2020-10-14| Asia-PacificR&D

Two Clinical-Stage Biopharmas Enter Agreement to Develop Drug for Hematologic Malignancies

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

The current hematologic malignancy treatments include active surveillance, chemotherapy, radiation therapy, bone marrow transplant, and immunotherapies, like CAR-T cell therapy. However, no drug specifically targets abnormal enzymes, which leads to hematologic malignancy. Although many publications have investigated potential enzymes or checkpoint inhibitors potentially causing hematologic malignancy such as PD-1, CTLA-4, LAG-3, and TIM-3 for developing medications, most of them are still in preclinical or clinical stages. In other words, the inadequate choice of treatment limits the survival possibility of over 1 million hematologic malignancy patients in the U.S.

On October 12th, Switzerland-based Rhizen Pharmaceuticals SA, an associate of Alembic Pharmaceuticals’ and Shanghai-based Curon Pharmaceuticals, announced that they have entered into an exclusive license agreement for the development and commercialization of Tenalisib (RP6530), a dual phosphoinositide-3 kinase (PI3K) delta and gamma inhibitor in the Greater China region. Their collaboration drove Alembic Pharmaceuticals’ share price to rise by 3.03% at Rs. 968.1 from the last close of Rs. 939.65 on BSE.

Swaroop Vakkalanka, Ph.D., President and Chief Executive Officer of Rhizen Pharmaceuticals, stated, “Emerging human clinical data demonstrates that Tenalisib is a differentiated, next-generation, orally active, dual PI3K delta and gamma inhibitor with an excellent safety profile and promising single-agent activity in [hematology] malignancies. We believe Tenalisib’s outstanding safety could allow rational combinations with other approved/investigational agents and enable us to unlock the true potential of this class of drugs. Our partnering with Curon is a first step towards achieving this objective, and we look forward to the day this novel drug reaches cancer patients in need of new and safe therapies.”


Agreement Terms

Both companies are clinical-stage biopharmaceuticals. Their agreement expands Rhizen financially and Curon the rights of Tenalisib across all oncology indications in Greater China. Rhizen will receive an undisclosed upfront cash payment and is eligible to receive additional milestone payments of 149.5 million USD plus double-digit royalties on annual net sales of Tenalisib. Curon will be responsible for Tenalisib’s clinical development with its expertise in translational research, clinical development, and regulatory registration to accelerate the regulatory approval of Tenalisib in Greater China.

Zhihong Chen, Ph.D., President of Curon, said, “Tenalisib has demonstrated great efficacy in lymphoma patients with outstanding safety profile, in-licensing this product to China would bring more effective and additional treatment options to Chinese cancer patients and greatly benefit these patients. Meanwhile, this will further enrich our diversified pipeline. We are very happy and look forward to closely collaborating with Rhizen to efficiently develop this molecule into an effective medicine to benefit patients not only in China but also around the world as soon as possible.”



At the end of 2018, the orally active Tenalisib had completed a Phase I/Ib dose-escalation study to evaluate its safety and efficacy in patients with relapsed or refractory T-cell lymphoma currently undergoes Phase II clinical development for hematological malignancies. Besides, Tenalisib has been granted US FDA Fast Track and Orphan-Drug Designation to treat relapsed/refractory T-cell lymphoma and cutaneous T-cell lymphoma by demonstrating it acts as anti-cellular proliferation agents for the treatment of hematologic malignancies.

Tenalisib’s inhibition of PI3K gamma and delta isoforms prevents the activation of the PI3K/AKT-mediated signaling pathway, triggering a reduction in cellular proliferation in PI3K delta/gamma-expressing tumor cells. Tenalisib is selective of PI3K gamma and delta isoforms over alpha and beta ones because the delta and gamma isoforms overexpress mainly in hematologic malignancies. Further, targeting only these two isoforms could minimize the drug’s impact on other isoforms. Tenalisib also modulates inflammatory response through various mechanisms, including the inhibition of both the release of reactive oxygen species from neutrophils and tumor necrosis factor-alpha activity.

Tenalisib’s potency was confirmed to induce many types of immune function-associated cells in target-specific assays, anti-FcεR1/fMLP and LPS. Anti-FcεR1 (EC50 = 37.8 nM) or fMLP (EC50 = 39.0 nM) induced CD63 expression in human whole blood basophils. LPS induced CD19+ cell proliferation in human whole blood (EC50 = 250 nM) and CD45R+ cell proliferation in mouse whole blood (EC50 = 101 nM).

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: Biotech Duo Revise Co-development & Commercialization Agreement of Intelligent Drug Delivery System



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