On February 7, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that it has received a confirmation from the US Food and Drug Administration (FDA) that the diagnostic 64Cu SAR-bisPSMA trial (COBRA) may proceed (Press release, Clarity Pharmaceuticals, FEB 7, 2022, View Source [SID1234607769]).

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Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to be progressing this stand-alone diagnostic trial following a Study May Proceed letter from the US FDA as we head towards registering this product in the US. Following this exciting news, we are now planning to commence recruitment in the trial in the second quarter of CY2022."

COBRA (Copper-64 SAR-BisPSMA in Biochemically Recurrent prostAte cancer) is a Phase I/II Positron Emission Tomography (PET) trial of participants with biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-bisPSMA in up to 50 participants. The primary objectives of the trial are to investigate safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect recurrence of prostate cancer.

Prostate cancer is a key focus of Clarity’s Targeted Copper Theranostics (TCT) program where COBRA is the third clinical trial of the optimised SAR-bisPSMA agent in prostate cancer. The US-based theranostic 64Cu/67Cu SAR-bisPSMA trial, SECuRE (NCT04868604)1, has already demonstrated utility in patients with metastatic castrate resistant prostate cancer with imaging from 1 hour to 72 hours post-injection. The diagnostic 64Cu SAR-bisPSMA trial in Australia, PROPELLER (NCT04839367)2, is well underway, having reached its 50% recruitment milestone in untreated, confirmed prostate cancer patients (i.e. pre-radical prostatectomy) in December 2021. Clarity has previously received advice from the FDA that its prostate diagnostic clinical program with 64Cu SAR-bisPSMA is addressing the two relevant patient populations for registration: pre-prostatectomy/pre-definitive treatment as well as patients with suspected biochemical recurrence.

Dr Alan Taylor further commented, "The preliminary data from our SAR-bisPSMA trials in Australia and the US look very promising and the high uptake and retention of SAR-bisPSMA shown in preclinical and clinical trials to date may lead to improved detection in patients with prostate cancer, particularly those with low PSA levels. Our team and our collaborators are excited to commence the COBRA trial, generating more data to progress the development of SAR-bisPSMA as we move this product closer to registration in the US.

"We also look forward to further validating our on-demand distribution model as the trial sites will be supplied with ready-to-use cGMP 64Cu-SAR-bisPSMA product. Clarity’s vision is to move the diagnostic field towards centrally manufactured products that can be delivered on demand, shifting away from the supply constraints of the first generation of PET agents such as gallium-68 and fluorine-18 and the burdensome challenges of short-lived radionuclides. But most importantly, on-demand central manufacture of radiopharmaceuticals could potentially improve patient care by focusing on the needs of patients and their treating staff, delivering critical treatments that are safe and efficacious, on time and at any treatment centre with a PET camera."

Dr Neal Shore MD, FACS (CMO – Urology/Surgical Oncology, GenesisCare, US and the Medical Director of Carolina Urologic Research Centre), Principal Investigator in the COBRA trial, commented, "I am impressed by the images seen to date and look forward to working together with Clarity on the COBRA trial, exploring the clinical benefits of 64Cu SAR-bisPSMA in patients with BCR of prostate cancer. Higher uptake of the product in tumours may offer improvements in diagnosis of disease, which is particularly relevant for patients with suspected recurrence of prostate cancer. The ability to diagnose the disease earlier offers the potential to provide better treatment options earlier. When these benefits are combined with the ability to supply the products on demand and in large scale, this may be a game changer for prostate cancer management."

This announcement has been authorised for release by the Executive Chairman.

On February 6, 2022 Statera Biopharma, Inc. (NASDAQ: STAB) (the "Company" or "Statera Biopharma"), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported that it entered into a securities purchase agreement with a certain institutional investor to purchase approximately $2.0 million worth of its common stock and warrants in a registered direct offering (Press release, Cleveland BioLabs, FEB 6, 2022, View Source [SID1234607784]).

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Under the terms of the securities purchase agreement, the Company has agreed to sell approximately 2.0 million shares of its common stock and warrants to purchase approximately 2.0 million shares of common stock. The warrants will be exercisable immediately, have an exercise price of $1.00 per share, and will expire five years from the initial exercise date. The purchase price for one share of common stock and one warrant will be $1.00.

The gross proceeds to the Company from the registered direct offering are estimated to be approximately $2.0 million, before deducting the placement agent’s fees and other estimated offering expenses. The offering is expected to close on or about February 9, 2022, subject to the satisfaction of customary closing conditions.

EF Hutton, division of Benchmark Investments, LLC, is acting as exclusive placement agent for the offering. Bridgeway Capital Partners is acting as the Company’s financial advisor.

Anthony L.G., PLLC is acting as legal counsel to Statera Biopharma, Inc. and Carmel, Milazzo & Feil LLP is acting as legal counsel to EF Hutton for the offering.

The proposed offering of the common stock and warrants described above is being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-238578) filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on May 29, 2020, and the accompanying prospectus contained therein.

The offering is being made only by means of a prospectus supplement and accompanying prospectus. A prospectus supplement describing the terms of the public offering will be filed with the SEC and will form a part of the effective registration statement.

Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, on the SEC’s website at View Source or by contacting EF Hutton, division of Benchmark Investments, LLC Attention: Syndicate Department, 590 Madison Avenue, 39th Floor, New York, NY 10022, by email at [email protected], or by telephone at (212) 404-7002.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

On February 6, 2022 Ascletis Pharma Inc. (HKEX: 1672) reported the approval of the Investigational New Drug (IND) application by U.S. Food and Drug Administration (FDA) for in-house developed oral PD-L1 small molecule inhibitor, ASC61, for the treatment of advanced solid tumors (Press release, Ascletis, FEB 6, 2022, View Source [SID1234607773]). This is Ascletis’ second U.S. IND approval in 2022 after ASC22 (Envafolimab) U.S. IND approval for functional cure of chronic hepatitis B (CHB).

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The ASC61 Phase I trial in the U.S. is a dose escalation study in patients with advanced solid tumors. The objectives of such study are to find a recommended Phase II dose (RP2D) and obtain preliminary efficacy in patients with advanced solid tumors. The first U.S. patient is expected to be dosed in the first half of 2022.

ASC61 is an oral potent and highly selective PD-L1 small molecule inhibitor and blocks PD-1/PD-L1 interaction through inducing PD-L1 dimerization and internalization. As a single agent, ASC61 demonstrated significant antitumor efficacy in multiple animal models such as the humanized mouse model. Preclinical studies showed that ASC61 has good safety and pharmacokinetic profiles in animal models.

ASC61 oral tablets, which will be used in the clinical trial, were developed with the in-house proprietary technology.

Compared to injectable PD-1/PD-L1 antibodies, ASC61, as an oral PD-L1 inhibitor, has the following benefits: (1) ease of dosing and no need for hospital visits for injections; (2) all-oral combinations with other oral anti-tumor drugs; and (3) rapid titration of doses for better management of immune-related adverse events (irAEs).

"We are excited about U.S. IND approval of ASC61," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, "This IND approval demonstrates Ascletis’ global R&D capability in oncology. As we are advancing the phase III clinical trial of ASC40, a fatty acid synthase (FASN) inhibitor, in combination with Bevacizumab for the treatment of recurrent glioblastoma (rGBM), this U.S. IND approval is another significant milestone for Ascletis’ oncology pipeline. Furthermore, we are exploring opportunities for all-oral combinations between oral PD-L1 small molecule inhibitor ASC61 and ASC40 as well as other oral anti-tumor drugs from our business partners."

On February 6, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that the Health Sciences Authority (HSA) of Singapore has approved Trodelvy(sacituzumab govitecan or SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease (Press release, Everest Medicines, FEB 6, 2022, View Source [SID1234607772]). This marks the first drug approval of Trodelvy received by Everest. The Company expects a series of approvals for Trodelvy in its license territories in the coming year.

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"As part of our larger business strategy to build a robust commercial presence in Asia Pacific markets, we are well-positioned to accelerate quickly during this next phase of growth with an established commercial team, bridging the gap between patients with unmet medical needs and first-in-class biopharmaceutical innovation," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "As a next step we will be working collaboratively with all stakeholders to bring Trodelvy to women in Singapore living with metastatic TNBC."

"TNBC accounts for 15-20% of all breast cancer cases in Singapore, and breast cancer is the country’s leading cause of cancer death in women. This aggressive and difficult-to-treat form of the disease has historically had very limited treatment options, with overall survival remaining unchanged among patients for nearly two decades," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. This regulatory milestone brings Trodelvy one step closer to Singaporean patients with metastatic TNBC."

In addition to Singapore, Everest is closely coordinating with regulatory bodies in Greater China and South Korea to review its applications for Trodelvy for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

In May 2021, the China National Medical Products Administration accepted its Biologics License Application for Trodelvy with priority review.
In December 2021, the Ministry of Food and Drug Safety (MFDS) of South Korea accepted a New Drug Application (NDA) for Trodelvy. Trodelvy was previously granted Fast Track Designation and Orphan Drug Designation in South Korea.
In December 2021, the Taiwan Food and Drug Administration accepted its NDA for Trodelvy. Trodelvy was previously granted Pediatric and Rare Severe Disease Priority Review Designation in Taiwan.
About Triple-Negative Breast Cancer (TNBC)

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

About Trodelvy

Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the TROP-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Trodelvy is approved for adults with second-line metastatic TNBC in the United States, the European Union, Australia, Canada, Great Britain and Switzerland and approval is based on data submitted from the Phase 3 ASCENT study. Review is also underway in Greater China and South Korea through Everest Medicines. Trodelvy is also approved under the accelerated approval pathway for use in metastatic UC in the United States and continues to be developed for potential use in other TNBC and metastatic UC populations. It is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

On February 6, 2022 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that ATG-037 has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I STAMINA trial, a first-in-human study of ATG-037 in patients with locally advanced or metastatic solid tumors (Press release, Antengene, FEB 6, 2022, View Source [SID1234607771]). The primary objective of the study is to evaluate the safety and tolerability of ATG-037 as monotherapy and in combination with an immune checkpoint inhibitor (CPI), to determine the appropriate dose for Phase II studies, and to assess preliminary signal of activity; the secondary objective is to characterize the pharmacology of ATG-037.

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ATG-037 is an orally available, small molecule CD73 inhibitor. CD73 generates adenosine, which leads to immunosuppression in the tumor microenvironment. ATG-037 has demonstrated promising preclinical efficacy as a monotherapy and in combination with CPIs and chemotherapy agents. In preclinical studies, the compound has demonstrated to overcome the "hook effect" that is common in anti-CD73 antibodies. In addition, GLP toxicology studies indicate the compound will have a broad therapeutic window.

Kevin Lynch, M.D., Chief Medical Officer of Antengene commented, "Developing novel molecules that can make a clinical difference in cancer is of paramount importance to Antengene. Preclinical toxicology data suggests that ATG-037 will have a broad therapeutic window and further preclinical data suggests the potential for differentiated characteristics compared to other CD73 inhibitors."

Dr. Lynch continued, "While we remain very interested to explore the drug as a monotherapy, combination therapy of ATG-037 with CPIs and chemotherapies could enable synergistic improvements in tumor response for patients with advanced and metastatic cancers. ATG-037 also has the potential to be used in combination with several agents in the Antengene pipeline including ATG-101, a proprietary PD-L1/4-1BB bispecific antibody, demonstrating the in-house combinatory potential of our pipeline programs. I’m very excited about the start of the clinical program and look forward to next steps with ATG-037."