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BioNTech (BNTX) Begins Dosing in mRNA Cancer Vaccine Study

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BioNTech SE (BNTX - Free Report) announced that it has dosed the first patient in a phase II study on BNT122 (RO7198457), its individualized mRNA cancer vaccine candidate, for colorectal cancer.

The open-label study will investigate the efficacy of BNT122 in approximately 200 high-risk colorectal cancer patients after surgical resection of their tumors and completion of adjuvant chemotherapy. The study is underway in the United States, Germany, Spain and Belgium.

Per the company, the current standard of care for the given indication is to see whether tumors recur following removal of the primary tumor and adjuvant chemotherapy. The study will evaluate BNT122 as a single agent versus standard of care watchful waiting in this high-risk patient population.

The primary endpoint of the study is to evaluate the disease-free survival, while secondary objectives include relapse-free survival, ovserall survival and safety.

Shares of BioNTech have skyrocketed 212.6% so far this year against the industry’s decline of 7.5%.

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BioNTech is jointly developing BNT122 with Genentech, a subsidiary of Swiss pharma giant Roche (RHHBY - Free Report) .

The current phase II study was based on data from a phase Ia/Ib basket study that evaluated BNT122 as a single agent and in combination with Roche’s anti-PD-L1 antibody, Tecentriq (atezolizumab), in patients with solid tumors.

Apart from BNT122, BioNTech’s pipeline boasts of several candidates, such as BNT111, the company’s mRNA-based FixVac cancer vaccine program, and BNT113, BNT211 and BNT311, to name a few which are in early- to mid-stage studies for addressing various cancer indications.

We remind investors that BioNTech has had tremendous success with its mRNA-based COVID-19 vaccine, Comirnaty, which has been developed in partnership with Pfizer (PFE - Free Report) . The vaccine is approved for emergency use in several countries and millions of doses have already been supplied across the globe.

Another key player in the mRNA-space is Moderna, Inc. (MRNA - Free Report) , which has developed the popular COVID-19 vaccine, mRNA-1273. The company has several mRNA-based vaccine candidates targeting multiple diseases.

Zacks Rank

BioNTech currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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