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 1, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the Hong Kong Department of Health has approved TIVDAK (tisotumab vedotin-tftv) in Hong Kong for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy (Press release, Zai Laboratory, SEP 1, 2025, View Source [SID1234655613]).

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!

"Today’s approval of TIVDAK marks an important milestone for Zai Lab, further strengthening our Women’s franchise in Greater China," said Andrew Zhu, Chief Commercial Officer, Greater China, Zai Lab. "Treatment options for patients with recurrent or metastatic cervical cancer after initial therapy are limited. TIVDAK, the first antibody-drug conjugate (ADC) therapy in cervical cancer, delivers a clinically meaningful survival benefit to patients. With our established commercial infrastructure for ZEJULA in Hong Kong, we are uniquely positioned to ensure TIVDAK reaches patients without delay."

TIVDAK is currently under regulatory review for its Biologics License Application by China’s National Medical Products Administration (NMPA), which was accepted in March 2025.

About TIVDAK (tisotumab vedotin-tftv)

TIVDAK (tisotumab vedotin) is an ADC composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

TIVDAK received full approval from U.S. Food and Drug Administration (FDA) in April 2024 for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Zai Lab has an exclusive license from Seagen Inc., acquired by Pfizer, to develop and commercialize TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively).

On September 1, 2025 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases, reported that the transaction announced last August 25th has now been completed with €500k in cash received by the Company August 28th (Press release, TME Pharma, SEP 1, 2025, View Source [SID1234655614]). The cash position of TME Pharma is up to €2.35M, showing the good progress of the new cost-efficient organization.

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!

Now that TME Pharma has implemented the lower cost-base model, it will be more able to attract partners for the development of new therapies for cancer and eye diseases. TME Pharma still has high expectations for its NOX-A12 and NOX-E36 programs. TME Pharma will keep informing the markets about the progress it is making.

CEO Van den Ouden will continue to use his experience and expertise to implement the Company’s treasury investment strategy to properly balance risk and return to achieve optimal results for shareholders. TME Pharma is continuing to search for suitable crypto and crypto related candidates for the treasury investment strategy but has no current exposure to crypto.