On June 1, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that TAZVERIK (tazemetostat) has been approved by the Health Commission and Medical Products Administration of Hainan Province to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone ("Hainan Pilot Zone"), under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with epithelioid sarcoma ("ES") and follicular lymphoma ("FL") consistent with the label as approved by the U.S. Food and Drug Administration ("FDA") (Press release, Hutchison China MediTech, JUN 1, 2022, View Source [SID1234615314]). Launched in 2013 and located in China, the Hainan Pilot Zone is a destination for international medical tourism and global hub for scientific innovation, welcoming 83,900 medical tourists in 2020, according to official data.

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TAZVERIK is a methyltransferase inhibitor of EZH2[1] developed by Epizyme, Inc. ("Epizyme"). It is approved by the FDA for the treatment of certain patients with ES and certain patients with FL under FDA accelerated approval granted in January and June 2020, respectively.

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: "The approval of TAZVERIK in the Hainan Pilot Zone allows patients to gain early access to this first-in-class EZH2 inhibitor in China, as part of our commitment to bringing innovative medicines to people in need. In addition to its use in the Hainan Pilot Zone, we also plan to initiate further registration-enabling studies in China under the terms of our agreement with Epizyme to facilitate wider and easier patient access."

In August 2021, HUTCHMED entered into a strategic collaboration with Epizyme to research, develop, manufacture and commercialize TAZVERIK in China, Hong Kong, Macau and Taiwan.

About FL and ES
Follicular lymphoma (FL) is a subtype of non-Hodgkin’s lymphoma ("NHL"). FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively. [2],[3],[4]

Epithelioid sarcoma (ES) is a rare, slow-growing type of soft tissue cancer. Radical tumor resection is the primary treatment for patients with ES. However, ES is known for its high propensity for locoregional recurrence and distant metastases. The survival of patients with ES is often unsatisfactory with very limited treatment options.[5]

About TAZVERIK (tazemetostat)
TAZVERIK is a methyltransferase inhibitor indicated in the United States for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval by the U.S. FDA based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

View the U.S. Full Prescribing Information here: www.tazverik.com

About Tazemetostat Clinical Development in China
HUTCHMED and Epizyme are developing tazemetostat in various hematological and solid tumors in Greater China, with HUTCHMED leading the China portion of Epizyme’s SYMPHONY-1 study. HUTCHMED and Epizyme also intend to conduct additional global studies jointly.

SYMPHONY-1 (EZH-302) is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase 1b/3 study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with R² in patients with relapsed or refractory FL after at least one prior line of therapy(clinicaltrials.gov identifier: NCT04224493).

We intend to initiate a bridging study in FL to support registration of tazemetostat in China, as well as several combination studies of tazemetostat with HUTCHMED assets.

On June 1, 2022 Hangzhou DAC Biotechnology Co., Ltd. ("DAC Biotechnology") reported a collaboration and license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson ("Janssen") (Press release, Hangzhou DAC Biotech, JUN 1, 2022, View Source [SID1234618939]). Under the terms of the agreement, DAC Biotechnology will apply its innovative and proprietary antibody drug conjugate (ADC) platform to Janssen’s proprietary antibodies with the aim to develop novel ADC products against up to five targets. The negotiation and finalization of the agreement was facilitated by Johnson & Johnson Innovation. DAC Biotechnology has also received an equity investment from Johnson & Johnson Innovation – JJDC, Inc.

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"We are very proud to mark this important collaboration with Janssen," said Dr. Robert Yongxin Zhao, President and Chief Executive Officer of DAC Biotechnology. "After years of dedicated research and development, DAC technology has become a key player in the field of ADC innovation. Our advanced ADC platform, with abundant reserve of payload/linker pairs, conjugation technologies and CMC capabilities, enables us to build a deep pipeline of products, many of them being first-in-class ADCs. We are committed to bringing safe and efficacious medicines not only to patients in China, but also those around the world."

"The collaboration with Janssen is the very first collaboration milestone in our global roadmap. The combination of the license agreement and equity investment creates an exciting approach to progressing novel therapeutic innovations in overseas markets," Dr. Zhao continues.

With the aim to discover novel ADC products via license collaboration, DAC Biotechnology will fully leverage its intellectual properties and proprietary ADC platform, while Janssen will provide its expertise in proprietary antibodies, clinical development and global commercialization. Through the collaboration agreement, DAC Biotechnology is eligible to receive an upfront payment, cost reimbursement and milestone payments, plus royalties on worldwide sales for each selected product.

On June 1, 2022 OncoNano Medicine, Inc. reported the appointment of Kartik Krishnan, M.D., Ph.D., as Chief Medical Officer (Press release, OncoNano Medicine, JUN 1, 2022, View Source [SID1234615330]). Dr. Krishnan will be responsible for formulating and leading all clinical development efforts and operations at OncoNano. Additionally, Dr. Krishnan will develop and implement the strategic clinical plans for OncoNano, including the creation of a medical affairs team, as the company further advances its clinical oncology development programs.

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"We are thrilled that OncoNano has been successful in attracting such a noted and impressive scientist as Dr. Krishnan. Kartik is a proven and respected oncology drug developer, with extensive experience in leading the development of novel oncology therapeutic programs," said Martin Driscoll, CEO of OncoNano. "His breadth of experience and history of drug development success will be instrumental to our company as we progress our differentiated portfolio of oncology development candidates into multiple clinical trials."

Dr. Krishnan previously served as Chief Medical Officer at Arcus Biosciences, where he led the expansion of the company’s portfolio into novel indications and combinations, as well as the initiation of a number of pivotal Phase 3 trials. Prior to joining Arcus, he served as Executive Medical Director at Astex Pharmaceuticals, providing strategic direction and tactical support across multiple programs in all phases of development. Dr. Krishnan has also held positions in clinical drug development at Genentech, FivePrime Therapeutics, BioMarin and Amgen. Dr. Krishnan earned both his M.D. and Ph.D. in Cellular, Molecular, and Biophysical Studies from Columbia University.

"My passion is working with novel technologies that have the potential to benefit the treatment of patients with cancer. I am excited about the potential for the core platform technology at OncoNano that can deliver oncology payloads in a targeted and efficient manner to the tumor microenvironment," said Dr. Krishnan. "I believe I am joining OncoNano at an ideal time because I can immediately impact the strategic development plans for the OncoNano therapeutics programs and lead the execution of the clinical programs at the company. I am impressed with the OncoNano organization and look forward to working with Marty and the OncoNano team to successfully advance our pipeline and achieve the company’s mission to benefit cancer patients."

On June 1, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported that Bharatt Chowrira, Ph.D., J.D., President and Chief Business, Legal & Operating Officer, and Julie Krop, M.D., Chief Medical Officer, will participate in a fireside chat at the Jefferies Healthcare Conference in New York City on Thursday, June 9, 2022, at 9:30am EDT (Press release, PureTech Health, JUN 1, 2022, View Source [SID1234615348]). A webcast of the presentation will be available at View Source

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On June 1, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, reported that company management will present its corporate highlights at the Jefferies Healthcare Conference, June 8, 2022 with a presentation at 11:00 a.m. ET in New York, NY (Press release, Gamida Cell, JUN 1, 2022, View Source [SID1234615367]).

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Management will discuss 2022 catalysts and potential milestones including the U.S. market opportunity for omidubicel upon potential U.S. Food and Drug Administration approval, accelerating the development of its first-in-class NAM-enabled natural killer (NK) cell therapy candidate, GDA-201, as a potential new approach for patients with follicular and diffuse large B-cell lymphomas, and expansion of its NAM-enabled cell therapy pipeline with multiple next-generation, genetically engineered NK cells.

A webcast of the event will be available on the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.

About Omidubicel

Omidubicel is an advanced cell therapy candidate under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. Gamida Cell has completed an international, multi-center, randomized Phase 3 study (NCT0273029) evaluating the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. That study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient’s recovery from a stem cell transplant. The Phase 3 study also achieved its secondary endpoints of reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. Gamida Cell initiated a rolling BLA submission for omidubicel in the first quarter of 2022 with full BLA submission on track for the second quarter of 2022. In 2019, approximately 8,000 patients who were 12 years old and up with hematologic malignancies underwent an allogeneic stem cell transplant.1 Unfortunately it is estimated that another 1,200 patients were eligible for transplant but could not find a donor source.2 Omidubicel has the opportunity, upon FDA approval to improve outcomes for patients based on transplanter feedback and increase access for patients to get to transplant. Omidubicel has the potential to treat approximately 2000 – 2500 patients each year in the U.S. For more information about omidubicel, please visit View Source

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the E.U.5 and U.S. which is the patient population that will be studied in the GDA-201 Phase 1/2 clinical trial.

For more information about GDA-201, please visit View Source For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About NAM Technology

Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (Nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.