Rigel gets hands on Pfizer's recently-approved breast cancer drug
Bayer cuts early-stage assets from pipeline
Superior weight loss in Wegovy HD early responders
'First-of-its-kind' collab aims to incubate new biotechs
Rigel gets hands on Pfizer's recently-approved breast cancer drug
Having signalled their intent last year to find a US commercialisation partner for vepdegestrant, Pfizer and Arvinas reached an agreement with Rigel Pharmaceuticals on Tuesday to both market and further develop the PROTAC oestrogen receptor (ER) degrader. The deal comes a matter of weeks after the FDA approved the oral drug as Veppanu for ER-positive, HER2-negative, advanced or metastatic breast cancer in adults carrying ESR1 mutations and who have progressed after at least one line of endocrine therapy (see – Spotlight On: Uncertain future resolved for Pfizer and Arvinas' once heavily touted breast cancer drug as Rigel steps in).
Under the agreement, Pfizer and Arvinas will receive $85 million in upfront and transition payments, with the potential for a further $320 million in development, regulatory and commercial milestones, plus tiered sales royalties in the mid-teens to mid-20s. All payments from Rigel will be split evenly between the two companies.
Pfizer itself had paid Arvinas $650 million upfront in 2021 to co-develop and co-commercialise vepdegestrant, but subsequent clinical readouts narrowed the addressable patient population. For its part, Rigel will own global rights to vepdegestrant, allowing it to sublicense the therapy to potential partners for development and marketing outside of the US.
-Matt Dennis
Bayer cuts early-stage assets from pipeline
As part of its first-quarter earnings report Tuesday, Bayer disclosed that it has cut two Phase I programmes from its pipeline and halted development of Verquvo (vericiguat) in adults with stable chronic heart failure (CHF) and reduced ejection fraction (HFrEF). In September, the pharma, alongside partner Merck & Co., reported that the sGC stimulator — approved in the US and EU for certain patients with worsening CHF — failed to meet its primary endpoint in a Phase III trial for HFrEF.
The axed early-stage assets include BAY 2701250, an atrial natriuretic peptide (ANP)-based candidate that was in Phase I testing for pulmonary hypertension. According to ClinicalTrials.gov, the 82-person study finished last May.
The third cut programme is BAY 3178275, a Phase I-stage GPR84 antagonist being developed for diabetic neuropathic pain.-Elizabeth Eaton
Superior weight loss in Wegovy HD early responders
New sub-analyses from the pivotal STEP UP trial show Novo Nordisk's 7.2-mg semaglutide injectable formulation (marketed as Wegovy HD) resulted in a ~28% weight loss among 'early responders' — outclassing the 20.7% reduction originally seen in the wider study.
Data presented Tuesday at the European Congress on Obesity (ECO) revealed that early responders — defined as those achieving ≥15% body weight loss within 24 weeks — accounted for 27% of Wegovy HD recipients, compared with 21% for the 2.4-mg dose and 3% on placebo. Novo said that the early responders on Wegovy HD lost on average 27.7% of their weight by week 72, versus.
Moreover, a separate MRI sub-analysis with STEP-UP confirmed that 84% of weight lost was attributable to fat mass reduction, including a >30% decrease in abdominal visceral fat, with muscle function largely preserved.
For further analysis, see — Spotlight On: Early responder analysis could be useful catalyst for Wegovy HD in US obesity showdown.
-Pavan Kamat
'First-of-its-kind' collab aims to incubate new biotechs
In what is being touted as a "first-of-its-kind" collaboration, life sciences investment firm Delos Capital is partnering with biopharmaceutical company AP Biosciences to create and incubate new biotechs. The tie-up combines Delos' company-building expertise with APBio's antibody discovery platforms in an effort to accelerate novel medicines through clinical proof of concept.
The collaboration will also take advantage of APBio's operational efficiency in Greater China, which the parties noted enables "faster and more capital-efficient translation from innovative concepts to clinical-stage assets."
The companies will initially focus on autoimmune diseases using bi- and tri-specific antibody approaches that combine novel and de-risked targets and mechanisms, with Delos — through its Delos Foundry — leading therapeutic ideation, financing and strategic development.
"This collaboration allows us to extend the impact of our antibody discovery platforms beyond our internal pipeline," said Jeng Her, APBio's chief executive. Meanwhile, Henry Chen, founder and managing partner of Delos noted that "if we don't see existing companies that match one of our investment theses, our team can fill that gap by incubating innovative assets in a US-based NewCo."
-Matt Dennis
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