Hanmi Pharmaceutical-Novomedicine, Technology Transfer Agreement Following Joint Development of ‘Poseltinib’

On August 22, 2024 Hanmi Pharmaceutical reported the company has signed a technology transfer agreement with domestic research and development company Novomedison for the BTK inhibitor ‘Poseltinib’ (Press release, Hanmi, AUG 22, 2024, View Source [SID1234649253]).

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On the 14th, Hanmi Pharmaceutical announced in its ‘Semi-Annual Report’ that it had transferred Poseltinib to Novomedison on June 3rd through major contracts and research and development activities.

The technology transfer target region is the entire world. The total contract amount and the amount received were not disclosed under the agreement of both companies.

Novomedison is the new name of Genome Opinion, which signed a joint development agreement with Hanmi Pharmaceutical for Poseltinib in October 2021.

After signing the joint development agreement, Hanmi Pharmaceutical and Novomedison have signed a technology transfer agreement.

After signing the joint development agreement, Novomedison has been conducting an investigator-led clinical trial with a three-drug combination therapy using Poseltinib.

Poseltinib is a drug that Hanmi Pharmaceutical has been developing since 2010 for the indication of diffuse large B-cell lymphoma. It was exported to Eli Lilly in 2015, but the rights were returned in 2019 as its efficacy was not proven in phase 2 for patients with rheumatoid arthritis.

Since then, Hanmi Pharmaceutical has been conducting phase 2 domestic trials for follow-up development.

Simcere Zaiming’s novel molecule targeting the synthetic lethal pathway Pol θ has obtained approval for clinical trials in China

On August 22, 2024, Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), reported that SIM0508, a DNA polymerase θ (Pol θ) small molecule inhibitor developed independently by the company, has received Clinical Trial Approval from the National Medical Products Administration of China (Press release, Jiangsu Simcere Pharmaceutical Company, AUG 22, 2024, View Source [SID1234648427]). This approval allows for the commencement of clinical trials to evaluate the efficacy of SIM0508 in treating locally advanced/metastatic solid tumor.

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Homologous recombination is a vital cellular process for repairing DNA double-strand breaks. When homologous recombination deficiency (HRD) occurs, genomic instability can lead to tumor development. HRD tumors rely on an alternative repair pathway called microhomology-mediated end joining (MMEJ), where Pol θ plays a crucial role. Interestingly, Pol θ is rarely expressed in normal tissues but highly expressed in various malignant tumor cells. By blocking Pol θ, we can disrupt the MMEJ pathway, precisely targeting HRD tumor cells while sparing normal cells.

SIM0508, a potent small molecule inhibitor, selectively targets and inhibits Pol θ, effectively blocking MMEJ repair and precisely inhibiting the proliferation of HRD tumor cells. SIM0508 also has potential synergy when used in combination with poly (ADP-ribose) polymerase (PARP) inhibitors or chemotherapeutic agents. Preclinical studies of SIM0508 revealed favorable oral pharmacokinetics and safety, with no evident hematologic toxicities. These findings suggest that combining SIM0508 with PARP inhibitors or chemotherapeutic agents carries a low risk of additive toxicity. The preclinical data were presented at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Simcere Zaiming’s pipeline currently includes 13 innovative drug projects either in the clinical study stage or with clinical approval.

Zai Lab Announces Participation in September Investor Conferences

On August 22, 2024 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that members of the Company’s senior management team will participate in the following investor conferences in September 2024 (Press release, Zai Laboratory, AUG 22, 2024, View Source [SID1234646067]):

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Morgan Stanley 22nd Annual Global Healthcare Conference
Location: New York, New York

Cantor Fitzgerald Global Healthcare Conference
Fireside Chat: Thursday, September 19, 2024, 8:00 a.m. ET in Track 2
Location: New York, New York

Vir Biotechnology to Participate in the Morgan Stanley 22nd Annual Global Healthcare Conference

On August 22, 2024 Vir Biotechnology Inc. (NASDAQ: VIR) reported that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer is scheduled to participate in a fireside chat at the Morgan Stanley 22nd Annual Global Healthcare Conference on Thursday, September 5, at 1:50 p.m. PT / 4:50 p.m. ET in New York City (Press release, Vir Biotechnology, AUG 22, 2024, View Source [SID1234646066]).

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A live webcast of the fireside chat will be made available under Events & Presentations in the Investors section of the Vir website at www.vir.bio and will be archived there for 30 days.

Stem Cell Therapy developers I Peace and iCamuno Biotherapeutics Start Natural Killer Cell Trial for Ovarian Cancer

On August 22, 2024 I Peace, a pioneering CDMO in induced pluripotent stem (iPS) cells, and iCamuno Biotherapeutics, a biotech company developing iPS cell-based therapies, reported a significant milestone with the dosing of the first patient in a clinical trial using iPS cell-derived natural killer (iNK) cells for ovarian cancer immunotherapy (Press release, iCamuno Biotherapeutics, AUG 22, 2024, View Source [SID1234646065]). iCamuno will lead the trial, which will test the safety and efficacy of NK cells made from I Peace’s cGMP-compliant iPS cells using iCamuno’s NK cell differentiation technology.

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Natural killer (NK) cells are a critical component of the anti-cancer immune system, with natural abilities to recognize and destroy tumor cells. This trial leverages iCamuno’s abilities to create cGMP-grade iPS cell-derived NK cells with improved consistency and effector function. The initial phase will focus on ovarian cancer, with potential expansion to a broader range of diseases.

"We are thrilled to reach this moment," said Koji Tanabe, CEO and founder at I Peace. "Dosing the first patient in this trial using our iPS cell line is a significant milestone in our goal to develop innovative immunotherapies for cancer."

"This is an important milestone for iCamuno," said Ethan Liu, Chairman and co-founder of iCamuno. "Given their safety and efficacy in preclinical testing, we are hopeful that our iNK cells will be a valuable weapon in the battle against ovarian cancer."