It was a busy week for the biotech sector, with quite a few study readouts. Among these, Novavax, Inc. (NVAX Quick QuoteNVAX - Free Report) and ALX Oncology Holdings Inc., (ALXO Quick QuoteALXO - Free Report) gained on positive regulatory and pipeline updates.

Recap of the Week’s Most Important Stories:

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. 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’s updated vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (“CDC”) last month. The EUA and CDC recommendation makes Novavax's vaccine the only protein-based non-mRNA COVID-19 vaccine option in the United States.

ALX Surges on Study Data:  Shares of ALX Oncology jumped as it announced positive prespecified interim data from its ASPEN-06 clinical trial on evorpacept. 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.
Patients in the evorpacept-combination treatment arm received a combination of evorpacept, trastuzumab, Cyramza (ramucirumab) and paclitaxel. On the other hand, patients in the control arm received a combination of trastuzumab, Cyramza and paclitaxel.

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. 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 median duration of response was not reached for the evorpacept combination treatment arm compared to 7.4 months for the control group. The safety profile of evorpacept was consistent with previous clinical trials and was well-tolerated.

ALX Oncology intends to report final data from the phase II portion of the ASPEN-06 study next year in the second quarter. Based on this data, management will start the phase III portion of the study before 2024-end.

ALX Oncology currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Updates From Regeneron: Regeneron Pharmaceuticals, Inc. (REGN Quick QuoteREGN - Free Report) announced that it has expanded its research collaboration with partner Intellia Therapeutics, Inc. (NTLA Quick QuoteNTLA - Free Report) to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases. 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.

Per the terms of the expanded agreement, both companies will initially research two in vivo non-liver targets. Intellia will lead the design of the editing methodology, and Regeneron will lead the design of the targeted viral vector delivery approach. 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.

Regeneron announced that the FDA has accepted for Priority Review the biologics license application (BLA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma or R/R diffuse large B-cell lymphoma, who have progressed after at least two prior systemic therapies. The target action date is Mar 31, 2024.  The BLA was supported by data from a phase I and pivotal phase II trial (ELM-1 and ELM-2).

Updates From Moderna:  Moderna (MRNA Quick QuoteMRNA - Free Report) announced positive interim results from the ongoing phase I/II study of mRNA-1083, its investigational combination vaccine against influenza and COVID-19, in older adults (50 years and older). The phase I/II study is a randomized, observer-blind study evaluating the safety and immunogenicity of mRNA-1083 compared to a standard dose influenza vaccine, Fluarix, in adults 50-64 years of age and against an enhanced influenza vaccine, Fluzone HD, in adults 65-79 years of age.

Data from the study showed strong immunogenicity against influenza and COVID-19 compared to licensed standalone influenza and COVID-19 vaccines. Per management, mRNA-1083 generated antibodies similar to or greater than Fluarix and Fluzone HD. With regards to COVID-19, the vaccine generated neutralizing antibodies similar to the previously approved/authorized Spikevax bivalent booster.

Based on this data, Moderna intends to advance mRNA-1083 to late-stage development. The company intends to start a phase III study in older adults before this year-end.

Performance

The Nasdaq Biotechnology Index has lost 2.41% in the past five trading sessions. Among the biotech giants, Moderna has gained 4.85% during the period. Over the past six months, shares of Moderna have plunged 33.39%. (See the last biotech stock roundup here: Biotech Stock Roundup: ICPT Up on Buyout Deal, IMVT & PLRX Gain on Study Data).

Image Source: Zacks Investment Research

What's Next in Biotech?

Stay tuned for more pipeline updates.