While each company gets the chance to lead the potential development and commercialization of product candidates for one target, the firm that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for that target. Intellia will lead the design of the editing methodology, and Regeneron will lead the design of the targeted viral vector delivery approach. Per the terms of the expanded agreement, both companies will initially research two in vivo non-liver targets. The collaboration combines Intellia’s leading genome editing platform, including its proprietary Nme2Cas9 technology, with Regeneron’s proprietary antibody-targeted viral vector delivery technologies to jointly advance in vivo programs outside the liver for neurological and muscular diseases. NTLA to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases. REGN announced that it has expanded its research collaboration with partner Intellia Therapeutics, Inc. Updates From Regeneron: Regeneron Pharmaceuticals, Inc. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Based on this data, management will start the phase III portion of the study before 2024-end.ĪLX Oncology currently carries a Zacks Rank #3 (Hold). The safety profile of evorpacept was consistent with previous clinical trials and was well-tolerated.ĪLX Oncology intends to report final data from the phase II portion of the ASPEN-06 study next year in the second quarter. The median duration of response was not reached for the evorpacept combination treatment arm compared to 7.4 months for the control group. Data from the study showed that patients in the evorpacept-combination treatment arm confirmed an overall response rate (ORR) of 52% compared to the 22% ORR achieved in the control group arm. The phase II portion of the study randomized patients into either of the two arms – the evorpacept-combination treatment arm and the control group arm. On the other hand, patients in the control arm received a combination of trastuzumab, Cyramza and paclitaxel. Patients in the evorpacept-combination treatment arm received a combination of evorpacept, trastuzumab, Cyramza (ramucirumab) and paclitaxel. The study is a randomized phase II (open-label) / phase III (double-blinded), multi-center international study of patients with second or third-line metastatic HER2-overexpressing gastric/ gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy. The EUA and CDC recommendation makes Novavax's vaccine the only protein-based non-mRNA COVID-19 vaccine option in the United States.ĪLX Surges on Study Data: Shares of ALX Oncology jumped as it announced positive prespecified interim data from its ASPEN-06 clinical trial on evorpacept. Centers for Disease Control and Prevention (“CDC”) last month. Novavax’s updated vaccine has also been included in the recommendations issued by the U.S. The FDA’s decision is based on data from non-clinical studies wherein Novavax’s updated vaccine generated functional immune responses against multiple circulating Omicron-related sub-lineages, including XBB.1.5, BA.2.86 (also called ‘Pirola’), EG.5.1 (also called ‘Eris’), FL.1.5.1 (also called ‘Fornax’) and XBB.1.16.6. Novavax Vaccine Updates: Novavax announced that the FDA has granted emergency use authorization (EUA) to its COVID-19 vaccine, Adjuvanted (2023-2024 Formula), which is an updated version of its protein-based COVID-19 vaccine, in individuals aged 12 years and older. Recap of the Week’s Most Important Stories: NVAX and ALX Oncology Holdings Inc., ALXO gained on positive regulatory and pipeline updates. It was a busy week for the biotech sector, with quite a few study readouts.

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