On September 9, 2026 1cBio, a biopharmaceutical company focused on discovering and developing innovative therapies for serious and underserved conditions including oncology and metabolic diseases, and Lee’s Pharmaceutical Holdings Ltd. ("Lee’s Pharm"), reported that the companies have entered into a licensing agreement granting Lee’s Pharm exclusive rights to develop and commercialize 1cBio’s lead PARP1 inhibitor, OC-3, in China and certain countries in Southeast Asia. Under the terms of the agreement, 1cBio is eligible to receive an upfront payment, development milestones and potential sales milestone payments totaling up to US$27 million, as well as royalties on future net sales.

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!

OC-3, currently in preclinical development, is a potential best-in-class PARP1 inhibitor for the treatment of cancers that are defective in DNA homologous recombination repair. These cancer types include predominately prostate, ovarian, breast and pancreatic cancers with known mutations in DNA repair genes such as BRCA1, BRCA2 or PALB2. In preclinical models of cancers known to have DNA repair deficiency of this kind, OC-3 demonstrated potent anticancer activities.

"This agreement with Lee’s Pharm provides 1cBio a valued China-based drug development and commercialization partner for OC-3," said Andrew Protter, PhD, CEO of 1cBio. "With Lee’s Pharm, 1cBio collaborates with a team that has a robust oncology group, strong manufacturing capabilities, and a proven ability to advance assets in various stages of development in Asia. This partnership will provide valuable resources as we work toward filing an IND in the U.S. and advancing OC-3 into clinical trials for patients with solid tumors."

"We believe that OC-3’s PARP1 inhibitor has the potential to become an important new treatment option for patients with cancer, with a differentiated profile that may offer meaningful improvements in both safety and efficacy," said Benjamin Li, Founder and Director of Lee’s Pharm. "We are pleased to enter into this collaborative development agreement with 1cBio and look forward to working together to advance the program."

Lee’s Pharm will be responsible for Good Laboratory Practice (GLP) safety studies and manufacturing activities required to gain regulatory approval for OC-3 in China and the other Southeast Asian territories included in the license. A drug supply manufacturing agreement is also included.

As part of the agreement, 1cBio will have rights to access and use any data generated as part of its efforts to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).

(Press release, 1cBio, SEP 9, 2026, View Source [SID1234670685])

On September 9, 2026 Apeximmune Therapeutics, Inc., an IND-stage immuno-oncology company, reported the publication of research in Nature validating PLA2G2D as a novel and mechanistically distinct immune checkpoint capable of addressing resistance to anti-PD-1 therapy. The publication represents the convergence of two independent research programs – one led by Apeximmune, the other by researchers at Erasmus University Medical Center (Erasmus MC) in Rotterdam, the Netherlands – that arrived at the same target using fundamentally different scientific approaches.

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!

Anti-PD-1 therapies have transformed the treatment of certain cancers, but the majority of patients across indications either fail to respond or eventually relapse. Response rates fall to single digits in gastrointestinal cancers and other tumor types. Overcoming this resistance remains one of the most significant unmet needs in oncology.1

Two paths, one target. Apeximmune and Erasmus MC reached phospholipase A2 group IID (PLA2G2D) by markedly different routes. Apeximmune’s team, led by founder and CEO, Li-Fen Lee, PhD, applied a proprietary bioinformatics algorithm to more than 9,000 primary tumor samples from The Cancer Genome Atlas (TCGA), surfacing 70 candidate novel immune checkpoints. PLA2G2D emerged as the top-ranked hit, well ahead of known checkpoints PD-1 and CTLA-4 in the same analysis.

Erasmus MC, working in parallel and unaware of Apeximmune’s program, applied a spatial proteogenomic approach to melanoma patient samples from individuals who had divergent clinical outcomes. Their analysis independently identified PLA2G2D as a top hit in the dendritic cell and macrophage populations interacting with CD8+ T cells in patients with worse outcomes.

A mechanism the field had overlooked. Beyond identifying the target, the Apeximmune team uncovered a mechanism that had eluded prior investigators. PLA2G2D has long been characterized for its phospholipase activity, and previous efforts to drug the broader sPLA2 family, including terminated late-stage small-molecule programs for inflammation from major pharmaceutical companies, had assumed its enzymatic function was central to its biology. Apeximmune demonstrated that an enzyme-dead form of PLA2G2D retains potent immunosuppressive activity, establishing that the molecule’s role in tumor immune evasion is independent of its enzymatic activity.

Preclinical data suggest a dual therapeutic opportunity. Data reported in the Nature publication indicate that PD-1 and PLA2G2D are nonredundant and reciprocally regulated. More importantly, blockade of PLA2G2D not only restores anti-tumor immunity in preclinical models resistant to anti-PD-1 therapy but also potentiates the activity of anti-PD-1 in tumor types that are otherwise unresponsive to checkpoint inhibition. Together, the Nature findings on PLA2G2D point to two potential paths for patient benefit: a new therapeutic option for patients who have failed anti-PD-1 therapy, and a way to extend the reach of anti-PD-1 into tumors currently considered "cold."

Apeximmune built an antibody against PLA2G2D. AI-306, the company’s lead product candidate, is a first-in-class monoclonal antibody that blocks both the enzymatic and non-enzymatic activity of PLA2G2D. Backed by key patents covering target antagonism, antibody constructs, and combination therapies, AI-306 is currently in IND-enabling development with cell line development underway. GLP toxicology studies are scheduled to initiate in late 2026, and an IND filing is targeted for the second quarter of 2027. Apeximmune has developed proprietary PLA2G2D knockout and humanized mouse models that support the program.

Quotes:

Li-Fen Lee, PhD, founder and CEO of Apeximmune. "For nearly a decade, we have pursued PLA2G2D based on a conviction that the field was overlooking a fundamentally different kind of immune checkpoint. The independent identification of the same target by the Erasmus team, using entirely different methods and starting from patient samples rather than computational discovery, is the strongest possible validation of the underlying biology. What matters most is what this means for patients: a potential new therapeutic path for the majority who do not respond to anti-PD-1, and possibly a way to make PD-1 therapy work in tumor types where it currently cannot."

Floris Dammeijer, MD, PhD, Erasmus MC. "When we began this work, we were asking a straightforward question: how do cancer cells block effective anti-tumor immune responses where they are first generated, in the lymph node? The answer, unexpectedly, kept pointing to PLA2G2D."

Ralph Stadhouders, PhD, Erasmus MC. "Discovering that a team at Apeximmune had independently reached the same target, from an entirely different starting point, was extraordinary. The collaboration that followed has produced a body of evidence neither group could have generated alone."

Dan Ross, managing partner at BioPharma Capital and advisor to Apeximmune. "This publication marks an inflection point for Apeximmune and the AI-306 program. We are actively engaging with partners who share our commitment to bringing this therapy to patients as quickly as possible."

(Press release, Apeximmune Therapeutics, SEP 9, 2026, View Source [SID1234670684])

On September 9, 2026 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, reported that the first patient has been dosed in the Phase 1 clinical trial of CT-202, a Nectin-4 x CD3 TCE bispecific antibody.

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!

"Dosing the first patient in the Phase 1 trial of CT-202 marks an important milestone as we advance our differentiated Nectin-4 x CD3 program into the clinic," said Martin Lehr, Chief Executive Officer of Context. "CT-202 is being evaluated as a potential monotherapy for patients with Nectin-4-positive tumors, where substantial unmet needs exist. We believe this study will provide important insights into CT-202’s safety, tolerability, pharmacokinetics and preliminary antitumor activity, and we look forward to reporting initial Phase 1a data in the second half of 2027."

The Phase 1 study (NCT07545122) is an open-label, dose escalation trial designed to evaluate safety, tolerability, and preliminary efficacy in patients with Nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant urothelial, colorectal and triple-negative breast cancers.

About CT-202

CT-202 is a Nectin-4 x CD3 TCE bispecific antibody that targets Nectin-4, a cell surface protein that is highly and frequently overexpressed in a variety of solid tumors, including bladder, colorectal, lung and breast. Nectin-4 is a clinically validated target for cancer therapy using a traditional antibody-drug conjugate, but it is also associated with certain adverse events, including neuropathy and rash. CT-202 is a pH-dependent TCE that is designed to be preferentially active within the tumor microenvironment. More information about the CT-202 clinical trial (NCT07545122) can be found on View Source

(Press release, Context Therapeutics, SEP 9, 2026, View Source [SID1234670683])

On September 9, 2026 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported that Eric Risser, President and CEO of MacroGenics, will present at the H.C. Wainwright 28th Annual Global Investment Conference on Wednesday, September 16, 2026, at 9:30 a.m. ET.

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 webcast of the presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of the webcasts on its website for 30 days.

(Press release, MacroGenics, SEP 9, 2026, View Source [SID1234670682])

On September 9, 2026 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that members of its senior management team will participate in a fireside chat at the H.C. Wainwright 28th Annual Global Investment Conference on Wednesday, September 16, 2026 at 8:30 a.m. ET in New York, NY.

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 through the investor relations section of the Company’s website at www.prothena.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 90 days following the presentation date.

(Press release, Prothena, SEP 9, 2026, View Source;Wainwright-28th-Annual-Global-Investment-Conference/default.aspx [SID1234670681])