On April 20, 2020, Cumberland Pharmaceuticals, Inc. (the "Company"), reported that received the funding of a loan ("Loan") from Pinnacle Bank in the aggregate amount of $2,187,140 pursuant to the Paycheck Protection Program (the "PPP") under the Federal Coronavirus Aid, Relief, and Economic Security Act ("CARES Act"), which was enacted March 27, 2020 (Filing, 8-K, Cumberland Pharmaceuticals, APR 20, 2020, View Source [SID1234556459]). The PPP is administered by the U.S. Small Business Administration.

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The Loan, which was in the form of a Note dated April 14, 2020, maturing on April 14, 2022 and bearing interest at a rate of 1.0% per year, payable monthly commencing during November 2020. The Note may be prepaid by the Borrower at any time prior to maturity with no prepayment penalties. Funds from the Loan are to be used to maintain payroll, continue group health care benefits and pay for rent and utilities. Under the terms of the PPP, certain amounts of the Loan may be forgiven if they are used for qualifying expenses as described in the CARES Act. The Company intends to use the majority of the Loan amount for such qualifying expenses.

On April 20, 2020 Genome & Company (KONEX: 314130), a biotechnology company developing innovative therapeutics in immune-oncology, reported that the United States (US) Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for GEN-001 for combination treatment with avelumab (BAVENCIO) in patients with solid cancers (Press release, Genome & Company, APR 20, 2020, View Source;company-receives-fda-ind-clearance-for-gen-001-its-first-anti-cancer-microbiome-therapeutic-301043307.html [SID1234556445]). Avelumab is an anti-PD-L1 antibody co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

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With this clearance, Genome & Company will be the first Asian company to initiate a first-in-human trial of anti-cancer microbiome and anti-PD1/anti-PD-L1 combination treatment as a sole sponsor. The phase 1/1b clinical trial will be initiated at the US clinical sites and the first patient is expected to be enrolled within this year.

"IND clearance from FDA for our first anti-cancer microbiome therapeutic GEN-001 is a very significant milestone as it will transition Genome & Company into a clinical-stage biotechnology company. We hope to add meaningful value and advancement in the microbiome and immuno-oncology industry with our combinational approach to cancer patients who have progressed on prior anti-PD1/anti-PD-L1 therapy," said Dr. Hansoo Park, Chief Technical Officer of Genome & Company.

Dr. Jisoo Pae, CEO of Genome & Company further quoted, "This IND approval is a meaningful corporate milestone and a critical step forward to achieving new arrangements in strategic partnering. We are indeed looking forward to further investigate how our clinical data will be translated into our cancer patients. I thank all the members and partners of Genome & Company for dedicating themselves to accomplishing this milestone."

In January this year, Genome & Company had entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the safety, tolerability, biological and clinical activities of GEN-001 therapy in combination with avelumab in multiple cancer indications. The combination trial is designed to be a first-in-human study including dose escalation and expansion cohorts to evaluate the safety and preliminary efficacy.

BAVENCIO is a trademark of Merck KGaA, Darmstadt, Germany.

About GEN-001

GEN-001 is an oral microbiome therapeutic candidate developed to have immune modulating activities, resulting in potential partnership with immune checkpoint inhibitors. GEN-001 consists a single strain bacteria isolated from gut of healthy human volunteers that has been shown to activate dendritic cells, macrophages and T cell response. In preclinical studies, GEN-001 has shown optimal safety margin and synergistic effects in combination with immune checkpoint inhibitors by enhancing the effect of suppressing the growth of both immune checkpoint inhibitor sensitive and resistant tumor models.

On April 20, 2020 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported the publication of a peer reviewed paper titled "Characterization of BAY 1905254, a novel immune checkpoint inhibitor targeting the immunoglobulin-like domain containing receptor 2 (ILDR2)" describing BAY 1905254’s ability to trigger an anti-tumor immune response in mice, supporting its clinical evaluation as a cancer immunotherapy (Press release, Compugen, APR 20, 2020, View Source [SID1234556444]). The preclinical studies, published in Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), were conducted in collaboration between Compugen and Bayer AG, with data demonstrating BAY 1905254 in vitro T cell activation and in vivo anti-tumor activity.

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ILDR2 is a novel therapeutic target in immuno-oncology discovered computationally by Compugen and licensed to Bayer under a research and development collaboration and license agreement. ILDR2 is expressed by a specialized stromal cell subset so called fibroblastic reticular cells (FRCs) located in the lymph node where T cell priming and initiation of local T cell responses occur. Therefore, the hypothesis on the mode of action of BAY 1905254 is that the blockade of the immunosuppressive function of ILDR2 in the lymph node results in enhanced T cell priming, allowing for enhanced anti-cancer immune responses. BAY 1905254 is currently being evaluated by Bayer in a Phase 1 study as monotherapy and in combination with Keytruda in patients with advanced solid tumors.

"This publication further supports and extends our prior published studies on ILDR2, offering additional validation to Compugen’s ability to discover computationally untapped drug targets. It also further substantiates ILDR2’s role as a new immune checkpoint with possible applications in oncology and autoimmune diseases," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "ILDR2’s differentiated mode of action suggests that BAY 1905254 has the potential to expand treatment options for cancer patients unresponsive or refractory to existing immunotherapies."

"Bayer has been an excellent partner to us and we are very pleased with their continued commitment and investment in the clinical development of BAY 1905254," added Dr. Cohen-Dayag.

The paper was co-authored by scientists at Bayer and Compugen.

On April 20, 2020 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that it will release its first quarter 2020 financial results on Thursday, April 30, 2020 (Press release, Insmed, APR 20, 2020, View Source [SID1234556443]).

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Thursday, April 30, 2020 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (888) 317-6003 (domestic) or (412) 317-6061 (international) and referencing conference ID number 2121512. The call will also be webcast live on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately one hour after its completion through May 14, 2020 by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and referencing replay access code 10142785. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.

On April 20, 2020 Transcenta Holding Limited. ("Transcenta"), a global biotherapeutics company that fully integrates antibody-based biotherapeutics discovery, R&D and manufacturing, reported that its subsidiary Mabspace Biosciences (Suzhou) Co., Limited has received clearance of its IND from FDA for its novel humanized Claudin 18.2 (CLDN18.2) monoclonal antibody (internal project number TST001) (Press release, Transcenta, APR 20, 2020, View Source;301043268.html [SID1234556442]). It is developed jointly by Mabspace Biosciences and HJB, another Transcenta’s subsidiary focusing on CMC and manufacturing.

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The unique expression profile of Claudin 18.2 in normal tissue and its aberrant expression in multiple tumor types make Claudin 18.2 an attractive anti-cancer therapeutic target. TST001 is a humanized high affinity anti-Claudin 18.2 antibody and kills tumor cells via antibody-dependent cellular cytotoxicity (ADCC). Through bioprocess engineering, TST001 is produced with reduced fucosylation and results in significant enhancement in its ADCC inducing activity against Claudin 18.2 expressing tumors. In preclinical studies, TST001 is efficacious in multiple tumor animal models, and well tolerated in GLP toxicology studies. As of today, TST001 has received clearance from both FDA and China National Medical Products Administration (NMPA) to initiate clinical trials in patients with metastatic solid tumors.

"The FDA’s clearance of our IND is an important milestone for TST001 project transition into clinical-stage. Our team is very excited to have the opportunity to test this differentiated Claudin 18.2 antibody in cancer patients. Our ongoing development of companion diagnostic antibody will help us to identify patients with Claudin 18.2 expression. We hope to expedite the development of this agent to bring potentially more efficacious treatment options to cancer patients around the world," said Dr. Xueming Qian, Transcenta’s Co-Founder and Chief Executive Officer.