On September 2, 2025 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that Chen Schor, President and Chief Executive Officer, will present at the H.C. Wainwright 27th Annual Global Investment Conference being held from September 8-10, 2025 in New York (Press release, Adicet Bio, SEP 2, 2025, View Source [SID1234655682]).

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!

Details of the event are as follows:
Date: Monday, September 8, 2025
Time: 4:30 p.m. ET

The live audio webcast can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

On September 2, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for AVZO-103 (formerly VAC-103), a potential best-in-class Nectin4/TROP2 bispecific antibody-drug conjugate (ADC) (Press release, Avenzo Therapeutics, SEP 2, 2025, View Source [SID1234655635]). Avenzo has also exercised its exclusive option for AVZO-103 from VelaVigo, securing global (excluding Greater China) development, manufacturing, and commercialization rights.

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!

Under the IND, the company plans to initiate a Phase 1/2 first-in-human, open-label clinical study later this year. The Phase 1 portion will assess the safety, tolerability, and preliminary clinical activity of AVZO-103 as a single agent and in combination therapy in patients with advanced solid tumors.

"The clearance of our IND for AVZO-103 marks our third IND clearance this year, highlighting the productivity and dedication of our R&D team," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "This bispecific ADC is designed to simultaneously target Nectin4 and TROP2 to potentially enhance tumor cell killing while sparing normal tissue. We look forward to studying its potential to address significant unmet needs for patients with cancers that co-express these targets, including urothelial cancer."

On September 2, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported a new clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) in metastatic breast cancer (Press release, Olema Oncology, SEP 2, 2025, View Source [SID1234655653]). The companies will evaluate in a Phase 1b/2 study the safety and combinability of palazestrant plus atirmociclib, Pfizer’s investigational, highly selective-CDK4 inhibitor, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast 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!

"We are excited to assess this combination in the clinic as we seek to establish palazestrant as a potential backbone endocrine therapy for metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Based on the promising profiles of palazestrant and atirmociclib to date, we look forward to evaluating the potential of this novel combination and, if successful, advancing to a pivotal trial in the frontline setting. With OPERA-01, our first pivotal study of palazestrant, underway and our OPERA-02 ribociclib combination trial in frontline metastatic breast cancer anticipated to initiate this quarter, we remain focused on achieving our goal of transforming the metastatic breast cancer treatment paradigm."

Under the terms of the agreement, Pfizer will supply atirmociclib for use in the Phase 1b/2 study and Olema will lead the conduct of the study. All clinical data and inventions relating to the combined use of atirmociclib and palazestrant resulting from the study will be jointly owned, with Olema maintaining full global commercial and marketing rights to palazestrant.

This announcement represents Olema’s second clinical trial agreement with Pfizer. The companies’ previous agreement was established in November 2020 to evaluate palazestrant in combination with palbociclib (IBRANCE) in patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer.

On September 2, 2025 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for difficult-to-treat cancers, reported that management will participate in two upcoming investor conferences (Press release, Circle Pharma, SEP 2, 2025, View Source [SID1234655636]):

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!

Morgan Stanley 23rd Annual Healthcare Conference

1X1 Meetings: Monday, September 8, 2025

Location: New York, NY

Oppenheimer Life Sciences Private Company Showcase

1X1 Meetings: Thursday, September 25, 2025

Location: Virtual

On September 2, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported an updated safety analysis of pelareorep, which has been administered in over 1,200 patients, including over 300 patients with various gastrointestinal tumors (Press release, Oncolytics Biotech, SEP 2, 2025, View Source [SID1234655654]).

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 previous analysis of safety data from studies involving pelareorep (link to the poster) in combination with multiple therapies in over 500 patients concluded that the most frequent adverse events were Grade 1 and 2 fever, chills, fatigue, nausea, vomiting, and diarrhea. Additionally, Grade 3 or 4 adverse events associated with chemotherapy do not appear to be modified by adding pelareorep to the treatment regimen. An updated analysis involving patients who received at least one intravenous dose of pelareorep demonstrates the existing favorable safety profile of pelareorep in combination with numerous treatment regimens across multiple tumor types.

"With over 1,200 patients dosed and a consistent safety profile, pelareorep represents one of the most de-risked immunotherapies that is not already approved as a treatment option in gastrointestinal tumors," said Jared Kelly, Chief Executive Officer of Oncolytics. "As we move forward to registration-enabled studies, we are confident the safety data will be a positive characteristic for regulators and potential partners."

To date, over 300 gastrointestinal cancer patients across 8 clinical studies have received pelareorep. It has been evaluated in combination with new treatment regimens like modified FOLFIRINOX in metastatic pancreatic cancer and in other tumor types, including colorectal cancer and anal cancer. The most common adverse events associated with pelareorep in patients with gastrointestinal tumors are flu-like symptoms and neutropenia.