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Cannabics Pharmaceuticals to launch Drug Development Programs for Prostate Cancer and Neurodegenerative & Mental Health Diseases

On June 17, 2021 Cannabics Pharmaceuticals Inc. (CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported the expansion of its research program with new drug development projects targeting Prostate Cancer, Neurodegenerative & Mental Health diseases (Press release, Cannabics Pharmaceuticals, JUN 17, 2021, View Source [SID1234584202]). The announcement of the new research projects follows promising initial preclinical results obtained in the company’s in-house drug discovery facility in Rehovot, Israel.

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Study results indicate the potential efficacy of a variety of specific analytes for the indications tested. The experiments performed were conducted on cell lines and human biopsies obtained under Helsinki Committee approval. The company plans to continue development of these drug candidates and continue testing with animal models while entering a drug regulatory development route for each indication.

This announcement also comes following the company’s promising animal model study results for company’s proprietary Colorectal Cancer treatment drug candidate RCC-33. The company has also recently announced a decision to enter the Melanoma and Breast Cancer markets with new drug development projects.

Gabriel Yariv, company President and COO said: "We have invested a great deal of effort over the past 18 months in expanding our drug development projects. In doing so, we have established a drug development pipeline addressing an estimated $78.1B market size. This market is also expected to grow in the coming years. For example, the Breast Cancer market alone is estimated to grow from $21.58B in 2019 to $55.27B in 2027, according to Fortune Business Insights. We now have four cancer treatment drug development projects for Colorectal Cancer (CRC), Melanoma, Breast Cancer and Prostate Cancer; one pre-cancer antitumor drug development project for the treatment of Adenomatous Polyps in collaboration with Digestix Bioscience Inc.; one palliative drug development project for the treatment of Cancer related Anorexia Cachexia Syndrome (CACS); and two early-stage drug discovery projects targeting Neurodegenerative and Mental Health diseases".

Eyal Barad, Cannabics Pharmaceuticals’ Co-founder and CEO commented: "During the past year and a half, we have made announcements of several important milestones that we have achieved, all as part of our strategy focused on creating a portfolio of valuable intellectual property to support our methodology and expanding product pipeline development. Today, we see the outcome of this ongoing effort in looking at our core growth initiatives ultimately aimed at developing products to help large groups of patients around the world and cater to their medical needs, including several of their unmet needs. We continue to put together a robust package for scheduling our Pre IND meeting with the FDA and before heading into human trials. We have doctors and hospitals already looking to collaborate with us on such clinical studies and hope to be able to do so during 2022. In parallel, we continue the development of our new drug candidates and plan to enter animal model studies later this year."

Orion Biotechnology Secures $11.5M Series A Financing

On June 17, 2021 Orion Biotechnology Canada Ltd., a clinical-stage biotechnology company, reported that it has raised $11.5M USD in a Series A financing (Press release, Orion Biotechnology, JUN 17, 2021, View Source [SID1234584176]).

The oversubscribed round was led by Keiretsu Forum, a global group of investors and included corporate/institutional investors, venture capitalists and existing shareholders. Howard Lubert, President Keiretsu Forum Mid-Atlantic, commented "As early investors in disruptive life sciences companies, we have seen how cutting-edge technologies like Orion’s can bring significant value to the industry and lead to the delivery of innovative new treatments for patients. We believe that Orion has developed a truly innovative technology for effectively targeting G Protein-Coupled Receptors (GPCRs)." The investment includes conversion of a Simple Agreement for Future Equity (SAFE) as well as closing the first tranche of a Series A investment.

"It’s rewarding to see a Canadian biotech company receive support for their novel technology from across the Keiretsu Forum ecosystem following our cross border due diligence process. Our investors are excited to be a part of their growth and innovation" said Kevin Sterling, President Keiretsu Forum Toronto.

Proceeds from the financing will be used to advance Orion’s pipeline of novel precision-engineered therapeutics, including its lead oncology candidate, which is a first-in-class Chemokine Analog with best-in-class potency. The investment will also enable the company to extend its proprietary discovery platform for effectively targeting complex GPCRs that have proven difficult to target using traditional drug classes.

"We are pleased to have the support and confidence of a large network of seasoned life science investors" said Mark Groper, President and CEO of Orion Biotechnology. "With the completion of this funding round, we are positioned to build on the momentum we have created, advance our multi-asset portfolio, and further leverage our proprietary discovery platform to deliver new precision engineered therapies in collaboration with industry partners".

Anji to Advance MCL1 Inhibitor Program from Broad Institute into Clinical Trials

On June 17, 2021 Anji Pharma ("Anji"), a global pharmaceutical company focused on tackling high-value drug targets validated by human genetics, reported that an Anji subsidiary has acquired worldwide development and commercialization rights to an MCL1 inhibitor program through a license from the Broad Institute of MIT and Harvard and will work to advance the program’s MCL1 inhibitors through clinical development (Press release, Anji Pharmaceuticals, JUN 17, 2021, View Source [SID1234584173]).

MCL1 is a member of the Bcl-2 family, normally acting as a "brake" on the apoptosis pathway. In many human cancers, the Mcl-1 gene is highly amplified, shifting the balance from pro- to anti-apoptotic signals and promoting cancer cell survival and tumor formation. Molecules which selectively block MCL1 function induce rapid and specific killing of cancer cells in preclinical models when administered as single agent or in combination with other targeted therapy.

"MCL1 has always been at the top of our list for oncology mechanisms, given its pronounced amplification across tumor types and central role in orchestrating chemotherapy resistance," noted Dan Meyers, M.D., Chief Medical Officer of Anji. "We believe this specific class of MCL1 inhibitors has a unique profile that could offer a wider safety window and better outcomes for cancer patients."

"Our interest in this MCL1 program reaffirms our commitment to pursue compelling mechanisms – regardless of disease indication – and develop therapies that can help patients across the globe," added Brian Hubbard, Ph.D., Chief Executive Officer of Anji. "What matters to us most is whether it will work, and then we commit our clinical and regulatory experience to bring treatments to patients as safely and quickly as possible."

The MCL1 program is one of several programs pursued by the Center for Development of Therapeutics (CDoT) at the Broad Institute. CDoT is a highly collaborative team of professional scientists who work closely with Broad’s principal investigators to advance deep biological insights into therapeutics.

Lineage Announces Exclusive Option Agreement With Amasa Therapeutics for Supply and Use of Clinical-Grade Hystem®

On June 17, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported it granted an exclusive option to Amasa Therapeutics, Inc. (Amasa), a privately-held biopharmaceutical company focused on the development of novel cell-based targeted biological therapeutics to treat cancer patients with unmet need, to acquire an exclusive, royalty-bearing license to use Lineage’s HyStem technology for the development and commercialization of therapies for local treatment of solid tumors under pre-negotiated terms (Press release, Lineage Cell Therapeutics, JUN 17, 2021, View Source [SID1234584170]). Under the option agreement, Amasa will purchase certain amounts of Lineage’s existing supply of clinical-grade HyStem biomaterial and has the right to purchase additional amounts in connection with its up to 12-month option to acquire the exclusive license. Lineage will receive an upfront cash payment and, if the option is exercised, would be entitled to additional payments, including event-specific payments, royalties on net sales and sublicense fees and royalties.

"Lineage is a clinical-stage cell therapy company supported by a vast intellectual property portfolio. From this portfolio, we continue to find opportunities to unlock value from non-core assets through option and license agreements for assets such as HyStem"

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"Lineage is a clinical-stage cell therapy company supported by a vast intellectual property portfolio. From this portfolio, we continue to find opportunities to unlock value from non-core assets through option and license agreements for assets such as HyStem," stated Brian Culley, Lineage CEO. "Many tissue engineering and regenerative cell-based therapies will require the delivery of therapeutic cells in a matrix or scaffold for accurate anatomical placement, cell retention, and engraftment. This option agreement represents an opportunity to provide Amasa with access to our clinical-grade HyStem material for future development of oncology-related products delivered via HyStem and, alongside a previously announced deal with Advanced BioMatrix, is the second HyStem-related transaction we have entered into."

HyStem is a patented biomaterial that is made from and structurally mimics naturally occurring extracellular matrix, the structural network of molecules surrounding cells in organs and tissues that is essential to cellular function and tissue structure. The technology underlying the HyStem hydrogels is based on a unique thiol cross-linking strategy. Building upon this technology, the HyStem family of hydrogels are novel biomaterials that offer unique strategies for cell therapy and bioactive molecule delivery. A distinctive feature of the HyStem hydrogel is that it allows the mixture of cells with the matrix in a liquid form such that the cells and matrix can be injected easily through a small gauge syringe, and then the matrix can polymerize around the cells to create a three-dimensional tissue within the body. When implanted in HyStem hydrogels, cells remain attached and localized within the hydrogel and slowly degrade the implanted matrix and replace it with their natural extracellular matrices. Current research at leading medical institutions has shown that HyStem is compatible with a wide variety of cells and tissue types including brain, bone, skin, cartilage, vascular and heart tissues.

"We believe use of Lineage’s clinical-grade HyStem hydrogels will allow us to quickly move candidates into the clinic with our novel approach of using receptor-targeted cell therapies to address intractable solid tumors such as glioblastoma," stated Arthur Hiller, Amasa CEO. "The physiochemical properties of the HyStem hydrogel and its ability to provide a suitable extracellular matrix give our cell therapies the best opportunity to remain viable, be retained in the targeted tumor resection cavity, and eradicate residual tumor cells," stated Khalid Shah, founder of Amasa.

About HyStem

Lineage has developed a family of hyaluronan based hydrogels (HyStem) that mimics the natural extracellular matrix and has potential applications in 3-D cell culture, stem cell propagation and differentiation, tissue engineering, regenerative medicine, cell-based therapies, and as delivery vehicles for bioactive molecules. HyStem hydrogels were designed to recapitulate the minimal composition necessary to obtain a functional extracellular matrix (ECM). The individual components of the hydrogels are cross-linkable over time, and thus may be seeded with cells prior to in vivo injection, without compromising either the cells or the recipient tissues. HyStem hydrogels have been shown to support attachment and proliferation of a wide variety of cell types in both 2-D and 3-D cultures and provide timed release of proteins and other bioactive moieties. HyStem hydrogels exhibit a high degree of biocompatibility when implanted in vivo and are readily degraded in vitro and biodegrade in vivo through hydrolysis via naturally occurring enzymes. When implanted in HyStem hydrogels, cells remain attached and localized within the hydrogel and slowly degrade the implanted matrix and replace it with their natural ECMs. When used as a delivery vehicle, bioactive molecules are released by both diffusion as well as degradation of the hydrogel. The patented technology underlying Lineage’s HyStem hydrogel products in development, such as Renevia, has been exclusively licensed to Lineage for human therapeutic uses. Since the first published report in 2002, there have been over 300 academic scientific publications supporting the biocompatibility of thiol cross-linked hyaluronan-based hydrogels and their applications as medical devices and in cell culture, tissue engineering, and animal models of cell-based therapies. Due to the unique cross-linking chemistry, HyStem hydrogels have the ability to be formulated with cells and can be injected or applied as a liquid and form a gel in situ, which allows the hydrogel to conform to a cavity or space. This property of HyStem hydrogels is expected to offer several distinct advantages over other hydrogels, including the possibility of combining bioactive materials with the hydrogel at the point of use.

Geron Announces Publication of IMbark Phase 2 Data in Journal of Clinical Oncology

On June 17, 2021 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the publication of data from the IMbark Phase 2 clinical trial in the Journal of Clinical Oncology in a paper entitled, "Randomized, Single-Blind, Multicenter Phase II Study of Two Doses of Imetelstat in Relapsed or Refractory Myelofibrosis (Press release, Geron, JUN 17, 2021, View Source [SID1234584165])." The publication highlights the clinical benefits observed in the study, including symptom response and overall survival, as well as the evidence of disease-modifying activity from biomarker and bone marrow fibrosis assessments.

"We are pleased with the publication of our IMbark Phase 2 data in the high-impact Journal of Clinical Oncology. This highlights the importance of the study data in the advancement of treatment options for MF patients who no longer respond to currently approved JAKi therapies," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "Imetelstat is a novel telomerase inhibition approach that may alter the course of the disease in patients with myelofibrosis. We look forward to confirming these results in our ongoing IMpactMF Phase 3 clinical trial in refractory MF."

The publication reports efficacy, safety and biomarker results from the IMbark Phase 2 clinical trial and is available online. As stated in the paper, IMbark tested two imetelstat doses and the 9.4 mg/kg dose every three weeks demonstrated clinical benefits in symptom response rate, with an acceptable safety profile for this poor-risk JAKi relapsed/refractory MF patient population. Biomarker and bone marrow assessments suggested selective effects on the malignant clone.

"In these heavily pre-treated patients with high disease burden whose outcome is dismal, imetelstat treatment resulted in multiple clinical meaningful benefits, including symptom response and potential improvement in overall survival," said John Mascarenhas, M.D., Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and lead author of the paper. "In addition, the reductions in key driver mutations of the disease that were also correlated to clinical benefits suggest disease-modifying activity of imetelstat by targeting the underlying MF malignant clones, which differentiates imetelstat from other therapeutic agents currently in development for MF."

Ongoing IMpactMF Phase 3 Clinical Trial

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is planned to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

About Myelofibrosis (MF)

Myelofibrosis, a type of myeloproliferative neoplasm, is a chronic blood cancer in which abnormal or malignant precursor cells in the bone marrow proliferate rapidly, causing scar tissue, or fibrosis, to form. People with MF may have abnormally low or high numbers of circulating red blood cells, white blood cells or platelets, and abnormally high numbers of immature cells in the blood or bone marrow. MF patients can also suffer from debilitating constitutional symptoms, such as drenching night sweats, fatigue, severe itching, or pruritus, abdominal pain, fever and bone pain.

Approximately 70% of MF patients are classified as having Intermediate-2 or High-risk disease, as defined by the Dynamic International Prognostic Scoring System Plus. There are more than 35,000 patients worldwide and more than 13,000 patients in the U.S. living with Intermediate-2 or High-risk MF. The only drug therapies approved for treating these MF patients are JAK inhibitors (JAKi). Currently, MF patients who fail or no longer respond to JAKi treatment have no or limited options, resulting in shortened median overall survival.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase inhibitor (JAKi) treatment.