On July 21, 2022 GlyTherix reported the successful completion of its high-yield GMP-grade stable cell line development program for its proprietary antibody Miltuximab in partnership with international biologics manufacturer GenScript ProBio (New Jersey, USA) (Press release, Glytherix, JUL 21, 2022, View Source [SID1234616831]).

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Establishing a stable, high-yield cell line suitable for commercial production of clinical-grade monoclonal antibody is a critical milestone for the Company. The Chinese Hamster Ovary (CHO) cell clones selected for Miltuximab cell banking have reached titres of above 8g/L. Work is now continuing on the process development program for scale-up of Miltuximab manufacturing at 100L-bioreactor scale for the Company’s upcoming Australian Phase I trial.

Miltuximab will be used in a Phase Ib trial as an antibody theranostic. Antibody labelled with 89-Zirconium will be used as an imaging agent to select patients showing tumor targeting. This will be followed by patients being offered Miltuximab labelled with 177-Lutetium as a therapeutic dose.

To find out more about GlyTherix’s technology and clinical program, visit www.glytherix.com

GlyTherix is seeking investors who would like to participate in the company’s Series A funding round.

This project received grant funding from the Australian Government.

On July 21, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that Christoph Franz has decided not to seek re-election to the Board of Directors at the AGM in March 2023 (Press release, Hoffmann-La Roche, JUL 21, 2022, View Source [SID1234616829]). The Board of Directors intends to propose Severin Schwan as new Chairman at the AGM and has appointed Thomas Schinecker as new Roche CEO effective 15 March 2023.

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Christoph Franz was elected to the Roche Board of Directors in 2011 and has served as its Chairman since 2014: "After serving twelve years on the Board of Directors, nine of which as Chairman, I have decided not to seek re-election to the Board next year. We have achieved many important milestones and with the conclusion of Roche’s 125th anniversary, it is now the right time for a change in leadership. I am proud of the significant contributions Roche has made in fighting the pandemic during the last two and a half years. I am also pleased that we could secure long term stability in our shareholder structure with the repurchase of Roche shares from Novartis. With the strong pipelines of innovative products in both our Pharma and Diagnostic businesses, we are set for continued growth in the future."

The Roche Board of Directors will propose Severin Schwan as new Chairman at the AGM on 14 March 2023. Severin Schwan has been a member of the Corporate Executive Committee since 2006 and has served as CEO of the company since 2008. He has been a member of the Roche Board of Directors since 2013. Severin Schwan: "I have very much appreciated the close and trusting collaboration with Christoph and would like to thank him. I am honoured to stand for the position of Chairman of the Roche Board of Directors and will continue to dedicate all my efforts to the future of this company."

André Hoffmann, Vice-Chairman of the Board of Directors and representative of the Oeri and Hoffmann shareholder group with pooled voting rights: "Thanks to Christoph’s long term strategic vision, he has steered our company confidently and successfully through challenging times. Roche’s continued success is in no small part due to his personal contributions. I would like to thank him sincerely, also in the name of our families. As in the past, we are able to secure the succession to the Chairman and CEO roles with excellent leaders from within Roche. This is a great quality of our company."

Effective 15 March 2023, the Board of Directors has appointed Thomas Schinecker, currently CEO of the Diagnostics Division, as CEO of Roche succeeding Severin Schwan. Thomas Schinecker holds a PhD in Molecular Biology and has been working for Roche in different leadership positions since 2003. He became CEO of the Diagnostics Division and a member of the Corporate Executive Committee in August 2019.

Severin Schwan: "I am very pleased that the Board has appointed Thomas as the new Roche CEO. He is a highly qualified successor who has been working for Roche in leadership positions around the globe for twenty years. Thomas successfully set up our Diagnostics Division for the future. Under his leadership our Diagnostics organisation also made considerable contributions in fighting the COVID-19 pandemic."

Thomas Schinecker: "I am deeply honoured by the Board’s decision and the trust placed in me. I am delighted to carry on working closely with Roche colleagues and the Corporate Executive Committee. Like we’ve done for the last 125 years, I am excited about the future innovations we will bring to patients around the globe."

On July 21, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that Sanofi has made the decision to progress IPH6401/SAR’514 into investigational new drug (IND)-enabling studies, triggering a €3 million milestone payment (Press release, Innate Pharma, JUL 21, 2022, View Source [SID1234616816]).

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IPH6401/SAR’514 is a BCMA-targeting NK cell engager using Sanofi’s proprietary CROSSODILE multi-functional platform, which comprises the Cross-Over-Dual-Variable-Domain (CODV) format. It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKETTM (Antibody-based NK cell Engager Therapeutics) proprietary platform. NK cell engagers are an alternative for cancer treatment aiming to offer an improved therapeutic window as compared to bispecific T lymphocyte-engaging formats.

IPH6401/SAR’514 has shown anti-tumor activity and promising drug properties in pre-clinical models. Sanofi will be responsible for all future development, manufacturing and commercialization of IPH6401/SAR’514.

"We are pleased that Sanofi has chosen to progress IPH6401/SAR’514 into development, building on our strong partnership which brought the first NKp46-based NK cell engager to the clinic last year," said Pr. Eric Vivier, DVM-PhD, Chief Scientific Officer at Innate Pharma. "Innate/Sanofi’s collaboration integrating Sanofi’s multi-functional CODV format and the dual NK cell targeting based on Innate’s multifunctional ANKET platform is creating an entirely new class of molecules to induce synthetic immunity against cancer, which have been designed to belong to the next wave of impactful medicines in immunotherapy."

This milestone is part of the previously announced research collaboration with Sanofi, under which the companies collaborate on the generation and evaluation of up to two bispecific NK cell engagers, using the ANKET platform from Innate that simultaneously targets two NK activating receptors, NKp46 and CD16, to optimize NK cell activation and Sanofi’s proprietary antibody format as well as anti-tumor target antibodies. In 2021, the companies announced plans to develop IPH6101/SAR’579, which is in Phase 1/2 in relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) and high risk-myelodysplastic syndrome (HR-MDS).

About the Innate-Sanofi agreement:

The Company has a research collaboration and licensing agreement with Sanofi to apply Innate’s proprietary platform to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells now called the ANKET platform.

Under the terms of the license agreement, Sanofi will be responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

About ANKETTM:

ANKETTM (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer.

On July 20, 2022 BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") reported that the first patient with advanced malignant tumors had been dosed in the Phase I Clinical trial of self-developed Category 1 innovative drug BR105 (Press release, Zhejiang Hisun Pharmaceutical, JUL 20, 2022, View Source;a=index&classid=43&id=1 [SID1234634616]). This is an open-label, dose-escalation, and dose-expansion trial to explore the safety, tolerability, and antitumor activity of BR105. The phase Ia part of the trial aims to evaluate the safety and tolerability of BR105 monotherapy (single and multiple doses) in subjects with advanced malignancies and to explore the maximum tolerated dose (MTD). The leading entity of the clinical trial is Beijing Cancer Hospital, and the principal investigators are Prof. Jun Zhu and Prof. Lin Shen.

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BR105 is a SIRPα-targeting humanized monoclonal antibody that was independently developed by BioRay, which can recognize the common variants of signal-regulated protein α (SIRPα), blocks the binding of SIRPα to CD47, disengage the "don’t eat me" signal and activate macrophages to promote phagocytosis of tumor cells.

SIRPα is a transmembrane protein expressed on the surface of myeloid cells such as macrophages, monocytes, dendritic cells, and granulocytes. The binding of SIRPα to CD47 activates phagocytosis-inhibitory signals in multiple cancer types, and tumor cells are able to evade phagocytosis by macrophages. Blocking CD47/SIRPα signaling potentiates phagocytosis of tumor cells by macrophages, and suppresses tumor growth. CD47/SIRPα can be a viable immune target for antitumor therapy.

Multiple tumor models have demonstrated the effectiveness of targeting CD47/SIRPα. Clinical studies suggest that blockage of CD47–SIRPα signaling pathway may generate antitumor activity in broad-spectrumof malignancies, including various hematologic and solid tumors. CD47/SIRPα-targeted therapy has shown positive efficacy results in acute myeloid leukemia, lymphoma, head, and neck squamous cell carcinoma, gastric cancer, and other tumors.

Unlike CD47, SIRPα has a limited tissue expression pattern. BR105 blocks CD47/SIRPα signaling pathway by targeting SIRPα, which is superior in safety. In addition, CD47 can interact with other proteins such as TSP-1 and SIRPγ, which are involved in more complex signaling pathways, and the corresponding targeted therapeutic regimens have more risk considerations to balance; therefore, developing SIRPα antibodies to block the CD47/SIRPα signaling pathway may be a more effective strategy for oncology drug development.

"CD47/SIRPα is considered one of the most prospective targets for tumor immunotherapy after PD-1/PD-L1," said Dr. Wei Zhu, Chief Medical Officer of BioRay, "BR105 is an important candidate of our tumor immunization pipeline. We are pleased that the first patient’s dosing of BR105 has been completed, and this marks important progress in the innovation and R&D of BioRay. We will next push forward with our research and development projects in the field of popular targets for tumor immunity and autoimmunity to benefit patients."

On July 20, 2022, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) reported that its CSF-1R inhibitor ABSK021 had been granted the breakthrough therapy designation from Center for Drug Evaluation, NMPA for the treatment of tenosynovial giant cell tumor (TGCT) that not amenable to surgery (Press release, Abbisko Therapeutics, JUL 20, 2022, View Source [SID1234633494]).

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The Breakthrough Therapy Designation is a CDE program for innovations during clinical trials that are used for the prevention and treatment of serious life-threatening diseases or seriously affect the quality of life, and there are no effective prevention and treatment methods or there is sufficient evidence to show that they have obvious clinical advantages compared with existing treatment methods.

This breakthrough therapy designation approval is based on results from the phase Ib clinical trial of TGCT cohort in China for CSF-1R inhibitor ABSK021.

TGCT, also known as pigmented villonodular synovitis, is a locally aggressive neoplasm that affects synovial joints, mucous sacs, and tendon membranes, resulting in swelling, pain, stiffness, and decreased activity of the affected joints which seriously affect the patient’s quality of life.

According to the 2013 World Health Organization classification, TGCTs were classified as localized TGCT and diffuse TGCT. Compared with localized TGCT (80%-90%), the incidence rate of diffuse TGCT is lower (10-20%).

Overexpression of colony-stimulating factor 1(CSF1) occurs in most TGCTs. Surgical resection is the standard treatment for TGCT. However, not all patients are suitable for surgical treatment. It is difficult to remove tumors of diffuse patients by surgery, which may possibly lead to severe joint damage, total synovectomy, joint replacement, or even amputation, and the risk of surgical complications can be high. It has been reported that more than 50% of patients with diffuse TGCT will undergo recurrence after surgical resection. For those TGCT patients not amenable to surgery, there is currently no approved drug available in China.

ABSK021 is a novel, orally available, highly selective, and highly potent small molecule inhibitor of CSF-1R, independently developed by Abbisko Therapeutics. It is also the first selective CSF-1R inhibitor discovered by a Chinese company that has advanced into human clinical trial. A number of studies have shown that blocking the CSF-1R signaling pathway could effectively modulate and change macrophage functions, and potentially treat many macrophage-dependent human diseases. Abbisko has completed a phase Ia dose escalation study for ABSK021 in the U.S., with phase Ib expansion ongoing in both U.S. and China. In addition to TGCT, Abbisko is actively exploring the potential of ABSK021 in treating other indications including many types of solid tumors in clinic, and has collaborated with Sperogenix in exploring its potential for treating ALS and other CNS diseases. As of the date of this press release, no high-selective CSF-1R inhibitor has been approved in China.