BioNTech (BNTX) Up on Initial Data From Lung Cancer Antibody

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.  

Zacks Investment Research
Image Source: Zacks Investment Research

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

BioNTech SE Sponsored ADR Price and Consensus

BioNTech SE Sponsored ADR price-consensus-chart | BioNTech SE Sponsored ADR Quote

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%.

Top 5 ChatGPT Stocks Revealed

Zacks Senior Stock Strategist, Kevin Cook names 5 hand-picked stocks with sky-high growth potential in a brilliant sector of Artificial Intelligence. By 2030, the AI industry is predicted to have an internet and iPhone-scale economic impact of $15.7 Trillion.

Today you can invest in the wave of the future, an automation that answers follow-up questions … admits mistakes … challenges incorrect premises … rejects inappropriate requests. As one of the selected companies puts it, “Automation frees people from the mundane so they can accomplish the miraculous.”

Download Free ChatGPT Stock Report Right Now >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

AstraZeneca PLC (AZN) : Free Stock Analysis Report

ADMA Biologics Inc (ADMA) : Free Stock Analysis Report

Akero Therapeutics, Inc. (AKRO) : Free Stock Analysis Report

BioNTech SE Sponsored ADR (BNTX) : Free Stock Analysis Report

To read this article on click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

More Related Articles

Info icon

This data feed is not available at this time.

Sign up for Smart Investing to get the latest news, strategies and tips to help you invest smarter.