~ Targeting CD38, a key biomarker in multiple myeloma and other cancers ~

Multiple myeloma is a cancer of plasma cells, which are white blood cells primarily found in bone marrow that normally produce large amounts of a specific antibody. While normally functioning plasma cells are critical components of the immune system, abnormal or cancerous plasma cells cause a range of severe health issues including anemia, thrombocytopenia, leukopenia, infections and serious bone and kidney disorders. About 30,770 new cases of multiple myeloma will be diagnosed in the US this year, according to the American Cancer Society, with about 12,770 deaths expected.

Austin-based Molecular Templates MTEM is developing next-generation immunotoxins called engineered toxin bodies (ETBs) that have a differentiated mechanism of action that may be beneficial in patients resistant to currently available cancer therapies. Its lead compound, MT-3724, has demonstrated good safety and efficacy in a Phase 1 and 1b study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma who had previously relapsed after anti-CD20 Mab and chemotherapy, with the best observed in heavily pretreated patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The company has initiated a Phase II combination study of MT-3724 with the chemotherapies gemcitabine and oxaliplatin in patients with advanced DLBCL.

Source: Cancer Prevention and Research Institute of Texas

Takeda development agreement

Molecular Templates announced an agreement yesterday with Takeda Pharmaceutical TKPYY for the joint development of CD38-targeted ETBs for the treatment of patients with multiple myeloma and other cancers. The lead development candidate is a CD38-targeted ETB that resulted from a previous discovery collaboration between the two companies.

Takeda will make an upfront payment of $30 million, and Molecular Templates is eligible to receive development, regulatory and commercial milestone payments of up to $632.5 million if Molecular Templates exercises its co-development option or up to $337.5 million if Molecular Templates does not exercise or opts out of its option. Molecular Templates is also eligible to receive royalties on sales of the commercial product developed through the collaboration, and the companies will share equally in the development costs.

This collaboration builds on Takeda’s deep history and commitment to the study of blood cancers, including multiple myeloma. Throughout our research collaboration with Molecular Templates, we have seen the promise of its ETB platform for the discovery and development of new therapies.

– Philip Rowlands, PhD, Head, Oncology Therapeutic Area Unit, Takeda Pharmaceutical

Multiple myeloma cells widely express the CD38 protein, making it a key biomarker target in the development of therapeutics for multiple myeloma. CD38-targeted ETBs recognize the protein and deliver a modified bacterial toxin that enters the myeloma cells and destroys them through the enzymatic and irreversible destruction of ribosomes. Unlike other CD38-targeted therapies, ETBs are not reliant on the body’s own immune system for effectiveness, offering the potential of broader and deeper responses.

We have worked closely with Takeda’s scientific team since October 2016 to develop CD38-targeted ETBs with substantial improvements over our own internal program, MT-4019. Takeda’s expertise in multiple myeloma and strong antibody capabilities allowed us to develop CD38-targeted ETBs that, of the ones tested to date, are the most potent ETBs we have created with our platform.

– Eric Poma, PhD, CEO and Chief Scientific Officer, Molecular Templates.

Follow-on equity offering

Subsequent to the announcement of the Takeda deal, Molecular Templates announced a $30 million follow-on common stock offering via Cowen, Evercore and UBS, pursuant to a Form S-3 shelf registration originally filed in 2015 when the company was called Threshold Pharmaceuticals. The current Molecular Templates is a product of a reverse merger completed in August 2017.

Eric Poma, PhD, has been CEO and Chief Scientific Officer of the company since its inception in 2009. He was previously VP of Business Development at Innovive Pharmaceuticals, now part of CytRx CYTR, and AVP of Business Development at ImClone Systems, now part of Eli Lilly LLY. Dr. Poma led the invention of technology underlying Molecuar Templates’ platform technology and what constitutes the whole of the company’s current lead and preclinical pipeline candidates.

Source: Molecular Templates

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