On March 14, 2023 Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing novel, multifunctional biotherapeutics, reported the acceptance of eleven abstracts for poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place at the Orange County Convention Center in Orlando, FL from April 14 – 19, 2023 (Press release, Zymeworks, MAR 14, 2023, View Source [SID1234628727]).

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"AACR represents an important opportunity for us to share recent progress in developing the next generation of novel therapeutics and highlights the unique capabilities of our proprietary engineering platforms and integrated technologies," stated Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks. "The acceptance of eleven abstracts reflects the rapid progress we have made in developing our robust and differentiated pipeline. During the meeting we look forward to sharing new preclinical data on our anticipated 2024 IND candidates, ZW171 and ZW191, as well as other programs that represent potential future therapeutic opportunities and areas of interest."

Presentation Details

Antibody Drug Conjugates

Title: Revisiting the dogma of antibody drug conjugates (ADCs): Emerging data challenge the benefit of linker stability and the primacy of payload delivery
Abstract: 1538
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Drug Conjugates

Title: ZW191, a novel FRa-targeting antibody drug conjugate bearing a topoisomerase 1 inhibitor payload
Abstract: 2641
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Technologies

Title: ZW220, a novel NaPi2b-targeting antibody drug conjugate bearing a topoisomerase 1 inhibitor payload
Abstract: 1533
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Drug Conjugates

Title: ZW251, a novel glypican-3-targeting antibody drug conjugate bearing a topoisomerase 1 inhibitor payload
Abstract: 2658
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Technologies

Multispecific Antibody Therapeutics

Title: ZW171, a T cell-engaging, bispecific antibody for the treatment of mesothelin-expressing solid tumors
Abstract: 2942
Session Category: Immunology
Session Title: Therapeutic Antibodies 2

Title: TriTCE Co-stim, next generation costimulatory trispecific T cell engagers for the treatment of solid tumors
Abstract: 5121
Session Category: Immunology
Session Title: Combination Immunotherapies 2

Title: TriTCE CPI, next generation trispecific T cell engagers with integrated checkpoint inhibition (CPI) for the treatment of solid tumors
Abstract: 2982
Session Category: Immunology
Session Title: Therapeutic Antibodies 3

Title: PROTECT, a novel trispecific antibody masking platform with integrated immune modulation displays unique activity and differentiated modes of action
Abstract: 2926
Session Category: Immunology
Session Title: Therapeutic Antibodies 2

Title: ZW270, a conditionally masked IL-12 cytokine fusion protein displaying potent anti-tumor activity absent systemic toxicity
Abstract: 2935
Session Category: Immunology
Session Title: Therapeutic Antibodies 2

Clinical Product Candidates

Title: ERBB2 amplification detected in ctDNA as a surrogate for tumor tissue FISH analysis of HER2 status in a phase 1, study with zanidatamab for the treatment of locally advanced or metastatic HER2 expressing cancers
Abstract: CT2781
Session Category: Clinical Trials Posters
Session Title: Phase I Clinical Trials 2

Title: Zanidatamab zovodotin (ZW49) induces hallmarks of immunogenic cell death and is active in patient-derived xenograft models of gastric cancer
Abstract: 2633
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Technologies

Abstracts can be found on AACR (Free AACR Whitepaper)’s website located at www.aacr.org. Posters will be available at the time of presentation at the conference on the Company’s website located at www.zymeworks.com.

1 Clinical trials abstract texts are embargoed until noon ET on April 14, 2023

Conference Call and Webcast Information:

Zymeworks management will host a conference call and webcast for investors and analysts on April 18, 2023, at 6:30 pm EST. The event will be webcast live with dial-in details and webcast replays available on Zymeworks’ website at View Source

On March 14, 2023 Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to EP0042, a dual FLT-3 and Aurora kinase inhibitor, for the treatment of acute myeloid leukaemia (AML) (Press release, Ellipses Pharma, MAR 14, 2023, View Source [SID1234628726]).

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The FDA grants ODD based on review of promising early clinical data from investigational treatments for rare diseases, such as AML, defined as affecting fewer than 200,000 people in the US. ODD qualifies the developer for certain incentives with the goal of accelerating drug development for patients, including tax credits and seven years of market exclusivity in the US upon approval by the FDA. In February 2023, the FDA approved EP0042’s Investigational New Drug Application, which allowed for the opening of additional trial sites in the US for this compound.

EP0042 is being developed as a new potential treatment to combat acquired resistance to FLT3 inhibitors in patients with AML. Around one third of patients with AML are diagnosed with FLT3-mutations, which are associated with a higher risk of relapse and poor clinical outcome.1

EP0042 is currently being investigated in an adaptive phase 1/2 dose ranging and optimisation study in patients with relapsed / refractory acute myeloid leukaemia, and Ellipses plans to further evaluate it as both a potential monotherapy and in combination with standard treatments once a phase 2 dose is confirmed. Preliminary data from this study was presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022, which demonstrated acceptable safety and tolerability for EP0042, and evidence of prolonged disease control in a number of heavily pre-treated AML patients.2

Dr Rajan Jethwa, Chief Executive Officer & co-Founder of Ellipses, commented:

"Receiving an FDA Orphan Drug Designation for EP0042 validates this compound’s potential in a currently underserved area of medicine. The designation is an important milestone in the development of EP0042, and underscores the work we are already undertaking towards accelerating its potential access to patients. We believe its early clinical data merits its continued study, and this FDA decision further focuses our vision as we continue our drive towards bringing EP0042 to more patients."

Professor Sir Christopher Evans, Chairman and Founder of Ellipses Pharma, said:

"Achievements like this FDA Orphan Drug Designation for EP0042 are why Rajan and I made the decision to found Ellipses Pharma, and underline the validity of our model of rapidly identifying and developing assets which we believe can have the most impact on patients around the world. I look forward to supporting the team as we continue to drive this compound through the clinic and as we continue our search for assets of promise."

Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses Pharma commented:

"We believe that this FDA decision is a reflection of the strength of the early clinical data for EP0042, which was demonstrated in a presentation at ASH (Free ASH Whitepaper) in December 2022. We are excited to continue the positive momentum in the clinical development of this drug, including progressing the ongoing phase 1/2 trial following the IND received earlier this year."

EP0042’s ongoing clinical-stage study follows earlier drug discovery and development work led by The Institute of Cancer Research, London, which was funded by organisations including The Institute of Cancer Research, Breast Cancer Now and Cancer Research UK.

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.