On May 25, 2020 Nail Imune Biotech Co., Ltd. (Location: Minato-ku, Tokyo, hereinafter "Noil Imune") and C4U Co., Ltd. (Location: Suita, Osaka Prefecture, hereinafter "C4U") are now editing the next-generation genome of C4U (Press release, Noile-Immune Biotech, MAY 25, 2020, View Source [SID1234561509]). Combining the CRISPR/Cas3 technology, which is a technology, with the PRIME (Proliferation inducing and migration enhancing) technology for adapting genetically modified immune cell therapies such as CAR-T and TCR-T possessed by Noil Imune to solid cancer We would like to inform you that we have signed an agreement for joint research and commercialization of cross-type allogeneic genetically modified immune cell therapy technology.

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The CRISPR/Cas3 technology, which is the basic technology of C4U, is the research result of Prof. Tomoshi Mashita of the Institute of Medical Science, University of Tokyo, who is the founding member of C4U and advisor of science and technology, and Professor Junji Takeda of the Institute of Microbial Diseases, Osaka University. A new genome editing technology using the CRISPR/Cas3 system developed based on It is a technology that can counter the CRISPR/Cas9 system, which is currently being researched all over the world, and is attracting attention as a promising genome editing technology that is not affected by the complicated patent situation regarding Cas9.

In addition, PRIME technology, which is the basic technology of Noyle Immune, is the scientific founder and director of Noyle Immune, and Professor Koji Tamada of the Graduate School of Medicine, Yamaguchi University (Professor, Gene and Cell Therapy Center, Institute of Medical Science, University of Tokyo). It is a technology related to cancer immune cell therapy such as CAR-T developed by et al. CAR-T is a technology that not only enhances the functions of CAR-T, etc. by producing cytokines and chemokines, but also causes cancer injury by cancer patients’ own endogenous immune cells.

"I am very pleased to be able to form a business alliance with C4U, which has excellent genome editing technology of its own." In this project, we will combine the PRIME CAR-T technology of Noil Imune and the genome editing technology of C4U. By combining these, we will promote the development of highly active CAR-T cells that utilize immune cells derived from alleles.The combination of domestic technologies is highly versatile and can exert therapeutic effects even on solid cancers. We hope that next-generation CAR-T cells will be developed and a treatment method that will save more patients will be created.This project is based on the Ministry of Education, Culture, Sports, Science and Technology subsidy project "Regional Innovation Ecosystem Formation Program". We are aiming to develop the world’s most advanced cancer immunotherapy with the help of various researches including the beginning."

In addition, C4U’s Satoshi Mashita said, "The PRIME CAR-T technology possessed by Noyle Imune is a wonderful technology that can be proud of in the world, which has successfully overcome the effects of CAR-T cells on solid cancer, which was a weak point, and the sustainability of the effects. By adding our newly developed CRISPR/Cas3 genome editing technology to this technology, it is possible to achieve a more inexpensive, more effective and superior allogeneic CAR-T cell therapy compared to the existing CAR-T cell therapy. I am confident that we will be able to provide to many suffering patients."

Neil Imune and C4U will collaborate on allogeneic genetically modified immune cell therapy under this partnership. Neil Imune will bear part of the costs necessary to carry out this joint research. In addition, both companies have the right to commercialize the results obtained by this joint research, and the right to mutually receive royalties based on the contract. Noil Imune will pay the access fee for the basic technology of C4U when commercializing. Further details of the contract are not disclosed.

On May 22, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical trial of NT219, a novel agent addressing treatment resistance in advanced cancer (Press release, Kitov Pharmaceuticals , MAY 22, 2020, View Source [SID1234558411]). The study will evaluate NT219 as monotherapy treatment of advanced solid tumors and in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma.

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"The acceptance of our IND by the FDA to conduct this important clinical study represents a significant achievement for our NT219 development program," said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Kitov. "Based on the encouraging preclinical data generated in various studies with NT219, we believe this promising drug candidate has the potential to be a safe and effective therapy for multiple treatment resistant cancers. We look forward to beginning to generate key clinical evidence for NT219 through this Phase 1/2 trial."

The primary objectives of the open-label Phase 1/2 trial are to evaluate safety, assess pharmacokinetics, identify the appropriate dose to be studied in the Phase 2 portion, and establish preliminary efficacy of NT219. The Phase 1 portion of the study will encompass a dose escalation evaluation of NT219 monotherapy administered weekly in patients with refractory advanced solid tumors. Upon reaching the third dose to be given, a second cohort of patients, with either recurrent or metastatic squamous cell carcinoma of the head and neck or colorectal adenocarcinoma, will be dosed weekly with NT219, dose escalated, in combination with cetuximab. Upon completion of the mono and combination therapy Phase 1 portion of the trial and establishment of the recommended Phase 2 dose for NT219, an expansion Phase 2 component of the study will be commenced at the recommended Phase 2 dose of NT219 in combination with cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

In previously completed preclinical studies, NT219 has demonstrated compelling anti-tumor activity, as both monotherapy and in combination with cetuximab. Most recently, in an abstract published at the American Association of Cancer Research Virtual Meeting II website, positive preclinical data were presented showing that NT219 demonstrated growth inhibition, both as monotherapy, as well as in combination with cetuximab or pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor, in multiple patient-derived xenograft models of subjects with head and neck squamous cell carcinoma.

On May 22, 2020 Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a pioneering global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs) while lowering costs, reported a research and development collaboration with Hospital Infantil Universitario Niño Jesús, Madrid, Spain, through its Biomedical Research Foundation, FIB, to establish a point-of-care center leveraging Orgenesis’ cell and gene therapy focused POCare Platform (Press release, Orgenesis, MAY 22, 2020, View Source [SID1234561710]).

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Under the collaboration agreement, FIB Hospital Infantil Universitario Niño Jesús will utilize Orgenesis’ CGT Biotech Platform to develop, optimize and manufacture cell and gene therapies. Orgenesis’ POCare Technologies enable hospitals to develop and supply cell and gene therapies, including Orgenesis’ proprietary POCare Therapies, by implementing Orgenesis’ proprietary know-how combined with automated, closed technology to process select cell therapies at each point-of-care site for the treatment of patients.

The first collaboration under the agreement between FIB Hospital Infantil Universitario Niño Jesús and Orgenesis involves the clinical development and validation of T-cell and dendritic cell-based therapies. Orgenesis’ CGT Biotech Platform, which combines processing and therapeutic technologies, is designed to allow for the efficient production of high quality, affordable cell and gene-based products. Upon successful completion of the first collaboration, Orgenesis and FIB Hospital Infantil Universitario Niño Jesús then plan to pursue the development of the Hospital’s oncolytic based cell therapy technology, Celyvir. This proprietary program represents a new strategy for the treatment of solid metastatic tumors based on oncolytic virotherapy administered by mesenchymal cells obtained from bone marrow.

Vered Caplan, CEO of Orgenesis, stated, "Hospital Infantil Universitario Niño Jesús will be an amazing addition to our POCare Network. We believe that our POCare Technologies will enable the hospital to advance this new therapy for the treatment of solid metastatic tumors based on oncolytic virotherapy. Our CGT Biotech Platform enables hospitals to accelerate the clinical development of life-saving therapies and potentially bring them to market in a more time and cost-effective manner. Furthermore, we expect that this collaboration will allow us to further develop and validate our POCare Therapies, including immune-oncology therapies."

Dr. Manuel Ramírez MD, PhD, Head of the Pediatric Advanced Therapies Unit at Hospital Infantil Universitario Niño Jesús in Madrid, commented, "We look forward to collaborating with Orgenesis in order to develop our oncolytic based cell therapy. By utilizing Orgenesis’ CGT Biotech Platform, we seek to reduce the cost of bringing our technology to market, enabling others to use it in their patients, assuring high quality standards by integrating Orgenesis’ proprietary POCare Technologies."

On May 22, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," "MTEM" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported it has secured a debt financing facility for up to $45 million from K2 HealthVentures, a healthcare-focused specialty finance company (Press release, Molecular Templates, MAY 22, 2020, View Source [SID1234558412]). MTEM received a first tranche of $15 million upon closing, a portion of which has been used to repay the remaining indebtedness that was outstanding under the Company’s prior credit facility. Two subsequent tranches totaling up to $30 million will become available to MTEM, at its option, upon the achievement of certain milestones with respect to the second tranche and, subject to lender consent and certain additional conditions with respect to the third tranche.

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"This debt facility strengthens our balance sheet in a non-dilutive fashion and increases our financial flexibility as we advance and expand our pipeline and grow our internal manufacturing capacity," said Eric Poma, Ph.D. Molecular Templates’ Chief Executive and Scientific Officer.

On May 22, 2020 Pfizer Inc. (NYSE: PFE) reported that it and Wyeth recommend rejection of the unsolicited tender offer made by Huguenot Bond Liquidity, LLC ("Offeror") on May 11, 2020 (as amended and restated on May 21, 2020) to purchase up to $162.5 million principal amount of Pfizer’s outstanding 7.200% notes due 2039 (the "Pfizer Notes") and up to $130.0 million principal amount of Wyeth’s 5.950% notes due 2037 (the "Wyeth Notes" and together with the Pfizer Notes, the "Notes") (Press release, Pfizer, MAY 22, 2020, View Source [SID1234558414]). Wyeth is a wholly-owned subsidiary of Pfizer. Pfizer and Wyeth do not endorse Offeror’s unsolicited tender offer, and neither Pfizer nor Wyeth is affiliated or associated with the Offeror, the tender offer or the offer documentation. The Offeror did not inform Pfizer of the tender offer, and Pfizer only became aware of the offer through a third party source. Further, there is no disclosure of information regarding the Offeror or any indication as to a source of financing for the offer in the offer documentation.

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Pfizer arrived at this position after considering all of the facts and circumstances surrounding the Offeror’s unsolicited tender offer. In particular, Pfizer believes that the tender offer is not in the best interest of the holders of the Notes for the following reasons, among others:

the applicable tender consideration offered by the Offeror, as calculated using a reference date of May 21, 2020, is approximately 7% lower than the last trade price of $166 per $100 principal amount of notes for the Pfizer Notes and approximately 8% lower than the last trade price of $145 per $100 principal amount of notes for the Wyeth Notes, in each case on May 21, 2020, the last business day prior to the issuance of this press release;
the tender consideration is variable and is based on a benchmark security that may trade based on factors independent of those that may affect the trading prices of the Notes; and
the consummation of the offer is subject to a number of conditions and Offeror has retained a right to terminate the tender offer if any of these conditions are not satisfied or, in its absolute discretion, at any time and for any reason, reducing the likelihood that the offer will be consummated.
The announcements contained in this press release were made pursuant to Pfizer and Wyeth’s obligations under Rule 14e-2 under the Securities Exchange Act of 1934. Pfizer and Wyeth are not taking a position on whether the unsolicited tender offer is being made in accordance with United States federal securities laws, including the applicable rules and regulations issued by the Securities and Exchange Commission.

Pfizer urges investors to obtain current market quotations for their Notes, to consult with their broker or financial advisor and to exercise caution with respect to the Offeror’s offer. Pfizer recommends that noteholders who have not responded to the Offeror’s offer take no action. Holders of Notes who have already tendered their Notes may withdraw them at any time prior to May 26, 2020, in accordance with the Offeror’s offering documents. The tender offer is currently scheduled to expire at 5:00 pm New York City time on Tuesday, June 9, 2020.

Pfizer requests that a copy of this news release be included with all distributions of materials relating to the Offeror’s offer related to the Notes.