On October 31, 2022 Theravance Biopharma, Inc. (NASDAQ: TBPH) reported that it will report its third quarter 2022 financial results and provide a business update after market close on Monday, November 7, 2022 (Press release, Theravance, OCT 31, 2022, View Source [SID1234622658]). An accompanying conference call and simultaneous webcast will be hosted at 5:00 pm ET (2:00 pm PT/10:00 pm GMT) that day.

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Conference Call Information

To participate in the live call by telephone, please pre-register here. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investors section, Presentations and Events.

A replay of the webcast will be available on Theravance Biopharma’s website for 30 days through December 7, 2022.

On October 31, 2022 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the Company will release its third quarter 2022 financial results on Monday, November 14, 2022, before the U.S. financial markets open (Press release, Compugen, OCT 31, 2022, View Source [SID1234622657]). Management will host a conference call and webcast to review the results and provide a corporate update at 8:30 AM ET.

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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

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As part of the update, management will discuss Compugen’s data to be presented at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held on November 8-12, 2022.

To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S.,
or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link

Following the live webcast, a replay will be available on the Company’s website.

On October 31, 2022 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported that their first patient has been successfully dosed, in a phase I clinical study evaluating the combined treatment with Senhwa’s Pidnarulex, the 2019 PCF-Pfizer Global Challenge Awards winner and Pfizer’s PARP inhibitor, Talazoparib (Talzenna), in patients with metastatic castration-resistant prostate cancer(mCRPC) (Press release, Senhwa Biosciences, OCT 31, 2022, View Source [SID1234622656]). The study will be conducted by Peter MacCallum Cancer Centre (PMCC), Senhwa’s clinical partner in Melbourne, Australia.

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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

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This Phase I trial of Pidnarulex and Talazoparib will be mainly funded by the US Prostate Cancer Foundation (PCF) and Pfizer. Senhwa will provide supplies of their study drug, Pidnarulex, in addition to specific funding for the study.

In 2020, US FDA granted approval of the use of PARP inhibitors (PARPi), such as olaparib (Lynparza) and rucaparib (Rubraca), to treat prostate cancer patients, whose tumors have specific genetic alterations. The most common gene alterations in this population were BCRA1/2. While BRCA1/2 deficient tumor cells are responsive to PARPi treatments, the development of PARPi resistance is common.

In a previous Phase I trial, Pidnarulex demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers, such as BRCA1/2 and PALB2 mutations and that were also resistant to PARP inhibitors, platinum-based drugs and other chemotherapeutics.

"Pidnarulex, alone, has shown efficacy in tumor cells resistant to PARPi in the preclinical studies. Therefore, we think Pidnarulex demonstrates great potential as an alternative treatment for prostate cancer patients who have acquired resistance to PARPi or other chemotherapies," said Dr. Jin-Ding Huang, Chief Executive Officer of Senhwa Biosciences.

Prostate Cancer is the second most lethal cancer for men in the United States. Although nearly 70% of patients can be cured with surgery, once the cancer has metastasized, almost all patients develop into castration-resistance (a form of advanced prostate cancer in which the cancer no longer completely responds to treatments that lower testosterone), with a median survival time of less than two years.

About Pidanrulex (CX-5461)

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by Pidnarulex through a synthetic lethality approach by targeting the DNA repair defects in Homologous Recombination Deficiency (HRD) tumors. Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death.

On October 31, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the Investigational New Drug (IND) application for ATG-017 has received clearance from the U.S. Food and Drug Administration (FDA) (Press release, Antengene, OCT 31, 2022, View Source [SID1234622654]). The IND clearance enables Antengene to initiate the combination portion of the Phase I "ERASER" clinical trial in the United States (U.S.) to evaluate the safety, pharmacokinetics, and preliminary efficacy of ATG-017 combination therapy with nivolumab in patients with advanced solid tumors.

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ATG-017 is an oral, potent, and selective inhibitor of extracellular signal-regulated protein kinase 1 and 2 (ERK1/2). Nivolumab is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells. The clinical collaboration between Antengene and Bristol Myers Squibb to evaluate ATG-017 in combination with nivolumab builds on Antengene’s preclinical data. The data, including studies presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-conference Programs in November 2021, has demonstrated that the combination of an ERK1/2 inhibitor and an immune checkpoint inhibitor (ICI) worked synergistically to produce improved efficacy in preclinical ICI-resistant in vivo mice models.

"We are excited to have received IND clearance for activation of the ERASER study in the U.S. Preclinical results with ATG-017 have been very promising both as a monotherapy and in combination with ICIs in aggressive and resistant malignancies. We are very pleased that the further clinical exploration will involve multiple geographies as we attempt to define the potential role of ATG-017 as a novel cancer treatment," said Dr. Kevin Lynch, Antengene’s Chief Medical Officer."Every day, we see advanced cancer patients with limited treatment options. We intend to initiate the study in the U.S. soon, and hope that ATG-017 will eventually offer a safe and effective new treatment option to those patients in need."

"The development of new therapies for cancer patients with refractory, relapsed, or advanced diseases is a cornerstone of Antengene’s work. ATG-017 is an exciting compound because of its attractive pharmacology, impressive preclinical activity on the RAS-MAPK pathway and the potential ability to synergize with ICIs. These attributes provide the rationale for evaluating ATG-017 as a monotherapy and in combination with ICIs such as nivolumab in patients with resistant or relapsed disease," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "We are very encouraged by this IND clearance from the U.S. FDA as it paves the way for one of Antengene’s first studies in the U.S. and marks an important milestone in the global clinical development of ATG-017. We look forward to initiating patient enrollment of the ERASER trial in the U.S."

About ATG-017

ATG-017 is an oral, potent, and selective small molecule extracellular signal-regulated kinases 1 and 2 (ERK1/2) inhibitor. ERK1/2 are related protein-serine/threonine kinases that function as terminal kinases in the RAS-MAPK signal transduction cascade. This cascade regulates a large variety of cellular processes, including proliferation. The RAS-MAPK pathway is dysregulated in more than 30% of human cancers with the most frequent alterations being observed in RAS or BRAF genes across multiple tumor types. An ERK inhibitor enables the targeting of both RAS and BRAF mutant diseases.

Antengene presented data at the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-conference Programs in November 2021 detailing compelling preclinical results showing the combination of ATG-017 and an anti-PD-L1 monoclonal antibody (atezolizumab) in an aggressive immune checkpoint resistant murine cancer model rendered "cold" tumors "hot". To date, ATG-017 has been approved in Australia and the United States to enter clinical studies in patients with advanced solid tumors or hematologic malignancies.

On October 31, 2022 Cellular Biomedicine Group Inc. (CBMG or the "Company"), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, reported that the Food and Drug Administration (FDA) granted clearance of the Investigational New Drug (IND) application to proceed with Phase 1 clinical development of its novel Tumor Infiltrating Lymphocyte (TIL) product C-TIL051 for late-stage Non-Small Cell Lung Cancer (NSCLC) patients that are relapsed or refractory to anti-PD1 therapy (Press release, Cellular Biomedicine Group, OCT 31, 2022, View Source [SID1234622653]).

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C-TIL051 is an autologous adoptive cell therapy comprised of a patient’s ex vivo expanded lymphocytes using CBMG’s proprietary manufacturing process.

"This is outstanding news for NSCLC patients who are faced with limited treatment options."

"This is outstanding news for NSCLC patients who are faced with limited treatment options. C-TIL051 could potentially offer an alternative treatment and our preclinical data show that C-TIL051 might have the potential to be superior. We are working closely with clinical sites and plan to initiate the C-TIL051 Phase 1 trial soon," said Tony (Bizuo) Liu, Chairman and CEO of CBMG. "FDA clearance of the C-TIL051 IND is a significant milestone for CBMG. We plan to start manufacture of clinical batches of C-TIL051 in our GMP facility at Rockville Maryland in the near future."

About C-TIL051
C-TIL051 is manufactured and released at CBMG’s state-of-the-art GMP facility in Rockville Maryland using a proprietary process that can achieve clinical doses more rapidly and more efficiently than traditional TIL manufacturing methods. The process involves ex vivo expansion of tumor infiltrating lymphocytes in a two-step process. C-TIL051 has not been previously studied in human clinical trials however the rationale for developing C-TIL051 was based on initial NSCLC TIL studies demonstrating encouraging safety and efficacy results (NCT03215810, NCT03645928).