Grid Therapeutics Announces Enrollment of First Patient in Phase 1 Study of GT103 in Refractory NSCLC Patients

On June 24, 2020 Grid Therapeutics, LLC, a clinical stage biotechnology company developing a first-in-class, novel, human-derived targeted immunotherapy for solid tumors, reported that the first patient has been dosed in a Phase 1/2 study of GT103 in patients with refractory NSCLC (Press release, Grid Therapeutics, JUN 24, 2020, View Source [SID1234561447]). The study is initially being conducted at the Duke University Medical Center.

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"Today’s announcement marks the first time a therapeutic antibody derived from single B cells of cancer patients, and the first IgG3 subclass, has advanced to the clinic," said Dr. Edward Patz Jr., M.D., Chief Executive Officer of Grid, and the James and Alice Chen Professor of Radiology, Professor in Pharmacology and Cancer Biology at Duke University School of Medicine. "Initiation of this study is a significant milestone for Grid, as we believe our unique strategy will transform cancer therapy."

The Phase 1 segment of this trial will generate important data about the safety and tolerability of GT103, which targets complement factor H, a protein that protects tumor cells from complement lysis. The Phase 2 segment will be performed in combination with a checkpoint inhibitor, as recent pre-clinical data shows GT103 modulates the adaptive immune response and may potentiate current immune-oncology therapy.

Paolo Paoletti, Grid Board member and Chief Executive Officer of GammaDelta Therapeutics, stated, "This is an exciting and pioneering approach to a highly prevalent and intractable cancer, which currently has a very poor prognosis despite best available treatments."

This trial is also designed to validate Grid’s innovative platform for the rapid development of additional therapeutic antibodies for the treatment of multiple forms of cancer.

About the Study

The Phase 1 open-label, dose-escalation clinical trial of GT103 is designed to assess the safety and tolerability of GT103 as a single agent. The study will enroll subjects with refractory NSCLC. Key objectives in the study include determining the recommended Phase 2 dose, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity. An expansion cohort and combination study with checkpoint inhibitors is planned to rapidly follow. Please refer to www.clinialtrials.gov for additional clinical trial details.

Celsion Corporation Announces Closing of Public Offering of Common Stock

On June 24, 2020 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported the closing of its previously announced public offering of 2,666,667 shares of common stock, resulting in net proceeds of $9.3 million, after deducting underwriting discounts and commissions but before expenses payable by the Company (Press release, Celsion, JUN 24, 2020, View Source [SID1234561446]).

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Oppenheimer & Co. Inc. acted as the sole underwriter for the offering.

Celsion intends to use the net proceeds for clinical development of our product candidates, working capital and other general corporate purposes.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-227236), previously filed with the Securities and Exchange Commission (SEC) on September 7, 2018 and declared effective on October 12, 2018. The offering of the shares of common stock were made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering are filed with the SEC, and are available on the SEC’s website at View Source or by contacting Oppenheimer & Co. Inc. at 85 Broad Street, 26th Floor, New York, NY 10004, Attention: Equity Syndicate Prospectus Department, by e-mail at [email protected] or by calling (212) 667-8055.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

NantKwest Announces Proposed Public Offering of Common Stock

On June 24, 2020 NantKwest, Inc. (Nasdaq: NK), a clinical-stage, natural killer cell-based therapeutics company, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, NantKwest, JUN 24, 2020, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-announces-proposed-public-offering-common-stock [SID1234561445]). In addition, NantKwest expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the offering. NantKwest intends to use the net proceeds of the offering for clinical development, manufacturing, upgrades to its facilities and equipment, and other working capital, capital expenditures and for general corporate purposes. All of the shares are being offered by NantKwest. There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Piper Sandler & Co. is acting as the sole bookrunning manager for the offering. LifeSci Capital is acting as co-manager for the offering.

A shelf registration statement on Form S-3 relating to the common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on August 23, 2019 and declared effective by the SEC on September 3, 2019. The proposed offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may also be obtained from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, via telephone at (800) 747-3924 or via email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Reata Pharmaceuticals, Inc. Closes $350 Million Strategic Investment From Blackstone Life Sciences

On June 24, 2020 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata" or the "Company"), a clinical-stage biopharmaceutical company, reported the receipt of $350 million related to the closing of its previously announced strategic investment from funds managed by Blackstone Life Sciences (Press release, Reata Pharmaceuticals, JUN 24, 2020, View Source [SID1234561444]). This financing includes $300 million in return for single-digit royalty payments on worldwide net sales of bardoxolone methyl ("bardoxolone") by Reata and its licensees, other than Kyowa Kirin Co., Ltd., and a $50 million investment in 340,793 shares of Reata’s Class A common stock at $146.72 per share.

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DelMar Pharmaceuticals Receives $500,000 Loan from the National Brain Tumor Society and National Foundation for Cancer Research to Support VAL-083’s Participation in a Pivotal Study for Glioblastoma Sponsored by the Global Coalition for Adaptive Research

On June 24, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies reported it has received a $500,000 loan from the National Brain Tumor Society (NBTS) and the National Foundation for Cancer Research (NFCR) to support VAL-083’s preparation for participation in the Global Coalition for Adaptive Research’s (GCAR) sponsored trial, Glioblastoma (GBM) Adaptive Global Innovative Learning Environment (GBM AGILE) study (Press release, DelMar Pharmaceuticals, JUN 24, 2020, View Source [SID1234561442]). On June 4, 2020, the Company announced that VAL-083, its "first-in-class," small-molecule chemotherapeutic with a novel mechanism of action, was selected by GCAR as the third investigational therapy to participate in GBM AGILE, in which the compounds will be simultaneously evaluated across multiple international trial sites of which 25 are currently activated. DelMar intends to utilize GBM AGILE, which is an adaptive registration clinical trial, to serve as the basis for VAL-083’s new drug application submission and registration.

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"It means a great deal to all of us involved with VAL-083’s development to receive support from the National Brain Tumor Society and the National Foundation for Cancer Research as these organizations are two of the leading advocacy and funding partners for GBM AGILE," commented Saiid Zarrabian, Chief Executive Officer of DelMar Pharmaceuticals. "This funding is an important milestone as it enables us to accelerate VAL-083’s participation in GBM AGILE, which is expected to reduce VAL-083’s pivotal trial completion and regulatory submission timeline by up to 18 months."

GBM AGILE is an international effort in newly diagnosed and recurrent GBM, utilizing an FDA approved master protocol to evaluate multiple therapies against a common control arm. As an approved registrational study, positive results from the VAL-083 arm of GBM AGILE are expected to be utilized to file for FDA approval. This study employs a cost-efficient, seamless phase 2/3 adaptive trial design with a Stage 1 learning and adapting phase and a Stage 2 expansion and confirmation phase. The effort is led by top-tier key opinion leaders in the GBM field and has the collective support of an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, leaders from government and industry, and patient advocates. GCAR, a 501(c)(3) organization, is the international trial sponsor, and provides financial support for the program infrastructure, as well as trial oversight and management. Comprised of the world’s foremost clinical, translational, and basic science investigators, GCAR strives to support the development of novel treatments to fight against rare and deadly diseases like GBM where patient prognosis is poor and treatment options are limited.

"We are supporting the inclusion of VAL-083 in the GBM AGILE adaptive clinical trial platform as it is consistent with our mission to support research for, and ultimately enable delivery of, effective treatments to patients with brain tumors. We are particularly pleased to lend our support to VAL-083 given the significant unmet medical need that exists for patients with GBM," commented David Arons, Chief Executive Officer of the National Brain Tumor Society.

Sujuan Ba, President & Chief Executive Officer of the National Foundation for Cancer Research added, "We are dedicated to facilitating the development of therapies for all cancers, and are pleased to lend our support to VAL-083’s participation in GBM AGILE. We are very hopeful that the knowledge established from VAL-083 in GBM AGILE can be insightful for other cancers – giving patients hope for treatments that are best suited for their care."

"We are delighted to help bring together our key strategic partners, NBTS, NFCR, and DelMar Pharmaceuticals," shared Faramarz Yousefzadeh, GCAR Board Chairman. "We believe this is a model for collaboration – aiding small pharma to test promising new drugs in GBM AGILE."

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

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