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Kyowa Hakko Kirin Submits the Partial Change Approval Application of KHK7580 (evocalcet) in Japan

On April 24, 2019 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Masashi Miyamoto, "Kyowa Hakko Kirin") reported that it has submitted a supplemental application of KHK7580 (evocalcet)*1 for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy*2 to the Ministry of Health, Labor and Welfare (MHLW) in Japan (Press release, Kyowa Hakko Kirin, APR 24, 2019, View Source [SID1234535342]).

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This application is based on the interim result (24 weeks) of the phase 3 study that evaluates the efficacy of KHK7580 for hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy. The primary endpoint is the percentage of subjects whose corrected serum calcium level is maintain ≤ 10.3 mg/dL for 2 weeks in the evaluation period in a time frame up to 24 weeks. The primary endpoint was met with a 77.8% result, which exceeds the threshold set in the protocol.

KHK7580 was also granted Orphan Drug Designation for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy by the MHLW on March 4, 2019.

"We are delighted to submit the supplemental application for evocalcet," said Mitsuo Satoh, Ph.D., Head of Research and Development Division of Kyowa Hakko Kirin. "As it was granted Orphan Drug Designation by the MHLW, we believe that evocalcet has the potentials to provide more efficient treatment for hypercalcemia patients with parathyroid carcinoma and primary hyperparathyroidism."

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

*1 About KHK7580 (evocalcet)
KHK7580 is a small molecular compound and a novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation (President & Representative Director, CEO: Masayuki Mitsuka, "Mitsubishi Tanabe Pharma"). Kyowa Hakko Kirin signed a license agreement of KHK7580 with Mitsubishi Tanabe Pharma for the rights to cooperative research, develop, market and manufacture the product in Japan and some parts of Asia in March 2008. On March 2018, Kyowa Hakko Kirin received approval of KHK7580 for secondary hyperparathyroidism in maintenance dialysis patients and later on May 2018, the product was launched in Japan market, named Orkedia Tablets.

*2 About Hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism under inability parathyroidectomy or relapse after parathyroidectomy
Parathyroid carcinoma and primary hyperparathyroidism (PHPT) are diseases in which serum calcium levels elevates due to over autonomous secretion of parathyroid hormone (PTH) from tumors of the parathyroid gland. Parathyroidectomy (PTx) is the only reliable method to treat parathyroid carcinoma and PHPT. Control of hypercalcemia can prove challenging in cases of PHPT where PTx cannot be considered because of concomitant diseases or where PHPT recur after PTx and parathyroid carcinoma, although patients with such hypercalcemia are very rare. Hypercalcemia causes symptoms of fatigue, polyuria, thirst, and renal impairment and severe hypercalcemia can result in death due to a hypercalcemic crisis.

EpimAb Biotherapeutics is Granted US Patent on Core Bispecific Antibody Technology

On April 24, 2019 EpimAb Biotherapeutics, an emerging biopharmaceutical company based in Shanghai, reported that the United States Patent and Trademark Office (USPTO) has granted the U.S. Patent No. 10,266,608 entitled "Fabs-In-Tandem Immunoglobulin and Uses Thereof" (Press release, EpimAb Biotherapeutics, APR 24, 2019, View Source [SID1234535333]). Based on EpimAb’s globally filed first application, this patent broadly covers bispecific antibodies obtained utilizing the company’s FIT-Ig technology in a composition of matter claim.

"This patent underscores the novelty of EpimAb’s approach in bispecific antibody generation and forms an important foundation of EpimAb’s growing IP portfolio," said Dr. Chengbin Wu, Founder and CEO of EpimAb Biotherapeutics. "The first granted patent in a major pharmaceutical market like the US therefore represents a significant milestone for EpimAb and takes us another step towards our goal to become a leading innovator in cancer biologics."

EpimAb is developing multiple programs based on its FIT-Ig platform for the treatment of various cancers. Its most advanced product candidate EMB-01, a cMet/EGFR bispecific with a novel mechanism of action was discovered and rapidly developed to the clinic by EpimAb. It is currently being investigated in a clinical Phase I/II trial in the USA and China. A second FIT-Ig molecule is currently under preclinical development with further molecules following soon, rapidly growing EpimAb’s pipeline of bispecific antibodies.

ZETAGEN THERAPEUTICS, INC. RECEIVES PATENT FOR REGULATION OF BONE GROWTH AND BONE DEGRADATION USING SMALL-MOLECULE

On April 23, 2019 Zetagen Therapeutics, Inc., a private, US-based biotechnology company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported that the U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent No. 102656437 to the Company (Press release, Zetagen Therapeutics, APR 23, 2019, View Source [SID1234643688]). This patent, entitled Neurogenic Regulation of Bone Growth and Bone Degradation, covers the use of methods for promoting controlled bone creation and destruction as a means to repair large bone segmental defects. This patent follows the previously issued U.S. Patent No. 10208306 and South African PCT. 2017/00029 covering the use of a method for stimulating bone growth using a small molecule.

"This latest patent issuance is a significant piece of our Global IP Strategy. This provides the opportunity to further develop our therapies to aid patients afflicted by metastatic lesions," said Joe C. Loy, CEO of Zetagen Therapeutics, Inc.

The new patent is part of an expanding and comprehensive portfolio of patents, patent applications and other intellectual property covering the composition, synthesis, manufacturing, formulations and uses for the treatment of a variety of metastatic bone lesions and osteologic interventions. Zetagen exclusively licensed its platform technology from the State University of New York in 2016.

Cytura Therapeutics to Develop a New Class of Drugs Targeting genomic instability in cancer

On April 23, 2020 Cytura Therapeutics reported the successful closure of a Seed financing round (Press release, Cytura Therapeutics, APR 23, 2019, View Source [SID1234572898]). The funding is provided by a syndicate led by Thuja Capital Healthcare (Seed) Fund II and includes BOM Brabant Ventures, the Centre for Drug Design and Discovery (CD3) – KU Leuven and the Gemma Frisius Fund. Cytura Therapeutics will use the new funding to advance its first proprietary small molecule program and to further expand their pipeline of new disruptive drugs, targeting genomic instability.

The company will be based at the Pivot Park Life Science Campus in Oss and collaborate with the Amsterdam UMC and the Centre for Drug Design and Discovery (CD3) of the KU Leuven. Genomic instability is a major problem in cancer progression and therapy resistance. By targeting genome instability this approach could be applied both as a stand-alone as in combinations therapy. On the latter, there is a large group of patients who will at first respond to the applied therapy and later on become resistant during treatment.

"One of the biggest issues in cancer treatment is that the disease has the ability to change its nature over time caused by the increasing genomic instability. Cytura’s R&D efforts are focused on the development of small molecules that will slow down or stop this genomic instability. I am committed to find this medicine which could lead to real advancements in the fight against cancer."

Mereo BioPharma Group plc ("Mereo" or the "Company" or the "Group") Completion of the Merger with OncoMed Pharmaceuticals, Inc.

On April 23, 2019 Mereo BioPharma Group plc (AIM: MPH), a clinical stage, UK-based, biopharmaceutical company focused on rare diseases, reported that the merger with OncoMed Pharmaceuticals, Inc. ("OncoMed" NASDAQ:OMED) announced on 5 December 2018 has completed (Press release, Mereo BioPharma, APR 23, 2019, View Source [SID1234553301]).

This follows the approval from the stockholders of OncoMed on 17 April 2019 of the transactions contemplated by the merger agreement dated 5 December 2018 (the "Merger") between Mereo, OncoMed and certain other parties thereto (the "Merger Agreement"), and OncoMed has today become a wholly-owned indirect subsidiary of Mereo following the effective filing of a certificate of merger with the Secretary of State of the State of Delaware. In connection with completion of the Merger:

Mereo has today issued 24,783,320 new ordinary shares (the "New Shares") to Citibank, N.A., London Branch, as custodian, and will instruct Citibank, N.A., as depositary, to deliver 4,956,664 American Depositary Shares (the "ADSs") to former OncoMed stockholders, each ADS representing five New Shares. The ADSs are expected to be admitted to trading on the Global Market of Nasdaq Stock Exchange Market LLC on 24 April 2019, under the ticker symbol "MREO"; and

Michael Wyzga and Deepa Pakianathan, Ph.D. today become non-executive directors of Mereo.
Mereo also announces today that its preliminary results for the Financial Year ended 31 December 2018 will be published on Monday 29 April 2019.

Commenting on the announcement, Mereo’s Chief Executive Officer, Dr. Denise Scots-Knight, said:

"We are pleased to have completed our merger with OncoMed which has broadened our asset base, strengthened our cash position and will enable us to further progress our two rare disease programmes. We are delighted to welcome both Michael and Deepa to our Board.

The ADR programme we have now initiated on NASDAQ, together with our existing AIM listing, will facilitate a deeper engagement with a broader international pool of capital. As we look forward to the remainder of 2019 we continue to anticipate several important data points from our two rare disease products. These include initial 6 month data from the open label arm our Phase 2b dose ranging study for BPS-804 in the treatment osteogenesis imperfecta in Q2 2019, 12 month data for this programme in Q4 2019 and data from our Phase 2 dose-ranging study with MPH-966 for alpha-1 antitrypsin deficiency (AATD), which we expect around the end of 2019.

Partnering discussions for BCT-197 for severe exacerbations of COPD are progressing following our successful end of Phase 2 Type B meeting with the FDA. We also intend to initiate partnering discussions for navicixizumab, which has generated encouraging clinical data in ovarian cancer and for BGS-649 in hypogonadotrophic hypogonadism in parallel with the regulatory interactions to determine the next development steps. We look forward to updating our shareholders on the progress of our pipeline more comprehensively on the publication of our preliminary financial results for 2018 at the end of April."

Issue of New Shares and Total Voting Rights

The New Shares rank pari passu with the existing ordinary shares of Mereo. Application has been made for the New Shares to be admitted to trading on AIM ("Admission") and it is expected that Admission will take place at 8.00 a.m. (BST) on 24 April 2019.

The New Shares represent approximately 25.8% of the enlarged issued share capital of Mereo which, following the issue, consists of an aggregate total of 96,023,592 ordinary shares of £0.003 each, none of which are held in treasury. Shareholders may use this figure as the denominator for the calculations by which they will determine if they are required to notify their interest in, or to notify a change to their interest in, the issued share capital of Mereo.

Appointment of Michael Wyzga and Deepa Pakianathan, Ph.D. as Non-Executive Directors of Mereo

In accordance with the Merger Agreement, Mereo has appointed Michael Wyzga and Deepa Pakianathan, Ph.D. as non-executive directors of Mereo.

Michael Wyzga served as a director of OncoMed from October 2013 until the closing of the Merger today. Mr. Wyzga is currently the President of MSW Consulting Inc., a strategic consulting group focused in the life sciences area. From December 2011 until November 2013, Mr. Wyzga served as President and Chief Executive Officer and a member of the board of directors of Radius Health, Inc. Prior to that, Mr. Wyzga served in various senior management positions at Genzyme Corporation, including as Chief Financial Officer from July 1999 until November 2011. Mr. Wyzga is a member of the boards of directors of Exact Sciences Corporation and LogicBio and is Chairman of the board of directors of GenSight Biologics S.A. and of X4 Biologics. Mr. Wyzga previously served as a member of the boards of directors of Idenix Pharmaceuticals, Inc. and Altus Pharmaceuticals, Inc., and as a member of the supervisory board of Prosensa Holding B.V. He received an M.B.A. from Providence College and a B.S. from Suffolk University.

Deepa Pakianathan, Ph.D. served as a director of OncoMed from December 2008 until the closing of the Merger today. Since 2001, Dr. Pakianathan has been a Managing Member at Delphi Ventures, a venture capital firm focused on biotechnology and medical device investments. Dr. Pakianathan serves on the boards of directors of Alder Biopharmaceuticals, Inc., Karyopharm Therapeutics, Inc., and Calithera Biosciences, Inc. Dr. Pakianathan previously served on the boards of directors of Alexza Pharmaceuticals, Inc., PTC Therapeutics, Inc. and Relypsa, Inc. Dr. Pakianathan received a B.Sc. from the University of Bombay, India, a M.Sc. from The Cancer Research Institute at the University of Bombay, India, and an M.S. and Ph.D. from Wake Forest University.

The following information is disclosed pursuant to Schedule Two paragraph (g) of the AIM Rules for Companies. Michael Stephen Wyzga, aged 63 years, and Deepa Rachel Pakianathan, Ph.D., aged 54 years, have been a director of the following companies during the five years preceding the date of this announcement:

Michael Stephen Wyzga

Current directorships/partnerships Past directorships/partnerships
Exact Sciences Corporation Idenix Pharmaceuticals, Inc
GenSight Biologics S.A. Prosensa Holding B.V.
LogicBio Akebia Therapeutics, Inc.
MSW Consulting Aura Biosciences, Inc.
X4 Biologics Dohman Co.
OncoMed Pharmaceuticals, Inc.
Deepa Rachel Pakianathan

Current directorships/partnerships Past directorships/partnerships
Delphi Management Partners VI, LLC Alexza Pharmaceuticals, Inc.
Alder Biopharmaceuticals, Inc. ForsightVision5
Calithera Biosciences, Inc. NeurAxon, Inc.
Karyopharm Therapeutics, Inc. OncoMed Pharmaceuticals, Inc.
Serplus Bio
Save as set out above there are no further disclosures pursuant to Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies in respect of the appointment of Michael Wyzga and Deepa Pakianathan, Ph.D.

Deepa Pakianathan, Ph.D. holds a beneficial interest in 256,734 ADSs.