Recent Developments and Pipeline Highlights of Viva BioInnovator's 12 Portfolio Companies

ShanghaiDecember 1, 2022PR Newswire -- In the face of an ever-changing landscape, technological innovation remains the eternal theme for the long-term development of biopharmaceutical enterprises, continuously injecting vitality into companies and driving the "from 0 to 1" transformation in research and development as well as commercialization success. Recently, 12 invested incubated companies of Viva Biotech have achieved significant results and progress: Focus-X Therapeutics successfully reached an acquisition agreement with Full-Life Technologies; Aleta Biotherapeutics, Domain, Triumvira, Brainstorm Pharma, and QureBio have advanced their R&D pipelines smoothly; Zizhen Biotech, Cybrexa, and Anji Pharma have respectively achieved important collaborations in their specific fields; DTx Pharma, HAYA Therapeutics, and AIxplorerBio have consecutively received prestigious honors. Below, let’s take a look at their developments together.

Viva Biotech Investment Incubator CompanyFocus-X Therapeutics Successfully Reaches Acquisition Agreement with Fulllink Pharmaceuticals

On November 29, 2022, Focus-X Therapeutics ("Focus-X"), a radiopharmaceutical company invested in and incubated by Viva Biotech, successfully reached an acquisition agreement with Full-Life Technologies ("Full-Life"). According to the terms of the acquisition agreement, Full-Life will pay Focus-X a total transaction value of $245 million, including upfront payments as well as potential development, registration, and sales milestone fees, along with royalties on commercial sales. The acquisition is expected to be completed in the first quarter of 2023. This marks another pre-clinical stage project acquired from Viva Biotech’s portfolio after Dogma and Totient, further validating Viva Biotech's investment team's ability to identify projects and provide professional post-investment support.

Focus-X is a company that develops targeted radiopharmaceuticals for cancer treatment based on its proprietary peptide engineering technology. It was led by Viva Biotech in the angel round of financing in the third quarter of 2020. In addition to financial support, Viva Biotech also provided Focus-X with comprehensive incubation services, assisting in its transformation from "concept to product."

AIxplorerBio Awarded "Top Ten Overseas Talent Entrepreneurship Projects in Haichuang Competition"

On November 28, AIxplorerBio, invested in and incubated by Viva Biotech, was invited to attend the 2022 Pudong New Area Innovation and Entrepreneurship Summit. It stood out from over 300 outstanding projects and was honored with the "Top Ten Overseas Talent Entrepreneurship Projects of Haichuanghui" award. This Haichuanghui event was jointly organized by the Shanghai Association for Science and Technology, the Organization Department of the Pudong New Area Committee, the Pudong New Area Commission of Economy and Technology, and the Zhangjiang Administration Bureau of the Free Trade Zone. AIxplorerBio will continue to better integrate resources and talent advantages in the biomedicine and artificial intelligence fields in the Pudong New Area, striving to accelerate innovative drug research and development projects by introducing more professional talents.

Zizhan+Corning: Building CAR-NKIn Vitro 3D Targeted Killing of Tumor Cells by Cellular Infiltration into the Extracellular Matrix of TumorsModel

On November 22, Shanghai Zizhan Pharmaceutical Technology Co., Ltd. ("Zizhan Bio"), in which Viva Biotech has participated in investment and incubation, together with Corning Life Sciences and Olympus Life Science ("Yijing Tong Optical Technology"), jointly announced the official establishment of the "Zizhan Bio Phenotypic Drug Screening Platform Based on Complex Disease Models and Bioimaging."

AIxplorerBio's Phenotypic Drug Screening Platform will perfectly integrate AIxplorerBio's complex disease modeling technology platform, Corning Life Sciences' high-quality biotechnology products and global expertise, as well as Olympus' excellent bioimaging solutions to provide customers with the highest quality phenotypic drug screening services.

Aleta BiotherapeuticsAnnounce CAR-TCell Therapy Adapter ALETA-001Qualification for Innovative Passport

Recently, Aleta Biotherapeutics ("Aleta"), in which Viva Biotech has participated in investment and incubation, announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted the company's R&D pipeline, ALETA-001 (a CAR-T cell therapy connector), an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP). It is intended for treating patients with B-cell malignancies, non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), as well as those who have not responded or relapsed after CD19 CAR-T cell therapy. ALETA-001 is expected to enter the clinical stage in 2023, with a Phase 1/2a clinical trial sponsored and conducted by the Centre for Drug Development of Cancer Research UK.

CybrexaAnd ExelixisReach an exclusive cooperation for ExelixisProvide Acquisition of CBX-12The Right

On November 1, Alameda, California, and New Haven, Connecticut — Exelixis and Cybrexa Therapeutics ("Cybrexa"), in which Viva Biotech has participated in investment and incubation, announced that the two parties have signed an exclusive cooperation agreement granting Exelixis the right to acquire CBX-12 (alphalex exatecan). According to the cooperation agreement, Exelixis will pay Cybrexa a $60 million upfront payment in exchange for the right to acquire CBX-12 after the publication of Phase I clinical results and to provide funding for Cybrexa to advance the agreed development and production plans. Cybrexa is also expected to receive up to $642.5 million in additional proceeds, including development, manufacturing, and commercial milestone payments, as well as the fee for purchasing CBX-12 after evaluating pre-specified clinical data.

CBX-12 is a first-in-class peptide-drug conjugate (PDC) currently in clinical research. It utilizes alphalex technology to directly deliver an efficient second-generation topoisomerase I inhibitor, exatecan, into tumor cells, enhancing the efficacy of the topoisomerase I inhibitor while reducing toxicity.

DTx Pharmaand HAYA TherapeuticsJointly selected for Clarivate's newly released "RNA Technology Companies to Watch"》Report

On October 25, in London, UK, Clarivate released a new report – "RNA Technology Companies to Watch." The report comprehensively analyzes the drug efficacy, financing, and R&D activities of RNA companies, revealing emerging RNA leaders in the medical field. A total of seven innovative RNA technology companies were selected, including DTx Pharma and HAYA Therapeutics, which were invested in and incubated by Viva Biotech.

In addition, Haya Therapeutics recently won the Seed Round Financing of the Year award at the "European Lifestars Awards" hosted by LSX.

DomainEP4R for the Treatment of Solid TumorsAntagonist DT-9081Approved for Clinical Use

October 19, Strasbourg, France & Montreal, Canada – Domain Therapeutics (“Domain”), a biopharmaceutical company invested in and incubated by Viva Biotech that focuses on researching and developing novel immuno-oncology drugs targeting G protein-coupled receptors (GPCR), announced that its first fully owned IO candidate drug, DT-9081, has received clinical trial application (CTA) approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) and the Belgian Federal Agency for Medicines and Health Products (AFMPS). With this clinical approval, Domain is set to initiate Phase I clinical trials and aims to complete the first patient dosing before the end of this year.

Anji and PHPEstablish Strategic Cooperation to Jointly Tackle High-Incidence Diseases

October 19, Cambridge and New York, USA — Anji Pharmaceuticals, incubated and invested in by Viva Biotech, and Population Health Partners officially announced a strategic partnership. The two teams will work closely together to address critical challenges in high-incidence human diseases.

After the partnership between Anji and PHP began, the recent focus has been on accelerating the development of two major clinical pipelines of Anji. ANJ900 (a new delayed-release formulation of metformin) is currently in Phase 3 clinical trials, aiming to make metformin safe for use in Type 2 diabetes patients with concurrent moderate to severe chronic kidney disease (CKD). ANJ908 (pradigastat), an innovative DGAT1 inhibitor, has successfully completed a Phase 2 clinical trial (NCT04620161) in patients with chronic functional constipation.

TriumviraExpanding Cell Therapy Capacity at South San Francisco Facility, Following Announcement of TAC01-HER21/2Initial Clinical Data

On October 19, Austin, Texas, South San Francisco, and Hamilton, Ontario – Triumvira Immunologics (“Triumvira”), a clinical-stage company focused on developing novel, targeted autologous and allogeneic TCR-T cell therapies for the treatment of solid tumors, which is incubated and invested in by Viva Biotech, announced a multi-year agreement with AmplifyBio to manufacture cell therapy candidates within the company’s pipeline at its facility in South San Francisco, California. Triumvira anticipates that the facility will be fully operational by 2023.

In September, Triumvira presented initial phase 1/2 clinical data for TAC01-HER2 in the treatment of HER2-positive solid tumors at the 2022 ESMO. The data showed that TAC01-HER2 was well-tolerated in both dosing groups, with early signs of clinical activity observed in the higher-dose group, achieving a 75% disease control rate, including one partial response.

Bace Pharmaceuticals Brain-Penetrant MEKInhibitor ABM-168Approved by the U.S. FDAClinical Trial Approval, and the Appointment of Dr. Yang Zandong as Chief Medical Officer

October 12, Shanghai, China/San Diego, USA – ABM Therapeutics (璧辰医药), a company incubated and invested in by Viva Biotech that focuses on the development of small molecule drugs capable of crossing the blood-brain barrier, announced that its self-developed brain-penetrant MEK1/2 inhibitor, ABM-168, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). This marks the second self-developed drug by ABM Therapeutics to receive clinical trial approval in the United States, following ABM-1310. With this clinical approval, ABM Therapeutics is set to initiate a Phase I clinical trial targeting patients with advanced solid tumors, particularly those with concurrent brain metastases or primary brain tumors. The trial aims to explore the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ABM-168 in these patients.

On October 10, BRI Biopharm announced the appointment of Dr. Zane Yang, M.D., as the company's Chief Medical Officer (CMO). Dr. Yang will comprehensively lead and manage BRI Biopharm’s global clinical development affairs, formulate and implement clinical development strategies, and participate in the planning and execution of the company’s overall business and development strategies. Dr. Yang has a very strong professional and academic background, along with extensive experience in clinical research and management.

QureBio Q-1801Project Receives U.S. FDA ApprovalClinical Approval

On September 24, QureBio, invested and incubated by Viva Biotech, announced that its self-developed Q-1801 project received the clinical trial approval letter from the U.S. FDA, while the IND application in China is currently underway. Q-1801, developed by QureBio using its antibody engineering technology platform, is the world's first bispecific antibody simultaneously targeting SIRPα and PD-L1. Q-1801 also marks QureBio’s second clinical application project, further demonstrating the company’s self-research and innovation capabilities.