On May 16, 2023 Sony Corporation (President and CEO: Kimio Maki, "Sony") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that they have entered into a collaborative research agreement to discover a novel Antibody-Drug Conjugate (ADC)*1 platform in oncology based on Sony’s unique polymeric material, "KIRAVIATM*2 Backbone*3 (Press release, Astellas, MAY 16, 2023, View Source [SID1234631768]). ADC is expected to selectively deliver anti-cancer drugs to target cells, thereby increasing efficacy and reducing side effects caused by anti-cancer drugs attacking normal cells. The technology to create linkers which conjugates antibodies and drugs, is considered to be a key to development of a better-performing ADC. This collaborative research leverages the flexibility in design and resulting properties such as high capacity and solubility of KIRAVIA Backbone as a linker of ADC, to effectively deliver anti-cancer drugs to targeted cells in a stable manner, aiming to further enhance therapeutic efficacy by achieving high Drug-to-Antibody Ratio (DAR) etc.

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The two companies jointly began exploratory research of new linker technology aimed at creating a new ADC platform in July 2022, and the expected profile was obtained in feasibility studies using human cancer cells. Under this agreement, Sony and Astellas will jointly develop and optimize a new ADC platform using the KIRAVIA Backbone as a linker. In addition, Astellas will conduct non-clinical trials of development candidates. Furthermore, in order to build a drug discovery platform not limited to ADC, the two companies have agreed to continue discussions on expanding research partnerships to create new value by combining Sony’s cutting-edge technology with Astellas’ renowned pharmaceutical capabilities.

"Sony’s life science business has accumulated substantial knowledge in the field of cell analysis," said Katsunori Ogawa, Head of Life Science & Technology Business Unit at Sony Corporation. "Through this collaboration, Sony is striving to contribute to the medical and drug discovery fields and provide further social value by leveraging Sony’s technological capabilities in the development of anti-cancer drugs therapy, which are expected to grow."

"We are pleased to enter into a joint research agreement with Sony," said Yoshitsugu Shitaka, Ph.D., Chief Scientific Officer (CScO), Astellas Pharma Inc. "Astellas is working to create innovative drugs from a multifaceted perspective called the Focus Area approach*4, which identifies combinations of biology, therapeutic modality or technology and diseases with high unmet medical needs. The partnership will further strengthen our ability to utilize suitable modalities. It is our expectation that the collaboration will lead to the continuous creation of innovative drugs for patients around the world."

On May 16, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported that the Company has received guidance from the U.S. Food and Drug Administration (FDA) on a registrational Phase 3 trial design for batiraxcept in clear cell renal cell carcinoma (ccRCC) at an End-of-Phase 2 (EOP2) meeting (Press release, Aravive, MAY 16, 2023, View Source [SID1234631767]).

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"We are very pleased to be advancing batiraxcept into Phase 3 development in ccRCC, having successfully completed our EOP2 meeting with the FDA," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "We believe our trial design and planned endpoint analyses are consistent with the FDA’s guidance, and we look forward to initiating our registrational Phase 3 trial in the second half of 2023. Topline results are expected in 2025 and, if successful, will support a supplemental biologics license application (sBLA) submission in ccRCC."

The randomized, double-blind, registrational Phase 3 trial is designed to evaluate efficacy and tolerability of batiraxcept at a dose of 15 mg/kg in combination with cabozantinib compared to cabozantinib alone. The trial is expected to enroll approximately 300 patients with histologically confirmed advanced or metastatic ccRCC who have progressed after one or two prior lines of systemic therapy, which include immuno-oncology (IO)-based and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)-based therapies (either in combination or sequentially). Patients who were previously treated with cabozantinib are excluded from the trial. This ccRCC population was chosen based upon results from our Phase 1/2 trial which demonstrated a benefit in both median PFS and ORR with the addition of batiraxcept to cabozantinib in patients who had failed prior IO and VEGF-TKI treatments. The global trial is planned to be conducted at approximately 100 sites in the U.S. and around the world. The primary endpoint is progression-free survival, and secondary endpoints include overall survival, duration of response, and objective response rates. Batiraxcept was granted Fast Track Designation by the FDA for ccRCC in November 2022.

On May 16, 2023 Fresh2 Group Limited (Formerly AnPac Bio-Medical Science Co., Ltd. ,"Fresh2," the "Company" or "we") (NASDAQ: ANPC), a company with operations in the United States and China focused on early cancer screening and detection and entering into the operation of a business-to-business e-commerce food platform focused on the sale of Asian sourced food products, reported its annual financial results for the year ended December 31, 2022 (Press release, Anpac Bio, MAY 16, 2023, View Source [SID1234631766]).

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Financial Highlights for Fiscal Year 2022

● Total revenues were RMB12.0 million (US$1.7 million) in the year ended December 31, 2022, a decrease of 33.0% from RMB18.0 million in the year ended December 31, 2021.

● Gross margin was 69.2% in the year ended December 31, 2022, an increase of 1.1 percentage point from 68.1% in the year ended December 31, 2021.

● The average selling price ("ASP") of CDA-based tests was RMB266 (US$39) in the year ended December 31, 2022, a decrease of RMB121, or 31.3% from RMB387 in the year ended December 31, 2021, primarily due to that more customers only performed basic CDA test with lower pricing instead of comprehensive combined CDA test.

● Net loss decreased to RMB103.6 million (US$15.0 million) in the year ended December 31, 2022 from RMB120.1 million in the year ended December 31, 2021, mainly attributable to the decrease of approximately RMB9.3 million in selling and marketing expenses, the decrease of approximately RMB6.7 million in research and development expenses, and the decrease of approximately RMB9.9 million in general and administrative expenses, offset by approximately $14.7 million decrease in impairment of intangible assets and goodwill.

● Non-GAAP net loss¹ was approximately RMB88.8 million (US$12.9 million) in the year ended December 31, 2022, an increase from a non-GAAP net loss of approximately RMB76.8 million in the year ended December 31, 2021. Non-GAAP net loss increased by 15.6% from the year ended December 31, 2021.

● Short-term debt decreased significantly (a decrease of approximately 85.1%) compared to December 31, 2021, because the conversion of Convertible Debentures into ordinary shares.

(1) Non-GAAP net loss is defined as net loss excluding change in fair value of convertible debts and share-based compensation. For more information, refer to "Use of Non-GAAP Financial Measures" and "Reconciliations of Non-GAAP Results" at the end of this report.

Business Highlights Fiscal Year 2022

● The Company continued to receive validation on the efficacy of CDA testing through clinical study follow-ups. As of December 31, 2022, the Company had contacted 30,526 individuals tested using CDA packages in China and received substantive feedback regarding health conditions and disease development from 17,824 individuals.

● As of December 31, 2022, the Company filed 260 patent applications globally, among which 155 patents had been granted, including 22 patents granted in the United States, 68 in greater China (including eight in Taiwan), and 65 in other countries and regions.

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The Company continued to build a cancer risk assessment database, which totaled approximately 280,095 samples as of December 31, 2022, including approximately 239759 samples from commercial CDA-based tests and approximately 44,653 samples from research studies.

Mr. Haohan Xu, the Co-CEO of the Company, commented "Despite facing tremendous challenges in the market, we have made progress in several areas during the year ended December 31, 2022. For instance, we achieved an increase in our gross margin, reflecting our focus on cost management and operational efficiency. While acknowledging the challenges in our existing biotech business, we have been actively exploring new business opportunities targeting restaurants and supermarkets, as mentioned in our recent press releases. Specifically, we acquired Fresh2 Ecommerce Inc, a business-to-business e-commerce platform focused on connecting Asian food suppliers and supermarkets in the U.S. to enter into the U.S. food market by initiating and developing a new e-commerce platform. We also acquired certain fixed assets of Easy Hundred Inc., a U.S.-based e-commerce company in the foodservice industry, and its intellectual property to optimize our industry supply chain and supplement the acquired Fresh2 Ecommerce Inc.’s business-to-business e-commerce platform. In addition, we acquired GISN (HK) LIMITED, a technical solution and outsourcing consulting services provider focused on the digital, internet and Web 3 business transformation for start-ups and traditional enterprises to improve the efficiency of our e-commerce operations. We believe that these acquisitions will diversify our revenue streams, help to fill financial gaps, drive growth for the Company, and ultimately create long term value for our shareholders."

On May 16, 2023 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, reported that the company will participate in Alliance Global Partners’ Virtual Healthcare Conference being held May 23-24, 2023 (Press release, Akari Therapeutics, MAY 16, 2023, View Source [SID1234631765]). During the event, the Akari management team will attend 1:1 investor meetings.

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On May 16, 2023 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported it has received positive feedback from the US Food and Drug Administration (FDA), regarding the Company’s late-stage clinical development plans for its first-in-class soluble LAG-3 protein and MHC Class II agonist, eftilagimod alpha ("efti"), for the treatment of 1st line nonsmall cell lung cancer (NSCLC) (Press release, Immutep, MAY 16, 2023, View Source [SID1234631754]).

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The FDA is supportive of a registrational trial to evaluate efti in combination with an anti-PD-1 therapy based on the encouraging data from the Phase II TACTI-002, Part A (N=114) in 1st line NSCLC patients, no matter their level of PD-L1 expression, presented in a late-breaking oral abstract presentation at the 37th Annual Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting in November 2022.

Among the items discussed at the meeting were the toxicological package and general aspects of the trial design, including statistics and potential patient population with a focus on 1st line NSCLC patients with a Tumor Proportion Score (TPS) PD-L1 of >1% for which efti plus pembrolizumab has already received Fast Track designation. This trial will be named TACTI-004 (Two ACTive Immunotherapies).

Immutep CEO, Marc Voigt, commented: "In light of our compelling clinical data that efti has generated in combination with anti-PD-1 therapy, this meeting with the FDA is a critical step in our late-stage development process for 1st line non-small cell lung cancer. We are thankful for the positive feedback as we continue moving forward with our unique immuno-oncology approach for the many cancer patients impacted by this difficult disease."

Immutep CSO, Dr. Frédéric Triebel, stated: "We are very pleased with our constructive dialogue with the FDA establishing a clear path forward for efti in front line non-small cell lung cancer. These interactions represent an important milestone within Immutep’s three main clinical programs targeting cancers that affect large patient populations, positioning efti to make a significant impact for the many patients in need of more effective, tolerable, and durable immunotherapy."

About Eftilagimod Alpha (Efti) Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and HER2–/HR+ metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).