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InnoCare Announces Approval of Tafasitamab in Combination With Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Hong Kong

On December 27, 2022 InnoCare Pharma (HKEX: 09969; SSE: 688428) reported the approval of tafasitamab in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT) by the Department of Health, the Hong Kong Special Administrative Region, China (Press release, InnoCare Pharma, DEC 27, 2022, View Source [SID1234625622]).

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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "The Hong Kong approval of tafasitamab and lenalidomide will not only provide access to eligible DLBCL patients in the region, but may also help patient access in the Greater Bay Area soon. Moving forward, we will accelerate the clinical trials of tafasitamab in China in the hopes of meeting more unmet medical needs."

Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, is not approved by the National Medical Products Administration (NMPA) for any indication in China, except that tafasitamab in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province for the treatment of eligible DLBCL patients, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone. As part of this early access program, the first prescription of tafasitamab in combination with lenalidomide was filed in July at the Ruijin Hainan Hospital for an eligible DLBCL patient.

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for autologous stem cell transplantation (ASCT).

About Tafasitamab

Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy.

In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name MONJUVI in the U.S., and marketed by Incyte under the brand name Minjuvi in Europe and Canada. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

ZielBio Receives Orphan Drug Designation for ZB131 for the Treatment of Pancreatic Cancer

On December 27, 2022 ZielBio, Inc., a clinical-stage biotechnology company discovering new treatments for cancer and other serious diseases through its innovative drug discovery platform, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead program, ZB131, for the treatment of treatment of pancreatic cancer, a rare solid-tumor cancer originating from the pancreas (Press release, ZielBio, DEC 27, 2022, View Source [SID1234625621]). ZB131 is a proprietary monoclonal antibody with a high affinity and specificity for cancer-specific plectin (CSP), a cell surface protein identified in a wide range of cancers that correlates with poor prognosis and aggressive tumors, including pancreatic cancer. ZielBio previously received Orphan Drug Designation for ZB131 for the treatment of cholangiocarcinoma (bile duct cancer).

"More than 62,000 people in the United States are diagnosed with pancreatic cancer each year and the five-year survival rate is only 11%," said Kimberly Kelly, Ph.D., founder and president of ZielBio. "We appreciate the special status that the FDA has granted ZB131 with this Orphan Drug Designation for pancreatic cancer, which is typically diagnosed at an advanced stage with few effective treatment options."

ZielBio developed ZB131 to target CSP after discovering that, unlike in healthy cells where plectin exists in the cytoplasm, plectin presents on the surface of cancer cells, where it functions as a driver of tumor growth and metastasis. In preclinical studies, ZB131 demonstrated high specific binding to CSP and strong anti-cancer activity. A Phase 1/2 trial is underway to study the safety, tolerability, and efficacy of ZB131 in patients with solid tumors, including cholangiocarcinoma, pancreatic, and ovarian cancers. Additional study details are available at clinicaltrials.gov with the trial identifier NCT05074472.

FDA Orphan Drug Designation may be granted to investigational drugs or biological products which show promise in treating rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Certain benefits associated with Orphan Drug Designation encourage the continued development of medicines that bring novel solutions to underserved patients. Roughly 32,970 men and 29,240 women in the United States are diagnosed each year with pancreatic cancer.

Deka Biosciences, Inc Announces Submission of Investigational New Drug (IND) Application for Lead Oncology Asset, DK210 (EGFR)

On December 27, 2022 Deka Biosciences, Inc. (Deka), a biotech company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on December 23, 2022 (Press release, Deka Biosciences, DEC 27, 2022, View Source [SID1234625620]). The IND application supports Deka’s DK210 (EGFR), a promising new cancer treatment that combines normal interleukin-2 with a high affinity interleukin-10, that is designed to accumulate in tumors by binding to the epidermal growth factor receptor (EGFR).

"With no dual cytokine therapy currently approved for the treatment of cancer, this IND application brings us one step closer to fulfilling our mission – to bring cures to patients with cancer and inflammatory diseases," said John Mumm, CEO & Co-Founder of Deka. "We are thrilled to advance DK210 (EGFR) to the clinical phase and anticipate beginning our Phase 1 trial as soon as possible after the FDA’s acceptance of our IND."

The IND filing comes nearly 18 months after the discovery of DK210 (EGFR), and the company is projecting to dose its first patient in early 2023.

DK210 (EGFR) is the first of many experimental therapeutics developed as part of Deka’s platform of molecules. Each Diakine in Deka’s platform consists of two complementary cytokines coupled together via attachment to a single chain variable fragment that enables the cytokines to accumulate more specifically in targeted tissues. The combination of the two cytokines increases potency and reduces toxicity while the targeting system also improves the drug’s efficacy, safety, and manufacturability. Deka has also identified genetic markers that are related to the differentiated responses to each Diakine. These markers will be evaluated in early clinical trials with the hope of using them as potential diagnostic tools to match patients with the most effective Diakine treatment in later stage trials.

Corporate Overview

On December 27, 2022 VBI Vaccines presented its Corporate overview (Presentation, VBI Vaccines, DEC 27, 2022, View Source [SID1234625619]).

TRACON Pharmaceuticals Announces up to $30M Non-Recourse Non-Dilutive Financing Related to Arbitration Award Decision Expected in Q1 2023

On December 27, 2022 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported entry into an up to $30 million non-recourse financing agreement (Press release, Tracon Pharmaceuticals, DEC 27, 2022, View Source [SID1234625618]).

"This non-dilutive funding provides for upfront capital along with potential post-award financing, so we may realize the value of a potential arbitration award once issued," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "We look forward to the announcement of the arbitration award that is expected in the first quarter of 2023."

$3.5 million will be funded before December 31, 2022. The additional $26.5 million, or a lesser amount based on the amount awarded, will be available subject to the award exceeding a threshold and satisfaction of other conditions set forth in the agreement, with 25% of the total being available to be funded after award announcement and the remainder available over a multi-year period. The non-recourse funding will be repaid upon collection of any award from I-Mab at varying rates that depend on the time elapsed from funding and certain other matters related to the arbitration.

The Company plans to use the funds to confirm and enforce any award and for working capital and general corporate purposes.