Yao-Chang Xu, Abbisko CEO

Shang­hai's Ab­bisko out-li­cens­es EGFR can­di­date in po­ten­tial­ly nine-fig­ure deal

A Shang­hai-based biotech is hand­ing off rights to one of its can­di­dates to an­oth­er Shang­hai com­pa­ny.

Qim­ing-backed Ab­bisko — head­ed by Eli Lil­ly and No­var­tis vet­er­an Yao-Chang Xu — said Wednes­day that it would be out-li­cens­ing its can­di­date ABK3376 to Al­list Phar­ma­ceu­ti­cals. The small mol­e­cule is a pre­clin­i­cal, brain-pen­e­trant EGFR in­hibitor which can in­hib­it dif­fer­ent mu­ta­tions such as L858R ac­ti­vat­ing mu­ta­tion or the ex­on 19 dele­tion mu­ta­tion, Ab­bisko said.

Ab­bisko wrote in a state­ment that it would be el­i­gi­ble for an up­front pay­ment from Al­list, the ex­act amount of which was undis­closed, along with $187.9 mil­lion in mile­stones and cer­tain roy­al­ties. An End­points News query to Ab­bisko was not im­me­di­ate­ly re­turned.

Pre­clin­i­cal stud­ies for the mol­e­cule, ac­cord­ing to the Shang­hai biotech, showed “pos­i­tive re­sults” when used as a sin­gle drug or if used in com­bi­na­tion with fur­mon­er­tinib, Al­list’s third-gen­er­a­tion EGFR in­hibitor.

While fur­mon­er­tinib is al­ready ap­proved in Chi­na, the drug was out-li­censed to Ar­riVent Bio­phar­ma, which launched in 2021. The biotech is cur­rent­ly test­ing the drug in a Phase Ib tri­al in pa­tients with ad­vanced or metasta­t­ic non-small cell lung can­cer (NSCLC) with EGFR or HER2 mu­ta­tions.

The deal calls for Al­list to de­vel­op, man­u­fac­ture and sell ABK3376 in Chi­na, Hong Kong, Tai­wan and Macau, though Al­list has a “time-lim­it­ed op­tion” to ex­pand its rights world­wide. The amount of time that Al­list has to make that op­tion is undis­closed.

Found­ed in 2016, Ab­bisko at­tract­ed VC in­vest­ment from Qim­ing Ven­ture Part­ners in 2019, when the promi­nent firm led the biotech’s Se­ries B for $42 mil­lion.

The Shang­hai biotech went pub­lic in Hong Kong back in 2021, rais­ing $226 mil­lion af­ter ini­tial­ly pric­ing on the Hong Kong In­dex for HK$12.46 a share. Sev­er­al months lat­er, Ab­bisko reached a deal with Eli Lil­ly, part­ner­ing up on co-de­vel­op­ing can­di­dates for car­diometa­bol­ic dis­eases in ear­ly 2022.

The deal gave Ab­bisko the op­por­tu­ni­ty to se­cure up to $258 mil­lion in mile­stones.

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.

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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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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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.

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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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.

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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Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

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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.