On October 17, 2024 Factor Bioscience Inc. ("Factor") and Eterna Therapeutics Inc. ("Eterna") reported an exclusive license and collaboration agreement aimed at accelerating the development of advanced cell therapy candidates for oncology, rare diseases, and autoimmune disorders. Under the terms of the agreement, Eterna has secured a worldwide, exclusive, non-transferable, royalty-bearing license, with the right to grant sublicenses, to develop and market certain induced pluripotent stem cell (iPSC)-based cell therapy products (in particular iPSC derived mesenchymal stem cells (iMSC) that are engineered to express certain cytokines) utilizing Factor’s cell reprogramming and gene-editing technologies, patents, and know-how. The agreement positions both companies with the potential to accelerate the development of advanced cell therapies in the oncology, rare disease, and autoimmune fields.

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"We are excited to collaborate with Factor to unlock the full potential of these transformative cell therapies," said Sanjeev Luther, Eterna’s President & CEO. "Our focus at Eterna has always been on developing transformative treatments for patients with difficult-to-treat diseases, and we believe this collaboration agreement increases our potential to rapidly advance therapies that target solid tumors, rare diseases, and autoimmune disorders."

Factor and Eterna will collaborate on data generation that seeks to demonstrate efficacy of the licensed drug candidates for development towards IND by Eterna directly or with third-party sublicensees. As part of the agreement, Factor is entitled to receive milestone payments per product candidate, as well as post-commercialization royalties.

"We are thrilled to support Eterna’s pipeline of advanced cell therapy product candidates," said Matt Angel, Ph.D., CEO of Factor. "Eterna’s team has deep translational and development expertise, making them the ideal partner to develop these products. Together, we are taking an important step toward making these therapies available to patients in need."

(Press release, Factor Bioscience, OCT 17, 2024, View Source [SID1234662301])

On October 17, 2024 Alphamab Oncology (stock code: 9966 HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK) reported that an application for a phase III clinical study (Study ID: KN026-004) of the anti-HER2 bispecific antibody KN026 combined with albumin-bound Docetaxel HB1801 has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer.

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Breast cancer is one of the most common malignant tumors in women. According to the latest data released by the International Agency for Research on Cancer (IARC) in 2024, there were 2.31 million new cases of breast cancer worldwide in 2022, with 357,000 new cases in China. Approximately 15%-20% of breast cancer patients are HER2-positive, a subtype characterized by high malignancy, rapid disease progression, prone to lymph node metastasis, and poorer prognosis. In recent years, both domestic and international breast cancer treatment guidelines have recommended anti-HER2 neoadjuvant therapy to further optimize treatment outcomes.

KN026 is an anti-HER2 bispecific antibody independently developed by Alphamab Oncology. Results from a phase II clinical study of KN026 combined with docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer (KN026-201, NCT04165993) demonstrated promising efficacy and tolerability. In terms of neoadjuvant therapy, data from a phase II clinical study of KN026 combined with docetaxel as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer (KN026-208, NCT04881929) presented at the 2023 ESMO (Free ESMO Whitepaper) Congress showed promising clinical benefit and good tolerability: the total pathological complete response (tpCR) rate was 56.7%, the breast pathological complete response (bpCR) rate was 60%, the confirmed objective response rate (ORR) was 86.7%, and the posterior probability for tpCR rate >40% was 96.7%, suggesting that the neoadjuvant regimen of KN026 combined with docetaxel within the same treatment cycles may be superior to existing standard neoadjuvant therapy regimens.

The approved study is a randomized, controlled, open-label, multicenter phase III clinical study aimed at comparing the efficacy and safety of KN026 combined with HB1801 versus trastuzumab combined with pertuzumab and docetaxel as neoadjuvant therapy in patients with HER2-positive early or locally advanced breast cancer. The primary endpoint is the tpCR rate as evaluated by a blinded independent review committee (BIRC). This study is anticipated to offer a treatment option with improved efficacy and safety for patients with HER2-positive breast cancer.

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 bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. KN026 has demonstrated potentially superior efficacy compared with Trastuzumab and Pertuzumab in combination, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.

The results of multiple clinical studies in different stages showed that KN026 has good efficacy and safety profiles, even in heavily pretreated patients with HER2-positive breast cancer (BC) and gastric cancer (GC). Currently, several pivotal clinical trials of KN026 for the treatment of BC and GC/ gastroesophageal junction cancer (GEJ) 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, 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).

On October 17, 2024 Sanofi and Orano Med, a subsidiary of the Orano Group and a pioneer in the development of targeted alphatherapies in oncology, reported to have entered into an agreement to combine their expertise in the fight against rare cancers and further accelerate the development of next-generation radioligand medicines (Press release, Sanofi, OCT 17, 2024, View Source [SID1234647289]).

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Building on the expertise and radioligand pipeline of Orano Med, Sanofi and Orano will invest in a new entity, operating under the Orano Med brand, and focusing on the discovery, design, and clinical development of next-generation radioligand therapies (RLTs) based on lead-212 (212Pb) alpha-emitting isotopes. This agreement follows Sanofi’s announcement of an exclusive licensing agreement with Orano Med and RadioMedix to advance radioligand therapies (RLTs) in rare cancers with a focus on one late-stage project, AlphaMedix.

Targeted alpha therapy relies on a simple concept: combining the ability of biological vectors to target cancer cells with the short-range and highly energetic cell-killing capabilities of alpha-emitting radioisotopes. The vector directs the radioisotope to the target cancer cells expressing the specific marker, even when they have spread throughout the body. This unique mechanism of action aims to damage or destroy target cancer cells, while limiting impact on nearby healthy cells. This novel precision medicine approach aims at changing the standard of care in some rare cancers to extend patients’ lives and improve their quality of life.

Paul Hudson

CEO, Sanofi

"We are excited to partner with Orano in establishing a French pioneer that unites our respective expertise in biopharma and nuclear technology to drive groundbreaking progress in the fight against cancer. As a French biopharmaceutical company, we are deeply committed to fostering and enabling innovation in our home country. This collaboration is part of a broader effort to strengthen our ties within the scientific community, both in France and globally, with the goal of advancing the development of cutting-edge treatments for patients."

Nicolas Maes

CEO, Orano Group

"The success of Orano Med is an example of our group’s ability to diversify beyond our core nuclear business. By applying our expertise in nuclear materials to fields like targeted alpha therapies, we are demonstrating that nuclear technology can have a positive societal impact, not just for energy and climate, but also for human health. This innovation reflects Orano’s commitment to exploring new opportunities and taking bold steps to address some of the world’s most pressing challenges."

Sanofi’s investment will further strengthen Orano Med and allow the company to accelerate the development of its pipeline, leveraging its unique capabilities in the discovery and development of lead-212 based therapies. Orano Med has also developed a highly differentiating global industrial platform, which, thanks to its vast stock of raw materials and patented manufacturing process, will ensure an independent, reliable, and scalable supply of lead-212 based therapies to patients worldwide.

In striving to become a leading immunoscience company globally, Sanofi remains committed to advancing oncology innovation. The pipeline is being reshaped and prioritized, leveraging expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including rare cancers such as multiple myeloma, acute myeloid leukemia, and certain types of lymphomas, as well as gastrointestinal and lung cancers.

Sanofi and Orano Med are members of the Paris Saclay Cancer Cluster and look forward to contributing to the ambitious agenda of the France 2030 plan to accelerate innovation in oncology.

This agreement is subject to standard regulatory approvals required for transactions of this nature.

Financial considerations

Under the terms of the agreement, Sanofi will make an equity investment of €300 million, approximately 16% equity stake in the new entity valued at €1.9bn.

On October 17, 2024 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that it will hold an investor webcast to discuss data from a Phase 1 clinical trial of ZL-1310, the Company’s investigational DLL3-targeted antibody-drug conjugate (ADC), in patients with advanced stage small cell lung cancer (SCLC) (Press release, Zai Laboratory, OCT 17, 2024, View Source [SID1234647260]). The live conference call and webcast will take place on Thursday, October 24, 2024, at 8:30 a.m. ET (8:30 p.m. HKT).

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Conference Call and Webcast Information

Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call.

Details are as follows:

Registration Link: https://register.vevent.com/register/BI6f8ba8dc42d04cd3afd7095cf7c83d40

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

On October 17, 2024 OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, reported that Paul Romness, Chief Executive Officer, will be presenting at the 2024 Maxim Healthcare Virtual Summit (Press release, OS Therapies, OCT 17, 2024, View Source [SID1234647259]). The summit is being held virtually on October 15 – 17, 2024.

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Event:

Fireside Chat at 2024 Maxim Healthcare Virtual Summit

Date:

Thursday, October 17, 2024

Time:

3:00 PM ET

Webcast:

https://m-vest.com/events/healthcare-10152024