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NEWS & EVENTS

NEWS & EVENTS

Subject

BIOGEMEX-XYLONIX XDX-01 IMMUNO-ONCOLOGY COMPANION DIAGNOSTIC CODEVELOPMENT KICKED OFF

Name BioGemex
Date 19-09-09 10:01
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Contents

 ANNOUNCEMENT -9 SEP 2019

 

-         BioGemex and Xylonix executed the first funding agreement for accelerating the XDX-01 co-development in accordance to the MOU entered in August

-         The remaining contractual details expected to be finalized and entered by 2019 Q4   

-         The first set of development tests to commence in October


SEOUL/SINGAPORE, 9 September 2019, BioGemex (BioGemex.com) and Xylonix (Xylonix.io) today announced the execution of the first funding agreement and the commencement of the studies for accelerating the co-development of XDX-01, the prediction biomarker for cancer patient response to immunotherapies.

Scheduled to start in October, the initial set of tests are intended for establishing the aggregation-free manufacturing scalability of XDX-01 and validating its biological mechanism of the disclosed prediction power over cancer patient response to immunotherapies. The tests will be conducted by external CRO services for data objectivity.

“A well-evidenced scientific explanation is a must in modern medicine, even if you have the numbers”, said Dr. Jinhyuk Fred Chung, CSO of Xylonix, “next several months will be the most critical time in the future commercialization of XDX-01, and I expect there will be some positive surprises and new developments along the way”.

“The swift development is the result of months of preparations by our two companies working closely”, said Mr. Tae Hyun Yun, CEO of BioGemex, “and we are working to formalize the remaining details of our collaboration by the end of 2019”.

Earlier on 16 Aug 2019, BioGemex and Xylonix entered the MOU for the joint development of the pre-treatment diagnostic biomarker XDX-01 for predicting the cancer patient response to T-cell mediated immunotherapies 1. 

Today in the US, the average cost of cancer immunotherapies is approximately $150,000 per year per patient to use, and it has been reported to fail in 85% of the prescribed patients in delivering any benefits 2.

Ends

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1. Xylonix "XYLONIX SIGNS MOU WITH BIOGEMEX TO CO-DEVELOP A PREDICTIVE CANCER IMMUNOTHERAPY TREATMENT RESPONSE DIAGNOSTIC." Media@xylonix.io, 16 Aug 2019

2.  Haslam, A. & Prasad, V. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs. JAMA Netw Open 2, e192535 (2019).

About Xylonix (Xylonix.io)

Xylonix (Xylonix Pte. Ltd.) is an immuno-oncology biotech that is developing a new way of combating cancer through PARP1 DNA-repair overdrive for toxicity-free, widely applicable and curative first-in-class cancer immunotherapy drugs. Dubbed as onco-parthanatos agents, Xylonix’ lead development candidates, C005D and C008D, are being developed for future indicated use as monotherapy or in combination with other leading immunotherapies such as immune checkpoint inhibitors or CSF1R inhibitors. For more information, visit https://xylonix.io.

About BioGemex (BioGemex.com)

BioGemex (BioGemex Inc.) is a diagnostic solutions provider focused on developing a world-first site-agnostic cancer diagnosis solutions for accelerating the breakthrough clinical investigations of cancer immunotherapies and site-agnostic precision drugs – a major unmet need in pharmaceutical industry. Building on its manufacturing experience and sustainable revenue platform, BioGemex is actively incorporating new developments and products into its pipeline.  In addition to its R&D and manufacturing operations, BioGemex also offers ODM/OEM pregnancy test kits of the highest accuracy and reliability for Korea and overseas markets. For more information, visit https://www.biogemex.com.

About XDX-01

XDX-01 is a Xylonix-proprietary pre-treatment diagnostic biomarker under co-development with BioGemex for the predictive assessment of cancer patient response to T-cell mediated immunotherapies. If translated successfully, its future utilities may include its use as companion diagnostics for various cancer immunotherapies including Xylonix C005D, C008D, and others. For more information, visit https://xylonix.io.

Forward-Looking Statement of Xylonix Pte. Ltd. (Singapore) and BioGemex Inc. (Korea)

This news release of Xylonix Pte. Ltd. (the “Xylonix.io”) and BioGemex Inc. (the “BioGemex”), collectively “Companies”, includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Companies undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

 


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