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."

On January 8, 2024 Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported substantial progress and outlined 2024 milestones related to its broad portfolio at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Biohaven Pharmaceutical, JAN 8, 2024, View Source [SID1234639121]). A copy of the slide presentation is available on the Events and Presentations section of the Biohaven website.

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Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, said, "Building upon our groundbreaking legacy of success in migraine, we have re-emerged a year after the spinoff from the Pfizer transaction with one of the most innovative portfolios in biotech with multiple clinical programs primarily focused on neuroscience, immunology, and oncology. We are very excited about each of these programs with particular emphasis on those with near-term potential, including our selective Kv7 activator platform. We have shown CNS target engagement and differentiated tolerability without the typical CNS side effects of other non-selective agents in this class. Given this remarkable profile, we are advancing BHV-7000 in an array of clinical studies for focal epilepsy, generalized epilepsy, bipolar disorder, and major depressive disorder. BHV-7000 has the potential to change the treatment paradigm in mood and epilepsy.

Further, our innovative extracellular protein degrader platform has generated multiple new investigational agents that are rapidly advancing into the clinic, initially targeting IgG, IgA, and β1-AR autoantibodies to treat both common and rare autoimmune diseases. This highlights the uniqueness of the platform to efficiently deliver highly differentiated assets that are finely tuned to specific clinical targets in relatively short development periods. For example, our newly disclosed β1-AR degrader went from concept to lead drug candidate in approximately one year. Our lead degrader candidate for β1-AR autoantibodies, BHV-1600, offers to re-route pathogenic antibodies to the liver where they can be degraded and help alleviate β1-AR+ heart failure. In addition, we have quickly advanced our next generation IgG degrader, BHV-1310, and shown that it can achieve ultra-rapid 90% IgG depletion after a single dose in preclinical models. This is particularly well suited to address indications such as acute myasthenia gravis, transplant rejection and other indications that require rapid clearance of disease-causing antibodies. In addition to completing enrollment in a pivotal spinal muscular atrophy clinical study, we have been opportunistic in exploring our myostatin inhibitor, taldefgrobep alfa, as a potential treatment approach for obesity demonstrating that it reduces adipose tissue and improves lean mass. Addressing the growing public health crisis of obesity by reducing fat while preserving and improving muscle mass would be a tremendous advancement in the field, especially as the field evaluates the potential long-term impact of reducing muscle mass that has been observed with GLP-1 medications. Finally, we look forward to an important milestone in our glutamate modulating program with the first quarter database lock for our interim efficacy analysis of our Phase 3 study of troriluzole in OCD. There have been no novel treatments in OCD in over 20 years and if troriluzole proves to be efficacious this will be an important breakthrough for the millions of patients suffering from this disorder."

Anticipated 2024 Clinical Milestones
Biohaven is positioned to achieve significant, value-creating milestones in 2024 across numerous programs:

Selective Kv7 Activator: BHV-7000 is a selective activator of Kv7.2/7.3 potassium channels, a breakthrough target in neurology and neuropsychiatry with blockbuster potential. Kv7 activation is a clinically validated target for treating epilepsy. More recently, clinical proof-of-concept studies have also demonstrated that Kv7 activators have robust antidepressant effects and rapid onset of action, providing strong clinical support for the transformative potential of BHV-7000 as a novel treatment for major depressive disorder.

Initiate BHV-7000 Phase 2/3 program in focal epilepsy in 1Q 2024
Initiate BHV-7000 Phase 2/3 study in bipolar disorder in 1Q 2024
Initiate BHV-7000 Phase 2 study in major depressive disorder in 1Q 2024
Initiate BHV-7000 Phase 2/3 study in generalized epilepsy in 2Q 2024

Troriluzole: Troriluzole is a novel glutamate modulator currently in Phase 3 development for obsessive-compulsive disorder (OCD). It is being evaluated as an adjunctive therapy in patients with an inadequate response to existing standard of care treatment. The troriluzole Phase 2 trial in OCD demonstrated consistent numerical benefits vs. placebo on the Yale-Brown Obsessive Compulsive Scale (primary endpoint) at all timepoints and informed the Phase 3 study design.

Database lock in 1Q 2024 and report troriluzole Phase 3 interim efficacy analysis topline results in OCD in 2Q 2024
Taldefgrobep alfa: Taldefgrobep is a novel myostatin inhibitor that is optimized to block both myostatin and activin A signaling, two key regulators of muscle growth, in a balanced manner. Biohaven is studying taldefgrobep in a global Phase 3 study in Spinal Muscular Atrophy (SMA), as an adjunctive therapy to enhance muscle mass and function in patients treated with standard-of-care treatments. Further, taldefgrobep also has significant promise as a potential treatment for obesity. In preclinical models, taldefgrobep demonstrated meaningful reductions in fat mass, the primary pathogenic tissue in obesity, while increasing lean mass. This is a paradigm-shift from obesity therapies that cause significant losses in muscle mass.

Initiate taldefgrobep Phase 2 study in obesity in 2Q 2024
Report taldefgrobep Phase 3 topline results in SMA in 2H 2024
First-in-class TRPM3 Antagonist: BHV-2100 is a first-in-class, oral, selective TRPM3 antagonist that offers a novel, non-addictive treatment for migraine and neuropathic pain. The preliminary pharmacokinetic and safety data from the ongoing Phase 1 study in healthy volunteers supports evaluation of BHV-2100 in acute migraine. It is rapidly absorbed and achieves 90% inhibitory concentrations within 1 hour, and it is well tolerated at projected therapeutic concentrations.

Initiate BHV-2100 Phase 2 study in acute migraine in 2H 2024
Conduct BHV-2100 POC study for neuropathic pain in 2H 2024
TYK2/JAK1 Inhibitor: BHV-8000 is a first-in-class, oral, brain-penetrant, selective TYK2/JAK1 inhibitor with broad potential for neuroinflammatory disorders. In the ongoing Phase 1 study in healthy volunteers, Biohaven has successfully dosed three single ascending dose cohorts and one multiple ascending dose cohort. Projected therapeutic concentrations were achieved, and BHV-8000 was well tolerated.

Initiate BHV-8000 Phase 2 study in Multiple Sclerosis in 2Q 2024
Initiate BHV-8000 Phase 2a study in prevention of amyloid therapy induced ARIA in 2H 2024
Initiate BHV-8000 Phase 2/3 study in early Parkinson’s disease in 2H 2024
Initiate BHV-8000 Phase 2/3 study in early Alzheimer’s disease in 2H 2024
Extracellular protein degradation platform: Four agents quickly advancing
From Biohaven’s targeted extracellular protein degradation platform, the Company is planning four INDs across a number of indications. The lead program, BHV-1300, offers a mechanism of action that is differentiated from FcRn targeting agents with the potential for a faster onset of action, deeper reductions in IgG, no mechanistic effects on albumin or cholesterol, self-administered subcutaneous dosing, and ability to dose in conjunction with Fc-containing biologic therapeutic agents. In a preclinical model, BHV-1300 demonstrated that it can be co-administered with Fc-containing biologics, such as Humira, supporting Biohaven’s strategy of advancing BHV-1300 in combination with standard of care treatments for rheumatoid arthritis (unlike the FcRn class which have limitations on co-administration with Fc containing biologics).

BHV-1300 clinical data regarding first-in-human of IgG lowering expected in 1Q 2024
A total of 4 INDs are expected for the degrader program in 2024
Next Generation ADC Platform: Biohaven’s ADC technology is focused on novel conjugation chemistry with the potential to be superior to the current industry standard maleimide and lipophilic click chemistry. The goal of its technology is to provide more stable and consistent drug antibody ratio (DAR) for use in oncology.

Initiate Phase 1 trial of BHV-1510 (Trop2) in 2Q 2024
File IND for BHV-1500 (next gen brentuximab ADC) in 2H 2024
Dr. Coric concluded, "2024 will be a groundbreaking year for Biohaven. We have the foundation and momentum to drive success across numerous clinical and preclinical programs, where our ability to execute with speed and efficiency is well proven. In only one short year, we have built a new company and portfolio that is well positioned to drive patient and shareholder value led by an experienced leadership team with a strong financial foundation to succeed."