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Rakuten Medical and Shimadzu Corporation announce a joint development and commercialization agreement on a medical device to be used with the Illuminox™ platform

On June 17, 2021 Rakuten Medical, Inc. (HQ: San Mateo, Calif.; Chairman and CEO: Hiroshi Mikitani; hereinafter "Rakuten Medical") and Shimadzu Corporation (HQ: Kyoto, Japan; President and CEO: Teruhisa Ueda; hereinafter "Shimadzu") reported a joint development and commercialization agreement to advance a medical device for use on the Illuminox platform (Press release, Rakuten Medical, JUN 17, 2021, View Source [SID1234584143]). This partnership will allow for the development of a medical device using optical measurement technologies to support cancer treatment by photoimmunotherapy.

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Therapies developed on the Illuminox platform involve administering a targeting moiety conjugated with one or more dyes, which is illuminated by light at a specific wavelength. Light illumination of the targeted cells transiently excites the drug, and pre-clinical data have shown this excitation elicits rapid and selective necrosis of targeted cells through a biophysical process.

Based on this agreement, both companies will use their expertise to work toward the joint development of technology that will allow visualization, measurement, and recording of the reaction of the dye to light illumination in real-time. This will allow for optimization of light irradiation depending on the tumor. Both companies will cooperate to aim for commercialization of the medical device using the technology on a worldwide basis.

Rakuten Medical is developing therapies on its Illuminox platform, an investigational treatment platform based on a cancer therapy called photoimmunotherapy developed by Dr. Kobayashi and team from the National Cancer Institute in the United States. In September 2020, Rakuten Medical announced that its wholly owned subsidiary Rakuten Medical Japan K.K. received conditional marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 Photoimmunotherapy and a laser light device to treat unresectable locally advanced or recurrent head and neck cancer, and began commercialization in January 2021. Shimadzu is focusing on creating innovative products and services, which combine analytical measurements with diagnostic imaging in the healthcare field. Utilizing its measurement technologies, Shimadzu has worked with cancer institutes in both USA and Japan for the development of photoimmunotherapy at the pre-clinical stage.

AbbVie Declares Quarterly Dividend

On June 17, 2021 The board of directors of AbbVie Inc. (NYSE: ABBV) reported a quarterly cash dividend of $1.30 per share (Press release, AbbVie, JUN 17, 2021, View Source [SID1234584137]).

The cash dividend is payable August 16, 2021 to stockholders of record at the close of business on July 15, 2021.

Since the company’s inception in 2013, AbbVie has increased its dividend by 225 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

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]).

"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."