Acquisition/Merger

Bristol Myers Squibb Pays $475M To Acquire Immunotherapy Program

September 08,2021 09:26 AM
- By Admin

Bristol Myers Squibb recently announced it acquired Dragonfly Therapeutics’ investigational immunotherapy program for $475 million.

Under the definitive agreement, Bristol Myers Squibb will be granted Dragonfly’s extended half-life cytokine DF6002, a monovalent IL-12 immunoglobulin Fc.

DF6002 is expected to achieve strong anti-tumor efficiency by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses, the company said.

Dragonfly is also eligible to receive performance-based development, regulatory, and commercial milestone payments, as well as receive up to 24 percent royalties on worldwide net sale, Bristol Myers Squibb said. 

“As we continue to expand our focus in oncology, we are pleased to be adding an IL-12 Fc-fusion protein to our oncology pipeline in the form of DF6002,” Rupert Vessey, MA, BM, BCh, FRCP, DPhil, executive vice president and president of research and early development at Bristol Myers Squibb, said in the announcement. 

“We look forward to our continued work with Dragonfly to further guide the program’s clinical data at this pivotal point in its development, as we continue to deliver on our commitment to serve more patients with cancer.”

Under the agreement, Bristol Myers Squibb will be responsible for the development of any commercialization of DF6002 and its related products worldwide. This includes strategic decisions, regulatory responsibilities, funding, and manufacturing.

“We are excited to be collaborating once again with Bristol Myers Squibb, whose broad range of oncology agents makes it a fantastic partner to accelerate the development of DF6002, the most advanced cytokine in Dragonfly’s pipeline,” said Bill Haney, co-founder and CEO of Dragonfly Therapeutics. 

“We are confident that the talent, experience and commitment to science-driven innovation of the Bristol Myers Squibb team will enable DF6002 to discover novel, lifesaving solutions for patients.”

Dragonfly received FDA approval in May 2020 for its investigational new drug application to develop DF6002. The company also has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July.

The Phase 1/2 clinical trial is a first-in-human, open-label, non-randomized, dose study to investigate the safety, tolerability, pharmacokinetics, biological, and clinical activity of DF6002, according to a July press release

The trial will test DF6002 alone and in combination with PD-1 inhibition in patients with locally advanced or metastatic solid tumors, followed by expansion in selected indications.

Immunotherapies enable the immune system to recognize and target cancer cells. This type of treatment has the potential to reshape cancer worldwide.

Many pharmaceutical companies are beginning to adopt immunotherapies to increase patient-centered care.

Last month, Gilead Sciences acquired 49.9 percent equity interest in Pionyr Immunotherapies Inc. with an exclusive option for $275 million.

Pionyr’s Myeloid Tuning therapies have the ability to treat patients who do not benefit from checkpoint inhibitor therapies. Currently, two of the company’s combination treatments, PY314 and PY159, have shown preclinical efficacy.

As part of the acquisition, Gilead will provide funding for Pionyr’s clinical programs and has the option to acquire the remainder of the company for a $315 million option exercise fee.

Pionyr is also eligible to receive nearly $1.15 billion in future milestone payments upon achievement of specific development and regulatory milestones, Gilead stated.

Although pharmaceutical companies are investing in immunotherapy programs to boost profits, not all patients are responding to the innovative treatment, according to a March JAMA Network Open study

Researchers carried out two calculated scenarios. The first scenario used 2019 estimations assuming that FDA limits were specific to pembrolizumab and atezolizumab, and the second was 2019 estimations assuming that all immunotherapies approved for urothelial cancers are limited to patients with programmed death-ligand 1 expression who are cisplatin ineligible. 

Researchers found that cancer patients eligible for immune checkpoint inhibitor therapy was 38.5 percent and 36.1 percent, respectively. And the estimated total response to these drug scenarios was 11.4 percent and 10.9 percent, respectively.  

Although ICI drugs have gained popularity in recent years due to their ability to boost a person’s immune response against cancer cells, experts highlighted that with quick approval of potentially beneficial drugs comes a high risk of approving drugs that are later found ineffective.