Astellas and Sutro Biopharma Announce Worldwide Strategic Collaboration to Advance Novel Immunostimulatory Antibody-Drug Conjugates (iADCs)

On June 27, 2022 Astellas Pharma Inc. (TSE: 4503), (President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Sutro Biopharma, Inc. (NASDAQ: STRO), (CEO: William J. Newell, JD, "Sutro") reported a worldwide, strategic collaboration and licensing agreement focused on the discovery and development of novel immunostimulatory antibody-drug conjugates (iADCs) (Press release, Astellas Pharma, JUN 27, 2022, View Source [SID1234616301]). The collaboration leverages the unique cancer-fighting potential of iADCs as a novel modality, enabled by Sutro’s ability to engineer complex conjugated antibodies, and Astellas’ global oncology R&D expertise.

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Astellas is excited to announce a new partnership with Sutro Biopharma, focused on the discovery and development of novel immunostimulatory antibody-drug conjugates (iADCs).
Astellas is excited to announce a new partnership with Sutro Biopharma, focused on the discovery and development of novel immunostimulatory antibody-drug conjugates (iADCs).
"We are delighted to work with Astellas, a premier biopharmaceutical company with substantial expertise in immuno-oncology, on this novel modality," said William J. Newell, Sutro’s Chief Executive Officer. "iADCs hold promise well beyond the existing success of ADCs. Sutro’s unique conjugation technology enables dual conjugations that site-specifically incorporate a potent cytotoxin that can directly kill tumor cells together with an immunostimulatory component that has the potential to locally prime an immune response to the patient’s particular tumor cells. We look forward to collaboratively exploring the potential of this approach to treat cold tumors and bring new drug therapies to patients who do not respond to existing immunotherapies."

Naoki Okamura, Chief Strategy Officer, at Astellas commented, "Astellas considers Immuno-Oncology as one of the Primary Focuses of its R&D strategy; our goal is to bring effective drugs to patients who do not respond to existing immune checkpoint inhibitors. Sutro is a leading company in the area of iADCs, a new modality, and has its own original iADC technologies. The strategic partnership with Sutro will help us expand our pipeline and widen the choice of cancer immunotherapies."

A key challenge with cancer immunotherapies, including immune checkpoint inhibitors, is the tumor microenvironment*1 within cold tumors creating barriers to immune cell infiltration and thus preventing the cure. The immune checkpoint inhibitors approved to date are efficacious as a monotherapy in only about 20% of cancer types, which vary widely1.

This strategic partnership will engage in the development of iADCs, a next generation modality with the potential for effective and efficient approaches for treatment of cold tumors so as to bring new drug therapies to patients who do not respond to existing therapies. An iADC, which combines an antibody with a small molecule compound that induces immunogenic cell death*2 in addition to an immune activating molecule, has the potential to boost the anti-cancer action.

This partnership will enable Astellas and Sutro to mutually leverage strengths in their respective fields to accelerate iADC development for three distinct biological targets; Sutro will engage in research and preclinical studies to identify candidate compounds and then Astellas will pursue clinical development. Sutro has advanced technologies for linking drugs to antibodies and proprietary component parts, including candidate antibodies and linkable cytotoxins and immunostimulatory molecules. For development of iADCs, Astellas will utilize the strength of its global R&D and commercialization capabilities in the area of antibodies and the small molecular components. These iADCs may have the potential to provide new therapeutic options for treatment of cancers for which no broadly effective therapy is currently available.

Under the terms of the agreement, Sutro will receive an upfront cash payment of US$90 million to develop iADCs for three biological targets and may be eligible to receive up to US$422.5 million in development, regulatory and commercial milestones for each product candidate, and tiered royalties ranging from low double-digit to mid-teens on worldwide sales of any commercial products that may result from the collaboration, subject to Sutro’s cost and profit sharing option for the United States.

Sutro has the option to share in the costs and profits for developing and commercializing product candidates in the United States. If Sutro exercise this option for a particular product candidate, Astellas and Sutro will equally share the costs of such co-development and co-commercialization, with the resulting profits/losses from co-commercialization also shared equally in the United States.

*1: Cancer surrounds itself with an environment advantageous to its own survival, that is, to protect itself from the immune system and help facilitate its own growth and metastasis. Such an environment is called a "tumor microenvironment."
*2: Immunogenic cell death is cancer cell death through the "cancer immune cycle" by which cancer antigens released by chemotherapy are captured by dendritic cells and then presented to T cells activated to kill the cancer cells. Regarding "cancer immune cycle," please refer to the materials from Astellas’ R&D meeting (held in December 2020).
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Sanofi Enters into a Partnering Agreement with Health2Sync

On June 27, 2022 Sanofi K.K. (Head office: Shinjuku-ku, Tokyo; President: Takahiko Iwaya; hereinafter "Sanofi") and Health2Sync. (Head office: Taito-ku, Tokyo; CEO: Ed Deng) reported that they have entered into a partnering agreement to support healthcare professionals and people living with diabetes mellitus through digital support programs (Press release, Sanofi, JUN 27, 2022, View Source [SID1234616300]).

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Health2Sync, a digital health startup, specializing in diabetes and other chronic disease management, has developed a healthcare/lifestyle app that has been used by about 290,000 users in Japan. Recently the mean HbA1c level has tended to increase among people living with diabetes mellitus.[i] Patients are receiving an average of 14.8 units of baseline insulin and have an HbA1c of 7.8%, which indicates that the basal insulin dose may be further optimized if an appropriate approach is taken.[ii]

It is not easy for people living with diabetes to continue recording their blood glucose levels to achieve their treatment goals. One of the challenges is that the environment to help them sufficiently control the disease is not fully fostered. Through this partnering agreement, Sanofi and Health2Sync will work together to develop digitized features for healthcare providers and patients on insulin in Japan that will help improve Hypoglycemia/Hyperglycemia insulin management by connected caps for insulin, and titration alerts, to people living with diabetes.

The two companies initiated their collaboration in Taiwan in September 2020 by providing digital health solutions to HCPs and patients and have witnessed a good adoption within more than 200 clinics and more than 10,000 insulin patients having already joined the program as of May 2022.

On this initial traction, Sanofi and Health2Sync announced last year that they will further develop an automated digital insulin management solution with titration algorithms to further enhance the efficiency of insulin treatment. The two companies are collaborating to generate studies on the therapeutic effects of the digital solution.

This agreement in Japan again emphasizes the companies’ ambition to realize a more comprehensive chronic disease management through digital solutions.

Moving forward, Sanofi and Health2Sync plan to further collaborate in bringing innovative digital therapeutics solutions to patients and healthcare professionals in Japan and other markets.

Dxcover Publishes Research Highlighting Effective Early Detection of Pancreatic Cancer Using Infrared Spectroscopy

On June 27, 2022 Dxcover Limited, a clinical stage diagnostics company developing spectroscopic liquid biopsy technology for early detection of multiple cancers, reported findings from a new study that shows how Dxcover’s infrared platform detects a solid and clear distinction between cancer and control samples when detecting early stage pancreatic cancer, suggesting a great potential for clinical implementation (Press release, Dxcover, JUN 27, 2022, View Source [SID1234616299]). The data has been published in Cancers. Pancreatic cancer is the seventh leading cause of cancer death and claims more than 460,000 lives per year. It is one of the hardest diseases to detect due to the lack of early symptomatic evidence and fast, simple, and non-invasive diagnostic tests. The carbohydrate antigen (CA) 19-9 test is the blood test used for pancreatic cancer’s detection, but its levels can be raised in symptomatic patients with other non-malignant diseases, or with other tumors in the surrounding area.

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Dxcover’s proof-of-concept study, investigating the use of attenuated total reflection Fourier-transform infrared (ATR-FTIR) spectroscopy on dried blood serum, focused on the discrimination of both cancer versus asymptomatic (healthy) control samples, and cancer versus symptomatic non-malignant control samples, as a novel liquid biopsy approach for pancreatic cancer diagnosis.

Machine learning algorithms were applied, achieving results of 92% sensitivity and 88% specificity when discriminating between cancers (n = 100) and asymptomatic (healthy) controls (n = 100). An area under the curve (AUC) of 0.95 was obtained through receiver operating characteristic (ROC) analysis. In addition, the test identified cancerous patients among a challenging symptomatic cohort to an AUC of 0.83.

"To our knowledge, this is the largest and most promising proof-of-concept study to date for clinical use of ATR-FTIR spectroscopy in the detection of early and advanced stages of pancreatic cancer. The use of our technology can save over $12 million in health care resources per 5000 cancers detected as well rapidly speed up the process for patients to get the required treatment sooner," said Dr. Matthew Baker, Chief Technology Officer and co-founder, Dxcover.

Kovina Therapeutics Receives National Cancer Institute Grant to Advance Human Papillomavirus Cancer Treatment

On June 27, 2022 Kovina Therapeutics Inc. reported receipt of a Fast-Track Small Business Technology Transfer (STTR) grant from the National Cancer Institute/NIH (Press release, Kovina Therapeutics, JUN 27, 2022, View Source [SID1234616298]). With successful achievement of its milestones, the award will transition to a Small Business Innovation Research (SBIR) award and will provide approximately $2,400,000 over three years.

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"We are excited to receive NCI funding to support Kovina’s development of therapeutic treatments for Human Papillomavirus (HPV) related cancers," said Kristin Sherman, CEO of Kovina Therapeutics. "HPV causes nearly all cervical and many oropharyngeal, anal, and genital cancers. Kovina is focused on developing expanded treatment options for patients afflicted with these malignancies."

"We are pleased Kovina’s research proposal successfully competed in NCI’s rigorous merit-based review process," said Dr. Elliot Androphy, CSO of Kovina Therapeutics. Kovina’s technology specifically targets a key HPV protein expressed in early, pre-malignant and cancerous pathologies. By inactivating this protein, Kovina’s compounds result in the selective death of HPV infected cells. "Our therapeutics are designed to stop HPV infections before cancer develops and to treat HPV related cancers after detection."

BWXT Medical Executes Commercial Agreement with Bayer for Supply of Actinium-225 Based Products

On June 27, 2022 BWX Technologies, Inc. (NYSE: BWXT) reported that subsidiary BWXT Medical Ltd. has executed a commercial agreement with Bayer AG (Bayer) to supply high-purity Actinium-225 (Ac-225) (Press release, Bayer, JUN 27, 2022, View Source [SID1234616297]).

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Today’s announcement follows the agreement reached by the two companies in September 2021. Under the terms of the commercial agreement, Bayer will purchase high-purity Ac-225 from BWXT Medical at pre-determined prices. The parties expect supply to commence later this year.

Ac-225 is a highly powerful radioisotope used in targeted alpha therapies (TATs). This emerging field combines Ac-225 with specific tumor-seeking targeting moieties, which deliver alpha radiation directly to tumors.

BWXT Medical is a global supplier of medical isotopes and radiopharmaceuticals. Bayer is a global enterprise with core competencies in the life science fields of healthcare and nutrition.

"We are very pleased to enter into this agreement with Bayer, one of the global leaders in the rapidly emerging field of targeted radionuclide therapies," said Martyn Coombs, president of BWXT Medical. "Targeted radionuclide therapies are developed to improve outcomes for patients with different types of cancers. We will leverage our nuclear medicine strengths to collaborate with Bayer over the long term."