Jane Huang, outgoing hematology CMO at BeiGene

BeiGene's hema­tol­ogy CMO is on her way out amid mar­ket tur­moil

Af­ter six years in the role, BeiGene’s hema­tol­ogy CMO has an­nounced her up­com­ing de­par­ture.

The biotech kept it short in an 8-K filed yes­ter­day, but here’s what we know: Jane Huang, fea­tured in our Top 20 Women in Bio­phar­ma spe­cial re­port just three months ago, ten­dered her res­ig­na­tion and gave 30 days no­tice on Wednes­day — and she will be no longer work­ing as an em­ploy­ee af­ter April 3. No rea­son was giv­en for her de­par­ture, and there has been no men­tion of who her re­place­ment will be.

Huang came to BeiGene in 2016 af­ter a short run at Ac­er­ta as their VP and head of clin­i­cal de­vel­op­ment. Be­fore Ac­er­ta, she had a 10-year stint at Genen­tech as a med­ical di­rec­tor.

Af­ter Huang of­fi­cial­ly re­signs on April 3rd, she will be a con­sul­tant for BeiGene for a few months un­til No­vem­ber 14. And that might come in handy with the churn­ing of R&D, the light of a his­toric bear mar­ket and what’s ex­pect­ed up ahead for its BTK in­hibitor Brukin­sa.

Back in Sep­tem­ber, the FDA ap­proved Brukin­sa for rare blood can­cer Walden­ström’s Macroglob­u­line­mia as BeiGene looked at rapid­ly ramp­ing up its US ex­pan­sion plans.

And af­ter show­ing Phase III da­ta in first-line chron­ic lym­pho­cyt­ic leukemia (CLL) or small lym­pho­cyt­ic leukemia (SLL) at ASH back in No­vem­ber, Huang told End­points News that while the com­pa­ny isn’t say­ing when it ex­pects to file for reg­u­la­to­ry ap­provals, it’s work­ing to get Brukin­sa to pa­tients in “as many coun­tries as pos­si­ble.”

BeiGene an­nounced last week that Brukin­sa is now await­ing a PDU­FA date of Oct. 22 for both CLL and SLL in­di­ca­tions.

Huang’s de­par­ture is one of the newest de­vel­op­ments hap­pen­ing in many biotech C-suites — with some­what of a small biotech CEO ex­o­dus, in­clud­ing Till­man Gern­gross from Ada­gio, Gem­i­ni Ther­a­peu­tics’ CEO Ja­son Meyen­berg, and Deepa Prasad re­signed from trou­bled Alzheimer’s play­er vTv Ther­a­peu­tics.

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.

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

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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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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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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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.

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.

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.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”