On December 27, 2021 WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, and ImmuneOncia Therapeutics, Inc., a clinical-stage, immuno-oncology company in South Korea, reported that a Memorandum of Understanding (MOU) was signed to form a strategic partnership in the development and manufacturing of IOH-001, ImmuneOncia’s therapeutic bispecific antibody targeting PD-L1 and CD47 (Press release, WuXi Biologics, DEC 27, 2021, View Source [SID1234597772]).

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Within the partnership, ImmuneOncia will have access to WuXi Biologics’ integrated services in cell line development, cell culture development, biologics manufacturing and bioassay development. WuXi Biologics will support ImmuneOncia on the whole CMC studies of IOH-001 for Investigational New Drug (IND) application.

Heung Tae Kim, CEO of ImmuneOncia, commented, "We are excited to collaborate with WuXi Biologics. WuXi Biologics’ comprehensive capabilities on bispecifics development and manufacturing will enable us to focus on realizing the therapeutic potential of IOH-001. More importantly, access to WuXi Biologics’ world-leading technologies will help ensuring its efficacious and sustainable development. We look forward to expanding collaboration in the future to bring more innovative biologics for patients in South Korea. "

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are glad to partner with ImmuneOncia to proceed its first bispecific antibody into clinical development through our integrated services and know-how. At WuXi Biologics, we have demonstrated our extensive capabilities for CMC development, analytical method, and quality control by enabling over 60 bispecific projects. We are committed to providing innovative technical solutions, reliable and sustainable manufacturing supply chain for our global partners to benefit patients worldwide."

On December 27, 2021 Regor Therapeutics, a clinical-stage biotech company, reported that authorization from the US Food and Drug Administration (FDA) to proceed with Regor’s Phase 1 clinical development plans for RGT-419B (Press release, Regor Therapeutics, DEC 27, 2021, View Source [SID1234597771]).

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RGT-419B is a new generation CDK2/4/6, small molecule inhibitor with an optimized kinase activity spectrum. It is expected to improve the safety of and combat the resistance to currently approved CDK4/6 inhibitors that are given in combination with endocrine-based therapy for treatment of pre/perimenopausal or postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer.

In cell model experiments, RGT-419B has demonstrated single agent activity with greater suppression of ER+ tumor cell growth when compared to abemaciclib and palbociclib. In ER+ breast cancer cells with acquired resistance to currently approved CDK4/6 inhibitors, RGT-419B has demonstrated full suppression of cancer cell proliferation. In these experiments, RGT-419B’s tumor cell suppression was further augmented when combined with a selective estrogen receptor degrader or a PI3K signaling pathway inhibitor.

As a single agent and in combination with other approved therapies, RGT-419B will initially be developed for the treatment of patients with HER2-, ER+ breast cancer who have primary or acquired resistance to currently approved CDK4/6 inhibitors. As CDK4/6 inhibitors are widely adopted in clinical practice, refractory and relapsed patients previously treated by CDK4/6 inhibitors are becoming a greater and clinically significant unmet medical need. RGT-419B’s clinical development programs will address this resistance to CDK4/6 and other hormone receptor modulation therapy, providing a new opportunity to improve the survival and quality of life in breast cancer patients with advanced disease.

RGT-419B is the first of many innovative oncology drugs being developed by Regor. Dr. Xiayang Qiu, Founder and CEO of Regor Therapeutics, said, "This milestone marks Regor’s success in entering into the area of oncology therapeutics. Achieving an optimal selectivity profile against several CDKs by leveraging Regor’s proprietary CARD platform, this innovative drug is entering clinical stage development in the U.S. We are excited by this opportunity to bring new and differentiated treatment options to the many patients suffering from breast cancer worldwide.

About breast cancer

HER2-, HR+ breast cancer is the most common type of breast cancer. Globally, breast cancer is one of the most common cancers affecting approximately 2.3 million women in 2020 and is the leading cause of death due to cancer in women. In China breast cancer ranks 4th amongst solid tumor types with over 400,000 new cases annually. Breast cancer poses a tremendous healthcare burden in China and across the world as well as having a significant negative impact on patients and their families.

On December 27, 2021 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Grand Pharmaceutical Group Limited (GP) a diversified global pharmaceutical company listed in Hong Kong, reported that they have entered into an exclusive licensing agreement for GP to develop, manufacture and commercialize ITM’s oncological radiopharmaceutical candidates, ITM-11 (n.c.a. 177Lu-edotreotide) and ITM-41 (n.c.a. 177Lu-zoledronate) as well as the diagnostic TOCscan (68Ga-edotreotide) in the territory of mainland China, Hong Kong, Macau and Taiwan (Press release, ITM Isotopen Technologien Munchen, DEC 27, 2021, View Source [SID1234597770]).

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Under the terms of the agreement, ITM grants GP an exclusive license for the named products in the licensed territory and will support the supply of the pharmaceutical materials needed to conduct clinical and commercial activities. GP will be responsible for clinical development, regulatory activities and commercialization of these products in the licensed geographies. ITM is eligible for a significant upfront payment as well as potential aggregate regulatory and commercial milestone payments totalling up to approximately EUR 520 million in addition to tiered royalties.

"In line with our isotope production collaboration with CIRC and the formation of our Shanghai subsidiary (WFOE) in 2021, ITM continues to strengthen its global footprint in Asian regions. This agreement with GP creates a strong partnership that supports the development and future commercial launch of our targeted radiopharmaceutical products with a recognized leader in Asia," commented Steffen Schuster, Chief Executive Officer of ITM. "We look forward to working with GP to develop and provide our radiopharmaceuticals in a region with a growing patient population in need of precision oncology treatments."

"We value our strategic partnership with ITM as we focus on bringing improved precision oncology treatments to Greater China," said Frank Zhou, Chief Executive Officer of GP. "By combining our resources, expertise and patient-centric approach we are confident in our ability to develop, distribute and commercialize innovative and high quality radiopharmaceutical products."

ITM-11 (n.c.a. 177Lu-edotreotide) is ITM’s most advanced Targeted Radionuclide Therapy being developed for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and is currently undergoing two phase III clinical trials, COMPETE for patients with grade 1 and grade 2 GEP-NETs and COMPOSE for grade 2 and grade 3 GEP-NETs. ITM-11 has already demonstrated a favorable safety and efficacy profile in phase II clinical evaluation in GEP-NET patients. ITM-41 (n.c.a. 177Lu-zoledronate) is in preclinical development for in the treatment of osteosarcoma and bone metastases. TOCscan (68Ga-edotreotide) is ITM’s radiopharmaceutical for the diagnosis and staging of neuroendocrine tumors (NETs).

About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific entities such as receptors which are expressed on the cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization potentially enables targeted treatment with minimal impact to healthy surrounding tissue.

About ITM-11 (n.c.a. 177Lu-edotreotide)

ITM-11 (n.c.a. 177Lu-edotreotide) is ITM’s therapeutic radiopharmaceutical candidate being investigated in the phase III clinical trials COMPETE and COMPOSE. ITM-11 consists of the medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu) linked to the targeting molecule edotreotide, a synthetic form of the peptide hormone somatostatin that targets receptors that are highly expressed by the tumor. ITM-11 is internalized into the tumor cells and decays, releasing medical radiation (ionizing β-radiation) destroying tumor tissue.

About ITM-41 (n.c.a. 177Lu-zoledronate)

ITM-41 (n.c.a. 177Lu-zoledronate) is a targeted radiopharmaceutical candidate being investigated for the treatment of osteosarcoma or osteoblastic bone metastases. ITM-41 consists of two molecular components: the medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu), and the novel bisphosphonate derivate zoledronate. ITM-41 binds to the bone mineral hydroxyapatite, accumulating in bone with malignant bone disease and may demonstrate potential therapeutic benefit.

About TOCscan (68Ga-edotreotide)

TOCscan (68Ga-edotreotide) is ITM’s ready-to-use radiopharmaceutical for diagnosis and staging of neuroendocrine tumors (NETs). TOCscan contains the targeting molecule edotreotide, a somatostatin analogue, labeled with the medical radioisotope Gallium-68 (68Ga). TOCscan is used for PET or PET/CT molecular imaging of neuroendocrine tumors (NETs). In addition to diagnosis and staging of NETs, 68Ga-edotreotide imaging is used for therapy planning and dosimetry in preparation for 177Lu-edotreotide or 90Y (Yttrium-90) DOTA therapy. Administered by injection, TOCscan provides high-quality PET imaging, low radiation exposure and quick procedures with short imaging time. TOCscan is authorized for use in Austria, France and Germany.

On December 27, 2021 Sutro Biopharma, Inc. ("Sutro") (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported an exclusive license agreement with Tasly Biopharmaceuticals Co., Ltd. (hereinafter referred to as "Tasly"), a holding subsidiary of Tasly Pharmaceutical Group Co., Ltd. (SHA:600535) for the development and commercialization of STRO-002 in Greater China, consisting of mainland China, Hong Kong, Macau and Taiwan (Press release, Sutro Biopharma, DEC 27, 2021, View Source [SID1234597769]). STRO-002 is a FolRα-targeting antibody-drug conjugate (ADC), currently in clinical studies for patients with ovarian and endometrial cancers in the U.S. and Europe.

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Under the terms of the agreement, Sutro will receive an upfront payment of $40 million and be eligible to receive potentially up to $345 million in development and commercial milestone payments. Tasly will pursue the clinical development, regulatory approval, and commercialization of STRO-002 in Greater China for ovarian and endometrial cancers, with the potential to expand to further oncological indications including non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). Sutro retains development and commercial rights of STRO-002 outside of Greater China. Sutro will be responsible for the clinical trial and initial commercial supply of STRO-002 for trials in the licensed territory pursuant to a supply agreement according to customary terms. Upon commercialization, Sutro will receive tiered, double-digit royalties based on annual net sales of STRO-002 in Greater China.

Kaijing Yan, Chairman of the Board, said, "We are delighted to gain access to this promising drug, which has the potential to be the best-in-class FolRα ADC for patients with debilitating cancers, including ovarian cancer and potentially FolRα-expressing cancers. There is a huge unmet need for oncology patients within Greater China and we look towards future development and commercialization of STRO-002 to serve these needs."

Bill Newell, Chief Executive Officer of Sutro added, "This agreement further validates our emerging clinical data surrounding the development of STRO-002. Tasly is an excellent partner for our Greater China collaboration, with a history of successful execution for developing and commercializing therapeutics. We are delighted to broaden the geographical footprint of STRO–002 and allow greater access for cancer patients to a new possible treatment option."

On December 27, 2021 Sutro Biopharma, Inc. ("Sutro"), (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that it will provide interim data from the Company’s ongoing dose-expansion cohort of the Phase 1 study of STRO-002, a folate receptor alpha (FolRα) targeting antibody-drug conjugate (ADC), for patients with advanced ovarian cancer, at a Company hosted KOL virtual event (Press release, Sutro Biopharma, DEC 27, 2021, View Source [SID1234597768]). The event and Q&A session will be available by webcast, to be held on Wednesday, Jan. 5, 2022, at 5 pm ET, or 2 pm PT.

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The Phase 1 dose-expansion cohort includes advanced ovarian cancer patients with progressive disease, who had previously received up to three lines of therapy, and is open to patients who have not been selected on the basis of FolRα-expression. The study had a target enrollment of 40 patients, with the first patient dosed in January 2021 and completed enrollment with 44 patients in November 2021.

The data will be presented by Sutro management and Dr. R. Wendel Naumann, Principal Investigator in the STRO-002-GM1 studies. Dr. Naumann is a professor and Director of Gynecologic Oncology Research and Associate Medical Director of Clinical Trials at the Levine Cancer Institute, Atrium Health in Charlotte, North Carolina. Dr. Naumann is also a member of Sutro’s Clinical Advisory Board.

Company KOL Virtual Event Information:

To access and register for the live webcast, please sign up here:
View Source;tp_key=62ffe993bc
To access the live call by phone, please dial:
(877) 405-1224 or (201) 389-0848
The webcast and dial-in information will also be available through the News and Events page of the Investor Relations section on the Company’s website at www.sutrobio.com. An archived replay will be available for at least 30 days after the event.

About STRO-002-GM1 Phase 1 Clinical Trial
STRO-002-GM1 is a Phase 1 trial for STRO-002 for patients with advanced ovarian cancer and endometrial cancer that have progressed or relapsed after standard of care treatments, to assess efficacy, safety, and tolerability. The dose-escalation cohort for ovarian cancer has completed enrollment. The dose-expansion cohort for ovarian cancer has completed enrollment and the study is ongoing, with participation from clinical sites in the U.S. and in Spain. The study is inclusive of all FolRα-expression levels and a tissue sample from each patient is required for biomarker analysis. Patients in the dose-expansion cohort are randomized 1:1 to either 4.3 or 5.2 mg/kg STRO-002 and treated every three weeks.