On January 24, 2022 EdiGene, Inc., a global biotechnology company focused on translating gene-editing technologies into transformative therapies for patients with serious genetic diseases and cancer, reported a research and development collaboration with Haihe Laboratory of Cell Ecosystem to develop hematopoietic stem cell regenerative therapies and platform technology by combining resources and expertise from both sides (Press release, EdiGene, JAN 24, 2022, View Source [SID1234606752]).

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The Haihe Laboratory of Cell Ecosystem, run by the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, is focused on conducting fundamental research, innovation, and translation in the cell ecosystem.

Under the agreement, both parties will jointly develop hematopoietic stem cell regenerative therapies, including the development of innovative genetically-modified hematopoietic stem cell therapies and the exploration of novel biomarkers to optimize quality control for stem cell production.

"With top-notch resources and industry-university-research cooperation, we’ll facilitate the development of cell-based medicine and therapies," said Professor Tao Cheng, Deputy Director of Haihe Laboratory of Cell Ecosystem and President of the Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences and Peking Union Medical College, a leading hematology researcher who has made a series of discoveries relating to the regulatory and regenerative mechanisms of hematopoietic stem cells. "Hematopoietic stem cells (HSCs) have the potential for long-term self-renewal and can differentiate into various types of mature blood cells. These stem cells can be harnessed to provide treatment for a broad range of diseases such as hematological tumors, autoimmune diseases, and hereditary blood disorders. We believe that this collaboration with EdiGene will accelerate the innovation and translation in the field of HSCs, thus enabling healthier patients with new therapies."

Professor Cheng was awarded the second prize of the National Natural Science Award 2020 as the first author of work on basic and translational research that advanced the development of adult hematopoietic stem cells for therapeutic applications.

EdiGene is scaling up clinical translation and development of the first gene-editing hematopoietic stem cell therapy in China following the 2021 approval by the China National Medical Products Administration its IND for its investigational therapy ET-01. "Our team has extensive experience in the development and translation of cutting-edge technologies including hematopoietic stem cell and gene editing," said Dong Wei, Ph.D., CEO of EdiGene. "This collaboration with Haihe Laboratory of Cell Ecosystem will further our exploration in the field of hematopoietic stem cells. The partnership with this leading academic institute and our translational know-how enable us to move forward in bringing more innovative treatment options to patients in China and around the world."

In 2021, EdiGene initiated a Phase I multicenter clinical trial of ET-01, its gene-editing hematopoietic stem cell therapy for transfusion-dependent β-thalassemia. EdiGene has enrolled the first patient at the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Currently, the clinical trial is being conducted in Tianjin and Guangdong-Hong Kong-Macao Greater Bay Area (Greater Bay Area). EdiGene also presented its latest research on new surface markers and migration of hematopoietic stem cells at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in 2021.

On January 24, 2022 Tiziana Life Sciences Ltd. (Nasdaq: TLSA) reported that its Board of Directors has today authorized the Company’s management to implement a stock repurchase program for up to $5 million of the Company’s common shares at any time (Press release, Tiziana Life Sciences, JAN 24, 2022, View Source [SID1234606719]). The term of the board authorization is until December 31, 2022. The repurchase program may be suspended or discontinued at any time and will be funded using the Company’s working capital.

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Executive Chairman Gabriele Cerrone commented, "This announcement demonstrates our confidence in Tiziana’s business and the growth opportunities we see over the long term. We believe this is an attractive use of capital, and based on the strength of our balance sheet, we continue to see ample opportunity to invest and grow our business."

On January 24, 2022 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in Phase 1 clinical study to evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of BAT6021, a monoclonal antibody with enhanced ADCC targeting TIGIT in cancer cells (Press release, BioThera Solutions, JAN 24, 2022, View Source [SID1234606736]).

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"BAT6021 is Bio-Thera’s third IO asset that has entered Phase 1 study in a month." said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. "We plan to explore combinations of BAT6021 with our other oncology assets to treat a broad range of cancers." Dr. Shengfeng Li continued, "we are very pleased to see BAT6021 enter clinical study in Australia, as this is an important step for bringing this innovative and highly differentiated anti-TIGIT antibody to cancer patients."

BAT6021 has demonstrated highly potent single-agent and combinatorial anti-tumor activity in vivo pharmacology studies. The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT6021 is designed to assess the safety and tolerability of BAT6021 as a single agent and in combination with BAT1308, a novel anti-PD-1 antibody in advanced solid tumor patients. Key objectives in the study include determining maximum tolerated dose and recommended phase 2 dose (RP2D), pharmacokinetics and preliminary anti-tumor activity in the monotherapy and combination therapy. Disease-specific expansion cohorts will be enrolled at the RP2D in Australia, China and other countries to further evaluate the safety and efficacy of BAT6021 in a series of malignancies.

Bio-Thera Solutions is developing several additional innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, CD47, and IO bispecifics targeting synergistic targets like PD-L1/CD47.

On January 24, 2022 Lyell Immunopharma, Inc., (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, announced today that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for LYL132, an investigational T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1) that the company is developing in collaboration with GSK (Press release, Lyell Immunopharma, JAN 24, 2022, View Source [SID1234608909]). LYL132 incorporates Epi-R, Lyell’s epigenetic reprogramming technology and is under investigation as a potential next-generation enhancement to letetresgene autoleucel (lete-cel), a GSK TCR therapy targeting NY-ESO-1 currently in pivotal clinical development. The cell surface antigen NY-ESO-1 is a clinically validated target present on many aggressive solid tumors. Lyell’s Epi-R technology is designed to address a major barrier to successful Adoptive Cell Therapy (ACT) by creating populations of T cells with properties of durable stemness. T cells with properties of durable stemness are able to proliferate, persist, and self-renew with anti-tumor functionality.

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"Clearance of the second IND incorporating Lyell’s novel reprogramming technologies is another important milestone for Lyell, especially coming within a month of FDA clearance of an IND for LYL797, our lead CAR program," said Liz Homans, Chief Executive Officer of Lyell. "We are eager to start multiple clinical trials that utilize our technologies to assess the potential benefits for patients with solid tumor cancers and also remain on track for two additional INDs by the end of this year."

"Clinically assessing, in a validated target, the potential benefit of reprogrammed T cells designed to have properties of durable stemness is a profoundly important and exciting milestone for Lyell and cancer drug development," stated Rick Klausner, MD, Chair of Lyell’s Board of Directors. "We believe lack of durable stemness is a major barrier to successful ACT in solid tumors and expect our Epi-R technology platform will offer a path forward to better outcomes for patients."

The planned Phase 1 trial will assess LYL132 in patients with NY-ESO-1+ advanced synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS). Lyell will manufacture LYL132 in its LyFE Manufacturing Center and GSK will conduct the Phase 1 trial.

About NY-ESO-1, Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCLS)

NY-ESO-1 is a member of the cancer testis-antigen (CTA) family of tumor-associated antigens and has been previously validated as a therapeutic target in clinical trials. NY-ESO-1 has low or no expression in healthy adult tissues but is detectable in multiple solid tumor cancer types including non-small cell lung cancer, bladder cancer, melanoma, liver cancer, SS and MRCLS. SS is a rare yet highly malignant tumor occurring in soft tissue and accounts for approximately 5-10% of all soft tissue sarcomas, with approximately 650 to 1,300 cases per year. It is more common in adolescents and young adults than in older individuals. Patients often develop metastases, particularly to the lungs, resulting in 10-year survival rates of <50%. MRCLS is a type of liposarcoma, a rare soft connective tissue tumor that grows in cells that store fat in the body, typically in the arms and legs. MRCLS is one of the most common types of liposarcoma and makes up approximately 30% of all cases, with 2,000 diagnosed occurrences in the United States each year. When this type of cancer metastasizes, the 5-year survival rate is approximately 40%.

About LYL132 and the GSK Collaboration

LYL132 is a novel, NY-ESO-1-targeted TCR product that incorporates Epi-R, Lyell’s proprietary epigenetic reprogramming technology designed to create populations of T cells which have the properties of durable stemness – the quality that enables T cells to proliferate, persist, and self-renew with anti-tumor functionality.

Preclinical in vitro and in vivo experiments of LYL132 have demonstrated that LYL132 has T cells with qualities consistent with T cell stemness, including enhanced metabolic fitness and proliferation. We believe these qualities could be associated with improved clinical responses that could further improve first generation approaches.

In 2019 Lyell and GSK entered into a collaboration agreement to research and develop potential T-cell therapies that apply Lyell’s platform technologies and cell therapy innovations to TCRs or chimeric antigen receptor (CAR) therapies under distinct programs for a specified number of targets. Lyell received $250 million in the form of a combined upfront payment and equity investment and is eligible for technology validation payments totaling approximately $200 million and up to approximately $400 million in additional aggregate development and sales milestones for LYL132. In addition to LYL132, a separate GSK-sponsored program evaluating an NY-ESO-1-targeted TCR that incorporates Lyell’s Gen-R genetic reprogramming technology is planned. These programs could represent a single future product opportunity for GSK utilizing one or both of Lyell’s platform technologies.

On January 24, 2022 AIkido Pharma Inc. (NASDAQ: AIKI ) ("AIkido" or the "Company"), a clinical and early-stage drug development company, reported that its board of directors (the "Board") has authorized a share repurchase program to repurchase up to $3 million of the Company’s outstanding common stock (Press release, Spherix, JAN 24, 2022, View Source [SID1234606720]). The share repurchase authorization is effective immediately.

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"The Board’s decision to establish this share repurchase program reflects the Company’s commitment to creating shareholder value, our strong balance sheet and the expectations we have for 2022." said Anthony Hayes, CEO of AIkido. "We will continue our efforts to create shareholder value by continuing to prioritize capital allocation that supports our growth strategies. Further, we anticipate several monetization events this year, from several of our recent investments, which we believe will further augment shareholder value."

The shares may be repurchased from time to time in open market transactions, or other means in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Rule 10b-18 of the Exchange Act. The timing, number of shares repurchased, and prices paid for the stock under this program will depend on general business and market conditions as well as corporate and regulatory limitations, including blackout period restrictions.