Ole­ma On­col­o­gy to cut 25% of staff, says it will fo­cus on late-stage pipeline

Ole­ma On­col­o­gy will let go of a quar­ter of its work­force, as well as two top ex­ec­u­tives, as the biotech works to keep alive work on an ex­per­i­men­tal breast can­cer drug that has so far been a dis­ap­point­ment.

Kin­ney Horn

The cuts will af­fect work­ers in R&D and cor­po­rate func­tions, the com­pa­ny said in a press re­lease Thurs­day. Al­so out are CBO Kin­ney Horn and Cyrus Har­mon, a co-founder of the com­pa­ny and its chief re­search of­fi­cer. Har­mon will stay as a mem­ber of the board. The com­pa­ny had 83 full-time em­ploy­ees as of Jan. 31, ac­cord­ing to a fi­nan­cial fil­ing.

CEO Sean Bo­hen has led the com­pa­ny since he left the top med­ical spot at As­traZeneca. The job cuts will let the com­pa­ny fo­cus re­sources on OP-1250, the breast can­cer drug that has worked — and strug­gled with — to move for­ward for years.

Cyrus Har­mon

“Giv­en the chal­leng­ing eq­ui­ty mar­ket en­vi­ron­ment, we made some dif­fi­cult de­ci­sions re­gard­ing our or­ga­ni­za­tion and ear­li­er-stage pro­grams,” Bo­hen said in the press re­lease.

The com­pa­ny is worth a frac­tion of its val­ue from when it IPOed in 2020, and the shares were trad­ing around $50 a share. In No­vem­ber 2021, it an­nounced re­sults from its Phase I/II tri­al of OP-1250 that great­ly dis­ap­point­ed in­vestors be­cause of the low re­sponse rate in ad­vanced ER+/HER2- breast can­cer. The stock plunged and has nev­er re­cov­ered, and now trades around $4 a share.

The San Fran­cis­co-based biotech says it has enough cash to last in­to 2025. It re­port­ed $204.4 mil­lion in cash, equiv­a­lents and mar­ketable se­cu­ri­ties as of the end of last year and a net loss of $104.8 mil­lion.

It plans to start a Phase III tri­al of OP-1250, an es­tro­gen re­cep­tor an­tag­o­nist, in the sec­ond half of the year, as a sec­ond- and third-line treat­ment for metasta­t­ic breast can­cer. And it has Phase II tri­als that it ex­pects will re­port out this year, both as a monother­a­py and in com­bi­na­tion with Pfiz­er’s Ibrance.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

Editor’s note: This is a live story and will be updated.

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.