On April 26, 2018 Abcam, a global leader in the supply of life science research tools, reported that signed a Memorandum of Understanding (MoU) with Shuwen Biotech, a leading player in the development and commercialization of companion diagnostics (CDx) (Press release, Shuwen Biotech, APR 26, 2018, View Source [SID1234525700]). Through the agreement, Abcam and Shuwen will jointly leverage their respective capabilities, in producing high-quality antibodies and CDx kit development and commercialization, to better serve the needs of the pharma industry.

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The two parties are responding to the increasing range of development needs from pharmaceutical and biopharma developers, patients, healthcare professionals, and regulatory authorities, The nature of any joint work is yet to be determined in detail but is likely to encompass Abcam providing reproducible highly-specific recombinant antibodies to key targets, which Shuwen will incorporate into companion diagnostic kits.

"Shuwen has a long-standing reputation amongst pharmaceutical companies for companion diagnostic kit development and central lab testing, and Abcam is a recognized leader in quality antibody development. This alliance will undoubtedly further strengthen Shuwen’s capabilities in developing quality companion diagnostic kits especially immunoassay kits," said Jay Z. Zhang, Shuwen’s Chief Executive Officer and Chairman. "We have seen continuous advances at all levels in personalized medicine over the past few years and these can only continue through innovative technologies like those that will be born out of joint efforts between Shuwen and Abcam."

John Baker, Abcam’s SVP Portfolio and Business Development said: "Abcam is pleased to establish this long-term collaborative strategic partnership, combining our unique capabilities to develop sensitive, highly-specific and validated antibodies with Shuwen’s proven track-record in the CDx space. Our work with Shuwen will focus on developing efficient and comprehensive solutions to advance clinical diagnostics and precision medicine, faster."

About Shuwen Biotech: Shuwen Biotech is a China-based diagnostics company founded on the principles of innovation, patent protection, and international collaboration as its strategic platforms for growth. Since 2011, Shuwen established strategic partnerships with numerous outstanding academic and commercial institutions such as Yale University, University of Chicago, Max-Plank Institute, BioNTech among others in the form of exclusive licensing of over 20 first-in-class diagnostic technologies and 50+ patents covering a range of novel biomarkers for companion diagnostics and other diagnostics in the fields of cancer, women’s health, critical care, and health screening and other fields. Shuwen houses an in-house development team, CAP-accredited central lab, and IVD manufacturing facilities all in line with global standards in order to continue to deliver transformational products to its customers globally and open new possibilities in the advancement of health.

To learn more, visit www.shuwenbiotech.com

On April 25, 2018 RhoVac AB (publ) ("RhoVac") reported that the company has received an invitation to meet with the European Medicines Agency (EMA) to further discuss a phase IIb clinical trial (Press release, RhoVac, APR 25, 2018, View Source [SID1234555936]).

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RhoVac initiated a Scientific Advice procedure with EMA immediately after completion of a pre-submission meeting end of February 2018; the procedure was originally estimated to be completed end of April 2018. Following invitation to participate at the EMA’s Scientific Advice Working Party’s meeting in London the entire procedure is, according to standard regulatory procedures, extended by approximately one month and completion is now estimated to be at the end of May 2018.

Invitation to a discussion meeting with the Working Party is not standard in a Scientific Advice procedure; however, EMA can provide this opportunity to a company to ensure that the development strategy of the company is fully understood and thereby to ensure that the most accurate advice is provided to the company for the design of the coming clinical phase IIb study.

On April 25, 2019 CrystalGenomics, a Korean biopharmaceutical company reported it has signed a co-development agreement with U.S.-based CBT Pharmaceuticals for an investigational combination therapy of CG200745 and CBT-501 across a variety of solid tumors with high unmet medical needs (Press release, CrystalGenomics, APR 25, 2018, View Source;year=2018&no=263708 [SID1234539164]).

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CG200745 from CrystalGenomics is a novel pan-HDAC inhibitor currently in Phase II clinical study for pancreatic cancer and Phase Ib for myelodysplastic syndrome in Korea.

CBT-501 from CBT Pharmaceuticals is a novel IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells. CBT-501 is under evaluation in two Phase I trials designed to evaluate the safety and efficacy in patients with advanced solid tumors, recurrent or refractory to standard of care therapies.

Under the exclusive agreement, the duo will be responsible for the co-development and global commercialization of the combination of CG200745 and CBT-501 in multiple tumor types, including hepatocarcinoma correlated with poor prognosis.

Immune checkpoint inhibitors such as the programmed death receptor-1 (PD-1) have been proven effective but many patients do not respond due to resistance. Recent reports suggest immune enhancing effects of HDAC inhibitors, in addition to their direct anti-tumor properties, making CG200745 a good candidate for combination therapy with CBT-501, according to CBT Pharmaceuticals.

Shares of Kosdaq-listed CrystalGenomics finished Wednesday down 2.8 percent at 26,000 won ($24.06).
By Shin Chan-ok and Minu Kim

On April 25, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that three abstracts describing CB-839, the Company’s novel, orally bioavailable glutaminase inhibitor, will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from June 1 to June 7, 2018 in Chicago, Illinois (Press release, Calithera Biosciences, APR 25, 2018, View Source [SID1234535240]).

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Calithera’s collaborators will present the following results:

Phase I clinical trial of the glutaminase inhibitor CB-839 plus capecitabine in patients with advanced solid tumors Abstract #2562 Presenter: Jennifer R. Eads, M.D., Case Comprehensive Cancer Center
Date: June 4, 2018
Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall
A Developmental Therapeutics–Clinical Pharmacology and Experimental Therapeutics Funding for this study was provided in part by Stand Up To Cancer1. Calithera and clinical collaborators will present two trials-in-progress abstracts, which describe the design of ongoing studies.

CANTATA: A randomized phase 2 study of CB-839 in combination with cabozantinib vs. placebo with cabozantinib in patients with advanced metastatic renal cell carcinoma.
Abstract #TPS4601 Presenter: Nizar M. Tannir, M.D., MD Anderson Cancer Center
Date: June 2, 2018
Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall A Genitourinary (Non-Prostate) Cancer

Novel PET/CT imaging biomarkers of CB-839 in combination with panitumumab and irinotecan in patients with metastatic and refractory RAS wildtype colorectal cancer: A phase I/II study Abstract #TPS3616 Presenter: Satya Das, M.D., Vanderbilt University Cancer Center Date: June 3, 2018 Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall A Gastrointestinal (Colorectal) Cancer About CB-839 Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.

On April 25, 2018 Takeda Pharmaceutical Company Limited ("Takeda") reported the statement made by Shire plc ("Shire") confirming that it has received a revised proposal from Takeda regarding a possible offer for Shire (Press release, Takeda, APR 25, 2018, View Source [SID1234525760]).

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Takeda confirms that the revised proposal comprises 0.839 new Takeda shares and US$30.33 in cash for each Shire ordinary share (the "Revised Proposal").

Based on Takeda’s share price of ¥4,923 and the exchange rates of £:¥ of 1:151.51 and £:US$ of 1:1.3945 as at the close of business on April 23, 2018, the Revised Proposal implies an equivalent value of approximately £49 per Shire ordinary share, comprising the equivalent of:

£27.26 in new Takeda shares; and
£21.75 in cash.
On this basis the Revised Proposal is equivalent to a value of approximately £46 billion for the entire issued and to be issued share capital of Shire. Shire shareholders would also be entitled to any dividends announced, declared, made or paid by Shire in the ordinary course prior to completion of the possible transaction.

Takeda and its Board have remained disciplined with respect to the terms of the Revised Proposal and Takeda intends to maintain its well-established dividend policy and investment grade credit rating.

At completion, Shire shareholders would own approximately 50 percent of the enlarged Takeda and the new Takeda shares will be listed in Japan and in the US through an ADR program.

The Board of Shire has indicated to Takeda that it would be willing to recommend the Revised Proposal to Shire shareholders, subject to satisfactory resolution of the other terms of the possible offer, including completion of reciprocal due diligence by Shire on Takeda. Accordingly, the Board of Shire will engage in discussions with Takeda in relation to these terms.

The making of any firm offer by Takeda would be subject to the following matters:

agreement of certain other terms of the Revised Proposal;
satisfactory completion of a confirmatory due diligence review by Takeda;
the unanimous and unconditional recommendation of the Board of Shire; and
final approval by the Board of Takeda.
Takeda reserves the right to waive in whole or in part any of the pre-conditions to making a firm offer set out in this announcement.

With the consent of the Panel on Takeovers and Mergers (the "Takeover Panel"), the Board of Shire has agreed to an extension of the relevant deadline under Rule 2.6(c) of the Code until 5.00 p.m. (London time) on May 8, 2018 to enable the parties to conclude their ongoing discussions. This deadline may be extended further with the consent of the Takeover Panel, at Shire’s request, in accordance with Rule 2.6(c) of the Code.

Takeda reserves the following rights in respect of the Revised Proposal:

to make an offer for Shire at any time on less favorable terms or to vary the mix of consideration:
with the agreement or recommendation of the Board of Shire;
if a third party announces a firm intention to make an offer for Shire which, at the date Takeda announces a firm intention to make an offer for Shire, is valued at a lower price than contemplated by the terms of the Revised Proposal; or
following the announcement by Shire of a whitewash transaction pursuant to the Code; and
in the event that any dividend and/or other form of capital return or distribution is announced, declared, made or paid by Shire otherwise than in the ordinary course, to reduce any offer by the amount of such dividend and/or other form of capital return or distribution.
There can be no certainty that any firm offer for Shire will be made.