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.

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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.

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].

On April 18, 2018 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported two posters highlighting data from pelareorep studies presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018. The conference takes place April 14-18, 2018, in Chicago (Press release, Oncolytics Biotech, 18 18, 2018, View Source [SID1234525555]).

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"These posters add additional confirmation of pelareorep’s promotion of an inflammatory signature in different cell lines," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "The study by doctor Wilkinson demonstrates that pelareorep can establish an inflamed tumor phenotype and the presentation by doctor Goel highlights the synergistic combination of pelareorep and an anti-PD1 agent. Taken together, these findings highlight that pelareorep is priming the immune system and enhancing the activity of checkpoint blockade. As MSS CRC typically does not respond to checkpoint blockade, viral priming could expand the use of this drug class by making non-susceptible tissue susceptible by turning cold tumors hot. This work will of course lead to additional studies in combination with other immunotherapies."

Presenter: Sanjay Goel, MD, Associate Professor of Medicine, Montefiore Medical Center
Presentation Title: Potentiating effect of reovirus in anti-PD1 therapy in colorectal cancer
Session Title: Receptor Targeting and the Tumor Microenvironment
Location: Poster Section 38
Poster Board #: 17
Poster Number: 3917

Data presented in the poster demonstrated:

pelareorep administration increased PD-L1 expression on MSS CRC cells;

possible evidence of a vaccine effect: immunologically competent mice were re-challenged with the original tumor and the tumor was unable to propagate;

combination therapy made statistically significant improvements in survival compared to controls in both BALB/c (median 42 vs. 16 days, p=0.003) and C57BL/6 (median 24 vs. 17 days, p=0.02) mice; and

pelareorep treated xenografted tumor tissue showed a higher infiltration of T lymphocytes as confirmed by CD8-positive and intensified granzyme staining.

Presenter: Grey Wilkinson, PhD, Translational Scientist, Oncolytics Biotech
Presentation Title:
Pelareorep promotes the expression of a chemokine signature that predicts response to immunotherapy
Session Title: Immunomodulatory Agents and Interventions 2
Location: Poster Section 33
Poster Board #: 10
Poster Number: 4707

Data presented in the poster demonstrated:

the expression of a chemokine signature that predicts response to immunotherapy;

global changes in gene expression are unique and different for each cell line following pelareorep infection and changes in gene expression occur before significant cell lysis;

pelareorep differentially promotes the expression of innate and adaptive immunity related genes in HCC, CRC, NSCLC cell lines; and

pelareorep promotes the expression of gene signatures that predict response to immuno-therapies in HCC cells.

These posters are now available on the Posters & Publications page of the company’s website: www.oncolyticsbiotech.com/technology/posters-publications.

About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.