ACE-1831

Plus, news about Anthos, Ascendis, Royalty Pharma, Semnur, Sonoma, Atara, Feldan, Indivior, Aelis Farma and Acepodia: Vaxcyte launches $1B offering: The raise comes fresh off the company’s pneumococcal vaccine data that sent its stock $PCVX soaring on Tuesday. Vaxcyte selected VAX-31 to advance to a Phase 3 trial in mid-2025 over another vaccine, VAX-24. It can tack on an additional $150 million if all the options are exercised. — Max Gelman Genentech to lay off 93 staffers: In another round of layoffs, Roche’s Genentech is cutting 93 roles at its South San Francisco site starting in October, according to a Californian WARN notice. The site houses over 40 buildings and includes scientific research, manufacturing and other business functions. Genentech said earlier this year that it has plans to cut around 400 workers and restructure its portfolio . — Anna Brown Anthos Therapeutics suggests patients can stay on experimental anticoagulant before surgery: The company on Tuesday shared additional data from a clinical study of its once-monthly factor XI antibody treatment in people with atrial fibrillation, suggesting they do not need to interrupt treatment with abelacimab before elective procedures. In the study, people on the control arm received Xarelto and were allowed to stop taking it 24 to 48 hours prior to their procedure. Seven of 852 patients (0.8%) in the abelacimab arm had major procedure-related bleeds, compared to 6 of 428 (1.4%) in the Xarelto arm. — Lei Lei Wu Ascendis snags $150M in new Royalty Pharma deal: Less than a month after snagging FDA approval for Yorvipath, Ascendis is selling off US royalties of the hypoparathyroidism drug. In exchange for paying $150 million upfront, Royalty Pharma gets 3% royalties on new US sales. The length of the payments is contingent on how quickly Royalty earns back its investment. — Max Bayer Semnur hits Wall Street via SPAC: The company is merging with special-acquisition company Denali Capital Acquisition Corp. in a $2.5 billion deal. Semnur is owned by Scilex Holding Company, which itself took the SPAC route to go public in 2022. — Max Bayer Sonoma Biotherapeutics records $45M milestone: The payment from Regeneron Pharmaceuticals stems from a deal inked in 2023 to develop and commercialize T cell therapies for inflammatory bowel disease and two other undisclosed indications. — Jaimy Lee Atara Biotherapeutics seeks $36M: The company raised the money in a registered direct offering, getting funding from Redmile Group, EcoR1 Capital and Adiumentum Capital Management. An unnamed “large public biotechnology company” also participated in the offering. — Max Gelman Feldan Therapeutics closes $21M Series B: The money will go toward completing a Phase 1/2a trial for the company’s non-invasive intralesional treatment for basal cell carcinoma, which is meant to be an alternative to surgery. Genesys Capital and Fonds de solidarité FTQ co-led the round . — Katherine Lewin Indivior, Aelis Farma drug fails Phase 2b trial: A study investigating a treatment for patients with moderate-to-severe cannabis use disorder didn’t hit the primary or secondary endpoints. The primary endpoint was the proportion of participants who reduced their cannabis use to one day or less per week. Indivior said it will not exercise an exclusive option to license the global rights to the treatment. — Katherine Lewin Acepodia inks Pfizer Ignite collab: The company is collaborating with Pfizer Ignite to advance its off-the-shelf cell therapies to treat autoimmune diseases. Financial terms weren’t disclosed. Acepodia said it retained all rights to its lead program, ACE1831, and Pfizer Ignite “will provide strategic guidance and resources.” — Max Bayer

The collaboration joins several rounds of funding in seeking to advance Acepodia’s promising ACC/γδ2 platforms. Image: Shutterstock / Yuri A. Taipei-based biotech Acepodia announced yesterday (3 September) that it has agreed to a collaboration with Pfizer Ignite, a subsidiary of Pfizer, in which Pfizer’s resources and expertise will be leveraged to advance Acepodia’s cell therapies for autoimmune disease. Pfizer will bolster Acepodia’s research and development capabilities to support the progress of the company’s unique antibody-cell conjugation (ACC) and allogeneic γδ2 T cell platforms, accelerating in particular the development of Acepodia’s candidates, ACE1831 and ACE2016. Acepodia will retain all rights to these programmes and any related partnerships. The ACC platform is said to produce a version of a chimeric antigen receptor (CAR)-T cell therapy without the usual side effects, such as neurotoxicity and cytokine release. The technology links antibodies to proprietary immune cells to enhance tumour binding where tumour antigen expression is low. Prior to the agreement, Acepodia stock had seen some decline. According to Yahoo Finance , share price dropped from a high in August 2023 of TWD 43.1 ($1.34 USD) following their initial public offering to as low as $20.90 TWD ($0.65 USD) in August 2024. It has since made a slight recovery, standing at $23.45 TWD ($0.73 USD) when the market opened today. The company’s market cap is TWD 14.412bn TWD ($447.9m USD). In June 2023, the company had raised Series D funding amounting to $259m . Both this funding and Pfizer’s collaboration are focused on advancing Acepodia’s lead candidates ACE1831 and ACE2016. See Also: Novavax wins FDA emergency approval for updated Covid-19 vaccine Global Calcium hit with Form 483 after Indian factory inspection ACE1831 is being tested in an open-label Phase I trial (NCT05653271) to evaluate safety and efficacy in patients with CD20-expressing non-Hodgkin lymphoma. Preliminary results released earlier this year indicated a robust and durable effect at the lowest dose tested; one out of five patients achieved complete response while three experienced disease stabilisation, and no serious adverse events were reported. Meanwhile, ACE2016 is set to enter Phase I trialling, having been granted Investigational New Drug (IND) clearance by the US Food and Drug Administration (FDA) in February of this year for solid tumours. Dr. Sonny Hsiao, CEO of Acepodia, said the agreement, “will position us well to deliver our immunotherapies to patients in desperate need of new options”. Kathy Fernando, head of Pfizer Ignite, stated Pfizer will “look forward to collaborating with Acepodia to help translate their compelling scientific platform into impactful new medicines for patients with unmet need”. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Optimise your cell therapy process: a guide to cell thawing Typically carried out at the point of care, errors in cell therapy thawing could compromise treatment efficacy, leading to significant patient impact as well as high costs and a compromised reputation for the product’s developer. This guide addresses how cell thawing has historically developed into the new techniques used today, along with the physical and biological implications of key metrics and components such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy