On April 26, 2021 Biond Biologics Ltd. ("Biond" or the "Company"), a private clinical-stage biopharmaceutical company, developing novel immunotherapies for cancer and a platform enabling the intracellular delivery of biologics, reported that the first patient has been dosed in the first-in-human, phase 1 clinical trial of BND-22 (SAR444881), an Ig-Like Transcript 2 (ILT2) receptor blocking antibody (Press release, Biond Biologics, APR 26, 2021, View Source [SID1234578511]).

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The first patient was administered BND-22 at the Oncology Research Unit of the Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, one of the six US and Israel trial sites planned to initially participate in the phase 1, open-label, dose escalation study exploring the safety, tolerability, pharmacokinetics (PK), anti-tumor activity, and exploratory biomarkers for BND-22 activity in patients with select advanced solid tumors.

"BND-22 represents a novel approach to cancer immunotherapy targeting both adaptive and innate immune cells," said Ravit Geva, M.D., Research Unit Head and Deputy Director, Division of Oncology at the Tel Aviv Sourasky Medical Center, and a clinical investigator in the trial. "There continues to be an urgent need to develop new treatments for patients with cancers refractory to standard of care therapy. BND-22 has demonstrated compelling preclinical activity, and we look forward to further investigate the potential of ILT2 blockade in this Phase 1 study."

"The entry of BND-22 into the clinic is a significant milestone for Biond as it represents the achievement of an important aspect of the company’s vision to progress our novel medicines into clinical evaluation while using our drug discovery, development, and translation capabilities," said Tehila Ben Moshe, Ph.D., Co-Founder and Chief Executive Officer of Biond. "BND-22, a multi-cell checkpoint inhibitor, was studied extensively by our scientific team for several years and was found to have the potential to improve upon current treatment paradigms, either as a monotherapy or in combination. Based on in-depth translational studies of real-world patient samples we have designed the Phase 1 trial to focus on patient populations we believe are most likely to respond to ILT2 blockade. We look forward to the results of the BND-22-001 trial as we strive to improve the treatment of cancer patients with dire needs for new therapies."

Biond announced on January 12th, 2021 an exclusive worldwide license agreement with Sanofi, for the development and commercialization of BND-22. Under the terms of the agreement, Biond will lead the first-in-human, phase 1 study of BND-22, evaluating its safety and tolerability as a single agent and in combination with approved cancer therapeutics as well as exploring the association between BND-22 anti-tumor activity and select tumor and blood-based biomarkers; Sanofi will assume clinical development and commercialization responsibilities thereafter.

About BND-22

BND-22 is a humanized IgG4, antagonist antibody targeting the ILT2 receptor in development for the treatment of solid tumors. ILT2, a member of the ILT family of immuno-modulating receptors, is an inhibitory receptor expressed on both innate and adaptive immune cells that binds major histocompatibility complex (MHC) class I molecules including HLA-G, an immunosuppressive protein expressed by multiple tumor types.

BND-22 has been shown in preclinical studies to have a broad anti-tumor effect by targeting ILT2-mediated "do not eat me" signals in macrophages and by activating NK and CD8+ lymphocytes. The program is supported by a comprehensive biomarker strategy designed to guide patient enrollment in advanced clinical trials.

BND-22-001 is the first-in-human clinical trial of BND-22. It is a Phase 1/2 multicenter, open-label, dose escalation and expansion study enrolling advanced cancer patients with solid tumor types known to express HLA-G. Following dose escalation and determination of BND-22′ recommended Phase 2 dose, the study design allows for the expansion of patient cohorts to evaluate the anti-tumor activity of BND-22 in specific tumor types. BND-22-001 is planned to be expanded to also evaluate the safety and anti-tumor activity of BND-22 in combination with other therapies. For more information about the trial, including participating medical centers, please visit View Source (Trial Identifier: NCT04717375).

On April 26, 2021 CARISMA Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported it has established a multi-year scientific collaboration with Bruce Blazar, MD, Regents Professor of Pediatrics, Division of Blood and Marrow Transplantation and Cellular Therapy at the University of Minnesota to investigate and develop allogeneic macrophage therapies (Press release, Carisma Therapeutics, APR 26, 2021, View Source [SID1234578510]).

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Allogeneic macrophage therapies may prove successful in providing a solution forged in cell therapy to a broader population of patients, further extending the potential benefits of CARISMA’s CAR-Macrophage (CAR-M) platform beyond oncology and into other disease states with unmet clinical needs.

"The collaboration with Dr. Blazar marks the initiation of the development of allogeneic, universal donor derived monocyte and macrophage cell therapies at CARISMA," said Michael Klichinsky, PharmD, PhD, Scientific Co-Founder and Senior Vice President of Research at CARISMA Therapeutics. "The focus of this multi-year collaboration will be optimizing and developing iPSC derived allogeneic chimeric antigen receptor macrophages, further expanding the potential of macrophage-based cell therapy for cancer and other diseases."

The announcement follows the recent dosing of the first patient in CARISMA’s Phase 1 multi-center clinical trial for CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted CAR-M. It is the first time CAR-engineered macrophages are being studied in humans.

"For more than 35 years, I have focused on transplantation immunobiology in my lab in order to develop new therapies that may improve patient health," said Dr. Blazar. "I look forward to working with the company to develop allogeneic CAR-Ms to help patients with hard-to-treat cancers and other severe diseases."

On April 26, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported the 2020 Annual Report (Press release, Oncopeptides, APR 26, 2021, View Source [SID1234578509]).

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The report summarizes an extraordinary year in the Company´s proud history, with significant advancements in the Research and Development programs, organizational capabilities, strategic direction, company culture and sustainability. Oncopeptides delivered on all major milestones, despite the challenging conditions caused by the ongoing global pandemic.

"The past year has been a transformational year for Oncopeptides highlighted by the FDA decision to grant our NDA submission of melflufen in triple class refractory multiple myeloma a priority review, leading to the accelerated approval and commercial launch of PEPAXTO in the U.S. early 2021", says Marty J Duvall, Chief Executive Officer at Oncopeptides AB. Not many emerging biotech companies cross the finish line in terms of launching a product that can make a significant difference for patients".

On April 26, 2021 Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported that new data demonstrating an unexpected synergy between its inducible pluripotent stem cell (StemVacs-V iPSC) derived immunotherapy product with low dose cyclophosphamide in evoking potent immune mediated cancer regression (Press release, Therapeutics Solutions International, APR 26, 2021, View Source [SID1234578507]).

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In a series of experiments, the Company demonstrated that its previously announced stem cell derived tumor endothelial-like cell vaccine1 enabled non-toxic doses of cyclophosphamide, an established chemotherapeutic agent, to induce significant reduction of established lung cancers, brain cancers, and skin cancers in animal models. Furthermore, it was demonstrated that reduction of tumors was associated with increased infiltration of immune cells.

"Previous companies, such as Batu Biologics, have demonstrated the clinical safety of using the immune system to selectively kill the blood vessels that feed cancer2, which was validated by FDA clearance3 to initiate clinical trials," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "As a physician who sees firsthand the suffering of cancer patients caused by current chemotherapy protocols, the thought of leveraging the patient’s own immune system to allow for increased efficacy with reduced toxicity is extremely exciting."

"From a business perspective, one of the significant hurdles preventing advancement in cancer therapeutics is lack of interdisciplinary collaboration," said Famela Ramos, Vice President of Business Development. "The demonstration that our immunotherapy possesses ability to potentiate anticancer activities of existing therapeutics, thus allowing for utilization of lower doses while retaining efficacy, is a game changer in my opinion."

"The idea that killing tumor blood vessels weakens cancer, and thus allows for lower doses of chemotherapy to be effective is very attractive. This concept has been validated in clinical trials which involved combinations of chemotherapy with the antiangiogenic activities of the monoclonal antibody drug Avastin," said Timothy Dixon, President and CEO of the Company. "Based on side-to-side comparisons, our stem cell based immunotherapy appears substantially more efficacious in inducing immune mediated "choking" of the tumor blood supply and demands deeper investigation."

On April 26, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported the launching of a new research program for the development of a Melanoma antitumor targeting medicine (Press release, Cannabics Pharmaceuticals, APR 26, 2021, View Source [SID1234578506]). The announcement comes amidst the recent completion of a series of preclinical experiments within the company’s in-house research facilities demonstrating promising antitumor results on Melanoma cell lines.

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The launching of the new research program for the development of Melanoma treatment follows a previous development by the company of Cannabics RCC-33, a proprietary formula for the treatment of Colorectal Cancer, who demonstrated a 33% reduction in tumor volume and a 35% increase in survival rate in recent in-vivo experiments in mice.

Gabriel Yariv, Cannabics Pharmaceuticals President & COO said: "The company has unique expertise and experience allowing it to develop new antitumor formulas from our built-to-spec in-house drug discovery platform. Accordingly, following our decision to develop an additional antitumor drug candidate to target Melanoma, we were able to produce high quality preclinical data, as well as identify several promising findings that we now plan to further investigate. This method of evaluation organically points towards the path of developing a new drug candidate for the treatment of Melanoma."

Eyal Barad Cannabics Pharmaceuticals’ Co-founder and CEO commented: "The company plans to use this new data to initiate in-vivo animal model studies to be included in a future product package that we intend to submit to the US Food and Drug Administration along with a Pre-IND Meeting request."

Melanoma is the most serious type of skin cancer, particularly given its characteristic of spreading deeper into the skin and into other organs. According to the Skin Cancer Foundation the estimated five-year survival rate for U.S. patients whose melanoma is detected early is about 99%, and it is estimated that some 200,000 new cases of Melanoma will be diagnosed in the US in 2021 alone.