On December 21, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that it will move forward with a singular focus on accelerating and expanding its genetically defined disease portfolio, including the mitapivat clinical programs and a robust pipeline of therapeutic candidates, and has entered into a definitive agreement to sell its commercial, clinical and research-stage oncology portfolio to Servier, an independent global pharmaceutical company (Press release, Agios Pharmaceuticals, DEC 21, 2020, View Source [SID1234573170]). Agios will receive a cash consideration of up to $2.0 billion, including $1.8 billion in upfront cash and $200 million in a potential future milestone payment for vorasidenib, as well as 5% royalties on U.S. net sales of TIBSOVO (ivosidenib tablets) from transaction close through loss of exclusivity and 15% royalties on U.S. net sales of vorasidenib from first commercial sale through loss of exclusivity.

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"Our decision to accelerate the next chapter of Agios’ success with a singular focus on genetically defined diseases and sell our oncology portfolio to Servier is a transformational milestone for Agios. The result of a deliberative strategic review, this decision reflects the progress we have made understanding and harnessing the science and promise of PK activation and captures the full value of our oncology assets," said Jackie Fouse, Ph.D., chief executive officer of Agios. "With mitapivat poised to become a new potential treatment option for patients with pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease and with a rich pipeline based on our pioneering leadership in PK activation and cellular metabolism, Agios’ near- and long-term future is filled with significant value-generating catalysts. The proceeds from the transaction will allow us to focus on rapidly advancing our genetically defined disease portfolio for patients in need, strengthen our capital structure and return at least $1.2 billion to shareholders post-closing, achieve capital markets independence and participate in the future success of TIBSOVO and vorasidenib."

"We are proud of our heritage in oncology and the novel therapies we have advanced for patients with hematologic malignancies and solid tumors, and we are pleased to have found an excellent home for our oncology portfolio in Servier, a successful, patient-focused, global pharmaceutical company," continued Dr. Fouse. "Servier is committed to the oncology patient community and to investing in our assets and our people. This transaction will allow the oncology portfolio to grow and thrive with Servier and will provide Agios with the resources required to optimize the development of our promising genetically defined disease therapies, ultimately enabling the greatest overall positive impact for patients."

"The strategic acquisition of Agios’ oncology business, including its precision medicine portfolio and pipeline, is aligned with our ambition to become a recognized player in oncology and further supports our commitment to provide innovative treatments to cancer patients with unmet medical needs. It is a key step for the Servier Group as it will significantly strengthen our position in the U.S. and reinforce our R&D capabilities in oncology," stated Olivier Laureau, president of Servier. "We look forward to welcoming the experienced Agios oncology teams to Servier following the closing."

"Agios is a leader in the cellular metabolism space with a proven track record of discovering, developing and commercializing precision medicines," said David K. Lee, CEO, Servier Pharmaceuticals, the U.S. subsidiary of Servier. "The acquisition of Agios’ oncology business, including highly experienced talent from research, development, technical operations and commercial functions, allows for an immediate expansion of our U.S. business into other hematologic malignances and provides the potential for longer-term growth into the solid tumor space, thus ensuring that we can serve more patients living with unmet cancer needs than ever before."

Transaction Details
The transaction includes the transfer of Agios’ oncology portfolio and associated employees, including its marketed medicine TIBSOVO which is approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML) and for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. TIBSOVO is also under investigation in two Phase 3 combination trials in newly diagnosed AML, and as a potential treatment for previously treated IDH1-mutant cholangiocarcinoma and IDH1-mutant myelodysplastic syndrome (MDS). Servier will also acquire Agios’ co-commercialization responsibilities for Bristol Myers Squibb’s IDHIFA (enasidenib) and conduct certain clinical development activities within the IDHIFA development program.

In addition, the transaction includes Agios’ oncology pipeline and clinical programs, including vorasidenib, an investigational, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 which is currently being studied in the registration-enabling Phase 3 INDIGO study in patients with IDH-mutant low-grade glioma; AG-270, an investigational first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor being evaluated in combination with taxanes in patients with methylthioadenosine phosphorylase (MTAP)-deleted non-small cell lung cancer and pancreatic cancer; AG-636, a novel inhibitor of dihydroorotate dehydrogenase (DHODH); and Agios’ oncology research programs.

All of Agios’ U.S.-based employees who primarily support the oncology business will receive a comparable offer at Servier.

The transaction has been approved by the Board of Directors and is subject to approval by Agios shareholders and satisfaction of regulatory conditions. It is currently expected that the transaction will close in the second quarter of 2021.

Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC are serving as financial advisers to Agios, and Wachtell, Lipton, Rosen & Katz is serving as its legal adviser.

Agios’ Genetically Defined Disease Portfolio
Agios’ genetically defined disease portfolio is anchored by its lead clinical candidate, mitapivat, which the company believes is a potential blockbuster across three distinct hemolytic anemias. Agios is conducting two global, pivotal Phase 3 studies to evaluate mitapivat as a potential treatment for adults with pyruvate kinase (PK) deficiency; the company recently announced positive topline results from the ACTIVATE study and expects to report data from the ACTIVATE-T study in the first quarter of 2021. Agios anticipates filing for U.S. and EU regulatory approval in adults with PK deficiency in 2021, with a potential 2022 commercial launch in both geographies. Mitapivat is also being evaluated in a fully enrolled Phase 2 study in adults with non-transfusion-dependent α- or β-thalassemia, and as a potential treatment for sickle cell disease under a Cooperative Research and Development Agreement (CRADA) with the U.S. National Institutes of Health. In 2021, Agios expects to initiate global, pivotal Phase 3 studies in thalassemia, including both α-and β-thalassemia, as well as transfusion dependent and non-transfusion dependent patient populations, and in sickle cell disease. In addition, Agios intends to evaluate mitapivat in pediatric patients across all three diseases.

Beyond mitapivat, Agios is advancing a growing genetically defined disease pipeline based on its core expertise in cellular metabolism and pioneering leadership in PK activation. AG-946, a clinical-stage, next-generation oral activator of both wild-type and mutated pyruvate kinase R (PKR) enzymes, entered a first-in-human clinical study in the third quarter of 2020. Agios’ late-stage research pipeline is evolving to include a rich and sustainable portfolio of genetically defined disease targets with clear disease area applications. These include hereditary and acquired anemias, myopathies, retinal diseases and diseases of inborn errors of metabolism such as aminoacidurias, aminoacidemias and others. As the company’s research efforts continue to develop, Agios may pursue value-adding partnerships that may bring complementary expertise for certain disease areas.

Investor Webcast Information
Agios will host an investor webcast today at 8:00 a.m. ET to discuss today’s announcement. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors section of Agios’ website at www.agios.com. The archived webcast will be available on Agios’ website beginning approximately two hours after the event.
bout Agios

On December 21, 2020 Servier, a global pharmaceutical Group, and Celsius Therapeutics, a company focused on bringing precision medicine to patients with cancer and autoimmunity, reported a strategic collaboration focused on the identification and validation of novel colorectal cancer (CRC) drug targets (Press release, Celsius Therapeutics, DEC 21, 2020, View Source [SID1234573168]).

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"As colorectal cancer remains a leading contributor to cancer deaths worldwide, we see an urgent need to bring forward new therapeutic options for patients. Through this collaboration, we will leverage Celsius’ single-cell genomics platform, machine learning capabilities, and target validation expertise to refine our understanding of the different subtypes of CRC and discover new drug targets with the goal of developing novel precision therapies for specific patient subsets. Servier will discover and develop candidate drugs leveraging our end-to-end small molecule and large molecule capabilities," said Hugues Dolgos, Global Head of Oncology R&D at Servier.

Under the terms of collaboration, Celsius will analyze hundreds of samples from defined CRC patient populations using its proprietary single-cell genomics platform and will work to identify and validate new drug targets during the three-year research period. Servier will receive an exclusive option to research, develop, and commercialize products directed to up to three of the targets. Celsius would receive an upfront payment and research funding, and would be eligible to receive over $700 million in potential discovery, development, and commercialization milestone payments, along with tiered royalties.

"Celsius’ mission is to understand how different cell populations and cellular programs drive disease, and to translate those insights into precision therapies for patients with difficult-to-treat diseases," said Tariq Kassum, M.D., chief executive officer of Celsius. "Servier is a complementary partner with a like-minded commitment to cancer patients in need of new therapeutic options. This collaboration, along with our growing network of academic and industry partnerships, validates Celsius as a partner of choice for target discovery in oncology and autoimmune diseases."

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.