On September 26, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that tumor outcomes data from its Phase 3 ROMAN trial of avasopasem for severe oral mucositis (SOM) and final data from its Phase 2 AESOP trial of avasopasem for chemoradiotherapy-induced esophagitis will be highlighted in two presentations at the upcoming 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place October 23-26, 2022 in San Antonio, Texas (Press release, Galera Therapeutics, SEP 26, 2022, View Source [SID1234621420]). Additionally, poster presentations will highlight the Phase 2 EUSOM trial of avasopasem for SOM in Europe and the ongoing GRECO-1 trial of rucosopasem for non-small cell lung cancer.

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!

Presentation Details

Title: Tumor Outcomes for ROMAN: Phase 3 Trial of Avasopasem Manganese (GC4419) for Severe Oral
Mucositis (SOM) in Patients Receiving Chemoradiotherapy (CRT) for Locally Advanced Head and Neck Cancer (LAHNC)
Abstract Number: 280
Presenter: Carryn M. Anderson, M.D., University of Iowa Hospitals & Clinics
Session Title: H&N 3 – Toxicity Mitigation and HPV-Unrelated Head and Neck Cancer – Life Beyond De-Intensification
Session Date and Time: Wednesday, October 26, 2022 | 12:40 p.m. CDT
Session Location: Henry B. Gonzalez Convention Center, Room 214

Title: AESOP: Phase 2 Open-Label Trial of Avasopasem Manganese (GC4419) for Reduction of Esophagitis in Patients Receiving Chemoradiotherapy for Nonmetastatic Lung Cancer
Abstract Number: 1124
Presenter: Bryan G. Allen, M.D., Ph.D., University of Iowa Hospitals & Clinics
Session Title: Lung 3 – Optimizing Radiation Dose, Volume, and Concomitant Systemic Agents
Session Date and Time: Wednesday, October 26, 2022 | 10:50 a.m. CDT
Session Location: Henry B. Gonzalez Convention Center, Room 303

Poster Q&A Details

Title: GRECO-1: Phase 1/2 Study of Stereotactic Body Radiation Therapy (SBRT) with or without Rucosopasem (GC4711) for Early Stage, Peripheral or Centrally Located Non-Small Cell Lung Cancer (NSCLC)
Abstract Number: 2841
Presenter: Puneeth Iyengar, M.D., Ph.D., UT Southwestern Medical Center
Session Title: Poster Q&A 01 – Lung Cancer and DEIH
Session Date and Time: Sunday, October 23, 2022 | 4:45 p.m. CDT
Session Location: Henry B. Gonzalez Convention Center, Exhibit Hall 1

Title: EUSOM: Phase 2 Trial of Avasopasem Manganese (GC4419) for Oral Mucositis in Patients Receiving Chemoradiotherapy for Locally Advanced, Nonmetastatic Head and Neck Cancer
Abstract Number: 2687
Presenter: Jordi Giralt, M.D., Ph.D., Vall d’Hebron University Hospital
Session Title: Poster Q&A 09 – Head & Neck Cancer and Health Services Research
Session Date and Time: Wednesday, October 26, 2022 | 10:30 a.m. CDT
Session Location: Henry B. Gonzalez Convention Center, Exhibit Hall 1

The titles of the abstracts are currently available in the ASTRO digital program, with the full abstracts available on Friday, October 21, 2022, at 5 p.m. CDT.

On September 26, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will participate in a fireside chat at Chardan’s 6th Annual Genetic Medicines Conference on Monday, October 3, 2022 at 2:00 p.m. ET in New York, NY (Press release, Oncorus, SEP 26, 2022, View Source [SID1234621419]).

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!

A live webcast of the fireside chat can be accessed by visiting the Investors & Media section of Oncorus’ website at View Source A replay of the webcast will be archived on Oncorus’ website for 90 days following the event.

On September 26, 2022 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that C4T management will participate in a fireside chat at the virtual Bank of America Securities Precision Oncology Conference 2022 (Press release, C4 Therapeutics, SEP 26, 2022, View Source [SID1234621418]).

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!

A live webcast of the presentation will be available on the Investors section of the company’s website at www.c4therapeutics.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On September 26, 2022 Qu Biologics Inc., a clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel immunotherapy platform designed to restore innate immune function, reported it has received Health Canada clearance (No Objection Letter) and institutional-level ethics approval to proceed with a randomized placebo-controlled Phase II multicenter trial to assess the effectiveness of QBECO SSI in reducing postoperative immune suppression and improving cancer outcomes in patients with late-stage colorectal cancer undergoing surgical resection of liver metastases (Press release, Qu Biologics, SEP 26, 2022, View Source [SID1234621417]). QBECO SSI is a first-in-class innate immune modulator specifically designed to restore innate immune function in the gastrointestinal (GI) tract, including the liver. The study, which is led by gastroenterology (GI) oncology surgeons Dr. Rebecca Auer (Ottawa Hospital Research Institute) and Dr. Paul Karanicolas (Sunnybrook Health Sciences Centre) and managed by the Centre of Clinical Trial Support at the Sunnybrook Research Institute, will enroll patients through a minimum of six academic oncology centers in Ontario.

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!

Major surgery results in immune paralysis in the days following surgery that can contribute to cancer growth and metastases, leading to poor outcomes for cancer patients undergoing surgical treatment. By programming immune cells to remain functionally active to deal with any postoperative remnants of cancer and targeting that response to the liver and GI tract, QBECO SSI is singularly positioned to overcome surgery-induced immune suppression and its negative consequences on patient outcomes.

Dr. Hal Gunn, CEO of Qu Biologics, stated, "A majority of patients diagnosed with cancer undergo surgery in the hope of cure. However, surgery profoundly suppresses immune function in the postoperative period, enabling residual cancers cells to grow and spread. This exciting study is designed to test whether we can prevent that postoperative immune suppression resulting in improved outcomes and survival." Immunologist Dr. Shirin Kalyan, Qu’s VP of Scientific Innovation, noted, "Proof-of-concept studies have shown that QBECO SSI treatment overcomes both cancer-induced and the more profound surgery-induced immune suppression through innate immune training and natural killer cell (NK cell) activation resulting in clearance of cancer cells in the targeted organ. This trial will assess whether perioperative QBECO SSI treatment can serve as a unique multi-pronged approach to transform outcomes for cancer patients undergoing surgery." Dr. Paul Karanicolas, study co-lead investigator noted, "Patients with late-stage colorectal cancer with liver metastases can potentially be cured by surgical excision of those metastases. Unfortunately, the majority of patients go on to have cancer recurrence and disease progression following surgery. There aren’t any current treatments that have been shown to improve overall survival in these patients; new effective treatments that improve survival are urgently needed." Dr. Rebecca Auer, co-lead investigator of the study and leading researcher in the field of postoperative immune suppression added, "As surgeons we recognize the significant impact of surgery on the immune system and, given the central role that the immune system plays in the clearance of cancer cells, it is paramount to find a therapeutic strategy to enhance postoperative immune function. Preclinical studies suggest that QBECO SSI could be that therapy for colorectal cancer surgery."

On September 26, 2022 CatalYm reported that it has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA) to expand its ongoing Phase 2 clinical program to include clinical trial centers in the U.S. The ongoing GDFATHER-2 program (GDF-15-neutralizing antibody-mediated human effector cell relocation) is evaluating the company’s lead candidate, visugromab in combination with an anti-PD1 antibody in patients with advanced solid tumors that are relapsed/refractory to prior anti-PD1/-PD-L1 treatment (Press release, Catalym, SEP 26, 2022, View Source [SID1234621416]). Visugromab is a monoclonal antibody that neutralizes GDF-15, a key immunosuppressor, which has been shown to prevent T cell migration into tumors, enabling cancerous cells to evade the immune system.

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!

"Adding trial sites in the U.S. is a critical component of our clinical development strategy for visugromab and we appreciate receiving this IND approval," said Prof. Dr. Eugen Leo, Chief Medical Officer at CatalYm. "Our focus is to rapidly advance the GDFATHER-2 program and we have now gained the opportunity to enroll a more diverse set of cancer patients. We are planning to further maximize the potential of this program with additional cohorts and trial modalities in the future."

Dr. Phil L’Huillier, Chief Executive Officer at CatalYm added: "The IND clearance demonstrates our ability to execute on our clinical objectives and heralds the next stage of our journey toward developing visugromab as a new class of anti-cancer immunotherapeutic treatment. We look forward to working with our clinical partners in the United States and to announcing initial results from the first ongoing Phase 2a cohorts by mid 2023."

The multi-center, open-label, cohort expansion GDFATHER-2 trial (NCT04725474) investigates the treatment of advanced stage cancer patients that are relapsed/refractory to prior anti-PD-1/-PD-L1 treatment with the GDF-15 neutralizing antibody, visugromab, in combination with the anti-PD-1 checkpoint inhibitor nivulomab. The GDFATHER-2a program will enroll up to 164 participants aged 18 years or older, who are relapsed or refractory to prior anti-PD-1/-PD-L1 treatment, at clinical centers across Europe and the United States. Phase 2a is currently recruiting at locations in Germany, Spain and Switzerland. Recruitment in the United States is expected to begin before end of 2022.

The full data readout from the visugromab Phase 1 trial, GDFATHER-1, was recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 and demonstrated encouraging signs of efficacy in a last-line patient setting with a favorable safety profile.