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.

Entry into a Material Definitive Agreement

On January 4, 2021, Kura Oncology, Inc., (the "Company"), reported that it entered into a Master Collaboration Agreement and a project schedule, collectively the Agreement, with Illumina, Inc. ("Illumina") (Filing, 8-K, Kura Oncology, JAN 4, 2021, View Source [SID1234573701]). Pursuant to the Agreement, Illumina has agreed to develop and commercialize an assay as a companion diagnostic test to identify head and neck squamous cell carcinoma patients with an HRAS mutation for use with tipifarnib, one of the Company’s lead drug candidates.

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Under the Agreement, Illumina is responsible for developing, and obtaining and maintaining regulatory approvals for, the companion diagnostic test in the United States, the United Kingdom and major European markets and such other countries as the parties may mutually agree. In addition, Illumina has agreed to use commercially reasonable efforts to manufacture the companion diagnostic test and to make the companion diagnostic test commercially available in the United States, the United Kingdom and major European markets and such other countries as the parties may mutually agree.