Jumping in for the first time to the hot antibody-drug conjugate (ADC) space, Paris-based Ipsen SA pulled in exclusive global rights to a preclinical ROR1-targeting candidate from Sutro Biopharma Inc. in a deal worth up to $900 million. STRO-003, the first ADC to join Ipsen’s portfolio, is a next-generation ROR1 ADC that leverages South San Francisco-based Sutro’s site-specific technology to create a highly stable conjugate combined with exatecan payloads. Having shown preclinical efficacy in solid tumors and hematological malignancies, and potentially a differentiated safety profile, STRO-003 is ready for phase I, with Ipsen planning to submit an IND application and covering all clinical development and commercialization activities going forward. About $90 million of the deal’s total $900 million is near-term money, including an up-front payment and an equity investment. The rest comes in the form of development, regulatory and commercial milestone payments, plus tiered royalties on global sales.

Gritstone shares in tailspin after phase II/III colorectal data

Shares of Gritstone Bio Inc. (NASDAQ:GRTS) were trading at $1.21, down $1.14, or 48%, after the company rolled out preliminary data from the signal-seeking phase II/III testing Granite, a personalized neoantigen cancer vaccine, in front-line metastatic microsatellite stable colorectal cancer. Overall progression-free survival (PFS) data show an early trend in benefit for and extended PFS benefit in high-risk patients in whom the disease advances faster. But while circulating tumor DNA (ctDNA) analysis over several months of treatment turned up the expected relationship with disease progression and favoring Granite, short-term ctDNA response analysis – molecular response as defined per protocol – yielded no difference between study arms.

Verve switches PCSK9 gears in wake of phase Ib study stumble

Trouble continues to dog Verve Therapeutics Inc.’s base editor of the PCSK9 gene, VERVE-101, so the company paused enrollment in a phase Ib study in cholesterol lowering to focus on the similarly designed VERVE-102. The switch was prompted by a patient who experienced a grade 3 drug-induced transient increase in serum alanine aminotransferase and a serious adverse event of grade 3 drug-induced thrombocytopenia. While the patient’s troubles resolved themselves, Verve decided to move on to the Heart-2 study of heterozygous familial hypercholesterolemia, a genetic condition that VERVE-101 also was being developed to treat. In November, Verve data demonstrated the first human proof of concept for a single-course in vivo base-editing treatment, but it was coupled with troublesome safety issues. The company’s stock (NASDAQ:VERV) had dropped precipitously at midday, with shares trading 35% downward at $8.24 each.

Teva, Janssen to continue squabble over schizophrenia drug patent

Yes, even a phase III protocol for a “failed” trial can constitute prior art, the U.S. Court of Appeals for the Federal Circuit told a lower court yesterday when it returned Janssen Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc.’s patent squabble for a do-over. The appellate court scolded the district court that originally heard the case for conflating the patent claims protecting Janssen’s schizophrenia drug, Invega Sustenna (paliperidone palmitate), with the drug approval process. That was just one of several errors the lower court made when it determined that Teva hadn’t proven any of the claims were obvious based on prior art, the Federal Circuit said in its precedential opinion.

After amyloid beta, Adel seeks next big target for Alzheimer’s

Alzheimer’s disease (AD) is recognized worldwide for its debilitating symptoms of declining cognitive function and gradual memory loss. What remains less clear is exactly what causes the neurodegenerative disease, and how to treat it. “Alzheimer’s disease is characterized by two key pathologies – beta-amyloid plaques and tau neurofibrillary tangles.” Seung-Yong Yoon, CEO of Adel Inc., told BioWorld. “Adel is looking to develop a tau-targeting drug, considering tau has been more correlated with AD symptom progression, and the industry’s need for tau pipelines.”

Also in the news

Adarx, Aditxt, Alexion, Annovis, Antibe, Apotex, Appili, Applied, Asha, Aurion, Avalo, Axsome, Be, Bioinvent, Biomea Fusion, Bristol Myers Squibb, Candel, Cartherics, CNX, Context, Disc, Eisai, Equillium, Eyepoint, Gilead, Ginkgo Bioworks, Innocare, Ipsen, Kiniksa, Marengo, Maxcyte, Melt, Mirum, Modulus, MSD, Natera, Neurobo, Nocion, Nurix, Oncoc4, Onconova, Pharmaessentia, Redhill, Redx, Roivant, Searchlight, Surrozen, Sutro, Ticaros, Trawsfynydd, Vertex, Vistagen