Biosion, Inc. and Celldex present positive preclinical data at SITC 2021. CDX-585 is the first compound from Celldex’s research and collaboration agreement with Biosion, Inc. and combines Celldex’s ILT4 mAb with Biosion’s PD-1 mAb.

Celldex Presents Positive Preclinical Data from PD-1/ILT4 Bispecific Antibody Program CDX-585 at SITC 2021

HAMPTON, N.J., November 12, 2021 — Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced positive preclinical data from CDX-585, the Company’s bispecific antibody with dual targeting of ILT4 and PD-1 checkpoint pathways, developed from its bispecific antibody platform. These data were presented in a poster session as part of the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021).

The data show CDX-585 effectively combines the blockade of ILT4 and PD-1 into one molecule, with favorable biophysical and functional characteristics, supporting the initiation of development activities including manufacturing and IND-enabling studies. CDX-585 is the first compound from Celldex’s research and collaboration agreement with Biosion, Inc. and combines Celldex’s ILT4 mAb with Biosion’s PD-1 mAb.

“We are pleased with this data which demonstrate we have successfully combined two important pathways into one molecule and support the further advancement of CDX-585,” said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. “We believe that co-targeting ILT4 and PD-1, which are both critical checkpoint pathways, has the potential to produce significant immune enhancing and antitumor effects. We are excited to move forward with CDX-585 in addition to the continued generation of other candidates from our bispecific antibody platform for oncology and inflammatory diseases.”

In the preclinical data presented at SITC, the simultaneous inhibition of ILT4 and PD-1 checkpoints with CDX-585 led to myeloid and T cell activation which may potentially demonstrate clinical utility, particularly in the T cell checkpoint inhibitor refractory setting. CDX-585 promoted T cell activation as measured by mixed lymphocyte reactions superior to that achieved by the combination of ILT4 and PD-1 monoclonal antibodies. CDX-585 also demonstrated anti-tumor activity in a humanized mouse model of melanoma and had a favorable pharmacokinetic profile in pilot studies, without adverse effects of treatment noted in clinical observations or clinical chemistry.

The poster presented at SITC can be viewed on the “Publications” page of the “Science” section of the Celldex website.

About CDX-585

CDX-585 is a dual targeting PD-1/ILT4 bispecific antibody from Celldex’s bispecific antibody platform, currently in preclinical studies including manufacturing and IND-enabling studies. Expression of ILT4 in several tumor types is associated with poor outcome and in preclinical models, antagonist antibodies to ILT4 have demonstrated immune enhancing and antitumor effects. CDX-585 is being developed as part of a research and collaboration agreement with Biosion, Inc.

About Celldex’s Bispecific Antibody Platform

Celldex’s deep antibody experience and in-house manufacturing capabilities support efficient development of next generation bispecific antibody programs for inflammatory/autoimmune diseases and oncology. Bispecific antibodies can engage two independent pathways involved in controlling immune reactions and combining these into one molecule can result in stronger activity than a combination of the independent antibodies. Targets are being selected based on new science as well as their compatibility to be used in bispecific antibody formats with Celldex’s existing antibody programs. Lead targets in development are emerging as important pathways controlling inflammatory diseases or immunity to tumors.

About Celldex Therapeutics, Inc.

Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with inflammatory diseases and many forms of cancer. Visit www.celldex.com.

About Biosion, Inc.

Biosion is a global clinical stage biotechnology company developing innovative therapeutics to address resistant, refractory, relapsed and residual disease for patients worldwide. The company is building its innovative pipeline through internally-derived proprietary technologies, including its H3 hybridoma platform, SynAb™ synergistic antibody evaluation, SynTracer™ HT-endocytosis screening and Flexibody™ bispecific platforms. Biosion is actively seeking global partners who are interested in licensing, partnership or co-development opportunities. For more information and full pipeline details, please visit www.biosion.com.

Forward Looking Statement

This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including CDX-0159, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the effects of the outbreak of COVID-19 on our business and results of operations; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact

Sarah Cavanaugh

Senior Vice President, Corporate Affairs & Administration

(508) 864-8337

scavanaugh@celldex.com

Patrick Till

Senior Director, Investor Relations & Corporate Communications

(484) 788-8560

ptill@celldex.com

Biosion, Inc. Appoints Yao-Yao Zhu, M.D., Ph.D., Head of Global Regulatory Affairs

NEWARK, Delaware, and NANJING, China. September 13, 2021 – Biosion Inc., announced the appointment of Dr. Yao-Yao Zhu as Head of Global Regulatory Affairs. Dr. Zhu joins Biosion from U.S. FDA where she served as Medical Officer in the Office of Immunology and Inflammation, Office of New Drugs, Center for Drug Evaluation and Research (CDER).

“We are pleased to welcome Yao-Yao to the executive team of Biosion. “Yao-Yao’s exceptional knowledge and experience, both as a physician and as a medical reviewer of novel gene and cell therapy programs at US FDA, will enable Biosion to accelerate regulatory filings and clinical development of our innovative biotherapeutics portfolio in immune and oncology-related diseases” said Dr. Hugh Davis, Chief Operating Officer and President of Biosion USA, Inc.  “In Dr. Zhu’s role as Head of Global Regulatory Affairs she will build Regulatory teams in both the U.S. and China, enabling Biosion to execute clinical development programs worldwide. In addition, Yao-Yao will be integral to developing and driving portfolio and corporate strategy for the next stage of our growth.”

Dr. Zhu brings to Biosion substantial regulatory experience as a medical officer/clinical reviewer at US FDA.  In this capacity Dr. Zhu participated in the review of both biologics and small molecule products with a wide range of indications at different stages of clinical development, contributing as a primary reviewer to the market approval of BYLVAY™, TRALEMENT®, LUXTURNA®, DUCORD, and LAVIV™. In addition, Dr. Zhu has over 20 years of clinical experience as an internal medicine physician, practicing and teaching at medical centers such as the Greater Baltimore Medical Center and Johns Hopkins School of Medicine. Dr. Zhu obtained her M.D. from Peking University Health Science Center. She also holds a Ph.D. degree in Neuroscience from Baylor College of Medicine and post-doctoral training in gene therapy of bone diseases from the University of Michigan.

About Biosion, Inc.

Biosion is a leading “In Global For Global” biotech company with corporate vision of delivering breakthrough therapeutics to patients worldwide. The company is building up its innovative clinical pipeline through internal R&D programs, co-development programs with partners and in-licensing efforts.

The Company integrates several internally-derived proprietary technologies including its H3 hybridoma platform, SynAbTM synergistic antibody technology, SynTracerTM internalization platform, and FlexibodyTM bispecific platform to significantly accelerate its discovery efforts for novel molecules. The company has operations in Newark, Delaware and Nanjing, China. For more information and full pipeline details, please visit www.biosion.com.

Contacts:

Ailie Su, Biosion, Inc. Nanjing, China +86-199-5241-5530, ailie.su@biosion.com 

Shengmei Ma, Biosion USA, Inc.  Newark, DE +1-508-410 6008,  shengmei.ma@biosion.com   

Biosion, Inc. Raises ¥200M RMB Financing to Support Further Global Development of Its Innovative Pipeline

Newark, DE, Nanjing CN – Dec 10, 2020. Biosion Inc. (“Biosion”) today announced completion of ¥200 Million RMB (~$30 Million USD) of financing to transition Biosion into a clinical stage company within twelve months. The financing was led by Lapam Capital, joined by Kaiyuan Capital, Oceanpine Healthcare Fund, C&D Emerging Industry Equity Investment, and Zheshang Innovest.

“We are very grateful to the investors for their confidence and support in our innovative pipeline portfolio, our proprietary integrated technology platforms, as well as our senior management team. Funds from this round of financing will be used to support global clinical development of our innovative pipelines, and to strengthen our preclinical development capabilities of innovative discovery engine.” said Dr. Mingjiu Chen, Founder, Chairman and CEO of Biosion.

Mr. Zhihua Yu, the Chairman of Lapam Capital, said: “We are very optimistic for Biosion’s unique and differentiated innovation pipeline, their highly competitive technology platforms, and their development team with global pharmaceutical experience. We look forward to helping Biosion develop its innovative medicines to benefit patients world-wide.”

Biosion’s Chief Operating Officer and member of the Board of Directors, former Vice President of Janssen Pharmaceuticals, Dr. Hugh Davis said: “With our portfolio of over a dozen high-quality preclinical assets from our unique discovery platforms, we are confident that we will be able to quickly advance the global IND filing and clinical development, thus transforming Biosion into a clinical stage biotech company.”

About Biosion, Inc.

Biosion is a global R&D biotech company developing innovative therapeutics in the fields of immuno-oncology and immunologic diseases. The company is building its proprietary pipeline through internal R&D programs, co-development programs with partners and in-licensing efforts.

The Company integrates several internally-derived proprietary technologies,including its H3 hybridoma platform, SynAbTM synergistic antibody technology, SynKronTM bispecific platform, and SynTracerTM HT-endocytosis screening platform, to significantly accelerate its discovery efforts for novel molecules. The company has operations in Newark, Delaware and Nanjing, China. For more information and full pipeline details, please visit www.biosion.com

About Lapam Capital

Lapam Capital is a leading healthcare-focused venture capital firm in China and manages over 4 billion RMB funds. Lapam is the only biomedical professional investment institution that has received funding from the National Social Security Fund so far. Lapam Capital has invested in more than 50 innovative drugs and innovative medical device companies, including Betta Pharmaceuticals, RemeGen, Clover biopharmaceuticals, Binhui Biotech, Eyebright Medical Group, and many other industry elite companies. The number of domestic NDAs and new drugs approved in Lapam investment portfolio is among the best in the industry. Highly recognized in the industry, Lapam Capital is committed to providing their invested bio-pharmaceutical companies with comprehensive value-added services that may play a key role in the development of the company.

About Zhongguancun Kaiyuan Capital

Zhongguancun Kaiyuan Capital is an industry-finance linkage investment fund initiated by Zhongguancun Venture Capital, focusing on early-stage venture capital in the fields of information technology and biomedicine. Zhongguancun Venture Capital is a venture capital business platform under the Zhongguancun Management Committee and Zhongguancun Development Group. It mainly conducts venture capital through fund of funds investment and direct investment, and strives to promote the effective connection of technology and capital.

About Oceanpine Healthcare Fund

Oceanpine Healthcare Fund (“OHF”), a member of the Oceanpine Capital group, is a healthcare venture fund that aims to connect innovation in the US to the Chinese consumer base, and primarily invests in Chinese and US firms with core technologies and proprietary R&D capabilities. We bridge a supply and demand gap exacerbated by limited R&D in China. Our unique “Dual Market” strategy will help our portfolio companies with local resources and guidance, as well as providing diversification and value-realization for investors. We have established extensive partnership with academic institutions in the USA, such as University of Chicago, MD Anderson Cancer Center, etc., to bring the research projects from these institutions to China and achieve successful transformation of technology. Since our establishment, we have invested in multiple outstanding companies in both China and USA, including Human Longevity Inc. (Genome Technology), Edigene (Gene editing), Hua Dao Biotech (CAR-T), etc.

About C&D Emerging Industry Equity Investment

Established in 2014, C&D Emerging Industry Equity Investment is a corporate venture capital backed by Xiamen C&D Co. Ltd(234# of Fortune 500, 2020)and has become one of the most active players in direct equity investment and FoF market with over RMB 8 billion in capital under management. Our vision is to create value and support companies with high growth potential to achieve better development. We focus on investment in innovative and emerging industries such as healthcare, advanced manufacturing, and TMT/consumption.

About Zheshang Innovest

Zheshang Innovest manages the Zhejiang Zheshang Transform and Upgrade Fund of Funds Partnership(Limited Partnership). It is the vice chairman member of Zhejiang Equity Investment Industry Association and the vice chairman member of Zhejiang M&A Federation. The fund of funds was established under the guidance of the Zhejiang Provincial Finance Office with an approved scale of 10 billion RMB.

Media and Investor Contact:

Ailie Su

Biosion USA, Inc.

E-mail: IR@biosion.com

Close Bitnami banner
Bitnami