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Turning Point Therapeutics Granted FDA Orphan Drug Designation for TPX-0022 in Gastric Cancer

On June 17, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that TPX-0022, the company’s inhibitor of MET and the associated cancer signaling pathways of SRC and CSF1R, has been granted orphan drug designation by the Food and Drug Administration (FDA) for the treatment of patients with gastric cancer, including gastroesophageal junction adenocarcinoma (Press release, Turning Point Therapeutics, JUN 17, 2021, View Source [SID1234584135]).

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"Aberrant signaling and genomic alterations in MET-driven gastric cancers are associated with a poor prognosis for patients, creating a high unmet need for therapies to target the molecular drivers of the disease," said Mohammad Hirmand, M.D., chief medical officer. "We are pleased to receive this designation for TPX-0022 as we work to develop it as a potentially differentiated option for patients affected by MET-driven gastric cancer."

There are currently no approved MET inhibitors for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma.

TPX-0022 is a potent inhibitor of the MET tyrosine kinase and has the potential to modulate the tumor microenvironment to augment its therapeutic effect. Initial clinical data presented from the ongoing Phase 1 SHIELD-1 study in October 2020 showed TPX-0022 has been generally well-tolerated and demonstrated clinical activity in patients with MET-amplified gastric cancer.

Orphan Drug Designation is granted by the FDA to assist in the development of drug candidates that may offer therapeutic benefits for diseases with a prevalence of fewer than 200,000 patients annually. Benefits of the designation may include the opportunity for accelerated approval, discounts on registration fees, tax credits for qualified clinical trials and eligibility for 7 years of market exclusivity post-regulatory approval.

Agenus Announces U.S. FDA Acceptance and Priority Review of Balstilimab Biologics License Application for the Treatment of Recurrent or Metastatic Cervical Cancer

On June 17, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that the U.S. Food and Drug Administration (FDA) has accepted Agenus’ Biologics License Application (BLA) for balstilimab, an anti-PD-1 antibody, for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy (Press release, Agenus, JUN 17, 2021, View Source [SID1234584134]). The FDA has granted Priority Review to this submission, a designation for drugs which, if approved, may provide significant improvements in the safety or effectiveness of the treatment of serious conditions. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 16, 2021.

About Cervical Cancer
Nearly 14,000 women are expected to be diagnosed with invasive cervical cancer in the United States this year and more than 4,000 are expected to die.1 Cervical cancer remains one of the leading causes of cancer death in women globally, annually killing more than 300,000 women worldwide.2 Despite advances in routine medical examinations and HPV vaccines, cervical cancer remains prevalent. When left undetected, recurrent or metastatic cervical cancer often develops, for which there are limited treatment options and a low chance of survival. Current therapies for recurrent or metastatic cervical cancer are limited to a small subset of patients with limited benefit.

About balstilimab
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Balstilimab is currently in clinical trials as monotherapy and in combination with Agenus’ anti-CTLA-4, zalifrelimab, in an ongoing Phase 2 study for recurrent/metastatic cervical cancer.

Actinium Further Strengthens Patent Portfolio with International IP Covering the Composition and Methods of Administration of Iomab-B Antibody Radiation Conjugate in the EU and Japan

On June 17, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that its intellectual property portfolio around its lead Phase 3 candidate, Iomab-B, has been further strengthened internationally (Press release, Actinium Pharmaceuticals, JUN 17, 2021, View Source [SID1234584133]). In the EU, Actinium has been issued a patent covering the composition and methods administration of Iomab-B, an Antibody Radiation Conjugate (ARC) comprised of apamistamab, a CD45 targeting antibody, and the radioisotope iodine-131. The issued patent in the EU is expected to have a useful life through 2036. In addition, Actinium has been granted a patent covering the same composition and methods of administration claims in Japan.

Dr. Dale Ludwig, Actinium’s Chief Scientific Officer, said, "We are excited to expand our already robust patent portfolio with these key patents in the EU and Japan. As the only CD45 ARC for targeting conditioning in clinical development, these international patents, together with our U.S. patents lay the foundation for aggressive development of Iomab-B for BMT conditioning and Iomab-ACT for conditioning prior to cell and gene therapies. Iomab-B is well characterized and supported by extensive clinical data across multiple clinical trials and indications. Our ARC approach has significant advantages over other approaches such as monoclonal antibodies or antibody drug conjugates that require payload internalization, making them impractical for targeting CD45. We look forward to continuing to build our leadership position in targeted conditioning led by Iomab-B and remaining at the forefront of innovation in targeted radiotherapy."

Actinium owns issued or pending patents within the United States and globally covering composition of matter, formulation, methods of use, and methods of administration with potential coverage for 19 years or longer. Importantly, Actinium owns an issued patent in the US covering composition of matter, for which the Company expects validity until 2037. In addition, the Company owns a second issued US patent that further covers composition of matter, methods of use, and methods of administration for Iomab-B.

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are delighted to now have wholly-owned issued patents in the U.S. and EU and a granted patent in Japan covering the composition and methods of Iomab-B, as these three regions represent an overwhelming majority of the global addressable market for Iomab-B. We have been aggressively building our patent portfolio and it is a major accomplishment to have IP protection on our lead asset into 2036 and 2037. In addition to IP protection, we also have orphan drug designation for Iomab-B in the U.S. and EU, providing potential market exclusivity. As we look to the future, our IP portfolio gives us great confidence in our ability to build the leading, multi-indication strategic business unit for the large and growing targeted conditioning market on a global scale."

Onconova Therapeutics Announces The Peer-Reviewed Publication Of Preclinical Data Demonstrating The Synergistic Anti-Cancer Activity Of Rigosertib Combined With Immune Checkpoint Blockade

On June 17, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported the publication of a preclinical study in the journal Molecular Cancer (Press release, Onconova, JUN 17, 2021, View Source [SID1234584132]). The study, entitled "Novel induction of CD40 expression by tumor cells with RAS/RAF/PI3K pathway inhibition augments response to checkpoint blockade," showed that rigosertib synergistically enhanced the efficacy of ICB in a murine melanoma model via the induction of immune-mediated cancer cell death.

"The data from this recent publication demonstrate rigosertib’s potential to address a pressing unmet need, as many patients do not respond to immune checkpoint blockade due to immunosuppressive tumor microenvironments," said Ann Richmond, Ph.D., Ingram Professor of Pharmacology and Medicine at the Vanderbilt University School of Medicine and lead author of the study. "By reversing immunosuppressive tumor microenvironments, rigosertib overcame pro-tumor resistance mechanisms and synergistically enhanced the efficacy of immune checkpoint blockade in a difficult-to-treat murine melanoma model. These compelling findings provide preclinical proof-of-concept for rigosertib-immune checkpoint blockade combination therapy and strongly support its evaluation in clinical trials."

Key data and conclusions from the recent publication include:

Rigosertib treatment enhanced the activation of anti-cancer immune cells and increased the frequency of these cells in the tumor microenvironment (TME).
Rigosertib treatment reduced the frequency of pro-tumor CD206+ M2-like macrophages in the TME.
Rigosertib monotherapy rapidly reduced PI3K signaling with induction of CD40 expression, leading to melanoma cell death and inhibition of tumor growth in vivo due to its ability to promote the tumor infiltration of activated anti-cancer immune cells.
Rigosertib’s ability to remodel the TME enabled it to synergistically combine with ICB and improve tumor growth inhibition and survival in a mouse model of melanoma that did not respond to ICB alone, or a clinically used combination of ICB plus BRAF and MEK inhibitors.
Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, added, "We are very pleased with these recently published results, which will inform the data driven approach guiding our clinical rigosertib investigator-initiated study program. They provide strong mechanistic support for both the ongoing KRAS mutated non-small cell lung cancer trial of rigosertib in combination with a check point inhibitor and a potential trial in patients with advanced melanoma evaluating a rigosertib-checkpoint inhibitor combination that is under active consideration. Looking ahead, we plan to continue leveraging our collaborations with leading institutions such as Vanderbilt University as we pursue opportunities for rigosertib while maintaining our primary focus and resources on our lead ON 123300 multi-kinase inhibitor program."

Codex DNA Announces Pricing of Initial Public Offering

On June 17, 2021 Codex DNA, Inc. ("Codex DNA"), creators of the BioXp system, a fully automated benchtop instrument that enables numerous synthetic biology workflows, reported the pricing of its initial public offering of 6,666,665 shares of its common stock at a public offering price of $16.00 per share (Press release, Research Corporation Tech, JUN 17, 2021, View Source [SID1234584131]). All of the shares are being offered by Codex DNA. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Codex DNA, are expected to be $106.7 million. The shares are expected to begin trading on the Nasdaq Global Select Market on June 18, 2021, under the ticker symbol "DNAY." The offering is expected to close on June 22, 2021, subject to the satisfaction of customary closing conditions. In addition, Codex DNA has granted the underwriters a 30-day option to purchase up to an additional 999,999 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

Jefferies LLC, Cowen and Company, LLC and KeyBanc Capital Markets Inc. are acting as joint book-running managers for the proposed offering.

A registration statement relating to these securities became effective on June 17, 2021. The offering will be made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by e-mail at [email protected]; or by telephone at (877) 821-7388; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, or by e-mail at [email protected]; or by telephone at (833) 297-2926; KeyBanc Capital Markets Inc., Attention: Equity Syndicate, 127 Public Square, 4th Floor, Cleveland, Ohio 44114, or by telephone at (800) 859-1783. Copies of the final prospectus, when available, related to the offering will be available at www.sec.gov.

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