It was a low-key week for the biotech sector with very few pipeline and regulatory updates. Collaboration news also took the centerstage.
Recap of the Week’s Most Important Stories:
Alector Gains on Glaxo Deal: Shares of Alector, Inc. ALEC surged after it announced a strategic global collaboration with GlaxoSmithKline plc GSK. The companies will co-develop progranulin (PGRN)-elevating monoclonal antibodies, AL001 and AL101, for a range of neurodegenerative diseases, including frontotemporal dementia, amyotrophic lateral sclerosis, Parkinson’s disease and Alzheimer’s disease. Enrollment is currently underway for a phase III study on AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). Per the terms, Alector will receive $700 million in upfront payments. In addition, it will be eligible to receive up to an additional $1.5 billion in clinical development, regulatory and commercial launch-related milestone payments.
Alector will lead the global clinical development of AL001 and AL101 through a phase II proof-of-concept study. Thereafter, both companies will share developmental responsibilities for all late-stage clinical studies on the candidates. All costs for global development will be divided between the companies. Alector and Glaxo will be jointly responsible for commercialization in the United States and share profits and losses. Alector will lead commercial efforts associated with AL001 in orphan indications and Glaxo will lead the commercialization of AL101 in Alzheimer’s and Parkinson’s disease. Outside the United States, Glaxo will be responsible for the commercialization of AL001 and AL101 and Alector will be eligible for tiered royalties.
Alector currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
CureVac Down on Vaccine Study News: Shares of clinical-stage biopharmaceutical company, CureVac N.V. CVAC, were down on the final analysis of the HERALD study on its first-generation COVID-19 vaccine candidate, CVnCoV. The sequencing of virus variants was performed on 588 COVID-19 cases to identify virus strains within the trial. Among these, 204 fulfilled adjudication criteria and were included in the efficacy analysis. In the study, 15 COVID-19 variant strains were present for efficacy analysis and the original strain was almost completely absent. CVnCoV demonstrated an overall vaccine efficacy of only 48% against COVID-19 disease of any severity, including single non-respiratory mild symptoms, which didn’t impress investors. The vaccine generated significant protection among participants in the age group of 18 to 60, with an efficacy of 53% against the disease of any severity and across all 15 identified strains.
Spero Surges on Pfizer Investment: Shares of Spero Therapeutics, Inc. SPRO surged after it announced that pharma giant Pfizer PFE has made a $40-million equity investment in the former. The companies have entered a licensing agreement for SPR206, Spero’s intravenously (IV)-administered next-generation polymyxin product candidate being developed to treat serious multi-drug resistant (MDR) Gram-negative infections in the hospital setting. In exchange, the company has granted Pfizer rights to develop, manufacture and commercialize SPR206 in ex-U.S. and ex-Asia territories in exchange for potential development and commercial milestone payments and royalties. Spero intends to use the proceeds from the equity investment to prepare for the potential approval and launch of tebipenem HBr and to support the continued clinical development of SPR720 and SPR206.
Kintara Surges on Study Results: Shares of Kintara Therapeutics, Inc. KTRA gained after it announced top-line data results from the recurrent arm of its open-label, phase II study of its lead compound, VAL-083, being conducted at the MD Anderson Cancer Center (MD Anderson) in Houston, TX. The study is a two-arm, biomarker-driven trial testing VAL-083 in glioblastoma multiforme (GBM) patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The recurrent arm of the study addressed patients who have been pre-treated with temozolomide prior to disease recurrence. The data showed a median overall survival (mOS) of 8 months for the 48 efficacy evaluable patients initially receiving the treatment dose of 30 mg/m2/day. The results were encouraging as lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated mOS of 7.2 months.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index lost 0.44% in the last four trading sessions. Among the biotech giants, Regeneron gained 6.64% during the period. Over the past six months, shares of Biogen have surged 39.21%. (See the last biotech stock roundup here: Biotech Stock Roundup: NTLA Surges on Study Data, EXEL & ALT Down on Updates & More) .
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What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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