BioNTech and Regeneron Partner to Advance BNT111/Libtayo Combination Therapy for Melanoma

August 02, 2020 /Bio ValleyBIOON/ -- BioNTech is an industry-leading mRNA therapeutics company, currently collaborating separately withPfizerCollaborating with Fosun Pharma to advance the mRNA vaccine for the prevention of novel coronavirus disease (COVID-19). mRNA is a nucleic acid molecule that carries genetic information. The mRNA vaccine willGeneticsInformation is introduced into the body, causing cells to produce corresponding antigens, thereby inducing the human body to generate neutralizing antibodies and stimulate T-cell responses, combating viruses through dual mechanisms of humoral and cellular immunity. In the face of sudden major outbreaks, compared with traditional vaccines, mRNA vaccine synthesis andManufacturing ProcessRelatively convenient, with strong immunogenicity, does not require additional adjuants necessary for traditional vaccines, and has good safety.

In mid-July, Fosun Pharma’s licensed COVID-19 mRNA vaccine BNT162b1 from BioNTech received approval from the National Medical Products Administration (NMPA) to initiate Phase I clinical trials. In the United States, Pfizer and BioNTech advanced another COVID-19 mRNA vaccine, BNT162b2, into Phase II/III clinical trials in late July. Based on Phase I/IIClinical Trialpositive results, these two COVID-19 mRNA vaccines were approved by the United States in July this yearFDAGranted Fast Track designation.

In addition to developing mRNA vaccines for COVID-19, BioNTech is also leveraging its mRNA technology to develop novel cancer immunotherapies. Recently, the company announced a strategic collaboration with Regeneron to conduct aClinical Trial, combining the mRNA immunotherapy BNT111 FixVac with the anti-PD-1 therapy Libtayo (cemiplimab) for the treatment ofMelanoma。

The two parties plan to jointly conduct a randomized Phase II study in patients with anti-PD-1 refractory/relapsed, unresectable advanced (Stage III or IV) cutaneousMelanomaPatients will receive BNT111 FixVac and Libtayo as second-line treatment. The two parties will announce relevant details of this Phase II study in the third quarter of this year, with the goal of initiating the trial in the fourth quarter.

BNT111 is the most advanced of the five clinical-stage FixVac candidates in BioNTech’s extensive development pipeline, a type of vaccine targetingMelanomamRNA Cancer Immunotherapy Targeting Four Antigens Frequently Expressed in Patient Tumors (NY-ESO-1, MAGE-A3, Tyrosinase, TPTE). FixVac is aTumorA fixed vaccine composition consisting of cancer-associated antigens with medium-to-high expression.

In an ongoing Phase 1Clinical TrialIn China, BNT111 has been demonstrated to be effective as a monotherapy and in combination with checkpoint inhibitors for advanced cases previously treated with checkpoint blockade therapy.MelanomaThe patient has anti-TumorActivity.

Melanoma is the most lethal form of skin cancer; in 2020, an estimated 63,000 people worldwide died from melanoma. In recent years, despite anti-PD-1 therapy in the treatmentMelanomaProgress has been made in this area, but most patients have not achieved durable clinical benefits.

Combination Therapy of BNT111 FixVac and Libtayo: Integrating Two Immunotherapies with Complementary Mechanisms of Action to Potentially Enhance the Immune System’s Ability to Effectively Recognize Targets Through Multiple PathwaysMelanomacapabilities, and is expected to enhance immune targeting for cancer control. (Bioon.com)

Original Source: BioNTech Announces Strategic Collaboration with Regeneron to Advance FixVac and Libtayo® (cemiplimab) Combination in Melanoma