Sosei Heptares is teaming up with a big-name partner: Alphabet’s Verily.
No financials were disclosed, but the pair will aim to use Verily’s immune profiling and Sosei Heptares’ GPCR drug design capabilities to develop a variety of new therapeutics. The collaboration will focus on GPCR drugs in the immunology, gastroenterology and immuno-oncology spaces, as well as other disorders with immunoprotective or immunopathogenic mechanisms, the companies said.
‘Immunology is a key area of focus for Sosei Heptares and this new collaboration brings together two world-class technologies and teams with the skills and expertise to define key GPCRs as targets for the discovery of new medicines that could have significant impact on patients with immune-based diseases worldwide,’ Sosei VP for drug discovery Matt Barnes said in a statement. — Max Gelman
ObsEva unveils new PhIII data for endometriosis pain
Just a month after women’s health biotech ObsEva brought on a new CFO, the company has some Phase III trial data for pain associated with endometriosis.
The trial was for linzagolix, an oral GnRH antagonist candidate for women with moderate-to-severe endometriosis-associated pain, also known as EAP. Two doses — 200 mg once-daily with add-back therapy (ABT) and 75 mg daily without back therapy — were tested.
The 200 mg dose, according to ObsEva, met the study’s co-primary efficacy objectives: reducing dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP) at 3 months. At 6 months of treatment at 200 mg, there were listed improvements in five secondary endpoints: dysmenorrhea, non-menstrual pelvic pain, dyschezia, overall pelvic pain, and ability to do daily activities.
The 75 mg dose did show a statistically significant reduction versus placebo in DYS at 3 months. Although it showed improvement in NMPP at 3 months, it did not reach statistical significance versus placebo.
ObsEva CMO Elizabeth Garner praised the results, saying in a statement that the biotech plans to complete its Phase III program for EAP, and said that it would explore a non-ABT option for that indication. — Paul Schloesser
Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)
It’s big days for biology.
The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.
But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.
Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.
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As the FDA is looking to reduce drug shortages further by collecting more data on the volume of drugs and APIs manufactured worldwide, companies like Pfizer, Thermo Fisher, Viatris and industry groups are pushing back on new guidance that seeks to establish how that data should be collected and submitted to the agency.
The technical conformance guide, released last October, spells out the requirements under Section 3112(e) of the CARES Act, which was signed into law in March 2020 and added a new section to the FD&C Act.
Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)
Bursting at the seams and executing plans for swift expansion to support its manufacturing work for the mRNA vaccine out of Pfizer/BioNTech, Indianapolis-based Exelead has now been scooped up in a $780 million cash buyout deal.
Germany’s Merck KGaA, which bought out another mRNA manufacturer, AmpTec, early last year, has been beefing up its ops around lipids, which, in mRNA vaccines, play a key role in turning human cells into a mini—vaccine factories?
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Jay Bradner, NIBR president (Jeff Rumans)
Alnylam was a few years ahead in the small interfering RNA (siRNA) space when Novartis jumped on the bandwagon in early 2020, licensing the company’s cholesterol-lowering drug Leqvio through its buyout of The Medicines Company. Less than a month after securing an approval, the pharma giant wants more where that came from.
Novartis is joining forces with Alnylam once again for the discovery and development of a regenerative siRNA-based therapy to treat end-stage liver disease, the companies announced on Thursday.
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After showcasing clinical data at #ASH21 for a sickle cell disease candidate, Sanofi has decided to throw in the towel on its 8-year partnership with collaborator Sangamo — and return its rights to the candidate.
The gene editing biotech announced the ‘transition’ this morning, several days after Sanofi told Sangamo that the biotech was backing out of the deal. The Paris-based pharma giant will be returning its rights and obligations on SAR445136, a zinc finger nuclease gene-edited cell therapy back to Sangamo by the end of June.
Chris Perkin, Altasciences via Youtube
Altasciences CEO Chris Perkin has gone through several acquisitions in his 45-year career. And if there’s one thing he learned, it’s how not to go through an acquisition.
His company put that knowledge to use on Tuesday when it announced that it had acquired competitor Sinclair research, a preclinical contract research organization in Missouri. With the pickup, Altasciences gains 80 animal rooms, and full-service IND and NDA-enabling toxicology and safety pharmacology services.
Eli Lilly is beefing up its fleet of vehicles being deployed to carry drugs to the brain.
Enlisting Canada’s Entos Pharmaceuticals, Eli Lilly has grabbed rights to a suite of proteo-lipid vehicles (PLVs) as part of a research collaboration that spans multiple programs focused on diseases of the central and peripheral nervous system. Entos will receive an upfront of $50 million, part of it as an equity investment, to start developing PLVs for Lilly’s selection.
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A group of institutional investors from Nomura, BMO, GAM and more than 60 others representing trillions in assets are now calling on Covid-19 vaccine developers to link their executives’ pay to ensure the vaccines are available globally.
‘It is clear that currently a large part of the world population still does not have sufficient and equitable access to vaccines,’ the investors said in explaining their reasoning behind Thursday’s letter to the execs at Pfizer, Moderna, AstraZeneca and J&J.
https://endpts.com/sosei-and-verily-partner-on-gpcrs-obseva-touts-phiii-data-in-endometriosis-pain/
