Earnings updates and regulatory news continue to drive activity in the biotech sector. Several key developments have emerged, including a clinical hold on RAPT Therapeutics' zelnecirnon trials and FDA approval for Iovance Biotherapeutics' Amtagvi.
RAPT Therapeutics' Zelnecirnon Trials Placed on Clinical Hold
RAPT Therapeutics, Inc. (RAPT) announced that the FDA has placed a clinical hold on its phase IIb trial of zelnecirnon (RPT193) in atopic dermatitis and phase IIa trial in asthma. This decision follows a serious adverse event of liver failure in one patient participating in the atopic dermatitis trial. The cause of the liver failure is currently under investigation but is suspected to be related to zelnecirnon. Consequently, dosing of zelnecirnon has been suspended in both trials, and enrollment of new participants has been paused. The clinical hold does not affect RAPT’s ongoing trial of tivumecirnon (FLX475) in oncology.
According to the company, approximately 350 patients have been enrolled across three clinical studies evaluating zelnecirnon, including the halted phase II trials and an earlier phase Ia/Ib study. No other trial participant has shown evidence of liver toxicity, and nonclinical studies also did not indicate liver toxicity. The impact of this clinical hold on RAPT's development timeline for zelnecirnon remains to be seen.
Iovance Biotherapeutics' Amtagvi Receives Accelerated FDA Approval for Melanoma
Iovance Biotherapeutics, Inc. (IOVA) has received accelerated approval from the FDA for lifileucel suspension for intravenous infusion, marketed under the brand name Amtagvi. This tumor-derived autologous T cell immunotherapy is indicated for the treatment of adult patients with unresectable or metastatic melanoma who have previously been treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
The FDA's accelerated approval was based on safety and efficacy data from the phase II C-144-01 study, which evaluated Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy. Treatment with Amtagvi demonstrated deep and durable responses in this patient population. The approval was granted based on overall response rate and duration of response. Iovance is currently evaluating Amtagvi in frontline advanced melanoma in the phase III confirmatory study, TILVANCE-301, as well as in additional solid tumor types. This approval marks a significant advancement in the treatment landscape for advanced melanoma, offering a new option for patients who have progressed on prior therapies.
Moderna's Financials and Pipeline Update
Moderna (MRNA) reported earnings of 55 cents per share in the fourth quarter of 2023, surpassing the Zacks Consensus Estimate of a loss of 78 cents per share. Revenues reached $2.8 billion, exceeding the Zacks Consensus Estimate of $2.5 billion. These revenues primarily consist of sales from the COVID-19 Vaccine Spikevax. Moderna has reaffirmed its product sales guidance of approximately $4 billion for 2024.
Moderna anticipates initial regulatory approvals for its RSV vaccine (mRNA-1345) starting in the first half of 2024, marking a potential expansion of its vaccine portfolio.
