Cerevel Therapeutics Inc. disclosed results from the pivotal phase III Tempo-3 trial with tavapadon, the first D1/D5 receptor partial agonist being studied as a once-daily treatment for Parkinson’s disease (PD). Tempo-3 tested the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa (LD) in adults. The trial met its primary endpoint, with tavapadon PD patients showing a clinically meaningful and statistically significant increase of 1.1 hours in total “on” time without troublesome dyskinesia vs. those treated with LD and placebo. A statistically significant reduction in “off” time, the key secondary endpoint, was also observed for the tavapadon treatment arm. Cambridge, Mass.-based Cerevel said more data from the trial will be offered at a medical meeting. Results from the tavapadon phase III monotherapy trials (Tempo-1 and Tempo-2) are expected in the second half of this year.

Metsera launches with $290M to develop weight loss and obesity treatments

Led by executives who helmed The Medicines Co., Metsera Inc. has launched with $290 million in financing to develop drugs for treating weight loss, obesity-related conditions and metabolic diseases. The company’s clinical-stage pipeline includes oral and injectable incretin, non-incretin and combination therapies. Metsera’s portfolio includes an injectable, fully-biased GLP-1 receptor agonist that is in phase I trials. Founded by Population Health Partners and Arch Venture Partners, Metsera’s financing was led by Arch with participation from other investors including F-Prime Capital, GV, Mubadala Capital, Newpath Partners, Softbank Vision Fund 2. For $9.7 billion, Novartis AG acquired of The Medicines Co. of Parsippany-Troy Hills, N.J., in 2020.

Biopharma financings hit $47B in Q1, marking second-highest quarter

Biopharma firms amassed a total of $47.07 billion in the first quarter of 2024, the second-highest quarter recorded by BioWorld since 2011, trailing only behind $48.18 billion raised in 2Q20. This robust fundraising was driven by exceptional performances in IPOs, follow-ons and public/other financings, as well as sustained trends in venture capital raises. The amount marks a 118% increase from $21.62 billion raised in the fourth quarter of 2023 and a 257% rise from 1Q23’s $13.19 billion.

China clears Immuneonco’s CD47 inhibitor for pivotal trials

China’s National Medical Products Administration has cleared Immuneonco Biopharmaceuticals Co. Ltd.’s’ IMM-01 (timdarpacept) to enter a pivotal phase III trial in combination with Beigene Co. Ltd.’s PD-1 inhibitor, tislelizumab, in relapsed or refractory classical Hodgkin lymphoma patients who relapsed or progressed after treatment with PD-1 inhibitors. An immune checkpoint inhibitor targeting CD47, lead product timdarpacept was the first SIRPα-Fc fusion protein to enter clinical trials in China. Designed with immunoglobulin G1 Fc, timdarpacept is designed to activate macrophages via a dual mechanism, simultaneously blocking the “don’t eat me” signal by disrupting CD47/SIRPα interaction and delivering the “eat me” signal by activating Fc-gamma receptors on macrophages.

Newco news: Outrun emerges from stealth with $10M for E3 ligase inhibitors

Newco Outrun Therapeutics Ltd. has raised $10 million in a seed round to develop small-molecule E3 ubiquitin ligase inhibitors that prevent programmed protein degradation. The lead program targeting an E3 ligase that tags a tumor suppressor protein for destruction will now advance to preclinical development.

SK Biopharm, Ignis shake on $58M deal for sodium channel blocker

South Korea’s SK Biopharmaceuticals Co. Ltd. and Shanghai-based Ignis Therapeutic Co. Ltd. signed a ₩804 billion (US$58 million) licensing deal on April 18, granting the latter global rights to a non-narcotic pain treatment candidate dubbed SKL-22544. A sodium channel blocker, SKL-22544 is in late discovery. The technology transfer agreement includes a non-refundable up-front payment of ₩4.15 billion to SK Biopharmaceuticals and potentially up to ₩76.24 billion in development and regulatory milestone payments, along with royalties on net sales.

Member of US House blasts FTC/DOJ merger guidelines

The new merger guidelines released by the U.S. Department of Justice and the Federal Trade Commission have proven controversial on several fronts, but now the House of Representatives is weighing in. Rep. Roger Williams (R-Texas) said the guidelines fail to account for the importance of these transactions for small businesses seeking to grow and requested that the two agencies provide data that would demonstrate whether such concerns were taken into account in drafting those rules.

BioWorld Insider Podcast: Biopharma execs seek to avoid pain points in AI integration

Because artificial intelligence is such a new technology it comes with a mountain of unknowns. Integrating it into a pharmaceutical company presents a unique series of challenges, as a new survey from Verix shows. The report is based on responses from directors, vice presidents and C-suite executives in sales, marketing and brand management at pharmaceutical companies in the U.S. that have more than $100 million in annual revenue. Doron Aspitz, the CEO of Verix, talked about the new findings with the BioWorld Insider podcast and the profound shift that executives face as the new technology takes over an entire industry.

Also in the news

89bio, Alvotech, Amgen, Artiva, Atai, Benitec, Biocryst, Biohaven, Biomx, Bivictrix, Celldex, Clene, Eli Lilly, Enterome, Evaxion, Evotec, Genentech, GSK, Immutep, Initial, Intra-Cellular Therapies, Korro, Morphoceuticals, Neurenati, Neurobo, Novartis, NRX, Organovo, Pathios, Paxmedica, Pharming, Sage, Sanofi, Serina, Soligenix, Teva, Tscan, UCB, Variant, Ventus, Xeno, Zura