French biotech and Pfizer find positives in data for Lyme disease vaccine candidate; Altimmune's obesity drug shows promise in PhI trial
French biotech Valneva and partner Pfizer continued to reveal positive results from its Phase II trial for its Lyme disease vaccine candidate.
The Phase II study, which enrolled 246 healthy adults between 18-65 in the US, met its primary endpoint last October, demonstrating that the candidate, known as VLA15, was immunogenic across all dose groups tested and elicited high antibody responses one month after the primary vaccination series. Continued evaluation at Month 18 showed that antibody titers declined across all groups, but remained above baseline, confirming the need for a booster.
Valneva and Pfizer joined forces in a $308 million deal to commercialize the candidate in April 2020. The vaccine targets the six most common types of Borrelia bacteria that cause Lyme disease — and Valneva CEO Thomas Lingelbach said he expects to bring the product to market in 3-4 years.
VLA15 also proved to be safe and well-tolerated across all doses and age groups tested in the trial. No related serious adverse events were observed in any treatment group, the companies said.
“We are excited by these additional Phase 2 results, which we believe take us a step closer to making a major contribution against this severe disease, subject to regulatory approval,” said Valneva CMO Juan Carlos Jaramillo in a statement.
Altimmune finds early success from Phase I trial of obesity drug candidate
Biopharma Altimmune released promising results from a 12-week, Phase I trial for its obesity drug candidate, finding significant weight loss among some participants, with higher rates of nausea and vomiting among those on the higher doses.
The Australian trial of the GLP-1/glucagon dual receptor agonist pemvidutide, formerly known as ALT-801, in 34 subjects showed an average weight loss of between 5% and 10% at different doses, depending on the dose. Those on placebo averaged 1.6% weight loss, according to an Altimmune statement.
“Given that these weight loss data were obtained without diet or behavioral modifications, we are excited to see weight loss reach its full potential during the planned 48-week Phase II obesity trial next year,” said Altimmune CMO Scott Harris in a statement.
Altimmune said back in July that the company planned to pivot focus back to the obesity drug candidate after disappointing clinical results with its Covid-19 vaccine candidate. ALT’s stock price was -20% pre-market as of this morning.
Hillstream files $17m IPO
Hillstream BioPharma filed an IPO on Monday with the SEC to raise up to $17 million.
The Bridgewater, NJ biopharma plans to raise $17 million by offering 3 million shares at a price range of between $5 and $6. At the midpoint of the proposed range, Hillstream BioPharma would command a fully diluted market value of $58 million, according to a Hillstream statement. Hillstream plans to list on the Nasdaq under the symbol $HILS.
The company has been focused on ferroptosis, a type of programmed cell death being studied for treatment resistant cancers. The company’s most advanced candidate is HSB-1216, an iron mediated cell death, or IMCD inducer for solid tumors. Hillstream aims to submit an IND and start a clinical study with the drug next year.
FDA accepts PD-1 drug Libtayo for priority review against cervical cancer
Regeneron announced this morning that the FDA has accepted PD-1 inhibitor Libtayo for priority review to potentially treat different types of cervical cancer.
The target action date for the FDA decision is Jan. 30, 2022. The sBLA is being reviewed under the FDA’s Project Orbis initiative, which will allow for concurrent reviews by other health authorities in Australia, Brazil, Canada and Switzerland. Regeneron is also planning additional global regulatory submissions, including in the EU, by the end of the year.
Libtayo was jointly developed by Regeneron and Sanofi and first approved in 2018 for locally advanced and metastatic cutaneous squamous cell carcinoma — then approved in 2021 for NSCLC and basal cell carcinoma.