Regenxbio scores $180M vector deal; Bristol-Myers expands agreement to test Opdivo with Infinity’s IPI-549

Abeona Therapeutics $ABEO has licensed Regenxbio’s $RGNX NAV AAV9 vector for four diseases: Sanfilippo syndrome type A (MPS IIIA), Sanfilippo syndrome type B (MPS IIIB), Infantile Batten Disease, also known as neuronal ceroid lipofuscinosis type 1 (CLN1 Disease), and Juvenile Batten Disease, also known as neuronal ceroid lipofuscinosis type 3 (CLN3 Disease). Regenxbio is guaranteed $40 million in cash for the deal, including $20 million in near-term payments, with another $140 million in potential fees and milestones.

With six approved PD-1/L1 drugs on the market and a plethora of others in development, makers of checkpoint inhibitors continue to test their offerings in combination with other drugs to eke out a bigger slice of the lucrative oncology market. On Monday, Bristol-Myers $BMY expanded its agreement with Infinity Pharmaceuticals’ $INFI to test Opdivo in combination with Infinity’s PI3K-gamma inhibitor, IPI-549, in patients with advanced urothelial cancer. The Phase II trial is expected to begin in the first half of 2019. A combination of Opdivo and IPI-549 continues to be evaluated in a Phase I study in patients with advanced solid tumors.

In other cancer-related news, Takeda has exercised its exclusive option to license Crescendo Biologics’ humabodies for one of its oncology targets, in a move that comes substantially earlier than planned, Crescendo said on Monday. The multi-target collaboration and license agreement was set up in 2016. Crescendo’s humabody-based products are an investigational class of protein therapeutics, which are designed to penetrate and accumulate in tissue/tumours whilst clearing quickly from circulation to minimise systemic toxicity.

In a separate oncology tie-up, little MEI Pharma $MEIP has granted Tokyo-listed Kyowa Hakko Kirin exclusive rights to develop and commercialize its experimental drug ME-401 in Japan for a $10 million upfront and potential milestone payments of up to $87.5 million. The drug, a PI3K delta inhibitor, is being developed by MEI to treat B-cell malignancies, and MEI is planning to initiate a Phase II study to evaluate the drug in patients with follicular lymphoma.

Germany’s Grünenthal is now the sole owner of the dermal pain patch Qutenza after it acquired the remaining rights to the product from Acorda Therapeutics $ACOR. Back in 2016, Grünenthal acquired exclusive commercial rights for the patch — which contains capsaicin, the active ingredient in chili peppers — in Europe, Middle East and Africa. Grünenthal has made a series of investments to expand its arsenal of pain products, including acquiring the European rights to Nexium and the global (ex US and Japan) rights to Vimovo

Another German company is also in the news. The Mainz-based biotech BioNTech has tied up with the University of Pennsylvania to develop mRNA vaccines to prevent and treat a host of infectious diseases. The company, which already has partnerships with with Roche’s Genentech, Pfizer, Genmab, Eli Lilly, Sanofi and Bayer, is betting that mRNA-based vaccines represent an opportunity to surpass conventional vaccine approaches because of their capacity for rapid development and their potential for low-cost manufacturing and potentially safe administration.

Israel’s Mapi Pharma has picked up its second $10 million equity investment from China’s Zhejiang Jingxin Pharmaceutical. The Chinese CNS drugmaker made its initial investment in Mapi back in 2016.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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