In­novent and Gen­Fleet reach deal for KRAS in­hibitor; TCR2 re­ceives FDA's ODD on ga­vo-cel

Am­gen be­came the first com­pa­ny in May to crack an un­drug­gable tar­get and earn ap­proval for a KRAS in­hibitor. Now, In­novent is look­ing to fol­low in its foot­steps.

Chi­nese phar­ma com­pa­nies In­novent and Gen­Fleet have en­tered in­to an ex­clu­sive li­cens­ing agree­ment for de­vel­op­ing and com­mer­cial­iz­ing Gen­Fleet’s GFH925, the com­pa­ny’s lead KRAS G12C can­di­date in the Chi­na, Hong Kong, Macau and Tai­wan mar­kets.

GFH925 is an oral­ly ac­tive in­hibitor of KRAS G12C, an onco­genic mu­ta­tion that can play a role in cer­tain types of can­cers. The drug re­ceived IND clear­ance from Chi­nese reg­u­la­tors in Ju­ly.

In­novent will be re­spon­si­ble for clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion of GFH925 in the re­gions, while re­tain­ing rights for de­vel­op­ment and com­mer­cial­iza­tion out­side these mar­kets.

Gen­Fleet will re­ceive $22 mil­lion at sign­ing, with po­ten­tial for up to $50 mil­lion for glob­al de­vel­op­ment sup­port. Up­on reach­ing cer­tain mile­stones in de­vel­op­ment, reg­is­tra­tion and glob­al sales, Gen­Fleet is el­i­gi­ble to re­ceive up to $240 mil­lion, in ad­di­tion to sales-based tiered roy­al­ties in both the afore­men­tioned and glob­al mar­kets.

“We are de­light­ed to form this strate­gic col­lab­o­ra­tion with Gen­Fleet,” said In­novent pres­i­dent Yong Jun Liu in a state­ment. “With the op­tion-in rights for glob­al de­vel­op­ment and com­mer­cial­iza­tion, we look for­ward to bring­ing GFH925 as a new and more ef­fec­tive treat­ment op­tion to pa­tients both in Chi­na and glob­al­ly.”

TCR² Ther­a­peu­tics re­ceives or­phan drug des­ig­na­tion for bile duct can­cer

Cam­bridge, MA-based TCR2 Ther­a­peu­tics was grant­ed or­phan drug des­ig­na­tion by the FDA for their drug ga­vo-cel for cholan­gio­car­ci­no­ma.

The com­pa­ny hopes this will be a sig­nif­i­cant boon, af­ter an­nounc­ing in March that it would lease Au­to­lus’ aban­doned 85,000 square-foot fa­cil­i­ty in Mary­land for ga­vo-cel pro­duc­tion. The fa­cil­i­ty is ex­pect­ed to come on­line in 2023.

Clin­i­cal da­ta from an on­go­ing Phase I/II tri­al will be high­light­ed at ES­MO in a pre­sen­ta­tion on Sep­tem­ber 17.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Can South Dako­ta's trans­genic cows help treat the flu?; A speedy re­view for Mer­ck­'s Pre­vnar ri­val in kids

Wednesday brought another win for South Dakota’s biggest transgenic cow so far.

SAB Biotherapeutics, which develops treatments by collecting and distilling antibodies from cows with humanized immune systems, announced that its antibody treatment for flu passed an early-stage challenge study.

Volunteers were intentionally exposed to the flu virus and then given infusions of the SAB antibody treatment or placebo. Those who received the antibody treatment saw a significantly greater reduction in viral load and symptoms than those who received placebo. The company didn’t release numbers but said the p-value was 0.026.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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