Roche's triplet in­volv­ing Tecen­triq clears the PFS bar for melanoma when added to BRAF/MEK com­bo

In a “check the box” ex­er­cise, Roche said it has shown that adding Tecen­triq to a com­bo of Cotel­lic and Zelb­o­raf was ef­fec­tive in ex­tend­ing pro­gres­sion-free sur­vival in melanoma pa­tients com­pared to place­bo plus the two drugs.

Pa­tients with pre­vi­ous­ly un­treat­ed BRAF V600 mu­ta­tions were re­cruit­ed to the Phase III study, dubbed IM­spire150.

Levi Gar­raway

Cotel­lic (which was ini­tial­ly de­vel­oped by Roche part­ner Ex­elix­is) and Zelb­o­raf are al­ready ap­proved to treat BRAF V600E or V600K mu­ta­tion-pos­i­tive un­re­sectable or metasta­t­ic melanoma. While the lat­ter blocks some BRAF ki­nas­es, the for­mer is be­lieved to help break treat­ment re­sis­tance by al­so in­hibit­ing MEK1/2.

Some­times, though, that’s still not enough, thus the at­tempts to add a third agent to in­crease the dura­bil­i­ty of treat­ment — ei­ther a tar­get­ed ther­a­py or, in this case, an im­munother­a­py.

Roche has tried to test a com­bo of Tecen­triq plus just Cotel­lic for treat­ment-naive cas­es, but that com­bi­na­tion failed to beat stan­dard-of-care Keytru­da in a sep­a­rate tri­al, IM­spire170, un­veiled ear­li­er this year.

The phar­ma gi­ant record­ed around $44 mil­lion in Cotel­lic sales in the first three quar­ters of 2019, while Tecen­triq fetched over $1.3 bil­lion.

Cotel­lic and Zelb­o­raf had two heavy­weight ri­vals in No­var­tis, which mar­kets Mekin­ist and Tafin­lar, as well as Pfiz­er af­ter it snapped up Ar­ray and its Mek­tovi/Braftovi pair­ing. All play­ers are look­ing to go be­yond melanoma now — Pfiz­er is es­pe­cial­ly keen about the prospects in col­orec­tal can­cer — though Roche has suf­fered some set­backs.

Stifel an­a­lyst Stephen Wil­ley has pre­vi­ous­ly de­scribed the triplet vs dou­blet com­par­i­son as more of a “check the box” than “ex­pand the mar­ket” move.

The next step will be to check the reg­u­la­to­ry box.

“By com­bin­ing a can­cer im­munother­a­py with tar­get­ed ther­a­pies, we hope to of­fer a new ap­proach that im­proves out­comes for peo­ple with ad­vanced, BRAF-mu­tant melanoma,” CMO Levi Gar­raway said in a state­ment.

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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Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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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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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.”

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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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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