Feeling Collaborative, Merck Inks Three More Deals to Strengthen Portfolio
Collaborations are the backbone of pharmaceutical research. Today, Merck entered into collaborations with three different companies as it looks to expand its oncology offerings. The company continues to assess its vaunted checkpoint inhibitor Keytruda in combination with experimental drugs in different cancer indications.
Xeris Ties Up with Merck
Chicago-based Xeris Biopharma and Merck collaborated on the development of Xeris’ suspension-based formulation technology, XeriJect. Merck, which has an option to license XeriJect, intends to use the technology with undisclosed monoclonal antibodies (mAbs) for the “purpose of engineering ultra-high concentration, ready-to-use formulations.”
Shares of Xeris have jumped more than 11% since the market opened this morning following news of the collaboration. The terms of the deal were not announced.
Paul R. Edick, chairman and chief executive officer of Xeris, expressed his excitement about collaborating with the pharma giant. He said the XeriJect platform has broad applications for the delivery of large molecules like mAbs.
Xeris, which is coming off its acquisition of Stonebridge Biopharma, has multiple partnerships with larger pharma companies, including Tetris Pharma. Edick said these collaborations are important in validating the company’s technology. In August, the U.S. Food and Drug Administration (FDA) approved the company’s supplemental new drug application for Xeris’ Gvoke Kit, a ready-to-use liquid glucagon for treating severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. The company also has a second approved product, Keveyis, the only FDA-approved therapy for primary periodic paralysis.
Evaxion Pairs Melanoma Asset with Keytruda
Denmark’s Evaxion Biotech A/S also entered into a collaboration with Merck. The companies will pair Evaxion’s immunotherapy EVX-01 with Merck’s vaunted checkpoint inhibitor, Keytruda (pembrolizumab). The two drugs will be assessed in a Phase IIb study for patients with stage III and stage IV metastatic melanoma. The trial is expected to begin in the last quarter of 2021.
Evaxion CEO Lars Wegner, M.D., said promising Phase I/IIa data revealed over the summer shows that EVX-01 may be able to improve the treatment landscape in melanoma and other cancers. Because checkpoint inhibitors are becoming a standard of care in these cancers, Wegner expressed excitement about the potential clinical benefit of pairing the drugs.
Merck Partners with Daiichi Sankyo and AstraZeneca
In a three-way partnership, Daiichi Sankyo and AstraZeneca collaborated with Merck to pair their TROP2 directed DXd antibody drug conjugate datopotamab deruxtecan (Dato-DXd) with Keytruda. The combination treatment will be assessed in a Phase III study. The study will examine datopotamab deruxtecan with Keytruda compared to the checkpoint inhibitor alone in treatment-naïve patients with PD-L1 high advanced or metastatic non-small cell lung cancer without actionable genomic alterations. The use of a checkpoint inhibitor like Keytruda is the current standard of care in the first-line treatment of these patients.
The two drugs have been paired before. Last year, the companies combined the drugs in previously treated or treatment-naive patients with advanced or metastatic NSCLC without actionable genomic alterations.
“In this specific trial, we will evaluate whether combining our TROP2 directed ADC with an anti-PD-1 therapy improves outcomes in patients with previously untreated advanced non-small cell lung cancer with no actionable genomic alterations,” Gilles Gallant, global head of Oncology Development and Oncology Research and Development at Daiichi Sankyo, said in a statement.
TCR2 Therapeutics Partners with BMS
Cambridge, Mass.-based TCR2 and Bristol Myers Squibb forged a clinical trial collaboration to assess the company’s gavo-cel in combination with Opdivo (nivolumab) and Yervoy (ipilimumab) in its planned Phase II clinical trial for the treatment of refractory mesothelin-expressing solid tumors. Mesothelin is a cell-surface glycoprotein highly expressed in a wide range of solid tumors.
Gavo-cel is TCR2’s lead T cell receptor (TCR) Fusion Construct T cells asset. According to company data, TRuC-T cells are designed to recognize and kill cancer cells by harnessing signals from the entire TCR.
The Phase II studies will assess the efficacy of gavo-cel in patients with unresectable, metastatic, or recurrent mesothelin-expressing tumors in multiple cancer types, including non-small cell lung cancer, ovarian cancer, malignant pleural/peritoneal mesothelioma and cholangiocarcinoma. Gavo-cel received Orphan Drug Designation from the FDA in September for the treatment of cholangiocarcinoma.
Dr. Garry Menzel, president and CEO of TCR2 Therapeutics, said the partnership with BMS will enable the company to evaluate the synergy between its gavo-cel asset and checkpoint inhibitors.
“The new standard of care established by Opdivo in difficult-to-treat diseases is important for cancer patients around the world, including the recent approval of the combination of Opdivo and Yervoy as first-line treatment for adult patients with unresectable malignant pleural mesothelioma. We look forward to determining whether gavo-cel can provide additional clinical benefit to these patients,” Menzel said in a statement.