On May 16, 2023 Cimeio Therapeutics, a biotechnology company developing a novel approach to cell therapies, presented data for its CD45 Shielded Cell & Immunotherapy Pair (SCIP) program at the American Society of Gene and Cell Therapy’s Annual Meeting in Los Angeles (Press release, Cimeio Therapeutics, MAY 16, 2023, View Source [SID1234631770]). The findings build upon prior successful studies using CD117 and CD123 variants and collectively provide further proof of concept for Cimeio’s platform, which offers a novel and promising therapeutic approach to improve the outcomes for patients with benign and malignant hematological diseases in need of a hematopoietic stem cell (HSC) transplant.

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The new study demonstrates that a genetically engineered variant of the cell surface receptor CD45 is fully functional and, importantly, evades a paired immunotherapy directed against the wild-type molecule.

CD45 is a pan-hematopoietic marker critical for the function of immune cells. While eradication of CD45+ cells could represent a universal approach to reset the hematopoietic system for hematologic malignancies or severe autoimmune diseases, the current application of CD45-targeted cell-depleting therapies is limited by potentially severe toxicities due to the near ubiquitous expression of the target on hematopoietic cells. In contrast, the molecular shielding of CD45 will allow a patient to develop a healthy, protected and fully functional hematopoietic system, ensuring the paired immunotherapy targets just the diseased host cells.

A poster titled, "Molecular Shielding of the Pan-Hematopoietic Marker CD45 May Enable a Targeted Universal Approach for Replacement of the Hematopoietic System," was authored by Lukas T. Jeker, M.D., Ph.D., co-founder of Cimeio and Professor of Experimental Transplantation Immunology & Nephrology at the Department of Biomedicine, University of Basel and at the Basel University Hospital, Switzerland.

Key takeaways from the poster are as follows:

Engineered HSCs were generated expressing a stable variant of CD45 and demonstrated no binding to the paired immunotherapy
A novel, humanized, potent CD45-targeting antibody-drug conjugate (ADC) was developed that killed CD45 cancer cells in vitro while sparing edited cells from depletion
In vivo experiments showed efficient engraftment and differentiation of the engineered CD45 variant HSCs, as well as shielding and strong enrichment in combination with the CD45 immunotherapy
"Cimeio’s platform continues to show potential as a safe and efficient method to enable HSC transplants for patients suffering from a variety of severe diseases," said Dr. Jeker. "I look forward to the continued progress of the CD45 program, as well as the additional programs in the company’s deep pipeline of medicines."

On May 16, 2023 Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, reported that George Buchman, Ph.D., Vice President, Pre-Clinical and Process Development, will present at the upcoming 26th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), which is being held at the Los Angeles Convention Center on May 16-20, 2023 (Press release, Catalent, MAY 16, 2023, https://www.catalent.com/catalent-news/catalent-to-present-on-integrated-uptempo-gene-therapy-development-platform/ [SID1234631769]).

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Dr. Buchman’s presentation, on Friday, May 19, at 4:30 p.m. PDT, is entitled "One-stop Integrated Viral Vector Platform for Speed to Clinic," and will focus on a consolidated and standardized platform to help fast-track AAV vectors to the clinic with a scalable CGMP-ready process. The complete UpTempo℠ AAV platform, which was re-launched in its expanded form in March 2023, provides increased consistency and efficiency, reducing the time to manufacture clinical-quality drug product to just nine months, while delivering a process that will readily advance to late-stage CGMP manufacture.

Dr. Buchman works in Catalent’s Cell & Gene Therapy business, which provides research services and process development and enables the translation of programs into clinical trials and commercial CGMP manufacturing. He has worked more than 30 years in the biotech industry, including at Life Technologies (now Thermo Fisher Scientific), Celera Genomics, and GeneLogic. Dr. Buchman obtained his bachelor’s degree in biochemistry from Albright College, Reading, Pennsylvania, and his doctorate in biochemistry from the University of Maryland.

Catalent will also be exhibiting at the conference, in booth 229. To find out more information about this event, visit https://www.catalent.com/events/asgct-annual-meeting-2023/ and to find out more about Catalent’s UpTempo AAV platform, visit Catalent.com/UpTempo.

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.

●
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."