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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]).

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].

Oncolytics Biotech® Demonstrates Positive Data in Two Posters
at AACR Annual Meeting 2018

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]).

"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.

OBI Pharma Announces FDA Clearance of OBI-3424 IND Application for A Phase I/II Study Targeting AKR1C3 Solid Tumors

On April 18, 2018 OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), reported that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase I/II study of OBI-3424, a first-in-class DNA alkylating agent that targets cancers that overexpress the aldo-keto reductase 1C3 (AKR1C3) enzyme (Press release, OBI Pharma, APR 18, 2018, View Source [SID1234525525]).

OBI plans to enroll patients with local solid tumors, including hepatocellular carcinoma (HCC) and castrate-resistant prostate cancer (CRPC). OBI Pharma’s Chief Medical Advisor, Tillman Pearce, M.D., noted, "This clinical trial intends to verify the safety and preliminary activity profile of OBI-3424, a novel first-in-class prodrug of a DNA alkylating cancer therapeutic that is selectively activated by AKR1C3, an enzyme that is overexpressed in a variety of solid and liquid tumors. We are delighted to conduct this first-in-man clinical trial at the University of Texas M.D. Anderson Cancer Center and The James Cancer Hospital and Solove Research Institute of Ohio State University, two of America’s leading academic oncology research institutions".

Amy Huang, General Manager of OBI Pharma, added, "OBI Pharma is proud to further develop our unique targeted cancer pipeline, including targets like the Globo series and AKR1C3. OBI-3424 enhances OBI’s pipeline in solid and liquid tumors for cancer patients who over-express AKR1C3. OBI is taking a first-step towards testing the safety and initial efficacy of a new class of AKR1C3 targeted therapy. We are excited to develop novel targeted therapeutics in the fight against cancers of unmet need."

About OBI-3424

OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.

AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including: hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and T-cell acute lymphoblastic leukemia (T-ALL). AKR1C3 is highly expressed in up to 15 solid and liquid tumors.

Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed based on tumor biopsies or circulating tumor cells to identify patients with other tumor types most likely to respond to treatment with OBI-3424, and thus offering the possibility for a streamlined clinical development strategy.

OBI Pharma holds worldwide rights for OBI-3424 with the exception of the following countries, whose rights are held by Ascenta Pharma: China, Hong Kong, Macao, Taiwan, Japan, South Korea, Singapore, Malaysia, Thailand, Turkey, and India.

Pre-Clinical Data Demonstrating Promising Potential of Prexigebersen as Treatment for Solid Tumors in Gynecologic Malignancies Presented at American Association for Cancer Research Annual Meeting

On April 18, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that data from pre-clinical studies supporting the potential of prexigebersen (BP1001, liposomal Grb2 antisense), in the treatment of solid tumors in gynecologic malignancies were presented in a poster at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), which took place in Chicago, IL (Press release, Bio-Path Holdings, APR 18, 2018, View Source [SID1234525522]).

The poster titled, "Grabbing GRB2: The use of Liposome-incorporated Grb2 antisense oligonucleotides as a novel therapy in gynecologic malignancies," was presented by Olivia D. Lara, M.D., University of Texas MD Anderson Cancer Center, Department of Gynecologic Oncology during the Experimental and Molecular Therapeutics Poster Session. The data summarize results from studies investigating the expression of GRB2 in a series of in vitro experiments in high-grade serous (HGSC) and uterine (UC) carcinoma models. The study also examined the biological effects of prexigebersen in HGSC mice models (OVCAR 5), first in a dose-defining experiment then in combination with standard dose paclitaxel.

The data showed there was an eighty-six percent (86%) decrease in tumor burden (p<0.05), and multinodular burden (p<0.01) in the combination prexigebersen/paclitaxel group compared to control. In addition, there was no apparent toxicity with mice on combination therapy losing less weight than the paclitaxel-only group (P = 0.005).

"We are delighted to present these very encouraging findings at this year’s AACR (Free AACR Whitepaper) before an audience of the world’s leading cancer researchers and clinicians," stated Peter H. Nielsen, chief executive officer of Bio-Path Holdings. "Our research continues to suggest that prexigebersen-based combination therapy may offer an attractive method for targeting solid tumors and these findings establish the GRB2/GAB2 complex as an important target for prexigebersen. We look forward to advancing this promising therapy in gynecologic and other solid tumor cancers and plan to initiate first-in-human studies as early as the end of this year.