BMS buys a biontech bispecific antibody, setting up $ 1.5 billion to collaborate in several cancers

Biontech’s oncology strategy focuses on a bispecific antibody that the company plans as the backbone of many combinations of potential drugs for many types of cancer. Bristol Myer Squibb buys this strategy, paying $ 1.5 billion in advance to associate on the assets of the clinical stage, which could have applications as part of combinations with the own immunotherapy of the pharmaceutical giant and other cancer drugs.

The agreement announced on Monday the two companies to share the development and manufacture of the bispecific antibody, BNT327, in monotherapy and in combination with other drugs. Each company retains the right to develop independently BNT327 independently in more indications and combinations of drugs, including combinations with their respective drug assets.

A bispecific antibody links simultaneously to two targets, offering two mechanisms to combat different diseases in a single drug. The first target of BNT327 is PD-L1, a protein known as a control point which prevents immune cells from recognizing cancer cells. The drug also blocks the VEGF-A, a protein key to the formation of blood vessels that support tumors. BNT327 was initially developed by Biotheus based in China; BionTech finished its acquisition of $ 800 million in biotechnology in February, gaining full control of the bispecific antibody.

Bispecific antibodies approaching PD-L1 / PD-1 and VEGF have become hot goods for drug developers. Summit Therapeutics, Merck, Instil organic and Pfizer are among the companies developing bispecific antibodies for these targets – each with a drug of a biotechnology based in China. The Summit drug, Ivonescimab, was closely monitored due to preliminary data last year, showing that he beat the inhibitor of the Merck Merck control point, Keytruda, in a phase 3 test. These results were only in China.

The new data from the drug at the top were not part of the annual meeting of the American Society of Clinical Oncology in Chicago this weekend, but it was still part of the Buzz Conference. Last Friday, Summit announced the preliminary results of a phase 3 study which compared its medication and chemotherapy to chemotherapy alone in advanced cases of lung cancer non -small cells. The company has reported statistically significant and clinically significant advantages in progression -free survival. But on global survival, Summit pointed out only a positive trend. Global survival is important because the FDA has made a statistically significant result on this measure a requirement for regulatory approval. Summit said he was planning to request the regulatory approval of Ivonescimab, but is not certain of the calendar.

There is a precedent for the FDA rejecting medication with data in China only. New Summit medication data is important because they include patients recruited in North America. It is this aspect of the results that encouraged the sales director of Biontech Annemarie Hanekamp. In an interview with the ASCO meeting before the announcement of the BMS partnership, Hanekamp said that the summit data is important for Biontech because they show that the positive results of a bispecific antibody in China can be reproduced in a non -Asian population. Hanekamp has recognized that the overall survival of data has yet to mature, but it said that these first results more and more for Biontech’s bispecific medication.

“You can see that it was very close to meaning and that it actually strengthened our confidence to see that we are also on the right trajectory,” she said.

Immunomodulation drugs, such as the bispecific antibodies PD-L1 and VEGF, constitute one of the three pillars of Biontech’s oncology strategy, Hanekamp said. The other pillars are the technology of the messenger RNA which was the foundation of Biontech, and targeted therapies, which includes the combination of antibodies (ADC). Commercial offers have widened the presence of Biontech in Adcs, via agreements with the Duality Bio and Medilink.

While the ADCs of these transactions were initially developed in the form of monotherapies, Hanekamp said that Biontech thinks that greater potential will be made by incorporating them into drug combinations. She added that an objective of the biontech agreement was to give it the opportunity to explore many different combinations with the methods he assembled. The combinations extend the inhibition of control points to tumors which are considered to be “cold”, which means that they do not trigger a strong immune response. The ADC association with an inhibition of the control point could provide additional advantages on blocking control point proteins only, said Hanekamp.

Leerink Partners analyst Daina Graybosch said in a research note than more than bringing his cancer medication for potential combinations, the BMS brings Biontech his deep experience in clinical trials. The relative inexperience of the German company in development in oncology at an advanced stage was considered to be “a major risk” before the BMS partnership.

“The agreement also strengthens our confidence in the capacity of the Biontech management team to make incisive commercial decisions that distribute the risk, preserve their assessment and protect their organization to increase internal capacities in a pragmatic manner,” said Graybosch. “We often hear the case of the investors’ bear that they are worried about investing in a company led by scientific doctors, and although we agree with this as a general risk, the CEO of Biontech, Uğur şahin, and his management team have shown several times in business and a strong leadership that cancels criticism.”

The Alliance calls on companies to develop BNT327 on several types of solid tumors. Biontech’s broad clinical development program for the drug currently covers several types of pulmonary and breast cancer as well as other types of tumors; Three of the studies are global pivotal studies in triple negative breast cancer, small cell lung cancer and lung cancer with small cells. Analysts say that BNT327 could become the second bispecific antibody PD-L1 / PD-1 and VEGF to market behind the Summit medication. The BionTech medication is also being evaluated in the context of a combination with BNT3213, an antibody designed to block two control point proteins. A phase 1/2 study in China is being evaluated by this combination in hepatocellular carcinoma.

Beyond the initial payment, the agreement provides that BMS pays $ 2 billion in non-continental birthday payments until 2028. BionTech is also eligible to receive up to $ 7.6 billion in step payments. If the bispecific antibody guarantees regulatory approval, the two companies will co-commercalize; BionTech will reserve sales in the United States while BMS will record them in the rest of the world.

Illustration: Thom Leach / Science Photo Library, via Getty Images