GEN Edge sums up the week’s leaders and laggards among publicly traded biotech companies. Stay at the forefront of the week’s champions and runners-up among publicly traded biotech companies and the reasons behind the ups or downs of their stock price fluctuations.
Moderna’s flurry of updates from its Vaccine Day scored well enough with investors as shares rose 6% on Tuesday. The SpikeVax™ developer raised its 2022 sales forecast for the COVID-19 vaccine by 10.5%, from $19 billion to $21 billion, citing Japan’s purchase of 70 million more doses plus the expectation of a sales jump as SARS-CoV-2 becomes endemic by fall/winter. Moderna also announced plans to develop two new mRNA vaccines: MRNA-1230, an annual booster targeting SARS-CoV-2 virus, influenza virus and respiratory syncytial virus (RSV); and MRNA-1287, targeting four endemic coronaviruses (HCoV-229E, -NL63, -OC43, and -HKU1).
Another Moderna candidate (MRNA-1283), a next-generation, refrigerator stable COVID-19 vaccine using doses of 5-10ug, just 10% those for approved SpikeVax, won welcome attention from one analyst: “More convenient and hugely boosts capacity if doses are this low per vial,” Michael Yee of Jefferies wrote on Thursday.
4D Pharma (DDDD)
4D shares climbed 27% on Wednesday following positive interim results from a Phase I/II trial (NCT03637803) assessing the combination of 4D’s Live Biotherapeutic candidate MRx0518 and Merck & Co.’s Keytruda® (pembrolizumab) in renal cell carcinoma (RCC). 4D said that the combo met its primary efficacy endpoint—namely more than three out of 30 patients per tumor group achieving clinical benefit, defined as complete response, partial response, or stable disease for at least six months. 4D pharma said it intended to discuss next steps with partners and its Genitourinary Cancers Advisory Board about the future development path of Mx0518, including a potentially pivotal study in prior immune checkpoint inhibitor (ICI)-refractory RCC patients.
Icosavax shares sank 56% after the company reported topline Phase I/II data for its COVID-19 candidate IVX-411 that disappointed investors. Icosavax said it launched an “end-to-end drug product investigation” to determine why the virus-like particle (VLP) vaccine candidate generated a lower immunogenic response than expected in both SARS-CoV-2 naïve and previously vaccinated subjects—a response “inconsistent with known data on company’s platform and VLP technology,” the company said. Immune response was comparable to or below the study’s control of human convalescent sera (HCS). Also, neutralizing antibody titers generated for the Omicron variant were up to eight-fold lower than seen for wild type virus in the same assay.
MEI Pharma (MEIP)
MEI Pharma shares plunged 60% on Friday after it joined Kyowa Kirin in acknowledging they scrapped plans to file for approval of their cancer treatment zandelisib, a once-daily, treatment for B-cell malignancies, based on data from the single-arm Phase II TIDAL trial (NCT03768505), after the FDA discouraged the submission. Instead, the companies will conduct a randomized Phase III trial to assess efficacy and safety to the agency’s satisfaction, since zandelisib is a phosphatidylinositol-3-kinase (PI3K) inhibitor. The FDA also told the companies that while safety results for the 60 mg intermittent dose schedule appeared reasonable, it recommended they continue studies to further support their current dose and regimen.
NeuroSense Therapeutics (NRSN)
NeuroSense shares all but quadrupled, rocketing 299% on Monday—to $6.23 a share from $1.56—the day the company won FDA clearance to begin a 12-adult, open-label Phase I pharmacokinetic study (NCT05232461) of PrimeC, an extended-release oral formulation designed to inhibit the progression of amyotrophic lateral sclerosis (ALS). PrimeC consists of ciprofloxacin and celecoxib, two approved drugs originally marketed by Pfizer but now also available in generic versions. NeuroSense also plans to launch a Phase IIb, placebo-controlled multinational study in Q2 2022 with an optimized dose and an upgraded formulation of PrimeC.