Giovanni Caforio, Bristol Myers Squibb CEO (Bristol Myers)

Bris­tol My­er­s' Op­di­vo turns the boat around in Q2 as man­u­fac­tur­ing is­sues haunt CAR-T launch

What a dif­fer­ence a quar­ter can make.

Sting­ing from a dip in sales for I/O block­buster Op­di­vo last quar­ter, Bris­tol My­ers Squibb’s top check­point in­hibitor turned the boat around in Q2, post­ing 16% growth from the same time­frame in 2020 to $1.91 bil­lion.

On a call with an­a­lysts, Bris­tol My­ers ex­ecs cit­ed the turn­around to Op­di­vo’s on­go­ing gas­tric can­cer launch as well as the in­evitable turn­around in pre­scrib­ing as the Covid-19 pan­dem­ic be­gins to wane. It’s a strong show­ing for Op­di­vo de­spite the fact that the Op­di­vo com­bo with CT­LA4 in­hibitor Yer­voy con­tin­ues turn­ing up red flags.

The drug­mak­er on Wednes­day re­vealed the Op­di­vo-Yer­voy com­bo couldn’t ex­tend the lives of pa­tients with gas­tric can­cer, GEJC or esophageal ade­no­car­ci­no­ma in the Phase III CHECK­MATE-649 study. The com­bo’s OS re­sults were a key sec­ondary end­point for that study, which served up the piv­otal da­ta used to ap­prove Op­di­vo in com­bi­na­tion with chemo in those pa­tients.

Yer­voy has for years been the fo­cus of raised eye­brows as more and more clin­i­cal da­ta from its key Op­di­vo pair­ing churns out mixed re­sults. Ear­li­er this month, the com­bi­na­tion failed to show clin­i­cal ben­e­fit in ex­tend­ing the lives of first-line pa­tients with re­cur­rent or metasta­t­ic squa­mous cell car­ci­no­ma of the head and neck, ac­cord­ing to topline re­sults from the Phase III CHECK­MATE-651 study.

The tri­al test­ed the duo against what’s known as the EX­TREME reg­i­men, a first-line com­bo of Er­bitux, cis­platin/car­bo­platin and flu­o­rouracil, the drug­mak­er said. Bris­tol My­ers took a shot at spin­ning a pos­i­tive, say­ing the study da­ta showed a “clear, pos­i­tive trend to­wards over­all sur­vival” for high ex­press­ing PD-L1 pos­i­tive pa­tients and not­ing the study’s con­trol arm per­formed “bet­ter than ex­pect­ed based on his­tor­i­cal da­ta.”

Even with those re­sults in mind, Yer­voy still turned in an up pe­ri­od in Q2, rak­ing in $541 mil­lion at a 38% growth clip.

Chris Boern­er

Mean­while, Bris­tol My­ers is keep­ing a close eye on its pair of CAR-T launch­es, Breyanzi and Abec­ma, with man­u­fac­tur­ing bot­tle­necks al­ready pos­ing a chal­lenge. CCO Chris Boern­er ad­mit­ted on the call that de­mand for Abec­ma, the first CAR-T ap­proved to tar­get BC­MA in fourth-line or lat­er mul­ti­ple myelo­ma pa­tients, has al­ready out­stripped the com­pa­ny’s abil­i­ty to sup­ply the drug.

The key bot­tle­neck is in the vi­ral vec­tors used to en­gi­neer the ther­a­py, Boern­er said, and Bris­tol My­ers is work­ing on short- and long-term mit­i­ga­tion plans to in­crease ca­pac­i­ty.

“We’re en­gag­ing in­ter­nal­ly and ex­ter­nal­ly to in­crease the slots we have avail­able, and that will be our fo­cus for that drug in the com­ing months,” he said.

Abec­ma cleared $24 mil­lion in sales in its first quar­ter on the mar­ket with Breyanzi tak­ing home $17 mil­lion.

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

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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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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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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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.”