CMC as the reason for the foiled Phase Ib study, the company said in a press release.

GSK touts topline win for PD-1 in head-to-head with Keytru­da — while steer­ing next big check­point drug in­to PhI­II

GSK is claiming a win for what it calls the largest head-to-head trial pitting a PD-1 against Merck’s best-selling Keytruda in a type of lung cancer, as its Jemperli met the primary endpoint of objective response rate.

In a separate positive move, GSK says it’s moving both arms of the COSTAR Lung trial into Phase III to test Jemperli as well as the TIM-3 inhibitor cobolimab.

Hesham Abdullah, GSK’s global head of oncology development, said in a statement that the two trials “support the ambition for dostarlimab to become the backbone of our ongoing immuno-oncology-based research and development programme when used alone and in combination with standard of care and future novel cancer therapies, particularly in patients with currently limited treatment options.”

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