On March 14, 2023 Catamaran Bio Inc., a biotechnology company developing off-the-shelf NK cell therapies to treat cancer, and OmniaBio Inc., a contract development and manufacturing organization (CDMO) focused on cell and gene therapy, reported their partnership to develop and manufacture Catamaran Bio’s allogeneic chimeric antigen receptor (CAR)-NK cell therapies for the treatment of solid tumors (Press release, Catamaran Bio, MAR 14, 2023, View Source [SID1234628725]).

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"This collaboration will allow us to develop scalable processes for the robust GMP manufacture of our off-the-shelf CAR-NK cell therapies," says Alvin Shih, MD, Chief Executive Officer at Catamaran Bio. "Catamaran Bio is pleased to have identified a partner with leading-edge expertise and a track record of success navigating the complex manufacturing needs of cell therapy. We are excited to work with OmniaBio to enable the development and manufacturing of our CAR-NK cell therapy as it advances toward the clinic to address solid tumors."

OmniaBio, along with its parent company CCRM, is developing Catamaran Bio’s CAR-NK cell therapy process at their Toronto site, where the process development lab is co-located with good manufacturing practices (GMP)-compliant clean room suites to offer a seamless transition between process development and clinical manufacturing. The OmniaBio-CCRM partnership enables highly adaptable and flexible end-to-end support for therapeutics developers, such as Catamaran Bio, that need to move rapidly from development to the clinic and beyond.

"We are pleased to leverage our extensive expertise in immunotherapy processes, analytical development, and GMP manufacturing to support Catamaran Bio," explains Mitchel Sivilotti, CEO of OmniaBio Inc. "This work has the potential to fight solid tumors, an area where new treatment options are needed. We look forward to serving as an extension of the Catamaran Bio team to advance a promising CAR-NK therapy with the potential to address this unmet medical need."

On March 14, 2023 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat cancer, reported it has entered into a license agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, to develop and commercialize a novel antibody targeting mesothelin (MSLN) in combination with Eureka’s proprietary ARTEMIS T-cell receptor platform (Press release, Eureka Therapeutics, MAR 14, 2023, View Source [SID1234628724]).

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MSLN is a cell-surface protein overexpressed in many solid tumors, including mesothelioma, ovarian, pancreatic, breast and lung cancers, making it a promising target for cancer therapies. The NCI antibody licensed to Eureka has shown potential in preclinical studies to selectively bind to and kill cancer cells expressing MSLN while sparing normal cells, which could make it an effective cancer treatment.

Eureka has previously demonstrated that its proprietary ARTEMIS T-cell receptor platform has several advantages over conventional chimeric antigen receptors (CARs), including better tumor infiltration, safety, and T cell persistence. By combining the newly licensed MSLN-targeting antibody with the ARTEMIS T-cell receptor platform, Eureka and NCI intend to develop a next-generation T-cell therapy that can effectively target and eliminate MSLN-expressing cancer cells.

"We are excited to add this promising antibody to our ARTEMIS receptor portfolio and to advance the development of a potentially transformative T-cell therapy for solid tumors," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "Our goal is to develop safe and effective T-cell therapies to treat MSLN-expressing cancers. We believe the combination of our ARTEMIS platform and this novel antibody targeting MSLN is a promising approach to achieve this goal."

"The license of NCI’s MSLN-targeting antibody highlights our commitment to advancing promising cancer therapies," said Dr. Ira Pastan, Chief Emeritus of the Laboratory of Molecular Biology and Head of the Molecular Biology Section at the NCI Center for Cancer Research. "Such partnerships have the potential to bring transformative therapies to patients."

Eureka plans to continue preclinical development of the antibody to support an investigational new drug (IND) application with the US Food and Drug Administration (FDA).

On March 14, 2023 Simcere Pharmaceutical Group Limited (2096.HK) (Simcere), an innovative global biopharmaceutical company, reported that Simcere Zaiming, an innovative oncology pharmaceutical company of Simcere has entered into a clinical collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate the combination of SIM0235, a potential first-in-class humanized anti-tumor necrosis factor receptor 2 (TNFR2) monoclonal antibody, and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced solid tumors and cutaneous T-cell lymphoma (CTCL) (Press release, Jiangsu Simcere Pharmaceutical Company, MAR 14, 2023, View Source [SID1234628723]).

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This is a Phase 1 trial（SIM1811-03-TNFR2-102） to evaluate the safety, efficacy, pharmacokinetic/pharmacodynamic characteristics and immunogenicity of SIM0235 monotherapy and SIM0235 in combination with KEYTRUDA in patients with advanced solid tumors and CTCL.

Tumor necrosis factor receptor 2 (TNFR2) is a member of the tumor necrosis factor receptor superfamily and is primarily expressed on the surface of tumor cells and immune suppressive cells in the tumor microenvironment, leading to immune escape and tumor proliferation.

"Data generated from preclinical models demonstrate the capability of our potential first-in-class monoclonal antibody, SIM0235, in combination with KEYTRUDA, to clinically benefit patients with these cancers," said Dr. Bijoyesh Mookerjee, M.D., Chief Medical Officer, Oncology, Simcere Pharmaceutical Group.

Under the terms of the agreement, MSD will supply KEYTRUDA and collaborate with Simcere Zaiming on this study. Simcere Zaiming retains all worldwide commercial rights to SIM0235.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About SIM0235

SIM0235 (SIM1811-03 injection) is an investigational humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets TNFR2 and blocks its activation by endogenous tumor necrosis factor (TNF), inhibiting the immunosuppressive function and proliferation mediated by TNFR2, to enhance the anti-tumor immune response. Additionally, the antibody has shown cytotoxic effect on TNFR2-expressing immune suppressive cells including regulatory T cells (Tregs) and bone marrow-derived suppressor cells via antibody-dependent cell cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). SIM0235 is currently being studied in patients with advanced solid tumors or cutaneous T-cell lymphoma (CTCL) in Phase 1 trials in China (SIM1811-03-TNFR2-101) and the US (SIM1811-03-TNFR2-102).

About Simcere Zaiming

Simcere Zaiming is an oncology biopharmaceutical company, and a subsidiary of Simcere Pharmaceutical Group Limited, that focuses on the R&D, production and commercialization of innovative cancer therapeutics. The company was formed in 2023 and is committed to solving unmet clinical needs for cancer patients in China and around the world by developing breakthrough treatments. Simcere Zaiming has built an innovative R&D pipeline with differentiated clinical value. In addition to the company’s R&D portfolio, Simcere Zaiming has three innovative drugs, COSELA, Endostar, and Envafolimab. By collaborating with partners globally, Simcere Zaiming strives to bring potentially new innovative therapeutics to cancer patients worldwide.

On March 14, 2023 Artisan Bio reported an extension of its research collaboration with Takeda which leverages Artisan’s genome editing technology (Press release, Artisan Bio, MAR 14, 2023, View Source [SID1234628722]). The amended agreement builds on the companies’ initial research program established in 2020 with a new research plan that includes gene targets of mutual interest to facilitate Takeda’s cell therapy research programs.

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"Takeda and Artisan both recognize the potential of engineered next-generation cell therapies to address the critical unmet patient needs not addressed by first generation CAR programs" said Artisan Bio CEO Dr. Ryan Gill. "We are excited to continue our collaboration combining our expertise in genome engineering with Takeda’s immuno-oncology expertise to accelerate the development of allogeneic cell therapies."

Under the terms of the agreement, Artisan Bio will receive additional funding to provide its genome editing tools for Takeda to use in the research and development of its cell therapy programs. Takeda will be responsible for the development, manufacturing, and commercialization of any potential resulting cell therapy products.

On March 14, 2023 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that the first patient with hepatocellular carcinoma (HCC) has started treatment in phase 2a with the candidate drug fostroxacitabine bralpamide (fostrox) in combination with Lenvima (Press release, Medivir, MAR 14, 2023, View Source [SID1234628721]).

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In Medivir’s ongoing phase 1b/2a study, fostrox is given in combination with two other drugs, either with Lenvima, a tyrosine kinase inhibitor, or with Keytruda, an anti-PD-1 checkpoint inhibitor. The study is an open-label, multicenter study and includes patients with HCC for whom current first- or second-line treatment has proven ineffective or is not tolerable. The phase 1b part of the study evaluates which dose of fostrox is most appropriate for the next phase. This dose is then used in the phase 2a part of the study where safety and signals of efficacy are further evaluated.

The preliminary results from the recently completed phase 1b for fostrox in combination with Lenvima were positive with a good safety and tolerability profile where no dose-limiting toxicity was observed. The recommended dose (RP2D) for fostrox in this combination arm was set at 30 mg.

"It is really exciting that we have been able to start the important expansion phase of the study so quickly, with the first patient now being treated with fostrox and Lenvima in phase 2a. The medical need for a new, effective treatment is immense and so is the interest from both investigators and patients, which is why I believe that the recruitment of patients to this part of the study will be completed swiftly," says Pia Baumann, Chief Medical Officer at Medivir AB.

The results from this study will form the basis for the future development plan for fostrox. A total of up to 30 patients with HCC are planned to be recruited in the study that is being conducted at 14 clinics in Great Britain, Spain and South Korea. In the second combination arm where fostrox is administered together with Keytruda, the phase 1b dose escalation is still ongoing.

For additional information, please contact

Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100.
E-mail: [email protected]

About fostrox

Fostrox is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.