On December 21, 2020 Ziopharm Oncology, Inc. ("Ziopharm" or "the Company") (Nasdaq: ZIOP), reported that the Taiwan Food and Drug Administration has cleared an investigational new drug application (IND) from Eden BioCell, a joint venture between Ziopharm and cell therapy company TriArm Therapeutics, for its phase 1 clinical trial to evaluate patient-derived CD19-specific CAR-T, using Ziopharm’s Rapid Personalized Manufacturing (RPM) technology (Press release, Ziopharm, DEC 21, 2020, View Source [SID1234573167]). This is an investigational treatment for patients with relapsed CD19+ leukemias and lymphomas and the first clinical study of autologous non-viral CD19-specific CAR-T in Taiwan.

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This trial will utilize Ziopharm’s non-viral Sleeping Beauty cell engineering technology to infuse autologous CAR-T the day after T cells have been genetically modified. Ziopharm’s RPM CD19-specific CAR-T therapy results from the stable, non-viral insertion of DNA into the genome of resting T cells to co-express the chimeric antigen receptor (CAR), membrane-bound IL-15 (mbIL15) and a safety switch. The trial is being conducted at National Taiwan University Hospital.

"This study is a testament to the relationship Ziopharm has quickly established with Eden BioCell and TriArm and the progress using patients’ T cells under RPM to target malignancies," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "The results will help us understand the benefit of engineering T cells with membrane bound IL-15 which could benefit not only CAR-T, but also the engineering of T cells to express T-cell receptors."

Jay Zhang, Co-Founder and Chief Executive Officer of TriArm, added, "We are very excited to receive clearance of our IND in Taiwan. The learnings from this study will build upon the encouraging early data we are seeing with patients treated with RPM CAR-T targeting CD19 malignancies under compassionate use. We believe our approach has the potential to transform CAR-T therapy by dramatically decreasing the amount of time needed for manufacturing engineered T cells, thereby increasing efficacy and decreasing cost."

"CAR-T therapy has proved an effective therapy for B-cell cancers," noted Dr. Shang-Ju Wu, Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital and Principal Investigator for the study. "Further optimization by shortening the manufacturing time would be of great importance to make this therapy more available to patients. We are honored to be involved in the clinical development of this non-viral CAR-T therapy produced using RPM. We hope the data derived from this current trial will advance CAR-T therapy to benefit our patients."

Up to 24 patients with relapsed CD19+ leukemias and lymphomas will be enrolled in this phase 1 trial, with the goal of infusing 16 subjects (Taiwan FDA #1096030182). The primary endpoint of the study is to evaluate the safety and tolerability of autologous CD19-specific T cells manufactured using the RPM process.

About Eden BioCell
In December 2018, Ziopharm and TriArm Therapeutics announced the launch of Eden BioCell to lead clinical development and commercialization of Sleeping Beauty-generated CAR-T therapies in Greater China. Ziopharm licensed the rights to Sleeping Beauty-generated CAR-T therapies targeting the CD19 antigen using Ziopharm’s RPM technology in Greater China to Eden BioCell. TriArm has committed up to $35 million to this joint venture, and Eden BioCell is owned 50-50 by Ziopharm and TriArm.

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."

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 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 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its breast cancer vaccine (Press release, Anixa Biosciences, DEC 21, 2020, View Source [SID1234573162]).

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This breast cancer vaccine technology was invented and developed by Cleveland Clinic immunologist Dr. Vincent Tuohy, and his research team.
Oncologist, Dr. Thomas Budd, also of Cleveland Clinic, will lead the clinical trial.
Anixa Biosciences has an exclusive worldwide license to the technology.
The technology immunizes against a protein called alpha-lactalbumin that is expressed in the mammary glands of women, only during the latter part of gestation and during lactation. After lactation ceases, this protein is no longer expressed until a woman develops breast cancer. In a vaccinated woman, the researchers anticipate that these cancer cells will be destroyed by the immune system before they have the opportunity to grow into a mature cancer.
The initial focus is Triple Negative Beast Cancer, but this technology is expected to potentially prevent other types of breast cancer.
Animal studies showed notable ability to prevent breast cancer.
The preclinical studies and two trials of this vaccine are being funded by the U.S. Department of Defense.
Dr. Amit Kumar, President and CEO of Anixa stated, "We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting vaccine for the prevention of breast cancer. This approval triggers a cascade of events and activities, that will eventually lead to recruitment of patients and initiation of the trial."

"This is a significant milestone for our program. Our vision has always been to prevent cancer before it arises," said Dr. Tuohy. "We are looking forward to beginning clinical trials in patients."