BioNTech’s BNTX shares rose almost 4% on Jun 2. This occurred soon after interim data from an ongoing phase I/II study on its anti-CTLA-4 monoclonal antibody, BNT316/ONC-392, demonstrated encouraging signs of clinical anti-tumor activity in a difficult-to-treat lung cancer indication.
The initial data from the study also showed the candidate’s manageable safety profile in patients with metastatic, PD-(L)1-resistant non-small cell lung cancer (NSCLC).
These results will be presented at the annual meeting of the American Society of Clinical Oncology, this week.
The study included 27 patients with metastatic, PD-(L)1-resistant NSCLC who received a minimum of two doses of 10 mg/kg of BNT316/ONC-392. The overall response rate among evaluated patients was 29.6% at data cut-off, with a disease control rate of 70.4%.
BioNTech’s shares have plunged 28% year to date compared with the industry’s 7.6% decline.
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Lung cancer is a leading cause of cancer deaths globally, and NSCLC accounts for approximately 85% of all lung cancers. BNT316/ONC-392 is a next-generation anti-CTLA-4 antibody, jointly developed by BioNTech and OncoC4 as monotherapy or combination therapy for various solid tumor indications. The candidate is aimed to block a protein called CTLA-4.
BNT316/ONC-392 is designed to target CTLA-4 for addressing advanced, hard-to-treat tumors. It received Fast Track designation from the FDA in April 2022 for treating patients with metastatic, PD-(L)1-resistant NSCLC.
The abovementioned new data will further support the initiation of a phase III study evaluating BNT316/ONC-392 as monotherapy for immunotherapy-resistant NSCLC. The study, named PRESERVE-003, is planned to commence by the third quarter of 2023.
The candidate will be competing with AstraZeneca's AZN approved injection Imjudo (tremelimumab) — a CTLA-4 antigen — which is to be administered in combination with AZN’s another cancer drug, Imfinzi (durvalumab). Imjudo was approved for treating patients with advanced liver cancer and lung cancer indication in October and November 2022, respectively.
BioNTech SE Sponsored ADR Price and Consensus
Zacks Rank and Stocks to Consider
Currently, BioNTech carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are Akero Therapeutics AKRO and ADMA Biologics, Inc. ADMA, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Akero Therapeutics has narrowed from a loss per share of $3.46 to loss of $2.78 for 2023 in the past 90 days. Shares of Akero Therapeutics have nosedived 14.7% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
The consensus estimate for ADMA Biologics has narrowed from a loss per share of 19 cents to 9 cents for 2023 in the past 90 days. In the year so far, shares of ADMA Biologics have risen 4.4%.
ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
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