Kymab presents data on two of its immuno-oncology antibodies, providing further evidence of the strength of its franchise

On April 18, 2018 Kymab Group Limited ("Kymab"), a biopharmaceutical company developing fully human monoclonal antibody therapeutics, reported data on KY1044 (a novel anti-ICOS antibody) and KY1055 (a novel ICOS/PD-L1 bispecific antibody), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual meeting held April 14-18, 2018 in Chicago, Illinois, USA (Press release, Kymab, APR 18, 2018, View Source [SID1234537006]).

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The AACR (Free AACR Whitepaper) Annual Meeting covers the latest basic, translational, clinical, and prevention-focused research in the field, including important areas such as early detection, cancer interception, and survivorship in all populations.

Notes to Editors
About Kymab’s AACR (Free AACR Whitepaper) Posters
KY1044 poster

Title: The combination of immune checkpoint blockers with the anti-ICOS KY1044 antibody results in a strong tumour response (#2792)

Session Title: Therapeutic Antibodies, Including Engineered Antibodies 2

Session Date and Time: Monday Apr 16, 2018 1:00 PM – 5:00 PM

Link to the Poster (1.4 Mb PDF)

KY1055 poster

Title: KY1055, a novel ICOS/PD-L1 bispecific antibody, efficiently enhances T cell activation and delivers a potent anti-tumour response in vivo. (#LB-153)

Session Title: Late-Breaking Research: Clinical Research 1

Session Date and Time: Monday Apr 16, 2018 1:00 PM – 5:00 PM

Calithera Biosciences Announces FDA Fast Track Designation Granted to CB-839 in Combination with Cabozantinib for Treatment of Patients with Advanced Renal Cell Carcinoma

On April 18, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CB-839 in combination with cabozantinib for the treatment of patients with metastatic renal cell carcinoma who have received one or two prior lines of therapy, including at least one vascular endothelial growth factor tyrosine kinase inhibitor or the combination of nivolumab and ipilimumab (Press release, Calithera Biosciences, APR 18, 2018, View Source [SID1234535241]). CB-839 is a first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in the CANTATA trial. The trial is a randomized double-blind clinical study of cabozantinib in combination with CB-839 or placebo in 298 patients with clear cell renal cell carcinoma. The primary endpoint is progression free survival and the global study is open for enrollment.

"Despite a number of new therapies for the treatment of renal cell carcinoma, there remains a significant unmet need among advanced patients who have received prior treatment," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We are pleased that CB-839 has been granted Fast Track designation, demonstrating the FDA’s commitment to facilitate the development and expedite the review of our glutaminase inhibitor as an important new therapy for patients with advanced or metastatic renal cell carcinoma who have failed prior systemic therapy."

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The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics, to treat serious or life threatening conditions, and to fill an unmet medical need. Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available. 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.

Some Fun Facts about AACR 2018

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Grid Therapeutics Closes Series B Financing

On April 18, 2018 Grid Therapeutics, LLC, a biotechnology company developing a first-in-class, novel human-derived targeted immunotherapy for cancer, reported the closing of its Series B financing (Press release, Grid Therapeutics, APR 18, 2018, View Source [SID1234526796]). Grid will use the proceeds from the financing to accelerate and expand the development of Grid’s lead therapeutic candidate, GT103, for the treatment of solid tumors, and to prepare for clinical trials in cancer patients scheduled to commence in early 2019. Grid’s foundation is the innovative science developed by Edward F. Patz, Jr., MD, and his team of scientists at Duke University Medical Center.

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Grid’s Series B financing was led by Milestone Holdings, a California-based venture company boasting a strong history of identifying and funding companies developing disruptive technologies with revolutionary intellectual property, Paul Funk, a veteran software entrepreneur and founder of Funk Software, and Jeffery "TJ" Heyman, Founder and Chief Investment Officer of Woodbourne Capital Management International.

Grid’s unique platform is based upon a groundbreaking approach of identifying specific tumor immunoglobulin G (IgG) antibodies from cancer patients with exceptional outcomes. Grid’s unique strategy obtained the sequence and isolated its lead IgG3 antibody directly from cancer patients’ single B cells, which will modulate the immune system to kill tumors without known side effects.

"Grid Therapeutics is very excited to welcome our new investors, all of whom bring a rich history of innovation and thought leadership. With this new round of capital, we are well positioned to accelerate the development and advancement of our novel antibody into the clinic," commented Dr. Patz, CEO of Grid.

MorphoSys Announces Pricing of Initial Public Offering of American Depositary Shares (ADSs) on Nasdaq

On APril 18, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported the pricing of its initial public offering (IPO) in the United States. The offering produced gross proceeds of USD 207,832,000 from the sale of 2,075,000 new ordinary shares in the form of 8,300,000 American Depositary Shares ("ADSs") at a price of USD 25.04 per ADS. Each ADS will represent 1/4 of a MorphoSys ordinary share (Press release, MorphoSys, APR 18, 2018, View Source [SID1234525575]).

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Furthermore, MorphoSys has granted the underwriters an option to purchase up to 1,245,000 additional ADSs, representing 15% of the total number of ADSs placed in the offering. This option can be exercised during the 30-day period commencing April 18, 2018.

The new ordinary shares underlying the ADSs and, if the option will be exercised, the additional ADSs will be issued from MorphoSys’s authorized capital 2017-II, excluding pre-emptive rights of existing shareholders and representing up to 8.1% (including the underwriters’ option to purchase additional ADSs) of the registered share capital of MorphoSys prior to the consummation of the offering.

MorphoSys’s ordinary shares are listed on the Frankfurt Stock Exchange under the symbol "MOR".

The ADSs are expected to begin trading on the Nasdaq Global Market on April 19, 2018, under the symbol "MOR".

The closing of the offering is expected to occur on April 23, 2018, subject to customary closing conditions.

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Leerink Partners LLC, are acting as lead book-running managers, and Berenberg Capital Markets, LLC and JMP Securities LLC are acting as co-managers for the ADS offering.

A Registration Statement relating to these securities has been declared effective by the U.S. Securities and Exchange Commission on April 18, 2018.

Within the United States of America, the securities referred to in this release are offered only by means of a prospectus. A copy of the prospectus can be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or by e-mailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by e-mailing [email protected].