BiocurePharm, Korea (BPK) Signs MOU With Symbasis GmbH to Develop CAR-T Therapy for Chronic Lymphocyte Leukemia (CLL)

On January 4, 2021 Biocure Technology Corp. (CURE or the Company) (CSE:CURE; OTCQB: BICTF) BiocurePharm, Korea (BPK), a subsidiary of Biocure Technology Inc. (CURE) reported that BPK has entered into a MOU with Symbasis GmbH. They have expressed a common interest in developing a CAR-T Therapy for Chronic Lymphocyte Leukemia (CLL) and wish to sign this MOU for the purpose of confirming their intention in respect to the development (Press release, Biocure Technology, JAN 4, 2021, View Source [SID1234628749]).

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The purpose of this MOU is to establish a Joint Venture in Germany under the name "Oncocart" for clinical trials, production and marketing in Europe, (potentially, including other regions of the world) of ROR1-based products for the CAR-T therapy the target indication of which is CLL.

The MOU is intended to form the basis of discussions and negotiations between the Parties for the purpose of entering into final agreements without creating any obligation to do so.

Both parties agree that this Joint Venture will enable them to bring together an extremely experienced group of experts and professionals, allowing for all phases of the development to advance more effectively.

"Oncocart" is advised by renowned hemato-oncological experts. Among others Prof. Dr. Karl-Anton Kreuzer and Prof. Dr. Christoph Scheid are providing their in-depth knowledge for the development of CAR-T therapy. Both are consultant physicians at the University of Cologne Medical Center, which hosts the world’s largest study group for Chronic Lymphocytic Leukemia (CLL), is a leading institution for clinical CAR-T trials and serves as a National Cancer Center in Germany.

Goldberg Consulting will act as advisors for the newly formed Oncocart. Goldberg supports companies in the health and social economy sector with an interdisciplinary network of qualified exprerts. (View Source)

Dr. Sang Mok Lee, CEO and President of Biocure and BPK, states "This MOU is an important milestone for the Company to advance it’s entrance into the European market with its CAR T technology. With clinical trials commencing in Korea, we are confident, that with the right positive outcomes, we can expedite the process into the European market, allowing patients access to an affordable CAR T Therapy and ultimately saving more lives. We continue to work hard to make this happen as soon as possible."

About Symbasis GmbH was founded in 2001 and supports organizations in the health care sector. Symbasis has a strong focus on strategy; access to market; quality assurance, and cost control specifically in Germany and India.

About Dr. Karl-Anton Kreuzer
Dr. Karl-Anton Kreuzer studied medicine at the Universities of Bonn, Munich (TU), Pittsburgh / USA and Zurich / Switzerland. He completed his scientific training with research grants at the Wistar Institute in Philadelphia / USA and the Weizmann Institute of Science in Rehovot / Israel. He completed his internistic training with Dr. Dieter Huhn at the Charité Virchow Clinic in Berlin. Dr. Kreuzer has been working at Clinic I for Internal Medicine at Cologne University Hospital since 2004 and was habilitated in 2006 on the topic of "Molecular Diagnostics in Hematology". At the local clinic, he is responsible for the treatment of acute leukemia (AML / ALL) and myelodysplastic syndrome (MDS). He also runs the clinic’s coagulation clinic and is a consultant in this regard. Dr. Kreuzer heads the interdisciplinary oncological project group (IOP) "Acute Leukemia and MDS" of the Center for Integrated Oncology (CIO) Cologne. In addition, he heads the routine laboratory for special hematological diagnostics at the clinic with a focus on hematological diagnostics. In this laboratory there is also a scientific working group that deals with the molecular pathogenesis and experimental therapy of malignant hematopoietic systemic diseases. Dr. Kreuzer is a member of national and international specialist societies in the field of hematology / oncology and is also an expert for domestic and foreign research funding institutions as well as for numerous specialist journals. Dr. Kreuzer is also the editor and co-editor of various hematological-oncological journals and standard internal works. – His research priorities cover acute leukemia and myelodysplastic syndromes. He is also a medical examiner for therapy studies on lymphomas and solid tumors. In addition to the routine diagnosis of leukemia and lymphoma, Dr. Kreuzer is also researching new molecular and immunological markers for the initial and follow-up diagnosis of hematological neoplasia.

About Dr. Christoph Scheid.
Dr. Christoph Scheid studied medicine at the universities of Bonn, Cologne and Clermont-Ferrand. After completing his doctorate and medical examination in 1991, he was a scholarship holder of the German Cancer Aid at the Paterson Institute for Cancer Research in Manchester and dealt with the research of changes in the immune system through experimental tumor therapies e.g. Interleukin-6 or the protein kinase C activator bryostatin-1. In addition, he examined the recovery of immune function after transplantation of autologous peripheral blood stem cells, a method that was still very new at the time. After moving to Clinic I for Internal Medicine at the University Hospital Cologne in 1994, he brought his experience into the development of an autologous and later also allogeneic transplant program in Cologne and later took over the management of the laboratory for stem cell transplantation and stem cell production. Dr. Scheid has been a specialist in internal medicine since 2001 and has had the additional qualification of hematology and internal oncology since 2004. Since 2002, he has headed the ward and transplant outpatient clinic (KMT), haemapheresis and the focus on stem cell transplantation (KMT). In addition, he is transfusion officer at Clinic I for internal medicine. In 2005 Professor Scheid habilitated in internal medicine. His research priorities include optimization of autologous stem cell transplantation and stem cell extraction, research into the role of stem cells in the context of ischemic heart diseases, and allogeneic stem cell transplantation. Dr. Scheid is clinically responsible for stem cell transplantation, the treatment of chronic myeloid leukemia and multiple myeloma. He is a member of numerous national and international specialist societies and is the author and co-author of a number of publications.

Charles River Laboratories Acquires Distributed Bio

On January 4, 2021 Charles River Laboratories International, Inc. reported that it acquired of Distributed Bio, Inc. on December 31, 2020 (Press release, Charles River Laboratories, JAN 4, 2021, View Source [SID1234577812]). The acquisition marks the culmination of an exclusive partnership between these companies that was initiated in October 2018.

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Based in South San Francisco, California, Distributed Bio is a next-generation antibody discovery company. Distributed Bio’s SuperHuman antibody libraries and integrated antibody optimization technologies help to enhance the probability of success for delivering high-quality, readily formattable antibody fragments to support antibody and cell and gene therapy candidates to biopharmaceutical clients. Distributed Bio’s libraries are computationally optimized for both sequence diversity and immuno-engineering fitness through the analysis of thousands of human antibody repertoires and all known monoclonal therapeutics in clinical trials, which can generate many unique binders against every antigen tested. This large molecule discovery platform improves the chance of successful hit finding, reduces optimization requirements, and thereby expedites the antibody discovery process by several months. Distributed Bio’s computational immunology expertise also enables optimization of existing client antibodies generated through more traditional platforms, such as hybridoma or traditional phage display.

The acquisition of Distributed Bio expands Charles River’s scientific capabilities with an innovative, large-molecule discovery platform. The transaction combines Distributed Bio’s antibody libraries and immuno-engineering platform with Charles River’s extensive drug discovery and non-clinical development expertise to create an integrated, end-to-end platform for therapeutic antibody and cell and gene therapy discovery and development.

James C. Foster, Chairman, President and Chief Executive Officer of Charles River Laboratories, commented, "The addition of Distributed Bio’s next-generation antibody discovery capabilities further enhances Charles River’s unique ability to serve as a single-source partner to support our clients’ early-stage research. Our successful partnership has already generated significant client interest and we believe our broader platform will continue to attract new discovery business opportunities. Distributed Bio’s large-molecule discovery platform fills a gap in our portfolio and expands our early discovery expertise in a complex drug modality that few CROs can successfully offer. With its focus on speed and design efficiency, we believe the acquisition of Distributed Bio will enable us to build upon the more than 80 novel small molecule candidates that we have discovered for our clients and meet our goal of eliminating an additional year from our clients’ early-stage development timelines. We are pleased to welcome Distributed Bio to the Charles River family."

"We believe our clients’ willingness to outsource more of their discovery programs will be predicated on our ability to continue to add innovative capabilities to meet our clients’ critical research needs, which we are accomplishing through strategic acquisitions and our partnership strategy. Distributed Bio is an example of our selective technology investments potentially becoming acquisitions after working with the target company for a meaningful period of time to provide its services to our clients. By adding innovative capabilities like large molecule discovery, we are enabling our clients to remain with one scientific partner from target identification through IND filing, and solidifying our position as the leading, early-stage contract research organization," Mr. Foster concluded.

Financial and Transaction Details

The purchase price was $83 million in cash, subject to customary closing adjustments. In addition to the initial purchase price, the transaction includes contingent additional payments of up to $21 million based on future performance. The proposed acquisition and associated fees have been financed through Charles River’s existing revolving credit facility and cash.

Distributed Bio’s estimated annual revenue in 2020 was approximately $15 million. The transaction is not expected to have a material impact on Charles River’s GAAP or non-GAAP financial results in 2021. Distributed Bio will become part of the Company’s Discovery and Safety Assessment segment.

Caution Concerning Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "expect," "will," "may," "estimate," "plan," "outlook," and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements include statements in this news release regarding the acquisition of Distributed Bio and Charles River’s expectations with respect to the impact of Distributed Bio on the Company, its product and service offerings, client perception, revenue, revenue growth rates, and earnings per share; Charles River’s projected future performance including revenue and earnings per share; as well as Charles River’s future growth for discovery services. Forward-looking statements are based on Charles River’s current expectations and beliefs, and involve a number of risks and uncertainties that are difficult to predict and that could cause actual results to differ materially from those stated or implied by the forward-looking statements. Those risks and uncertainties include, but are not limited to, the ability to successfully integrate the acquisition of Distributed. A further description of these risks, uncertainties, and other matters can be found in the Risk Factors detailed in Charles River’s Annual Report on Form 10-K as filed on February 11, 2020 and the Quarterly Report on Form 10-Q as filed on October 29, 2020, as well as other filings we make with the Securities and Exchange Commission. Because forward-looking statements involve risks and uncertainties, actual results and events may differ materially from results and events currently expected by Charles River, and Charles River assumes no obligation and expressly disclaims any duty to update information contained in this news release except as required by law.

Precision BioSciences to Present at the Annual J.P. Morgan Healthcare Conference

On January 4, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS genome editing platform, reported that Matt Kane, Co-founder and Chief Executive Officer and Derek Jantz, Ph.D., Co-Founder and Chief Scientific Officer, will present at the 39th Annual J.P. Morgan Healthcare Conference taking place virtually from January 11-14, 2021 (Press release, Precision Biosciences, JAN 4, 2021, View Source [SID1234576679]).

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Details for the company presentation are as follows:

39th Annual J.P. Morgan Healthcare Conference
Date: Wednesday, January 13, 2021
Time: 2:00 – 2:40 p.m. ET

A live webcast of the presentation will be accessible on the Company’s website, www.precisionbiosciences.com, in the Investors & Media section under Events and Presentations. An archived replay of the webcasts will be available for approximately 30 days following the presentations.

Arbutus to Participate in Virtual Fireside Chat at H.C. Wainwright BioConnect 2021 Conference

On January 4, 2021 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), reported that the Company will participate in a virtual fireside chat at the H.C. Wainwright BioConnect 2021 Conference taking place from January 11 – 14, 2021 (Press release, Arbutus Biopharma, JAN 4, 2021, View Source [SID1234576179]).

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Arbutus Fireside Chat Presenters:

William Collier, President and CEO; Dr. Michael Sofia, Chief Scientific Officer; Dr. Gaston Picchio, Chief Development Officer; and David Hastings, Chief Financial Officer.

A webcast of the virtual fireside chat will be available starting at 6:00 am (EST) on January 11, 2021, and can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com or directly at Webcast. An archived replay of the webcast will be available on the Company’s website after the conference.

F-star Therapeutics Announces First Patient Dosed in FS222 Phase 1 Clinical Trial

On January 4, 2021 F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer, reported that the first patient has been dosed in its Phase 1 trial evaluating FS222, a potentially best-in-class bispecific antibody targeting CD137 and PD-L1 (Press release, F-star, JAN 4, 2021, View Source [SID1234574525]).

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This multicenter, open-label, first-in-human trial will evaluate the safety, tolerability, and clinical activity of FS222 in adult patients diagnosed with advanced malignancies. The adaptive study design will allow for the early exploration of clinical activity of FS222 in a range of selected solid tumor types that will guide further targeted future clinical development.

Dr. Louis Kayitalire, CMO of F-star said: "There remains a significant opportunity to provide treatments for patients with difficult to treat cancers, and FS222 may offer an option for patients with low levels of PD-L1 expression. Activation of an immune response in these tumor types creates the potential for a best-in-class therapy, both as a monotherapy and, eventually, in combination. With three bispecifics now in the clinic, we believe we are closer than ever to providing treatment options that many patients have been waiting for."

FS222 targets critical tumoral immune-suppressing pathways via PD-L1 checkpoint blockade and has exhibited in preclinical studies important costimulatory effects through potent clustering and activation of CD137, which in turn, synergistically promote T cell activation and enhance cytotoxic T cell responses. In preclinical models, engagement of PD-L1 and CD137 by FS222 induced T cell proliferation and cytokine production associated with significant tumor regression, significantly better than that observed with a combination of CD137 and PD-L1 targeting antibodies.