On December 21, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), reported that the first patient has been dosed in the phase 3 LIGHTHOUSE study, evaluating the efficacy and safety of a triple combination therapy with melflufen plus dexamethasone and subcutaneous daratumumab compared to daratumumab alone (Press release, Oncopeptides, DEC 21, 2020, View Source [SID1234573164]). The phase 3 LIGHTHOUSE study is a randomized, open-label study in patients with relapsed refractory multiple myeloma who are refractory to an immunomodulatory agent and a proteasome inhibitor or who have had at least three prior lines of therapy, including these agents.

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"Following the encouraging results of our ANCHOR study this is an important study to further evaluate the potential role of melflufen in triplet regimens", says Klaas Bakker, MD, PhD, Chief Medical Officer, Oncopeptides AB. "There is an imminent need for additional therapeutic options as myeloma patients become multi-resistant earlier in their treatment journey. A positive outcome may potentially support the use of melflufen as combination therapy with daratumumab in earlier stages of multiple myeloma".

Additional study information can be found on View Source, identifier: NCT04649060.

About melflufen

Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.

On December 21, 2020 BioEclipse Therapeutics (BioEclipse), a private clinical-stage biopharmaceutical company with a proprietary platform for developing next-generation cancer immunotherapies, reported the initiation of patient enrollment in a Phase 1 dose-escalation trial to treat refractory solid tumors (Press release, BioEclipse Therapeutics, DEC 21, 2020, View Source [SID1234573186]). The trial marks the first-in-human study of CRX100, an intravenously-delivered cancer therapy designed to target and destroy multiple cancer types and address disease recurrence.

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Patient enrollment is underway at our first clinical trial site, Moores Cancer Center at UC San Diego Health in La Jolla, CA. Additional clinical trial sites are expected to follow. More information about this study and general information about participating in clinical trials can be found at ClinicalTrials.gov.

"The launch of this clinical trial marks a significant milestone in the clinical development of CRX100 and is a further step toward bringing patients with few treatment options a single therapeutic designed to attack multiple cancer types," stated Pamela Contag, Ph.D., founder and CEO of BioEclipse. "We believe CRX100 has the potential to address the growing unmet need for treatments of solid tumors and metastatic disease believed to be untreatable, and that are currently underrepresented in clinical trials."

This open-label, Phase 1 dose-escalation study is designed to determine the safety, tolerability, and pharmacokinetic (PK) properties of CRX100 in up to 24 participants ­18 years or older with advanced solid tumors that do not respond to standard of care. The trial specifically targets six potential cancer indications, including: triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, and gastric cancer. Each patient will receive up to two doses of CRX100. As secondary endpoints, the trial will also investigate the effect CRX100 has on a participant’s tumor progression and overall immune response.

BioEclipse is currently focused on the treatment of recurring cancers with a unique multi-mechanistic approach that could address cancers believed to be untreatable. Developed with technology exclusively licensed from Stanford University, CRX100 combines activated immune cells, known as cytokine-induced killer (CIK) cells, with a tumor-killing virus. As stand-alone therapies, these two agents have previously been assessed in human studies. When combined to create CRX100, the CIK cells protect the oncolytic virus and deliver it to cancer cells throughout the body. The two components then work together to attack primary tumors and metastatic disease. Data from preclinical studies shows that this combination approach also can trigger a long-lasting immune response that protects against relapse and disease recurrence.

"The initiation of this clinical trial is welcome news given the urgent need for more effective approaches, especially for patients with cancer refractory to standard treatments," said Sandip Patel, M.D., Associate Professor at University of California San Diego School of Medicine and a Principal Investigator for this study. "If CRX100’s treatment approach delivers the same compelling results in humans as it has in preclinical models, it has the potential to address several types of cancer with an otherwise poor prognosis and bring new hope to our patients and their families."

On December 21, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTCQB: IPATF) reported financial results for the second quarter of its 2021 fiscal year ended October 31, 2020 (Press release, ImmunoPrecise Antibodies, DEC 21, 2020, View Source [SID1234573165]).

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Q2 Fiscal 2021 Financial Highlights:

• Revenue was $4.8 million for the quarter ended October 31, 2020, an increase of $1.6 million, or 50%, compared to $3.2 million in the same quarter last year.
• Adjusted EBITDA was $795,159 for the quarter ended October 31, 2020, an increase of $858,577 compared to ($63,418) in the same quarter last year.
• Current cash balance is $16.8 million as of October 31, 2020 compared to $2.6 million as of the fiscal year end April 30, 2020.

Financial Results

Revenue: The Company’s revenues were $4,754,545 for the three-months ended October 31, 2020 compared to revenues of $3,162,365 for the same period last year, a 50% increase. This was a result of the Company’s increased contract volume, which is due to ongoing emphasis on generating diversified discovery programs utilizing distinctive animal repertoires and multiple technologies with unique advantages.

Research and Development: The Company has invested $1,358,529 in research and has recorded $2,154,577 in grant income and subsidies through October 31, 2020. The Company has been expanding its commitment to research and development initiatives aimed at introducing new services through both internal development as well as through partnerships. The company has also undertaken research and development projects related to COVID-19 and has been awarded government grants and subsidies to support those efforts.

Net Loss. The Company recorded a net loss of $463,583 during the three-months ended October 31, 2020, a decrease of $899,962 from the net loss of $1,363,545 for the three months ended October 31, 2019. The improvement is a result of the Company’s increase in revenue, higher gross profit and grant and subsidy income offset by higher research and development expenses and other operating expenses.

Non-IFRS Measures. *Adjusted EBITDA for the three-months ended October 31, 2020 was $795,159, an increase of $858,577 from the Adjusted EBITDA of ($63,418) for the three months ended October 31, 2019. The increase is a result of the increase in revenue, higher gross profit and grant and subsidy income offset by higher research and development expenses and other operating expenses compared to the prior period.

Dr. Jennifer Bath, CEO of ImmunoPrecise, stated, "We have again achieved accelerated revenue growth in the second quarter of Fiscal Year 2021 as we continued to gain market share across different business units. We are anticipating additional commercial opportunities that will bolster our CRO revenues going forward, including within our partnered programs in our subsidiary, Talem Therapeutics."

Dr. Bath concluded, "The Company’s financial position is strong, providing support for our strategic growth plans in geographical expansion and digital transformations within AI at the intersection of genomics and immunology. We are grateful for the dedication of our employees and partners and remain committed to working with them to enable scientific innovation worldwide. Looking ahead, we will continue to invest in new capabilities that help our partners across the globe progress in their research and bring groundbreaking medicines and treatments to patients in need."

Recent Business Highlights

•Selected Lead Formulation for Preclinical PolyTope Antibody Cocktail Therapy: In November 2020, ImmunoPrecise announced the nomination the first anti-SARS-CoV-2 cocktail therapy consisting of four, human, synergistic antibodies for preclinical testing. The preclinical trial will examine the safety, tolerability and efficacy of the proposed therapeutic cocktail in the well-defined, SARS-CoV-2, Syrian hamster model.

•Entered into Technology Partnership with Genmab Targeting Infectious Disease: In November 2020, ImmunoPrecise entered into a research agreement with Genmab A/S, to generate novel bispecific antibody combinations using Genmab’s proprietary DuoBody platform and IPA’s proprietary antibodies in the field of infectious disease.

•Announced Strategic AI Partnership with Mila: In November 2020, ImmunoPrecise announced a partnership with Mila, a world-renowned artificial intelligence (AI) research institute, to research and develop novel therapeutics. Through the partnership, the companies will access previously unexplored datasets generated by ImmunoPrecise to explore how to better design new therapeutics against life-threatening disease.

•Announced Collaboration with Twist Biosciences for the Creation of Novel, Therapeutic Antibody Products: In October 2020, ImmunoPrecise announced a collaboration with Twist Biosciences to leverage Twist’s silicon DNA platform to enhance its antibody therapeutics and expand its early-stage pipeline into a wider range of oncology targets. Following initial discovery work, the companies will then aim to jointly advance the programs through proof-of-concept and preclinical, and eventually clinical, development.

•Initiated Preclinical Trials for SARS-CoV-2 Vaccines in Collaboration with LiteVax: In September 2020, ImmunoPrecise, in partnership with LiteVax, initiated preclinical trials for a set of vaccine candidates being developed against SARS-CoV-2. The formulations were designed using ImmunoPrecise’s extensive data sources and co-formulated with LiteVax’s novel class of synthetic carbohydrate derivates designed to act as a vaccine adjuvant.

•Released Second-Generation B Cell Select: In September 2020, IPA Europe, a subsidiary of ImmunoPrecise, announced the release of a second-generation B-Cell Select platform. The new technology will accelerate antibody identification and discovery capabilities by allowing for increased automation of their selection technology and subsequent single cell cloning.

•Announced Multi-Specific SARS-CoV-2 Antibody Collaboration with Zymeworks: In September 2020, ImmunoPrecise announced a research collaboration with Zymeworks to utilize their Azymetric and EFECT platforms for the development of antibody candidates against COVID-19. Candidates obtained from this collaboration will undergo thorough testing using spike proteins provided by the National Research Council Canada and if effective, will proceed to further animal testing.

•Commenced Application Process to Dual Listing on NASDAQ: In September 2020, ImmunoPrecise announced its application to list on the Capital Market "NASDAQ" exchange. NASDAQ is the world’s pre-eminent exchange for biotech and pharma companies and will expand the Company’s exposure and access to U.S. and international investors.

IPA periodically provides information for investors on its corporate website, immunoprecise.com. This includes press releases and other information on financial performance, reports filed or furnished with the TSX, information on corporate governance and details related to its annual meeting of shareholders. Reports filed or furnished with the TSX can be found at sedar.com.

On December 21, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the initiation of a rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed and/or refractory multiple myeloma (Press release, Janssen Pharmaceuticals, DEC 21, 2020, View Source [SID1234573187]).

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"We are committed to innovation in cell therapy and advancing the science of multiple myeloma to improve patients’ lives," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "Today’s milestone is the culmination of a remarkable clinical development effort and collaboration with Legend Biotech. We look forward to working with the FDA in their review of cilta-cel with the goal of bringing a highly-active, dual-binding BCMA CAR-T therapy to patients with relapsed and/or refractory multiple myeloma who are in need of new treatment options."

The FDA previously granted Breakthrough Therapy Designation (BTD) for cilta-cel and has agreed to a rolling review of the BLA in which completed portions of the application will be submitted and reviewed on an ongoing basis. Data for cilta-cel were recently presented (Abstract #177) at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

"Our immuno-oncology capabilities combined with our dedicated Janssen R&D team, who continue to work in close collaboration with Legend Biotech, have enabled the expeditious investigational advancement of cilta-cel," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "Today’s submission marks Janssen’s first cell therapy application, but more importantly, brings cilta-cel one step closer to our goal of making new medical options available to patients with multiple myeloma."

About CARTITUDE-1
CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multi-center study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma, 99 percent of whom were refractory to the last line of treatment and 88 percent of whom were triple-class refractory, meaning their cancer did not respond, or no longer responds, to an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody.

The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). Based on the safety profile observed in this portion of the CARTITUDE-1 study, the Phase 2 portion further evaluated the efficacy of cilta-cel at the recommended Phase 2 dose with overall response as the primary endpoint.

About ciltacabtagene autoleucel (cilta-cel)
Cilta-cel is an investigational CAR-T therapy being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. Cilta-cel is a unique, structurally differentiated CAR-T cell therapy containing a 4-1BB co-stimulatory domain and two BCMA-targeting single-domain antibodies with a preferential CD8+ T-cell expansion. BCMA is a protein that is highly expressed on myeloma cells.1 CAR-T cells are an innovative approach to eradicating cancer cells by harnessing the power of a patient’s own immune system. The safety profile observed to date for cilta-cel supports the potential for outpatient dosing, which will be evaluated in ongoing clinical studies.

In December 2017, Janssen Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA Inc. to develop and commercialize cilta-cel.

In addition to a U.S. BTD granted in December 2019, cilta-cel received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. Janssen also received Orphan Drug Designation for cilta-cel from the FDA in February 2019 and from the European Commission in February 2020.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.2,3 When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow.3 In 2020, it is estimated that 32,270 people will be diagnosed and 12,830 will die from the disease in the U.S.4 While some patients with multiple myeloma have no symptoms, most patients are diagnosed due to symptoms which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.3

On December 21, 2020 (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based therapeutic formulations and medicines, reported that it has initiated a series of proof of concept (POC), in-vivo, animal model studies to test its drug candidate RCC-33 on mice transplanted with colorectal cancer tumor cell lines (Press release, Cannabics Pharmaceuticals, DEC 21, 2020, View Source [SID1234573166]). Study results are to be included in the data package being prepared for submission to the US Food and Drug Administration along with a request for a pre-IND Meeting.

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The animal studies follow previous successful completion of In-Vitro studies using the company’s proprietary Drug Candidate RCC-33 on colorectal cancer cell lines and fresh human biopsies obtained under Helsinki Approved Protocol at the company’s in-house laboratory in Israel.

Gabriel Yariv, Cannabics Pharmaceuticals’ President and COO said: "We are proud to be at the forefront of cannabinoid-based drug discovery and clinical development. Our aim is to be the first company to bring a comprehensive pre-clinical data package before the FDA in support of a cannabinoid-based Drug Candidate for the treatment of colorectal cancer. Today marks an important step in that direction."

Eyal Ballan, Cannabics Pharmaceuticals’ CTO said: "The initiation of In-Vivo studies in animals represents an important milestone for the company in beginning a clinical path we have specifically designed to bring our proprietary RCC-33 drug candidate before the US Food and Drug Administration for review."