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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.

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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.

Autolus Therapeutics Receives FDA Orphan Drug Designation for AUTO3 for Treatment of Acute Lymphoblastic Leukemia

On April 23, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, reported that the United States Food and Drug Administration (FDA) has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors targeting CD19 and CD22 (AUTO3) for the treatment of acute lymphoblastic leukemia (ALL) (Press release, Autolus, APR 23, 2019, View Source [SID1234550819]).

According to the National Institute of Health’s National Cancer Institute, in the United States, there will be an estimated 5,930 new cases of ALL and an estimated 1,500 related deaths in 2019. Patients are predominantly children; approximately 60% of cases occur at age < 20 years. ALL occurs when the bone marrow makes too many immature lymphocytes, which are a type of white blood cell. Despite a high rate of response to induction chemotherapy, only 30–40% of adult patients with ALL will achieve long-term remission. Similarly, pediatric patients typically respond well to first-line treatment (combination chemotherapy) but 10 to 20% of total patients relapse with chemotherapy-resistant disease, leading to a significant unmet need in pediatric patients with high-risk relapsed or refractory ALL.

"We are pleased to receive orphan drug designation for AUTO3 for acute lymphoblastic leukemia," said Dr. Christian Itin, chairman and chief executive officer of Autolus. "Earlier this year, we presented encouraging updated data from the AMELIA phase 1/2 trial of AUTO3 in pediatric ALL patients. We believe that AUTO3 has the potential to be a best in class therapy in pediatric ALL by addressing antigen escape, a common cause of relapse in these patients. AUTO3 may also provide an improved safety profile over currently marketed CAR T therapies with low levels of severe CRS and neurotoxicity observed in clinical studies."

Orphan drug designation is granted by the FDA Office of Orphan Products Development to drugs and biologics which are intended for the treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by the FDA. For more information about orphan designation, please visit the FDA website at www.fda.gov.

About AUTO3
AUTO3 is a programmed T cell therapy containing two independent chimeric antigen receptors targeting CD19 and CD22 that have each been independently optimized for single target activity. By simultaneously targeting two B cell antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in pediatric ALL in the AMELIA clinical trial and in diffuse large B cell lymphoma in the ALEXANDER clinical trial.

For more information about the AMELIA trial, visit www.ClinicalTrials.gov (NCT03289455). For more information about the ALEXANDER trial, visit www.ClinicalTrials.gov (NCT03287817).

Gracell Bio Announces FasT CAR-T, a Breakthrough Technology for Hematological Malignancies

On April 23, 2019 Gracell Biotechnologies, Co., Ltd. ("Gracell"), an immune cell gene therapy company, reported it has developed FasT CAR-T, a revolutionary platform that shortens the manufacturing time of CAR-T treatments from two weeks to one day (Press release, Gracell Biotechnologies, APR 23, 2019, View Source [SID1234539456]). FasT CAR-T also lowers manufacturing costs to a fraction of previous CAR-T therapies, while showing higher potency of CD19-directed FasT CAR-T ("CD19-F-CAR-T") in B-Cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin Lymphoma (NHL), both in vitro and in vivo.

With a first-in-human clinical study of CD19-F-CAR-T ongoing, Gracell said early clinical results show the therapy is safe and significantly more potent (20-40 times) than conventionally manufactured CAR-T agents (C-CAR-T) for treating B-ALL. Gracell released the data of CD19-F-CAR-T during a presentation at the Global CAR-T Cell Therapy Development Shanghai Forum, held April 16-17, 2019.

FasT CAR-T requires only one day for manufacturing (plus 7 days for releasing tests per regulatory requirement), while C-CAR-T manufacturing takes about two weeks plus 7 days for testing. Hence, FasT CAR-T reduces vein-to-vein time by an average of 12 days, which is critical for patients with rapidly progressing disease. More importantly, CD19-F-CAR-T has demonstrated superior expansion capability, with a younger and less exhausted phenotype, according to the Company.

Dr. William Wei Cao, founder, chairman and CEO of Gracell, said, "Lengthy manufacture, high cost, relapse, and ineffectiveness in solid tumors of CAR-T products are the major challenges the CAR-T industry is facing. Gracell’s mission is to develop highly effective but low cost CAR-T cancer therapies for large unmet needs. Without support from patients, their families, and clinical scientists, we wouldn’t be able to advance the very promising FasT CAR-T technology."

Gracell has been developing a series of highly effective and low-cost CAR-T products, including Dual-CAR-T, Off-the-shelf CAR-T, and Enhanced-CAR-T products for treating solid tumors, two of which will be entering IND filing by the end of this year. Next year, the company plans to file INDs for three additional products.

Led by Dr. Cao, who previously served as co-founder and CEO of a Nasdaq-listed cell therapy company, Gracell was founded in 2017. Up to today, the company has raised nearly US$100 million combined, with Series B financing led by Temasek, joined by Lilly Asia Ventures, Kington Capital, King Star Capital and Chengdu Miaoji, and Series A led by 6 Dimensions.

Roche launches new VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients eligible for targeted therapy

On April 23, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the launch of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast and gastric cancer (Press release, Hoffmann-La Roche, APR 23, 2019, View Source [SID1234535348]). HER2 – human epidermal growth factor receptor 2 – is an important biomarker found in breast and gastric cancers.4 Its detection and inhibition can help to more effectively manage these aggressive cancers.

The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is designed to be completed within the same day, providing clinicians the ability to get results back quicker than the most common methods of confirmatory testing for HER2. Results can be read using light microscopy, eliminating the need for a specialized fluorescence microscope.

"The new VENTANA HER2 Dual ISH assay advances Roche’s commitment to personalized healthcare by delivering critical information on treatment options for breast and gastric cancer patients faster," said Michael Heuer, CEO Roche Diagnostics. "Quick results are crucial in the fight against cancer, and every additional day that a clinician and a patient must wait for test results is a day too long."

This assay is currently being launched in Europe, the Middle East and Africa, as well as Latin America and Asia Pacific. It will be submitted to the U.S. Food and Drug Administration for approval.

For more information about the assay, please visit the Roche Tissue Diagnostics breast cancer IHC/ISH portfolio page or the Anatomic Pathology site.

About the VENTANA HER2 Dual ISH DNA Probe Cocktail assay
Roche is the only provider of a fully automated brightfield Dual ISH solution for the detection of HER2 amplification. With the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay, Roche provides an improved brightfield assay that is fully automated on the BenchMark IHC/ISH instruments. The assay provides clear results to pathology labs more quickly, allowing clinicians to make treatment decisions earlier.
As a global leader in breast cancer diagnostics, Roche provides a comprehensive menu of both diagnostic and predictive assays, including the VENTANA HER2/neu (4B5) Rabbit Monoclonal Primary Antibody that is indicated as an aid in the assessment of breast cancer patients for whom Herceptin treatment is considered.

About Herceptin (trastuzumab)
Herceptin is a humanised monoclonal antibody designed to target and block the function of the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Herceptin binds to a specific section of the HER2 protein, inhibiting the signals it sends that encourage tumour cell growth, while also calling on the body’s immune system to attack the cancer cells.

Since it was first approved in 1998, Herceptin has been used to treat over two million patients worldwide, diagnosed with HER2-positive breast and gastric cancers. It has also become the backbone of other innovative treatments for HER2-positive breast cancer, which have continued to improve the outcomes of patients with this otherwise aggressive disease. In addition to the standard intravenous formulation, Herceptin is available in a subcutaneous (SC) formulation which was first approved in 2013. Herceptin SC represents a significant step forward in the treatment of HER2-positive breast cancer as it offers patients a faster, more convenient and less painful way to receive treatment with Herceptin.