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."

On December 21, 2020 Aileron Therapeutics (NASDAQ:ALRN) reported a business update and outlined its strategic priorities for 2021, including announcing more details about the design and conduct of a Phase 1b randomized, double-blind, placebo-controlled clinical trial of ALRN-6924 in patients with advanced non-small cell lung cancer (NSCLC) undergoing treatment with first-line carboplatin doublet chemotherapy (with or without immune checkpoint inhibitors), planned to begin enrolling in the second quarter of 2021 (Press release, Aileron Therapeutics, DEC 21, 2020, View Source [SID1234573141]). Aileron is developing ALRN-6924 as a novel medicine to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving chemotherapy’s activity on cancer cells, a concept known as chemoprotection.

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"2020 has been a year of important progress for Aileron, most notably achieving clinical proof-of-concept for ALRN-6924 as a chemoprotective agent in patients with p53-mutated small cell lung cancer (SCLC) undergoing treatment with topotecan," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer of Aileron. "In 2021, we aim to make further strides in our clinical development efforts by initiating a randomized, placebo-controlled trial of ALRN-6924 in patients with advanced NSCLC. This trial represents a key step toward advancing our vision to bring chemoprotection to all patients with p53-mutant cancer regardless of cancer type or chemotherapy. We believe chemoprotection has the potential to transform chemotherapy similar to the way anesthesia transformed surgery."

Dr. Aivado further commented, "February 2021 will mark a critical milestone for the emerging chemoprotection field – the first PDUFA date of a chemoprotective agent. While that therapeutic’s focus is myelopreservation, or the concept of protecting bone marrow cells from chemotherapy-induced toxicities, we view chemoprotection’s potential through a broader lens. We believe that, due to its mechanism of action, ALRN-6924 may have the potential not only to protect bone marrow cells from chemotherapy but also to protect other cell types, such as hair follicle cells and cells lining the oral cavity, among others. Currently there are no therapies to prevent hair loss or the painful mouth sores that patients undergoing chemotherapy often experience due to chemotherapy’s destruction of healthy cells."

Aileron Strategic Priorities and Anticipated Key Value Drivers in 2021

Initiate Phase 1b Randomized, Double-Blind, Placebo-Controlled Clinical Trial in First-Line NSCLC and Report Initial Data

Today, Aileron announced additional details about its planned Phase 1b clinical trial of ALRN-6924 in patients with advanced NSCLC. The company plans to begin patient enrollment in the second quarter of 2021, subject to obtaining funding for the trial, and expects that the randomized, double-blind, placebo-controlled trial will be part of a registration program designed to ultimately support approval for ALRN-6924 in NSCLC. Aileron anticipates enrolling approximately 40 patients with stage IV NSCLC undergoing treatment with first-line carboplatin doublet chemotherapy with or without an immune checkpoint inhibitor. Patients will be randomized 1:1 to receive either 0.3 mg/kg of ALRN-6924 or placebo. Endpoints will include the effect of ALRN-6924 to limit chemotherapy-induced bone marrow toxicities. Aileron anticipates reporting initial results from the trial late in the fourth quarter of 2021 and full results mid-2022.

In the U.S. alone, there are nearly 200,000 new cases of NSCLC diagnosed each year, and an estimated 50% or more of patients with NSCLC have p53-mutated cancer.1,2 Across all cancer types, there are an estimated 1.8 million patients in the U.S. diagnosed each year, and an estimated 50% of all cancer patients have p53-mutated cancer.1,3

Report Data Readouts from Ongoing Phase 1b Clinical Trial of ALRN-6924 in SCLC and Ongoing Healthy Volunteer Study

In 2021, Aileron plans to report additional results from its ongoing Phase 1b clinical trial in patients with SCLC. In October 2020, Aileron presented positive clinical data from the trial demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against severe anemia, thrombocytopenia and neutropenia in patients with p53-mutated SCLC treated with topotecan. The data set from this trial, which Aileron plans to announce in the first quarter of 2021, will include results across all dose levels evaluating ALRN-6924 administered 24 hours prior to topotecan administration ("24-hr schedule"), including an exploratory 0.2 mg/kg dose level, as well as results from a cohort evaluating 0.3 mg/kg ALRN-6924 administered six hours prior to topotecan administration ("6-hr schedule"), which has now completed enrollment, with a total of six patients. In addition, Aileron initiated a healthy volunteer study in November 2020 to characterize the time to onset, and magnitude and duration of cell cycle arrest in human bone marrow relative to ALRN-6924 administration. Due to COVID-19-related delays, Aileron is updating its guidance on the readout of the healthy volunteer study from the second quarter of 2021 to mid-2021.

"We expect that, taken together, these additional results from the Phase 1b clinical trial of ALRN-6924 in patients with small cell lung cancer and the results from the healthy volunteer study, will further inform and support future randomized, controlled trials of ALRN-6924 when given prior to various chemotherapies," said Dr. Aivado.

How ALRN-6924 Is Designed to Protect Healthy Cells from Chemotherapy

ALRN-6924 is being developed by Aileron as a novel chemoprotective medicine to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects.

Chemotherapy preferentially acts on cells that are cycling or undergoing the process of cell division. In cancer cells, the cell cycle is unchecked, which leads to uncontrolled cell proliferation, a hallmark of cancer. Certain types of healthy cells also naturally need to cycle, such as bone marrow cells, hair follicle cells, skin cells, and cells lining the oral cavity and the gastrointestinal tract. As a result, chemotherapy preferentially targets and kills both cycling healthy cells and cycling cancer cells. This, in turn, can lead to a spectrum of chemotherapy-induced side effects, from unpleasant to life-threatening and fatal.

ALRN-6924, an investigational first-in-class MDM2/MDMX dual inhibitor, is administered prior to chemotherapy to patients with p53-mutant cancers. ALRN-6924 is designed to activate normal p53 protein in patients’ healthy cells, temporarily and reversibly pausing cell cycling to selectively shield the patients’ healthy cells from chemotherapy. The protection is limited to healthy cells, as ALRN-6924 cannot work in p53-mutated cancer cells given that p53 has lost its function in those cells. Therefore, cancer cells continue to cycle uninterrupted and remain fully susceptible to destruction by chemotherapy.

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.