On September 12, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) ("OTLC" or the "Company"), a clinical-stage biopharmaceutical company developing transformative oncology and immunotherapy treatments, reported a summary of its major accomplishments over the past two years (Press release, Oncotelic, SEP 12, 2025, View Source [SID1234655949]). These milestones underscore meaningful clinical progress and regulatory validation across the Company’s lead drug candidates.

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Oncotelic’s pipeline includes multiple late-stage programs targeting oncology and rare diseases, with several drug candidates achieving significant clinical milestones

Two-Year Clinical Progress Snapshot

OT-101 (TGF-β inhibitor): Phase 3 for pancreatic cancer, with additional applications in ARDS/COVID-19
OXi4503 (vascular disrupting agent): Phase 2 in AML/MDS; advancing toward pivotal phase 3 design
CA4P / Fosbretabulin: Late-stage oncology asset currently under repositioning
AL-101 (intranasal apomorphine): Phase 2 for Parkinson’s disease and sexual dysfunctions
AL-102 (oligonucleotide antisense via intrathecal injection): Discovery stage for Alzheimer’s disease
Pediatric Rare Disease Programs: Targeting orphan indications with the potential to generate Priority Review Vouchers (PRVs)
Nanomedicine Pipeline: Advancing multiple 505(b)(2) drug candidates into clinical testing, leveraging the 505(b)(2) pathway-a faster and more cost-efficient route to market approval compared to a full New Drug Application (NDA).
"OTLC has achieved steady progress across multiple programs, strengthening our position as a late-stage biotech with broad value creation potential. Our pipeline addresses multi-billion-dollar markets with high unmet medical need," said Dr. Vuong Trieu, Chairman and CEO of Oncotelic.

On September 12, 2025 Alphamab Oncology (Stock Code: 9966.HK) reported that the New Drug Application (NDA) for anbenitamab injection (KN026), independently developed by the Company and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), has been accepted by the National Medical Products Administration (NMPA). KN026 has been applied for as a Class 1 therapeutic biological product and the indication is for use in combination with chemotherapy for the treatment of patients with HER2-positive locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior systemic therapy (which must include trastuzumab in combination with chemotherapy).

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This NDA for KN026 is primarily based on a pivotal Phase II/III clinical trial (Study ID: KN026-001). Results from the first interim analysis of the Phase III clinical study demonstrated that, compared to the current standard of care, KN026 combined with chemotherapy significantly improved clinical efficacy, by prolonging progression-free survival (PFS) and overall survival (OS). Furthermore, the combination showed no new safety signals, with a low incidence of cardiotoxicity and low immunogenicity in terms of safety profile. Previously, results from the Phase II clinical study, presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, showed that KN026 in combination with chemotherapy achieved an objective response rate (ORR) of 40.0%, with a median PFS of 8.6 months as assessed by the independent review committee (IRC). KN026 was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the NMPA on November 4, 2023, and received Priority Review status on August 28, 2025.

Currently, there are no approved anti-HER2 therapies for the second-line treatment of HER2-positive gastric cancer. KN026 is the first HER2 bispecific antibody to demonstrate positive results in the second-line treatment of gastric cancer in China. Meanwhile, multiple pivotal Phase III clinical studies of KN026 in gastric cancer and breast cancer are undergoing smoothly, with the aim of benefiting more patients.

About KN026

KN026 is an anti-HER2 bispecific antibody independently developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can simultaneously bind two non-overlapping epitopes of HER2, leading to HER2 signal blockade. KN026 has demonstrated better tumor inhibition in HER2-positive tumor cell lines compared with trastuzumab and pertuzumab in combination. Additionally, KN026 has also shown inhibitory effect on tumor cells with trastuzumab-resistant cell lines.

The results of multiple clinical studies in different stages showed that KN026 has significant anti-tumor activities, even in heavily pretreated patients with HER2-positive breast cancer (BC) and gastric cancer (GC), including those with prior anti-HER2 treatment. Currently, several pivotal clinical trials of KN026 for the second-line or above treatment of HER2-positive GC/gastroesophageal junction cancer (GEJ), the first-line treatment of HER2-positive BC, neoadjuvant treatment for HER2-positive BC are being conducted. KN026 in combination with chemotherapy for the treatment of patients with HER2-positive GC (including GEJ) who have failed first-line standard treatment was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA).

In August 2021, the Company entered an agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China, pursuant to which, JMT-Bio was granted exclusive license rights of KN026 for the development and commercialization in the indications of BC an GC/GEJ in Mainland China (excluding Hong Kong, Macau and Taiwan).

(Press release, Alphamab, SEP 12, 2025, View Source [SID1234656998])

On September 12, 2025 Alkermes plc (Nasdaq: ALKS) reported the appointment of Joshua Reed as Chief Financial Officer (CFO), effective Monday, Sept. 15, 2025 (Press release, Alkermes, SEP 12, 2025, View Source [SID1234655943]). Mr. Reed will report to Richard Pops, Chief Executive Officer of Alkermes, and will join the company’s management committee.

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"I’m delighted to be joining Alkermes and look forward to working with Richard and the team to build on Alkermes’ strong financial foundation and advance its strategic priorities with a financial strategy that supports continued innovation, operational excellence and long-term growth," said Mr. Reed.

Mr. Reed brings over 30 years of financial leadership experience, with a strong focus in the biotechnology and pharmaceutical sectors. Most recently, he served as CFO of Omega Therapeutics, a then publicly-traded biotechnology company. Prior to that, he was the CFO at Aldeyra Therapeutics. Earlier in his career, Mr. Reed spent more than a decade at Bristol Myers Squibb, culminating in his role as Vice President and Head of Finance Operations for the U.S. and Puerto Rico. His experience also includes roles at JPMorganChase, Credit Suisse First Boston, and Chase Manhattan Bank.

Mr. Reed currently serves on the board of directors of Scholar Rock Holding Corporation, a publicly-traded biotechnology company. He earned a Bachelor of Science in Finance from Rutgers University and a Master of Business Administration from the University of Michigan’s Ross School of Business.

"We are pleased to welcome Joshua to Alkermes at such an exciting time in our company’s evolution," said Mr. Pops. "Joshua brings a wealth of financial expertise and strategic insight from his extensive experience in the biopharmaceutical industry. We gain his financial acumen and dedication to excellence as we continue to focus on driving strong performance across our commercial business, advancing our pipeline, and delivering long-term shareholder value. I look forward to the positive impact he will have across our organization."

On September 12, 2025 Alkermes plc (Nasdaq: ALKS) reported the appointment of Joshua Reed as Chief Financial Officer (CFO), effective Monday, Sept. 15, 2025 (Press release, Alkermes, SEP 12, 2025, View Source [SID1234655943]). Mr. Reed will report to Richard Pops, Chief Executive Officer of Alkermes, and will join the company’s management committee.

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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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"I’m delighted to be joining Alkermes and look forward to working with Richard and the team to build on Alkermes’ strong financial foundation and advance its strategic priorities with a financial strategy that supports continued innovation, operational excellence and long-term growth," said Mr. Reed.

Mr. Reed brings over 30 years of financial leadership experience, with a strong focus in the biotechnology and pharmaceutical sectors. Most recently, he served as CFO of Omega Therapeutics, a then publicly-traded biotechnology company. Prior to that, he was the CFO at Aldeyra Therapeutics. Earlier in his career, Mr. Reed spent more than a decade at Bristol Myers Squibb, culminating in his role as Vice President and Head of Finance Operations for the U.S. and Puerto Rico. His experience also includes roles at JPMorganChase, Credit Suisse First Boston, and Chase Manhattan Bank.

Mr. Reed currently serves on the board of directors of Scholar Rock Holding Corporation, a publicly-traded biotechnology company. He earned a Bachelor of Science in Finance from Rutgers University and a Master of Business Administration from the University of Michigan’s Ross School of Business.

"We are pleased to welcome Joshua to Alkermes at such an exciting time in our company’s evolution," said Mr. Pops. "Joshua brings a wealth of financial expertise and strategic insight from his extensive experience in the biopharmaceutical industry. We gain his financial acumen and dedication to excellence as we continue to focus on driving strong performance across our commercial business, advancing our pipeline, and delivering long-term shareholder value. I look forward to the positive impact he will have across our organization."

On September 12, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that new preclinical results on its bispecific antibody ATOR-4066 will be presented today at the 9th International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (CICON25), jointly organized in Utrecht, by the Cancer Research Institute (CRI), the European Network for Cancer Immunotherapy (ENCI), and other leading partners (Press release, Alligator Bioscience, SEP 12, 2025, View Source [SID1234655945]). The poster presentation (Poster #253) will take place during Poster Session B, from 12:00–15:00 CEST.

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Summary of results
ATOR-4066 is a bispecific antibody designed to activate the immune system against CEACAM5-positive cancers, such as colorectal and gastric cancer. The new preclinical data, in the presentation "ATOR-4066, a Neo-X-Prime bispecific antibody targeting CD40 and CEACAM5, induces strong myeloid and T cell dependent tumor immunity and synergizes with PD-1 blockade," show that ATOR-4066 strongly stimulates both myeloid cells and T cells inside tumors, leading to powerful and durable anti-tumor effects. In preclinical models, ATOR-4066 eliminated established tumors, showed limited immune activation outside the tumor, and demonstrated enhanced efficacy in combination with PD-1 blockade. These findings provide strong support for advancing ATOR-4066 into further development.

"We are excited to present these new preclinical findings demonstrating that ATOR-4066 triggers potent, dual-acting immune responses that translate into strong anti-tumor activity," said Peter Ellmark, CSO at Alligator Bioscience. "ATOR-4066 represents the next step in our mission to develop best-in-class CD40-based therapies and builds directly on the promising clinical progress made with mitazalimab. The data to be presented at CICON25 support the continued development of ATOR-4066 as a differentiated bispecific candidate with potential to transform treatment outcomes in solid tumors."
The poster will be made available on Alligator’s website, following the presentation.