On January 8, 2024 GC Cell, a fully integrated cell therapy pioneer, reported the approval from both the Australian Human Research Ethics Committee (HREC) and the Korean Ministry of Food and Drug Safety (MFDS) for a Phase 1 Investigational New Drug (IND) trial for its AB-201 cancer treatment, a HER2 targeted chimeric antigen receptor-natural killer (CAR-NK) cell therapy that shows great promise (Press release, GC Cell, JAN 8, 2024, View Source [SID1234639126]). Additionally, GC Cell is excited to reveal a strategic partnership with Lunit, the medical AI leader, to enhance precision and clinical intelligence of AB-201’s efficacy evaluation by applying its advanced AI technology, in addition to traditional Immunohistochemistry (IHC) based assessments. After participating in the US White House’s Cancer Moonshot initiative this past October, both accomplishments represent major milestones in GC Cell’s efforts to revolutionize immunotherapy-based cancer treatment while harnessing AI and digital transformation to fight cancer.

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"Our preclinical studies suggest the possibility that AB-201 causes complete cancer remission and tumor suppression," remarked James Park, CEO of GC Cell. "We are thrilled to move forward to Phase 1 trials — the first Korean company to do so for CAR-NK cell therapy — and we are grateful to Lunit for joining hands with us in our digital transformation and the fight against cancer — now armed with the power of AI. This initiative is part of GC Cell’s broader strategy to integrate digital & AI technology into all aspects of healthcare, from research and development to patient care. I believe it will prepare our company for the upcoming era of digital healthcare."

Promising treatment to begin clinical trials

AB-201, a novel CAR-NK cell therapy targeting solid tumors, represents a breakthrough in cancer immunotherapy, capable of killing malignant cells. While existing NK cell treatments typically dissipate within a few weeks, AB-201 has demonstrated persistence for over three months in preclinical studies, highlighting its potential in managing long-term, advanced cancers. A multi-country study, the Phase 1 trial will evaluate safety and efficacy in 48 patients with HER2-overexpressing breast, gastric, and gastroesophageal junction cancers. GC Cell holds exclusive rights to AB-201 in the Asia Pacific region, while ex-Asia-Pacific rights were licensed to Artiva Biotherapeutics, Inc. in an exclusive partnership.

Lunit partnership for AI-powered pharma development

A recent McKinsey report found that AI has the potential to increase the value of the pharmaceutical R&D industry by six to eleven billion US dollars. Employing the technology, GC Cell anticipates that AI-driven imaging can analyze vast amounts of data with a high degree of precision and consistency while reducing variability by individual interpretation. This leads to a more accurate assessment of HER2 expression levels, which is vital for appropriate treatment decisions. With such quantitative analysis, AI can help standardize the assessment of cancer target expression across different laboratories and geographical locations. This standardization is essential for multicenter clinical trials and for ensuring that patients receive consistent care regardless of where they are treated. It’s a pivotal step in GC Cell’s journey towards a digital future, aligning with the broader healthcare industry’s shift towards technology-enhanced solutions.

About AB-201

AB-201 is an allogeneic HER2-targeted chimeric antigen receptor NK (CAR-NK) cell therapy for the treatment of solid tumors in the outpatient setting with the option for repeat dosing. A novel, high affinity anti-HER2 antibody converted to scFv structure confers highly specific tumor targeting and is coupled with a unique costimulatory structure and IL-15 expression for enhanced activity and persistence. AB-201 has demonstrated potent anti-tumor activity in multiple preclinical HER2-positive tumor model systems. The underlying NK cell is derived from umbilical cord blood donors preselected for advantageous attributes including the high affinity variant of the CD16 receptor and a KIR-B haplotype. AB-201 cell products maintain high expression of CD16, as well as other activating innate cell tumor engaging receptors, enabling the potential for dual targeting therapeutic approaches via monoclonal antibody combinations. The resulting CAR-NK is manufactured at very large scale and cryopreserved in infusion-ready media to enable repeat clinical administrations in the outpatient setting.

GC Cell holds exclusive rights to AB-201 in the Asia-Pacific region, while ex-Asia-Pacific rights were licensed to Artiva Biotherapeutics, Inc. in an exclusive partnership. The U.S. Food and Drug Administration previously cleared Artiva’s investigational new drug (IND) application for AB-201 in 2022.

On January 8, 2024 BioVaxys Technology Corp. (CSE: BIOV, FRA: 5LB, OTCQB: BVAXF) ("BioVaxys" or the "Company") reported that it intends to complete a non-brokered private placement (the "Private Placement") consisting of up to 53,333,333 units ("Units") at a price of $0.03 per Unit for total gross proceeds of CAD$1,600,000. Each Unit consists of one common share (a "Common Share") and one whole Common Share purchase warrant (a "Warrant") (Press release, BioVaxys Technology, JAN 8, 2024, View Source [SID1234639125]). Each Warrant is exercisable for one additional Common Share at an exercise price of $0.05 for a period of 24 months. In total it is anticipated that on a fully diluted basis the number of securities issuable is 106,666,666 which is less than 100% of the total number of securities or votes outstanding and as such the Company believes that security holder approval for the sale of the said securities is not required under section 4.6 of CSE Policy 5 – Corporate Governance, Security Holder Approvals and Miscellaneous Provisions. Closing of the proposed financing is expected to occur on or before January 26th, 2024.

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Closing of the private placement is conditional upon finalizing all contractual documentation and receipt of all applicable regulatory approvals and the policies of the Canadian Securities Exchange ("CSE").

All securities issued pursuant to the Private Placement are subject to a statutory hold period of four months and one day from the date of issuance. The Company intends to use the net proceeds of the Private Placement for working capital purposes and for the potential acquisition described in a previous press release dated December 22nd, 2023.

The Company may pay a finder’s fee related to the financing.

In addition, the Company announces that it intends to settle up to a maximum of CAD$216,575 in debt through the issuance of a maximum of 7,218,167 common shares issued at a deemed price of $0.03 per common share. None of the debt being settled includes accrued salaries to officers or directors of the Company, nor does it include payment for Investor Relations Activities The debt settlement is expected to include the participation of certain related parties including BioVaxys CEO James Passin and BioVaxys COO and President Kenneth Kovan, both of whom are officers of the Company, with James Passin being a director of the Company, and as such it will constitute a "related party transaction" within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Company is relying on the exemptions from the valuation and minority shareholder approval requirements of MI 61-101 contained in sections 5.5(a) and 5.7(1)(a) of MI 61-101, as the fair market value of the shares for debt transaction with the forgoing insiders does not exceed 25% of the market capitalization of the Company, as determined in accordance with MI 61-101. Closing of the proposed financing is expected to occur by January 19th, 2024.

All securities proposed to be issued in connection with the Debt Settlement will be subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable securities legislation. Closing of the Debt Settlement is conditional upon a number of conditions, including finalizing all contractual documentation and receipt of all applicable regulatory approvals and the policies of the CSE.

On January 8, 2024 The Partner of Biosion Inc. (Biosion) , OBI Pharma (4174.TWO), reported that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-992, to conduct a Phase 1/2 study of its novel antibody drug conjugate (ADC) cancer therapy targeting TROP2 (Press release, Biosion, JAN 8, 2024, View Source [SID1234639124]). The targeting antibody was discovered through Biosion’s SynTracer High Throughput Endocytosis Platform and was licensed to OBI Pharma in Dec 2021. OBI Pharma owns ex-China commercial rights for OBI-992 (BSI-992), and Biosion owns China rights.

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"We are very pleased to see OBI Pharma receive FDA clearance for OBI-992 (BSI-992)," said Hugh M. Davis, Ph.D., Chief Business & Development Officer, and President of Biosion USA, Inc. "OBI-992 demonstrated superiority over other TROP2 ADCs in pre-clinical studies. It is a solid validation of the unique advantages of Biosion’s SynTracer platform to identify fit-for-purpose antibodies for the development of novel ADC therapies. We are excited about this innovative treatment and making a meaningful difference for patients worldwide."

OBI Pharma plans to enroll patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC), although several other cancers are also potential targets. OBI Pharma’s Chief Medical Officer, Wayne Saville, M.D. noted, "The clinical trial intends to evaluate the safety, pharmacokinetics, and preliminary efficacy of OBI-992, a novel anti-TROP2 ADC with best-in-class potential. We look forward to dosing the first patient in our Phase 1/2 clinical study of OBI-992, which is expected to begin in early 2024."

Heidi Wang, Ph.D., OBI Pharma’s Chief Executive Officer, added, "OBI-992 is a novel anti-TROP2 ADC designed and engineered by OBI Pharma. It demonstrates outstanding preclinical efficacy, favorable safety, and high stability in numerous in-vivo studies compared to other TROP2 ADCs. We are excited to commence the first-in-human clinical trial of OBI-992. OBI Pharma strives to advance our promising therapeutics to the clinic for cancer patients."

About OBI-992 (BSI-992)

OBI-992 (BSI-992) is a TROP2-targeted antibody-drug-conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill solid tumors. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, and gastric cancer, rendering it an ideal target for cancer therapy. OBI-992 (BSI-992) uses a differentiated hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. OBI-992 (BSI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in animal models. The anti-TROP-2 targeting antibody was discovered and developed by Biosion, OBI Pharma owns ex-China commercial rights for OBI-992 (BSI-992).

On January 8, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that Compugen is entitled to receive a $10 million milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN), after the first patient was dosed in AstraZeneca’s ARTEMIDE-Bil01 trial with rilvegostomig (Press release, Compugen, JAN 8, 2024, View Source [SID1234639123]). Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen’s clinical-stage anti-TIGIT antibody, COM902. The ARTEMIDE-Bil01 trial is expected to recruit about 750 subjects in more than 20 countries with biliary tract cancer who will be randomized to receive rilvegostomig or placebo with investigator choice chemotherapy as adjuvant treatment after resection with curative intent.

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"I am delighted to see the advancement of the rilvegostomig Phase 3 trial by AstraZeneca, a global leader in oncology, which has dosed the first patient triggering a $10 million milestone payment to Compugen," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "Our license agreement with AstraZeneca is part of our strategy to broaden commercialization opportunities for our pipeline and specifically capitalize on the potentially emerging promise of bispecific therapies while maintaining our focus on the development of COM902 as part of the combination with COM701, our potential first-in-class anti-PVRIG antibody."

About the Compugen-AstraZeneca license agreement

In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca to use Compugen’s monospecific antibodies that bind to TIGIT, including COM902, for the development of bispecific and multispecific antibody products, excluding such bispecific and multispecific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT. AstraZeneca is responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. In addition to the $10 million milestone payment described in this press release, Compugen has received a $10 million upfront payment, and an additional $15.5 million in milestone payments to date, all out of up to an aggregate milestone amount of $200 million that the Company is eligible to receive in development, regulatory and commercial milestones for the first product, as well as tiered royalties on future product sales. If additional bi- or multi-specific therapies are developed based on Compugen’s monospecific antibodies that bind to TIGIT, additional milestones and royalties would be due to Compugen.

Further details about ARTEMIDE-Bil01 trial are available on ClinicalTrials.gov, identifier: NCT06109779

On January 8, 2024 KeifeRx, an emerging clinical-stage biopharmaceutical company specializing in the discovery and development of new treatment options for neurodegenerative and immune diseases, reported entry into an amended exclusive licensing agreement with Georgetown University to advance the development of novel tyrosine kinase inhibitor (TKI) chemical entities (NCE) for the treatment of multiple disease indications (Press release, Georgetown University, JAN 8, 2024, View Source [SID1234639122]). The amendment provides an extension of the exclusively licensed rights to these four novel chemical entities for the treatment of new disease conditions including inflammatory, mast-cell associated diseases, and oncology, in addition to existing rights in neurodegenerative diseases. KeifeRx is currently conducting optimizing and IND-enabling studies involving four separate formulations of the TKI (renamed KFRX03, KFRX04, KFRX05, and KFRX06) with patent life through 2037.

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Early-stage clinical trials conducted at Georgetown University, along with compelling preclinical research conducted at the university led by KeifeRx’s co-founder, Charbel Moussa, MBBS, Ph.D., and colleagues, demonstrated the ability of TKIs to penetrate the brain, induce autophagy, and enable the bulk disposal of disease-causing toxic proteins to treat neurodegenerative diseases, as well as the ability to target mast cells and simultaneously modulate peripheral and central immunity, providing therapeutic potential for an array of immune diseases. These properties offer the potential to significantly improve upon current neurodegenerative and immune disease treatments, which are primarily palliative and offer minimal and temporary benefits due to their inability to adequately eliminate toxic proteins and mitigate inflammation.

"Entry into this expanded exclusive licensing agreement with Georgetown is a pivotal milestone for the growth of KeifeRx as we have significantly increased the range of indications we can pursue with our portfolio of new chemical entity TKIs, including the treatment of neurodegenerative, neuroinflammatory, and mast cell-related diseases," said Chris Hoyt, Chief Executive Officer of KeifeRx. "We look forward to working with the research team at Georgetown University to spearhead the development of KFRX03, KFRX04, KFRX05, and KFRX06 for the treatment of multiple, underserved disease indications. The IP covering these assets extends through 2037, making the portfolio a high-value drug opportunity given its numerous potential disease indications, including Alzheimer’s disease, ALS, mast cell activation syndrome (MCAS), and urticaria."