On April 20, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) of BeiGene’s anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) (Press release, BeiGene, APR 20, 2020, View Source [SID1234556465]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This sNDA filing is another important milestone in tislelizumab’s development program, coming on the heels of its recent approval in urothelial carcinoma in China – our first approval in solid tumors and the announcement of the positive outcome of our second study in first-line NSCLC, in patients with non-squamous histology. Our team was able to submit the regulatory application only 20 months after trial initiation, illustrating how efficiently we can move to serve those in need," commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "We look forward to working closely with the CDE on this filing and hope to bring a new treatment option to the large population of patients with advanced squamous NSCLC in China who could benefit from immunotherapy."

This sNDA is supported by clinical results from a Phase 3 trial of tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE) and carboplatin compared to paclitaxel and carboplatin alone in patients with untreated stage IIIB or IV squamous NSCLC from mainland China (NCT03594747). A total of 360 patients were randomized 1:1:1 to receive tislelizumab in combination with either chemotherapy regimen or chemotherapy alone. As announced in January 2020, the trial met the primary endpoint of statistically significant improvement in progression-free survival (PFS), as assessed by independent review committee (IRC), in the pre-planned interim analysis. The safety profile of tislelizumab in both combinations was consistent with the known risks of each study treatment, and no new safety signals were identified. Full results of the trial will be presented at an upcoming meeting.

About Non-Small Cell Lung Cancer

In contrast to most Western countries where lung cancer death rates are decreasing, lung cancer incidence rate is still increasing in China.1,2 There were approximately 770,000 new cases of lung cancer in China in 2018 and it is the leading cause of cancer-related death in both men and women, with approximately 690,500 deaths in China in 2018.3 Non-small cell lung cancer comprises the most common form of lung cancer in China.4

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is approved by the China National Medical Products Administration as a treatment for patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 11 Phase 3 trials and four pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China and is not approved to treat non-small cell lung cancer.

About Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);

Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);

Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);

Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);

Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);

Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);

Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);

Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);

Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);

Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);

Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);

Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and

Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.