Genexine Announces Merger with EPD Biotherapeutics to Strengthen Drug Development Pipeline

  • Merger with EPD Bio, a biotech developing a target protein degrader (TPD) platform technology
  • Jaehyun Choi, Ph.D. founder and CEO of EPD Bio, joins Genexine as head of R&D

SEOUL, South Korea–(BUSINESS WIRE)–Genexine (KOSDAQ: 095700), a publicly-listed, clinical-stage Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of serious unmet medical needs, announced a merger with EPD Biotherapeutics (hereinafter referred to as ‘EPD Bio’), a company developing an innovative targeted protein degradation (TPD) bioPROTAC platform technology, to strengthen its research workforce with expertise in PROTAC technology and enhance Genexine’s drug pipeline.

“Through this merger, Genexine has secured key talent with innovative technology that can lead the global market and at the same time added innovative new drugs based on bioPROTAC technology. Combining EPD Bio’s bioPROTAC technology with Genexine’s clinical and CMC development capabilities will enable us to continue pursuing the development of innovative new drugs that can lead the global market,” said Sungjune Hong, CEO of Genexine.

EPD Bio founder and CEO Dr. Jaehyun Choi, an expert in the field of targeted protein degradation technology, previously worked at Arvinas, a global leader in PROTAC (Proteolysis targeting chimera) technology and held research and scientific positions at Samsung Advanced Institute of Technology and Trillium Therapeutics. Following the merger, Dr. Choi will join Genexine as a representative director in charge of R&D along with EPD Bio’s core research team. Mr. Hong will continue as a representative director overseeing corporate development and business management.

Genexine announced that, at the board of directors meeting held on June 26th, it decided to merge with EPD Bio through a small-scale merger. The merger ratio is 1:6.1924079, and Genexine will issue new shares to the existing shareholders of EPD Bio according to the merger ratio. Detailed merger procedures are scheduled to be completed by early October.

EPD Bio is developing EPDegTM, an mRNA-based bioPROTAC technology that can overcome the limitations of existing small molecule- based PROTAC technology. The platform creates fusion-protein degraders delivered as mRNA-LNP whereby they remove the dependence on tissue specific expression of E3 ligase. As a unique technology with a potential to be first-in-class, it can generate a diverse pipeline of TPDs for multiple undruggable targets in different disease indications. EPD Bio has been receiving significant attention from the industry domestically and internationally as EPD Bio won the ‘Korea Startup/Biopharma Acceleration Program 2023’ led by the Korea Health Industry Development Institute and Takeda Pharmaceutical which supports domestic bio pharmaceutical companies to discover and develop innovative technologies.

RM Global Partners LLC acted as Genexine’s strategic advisor.

About Genexine

Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on developing and commercializing immunotherapeutics and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFc® fusion technology. The company has multiple products in clinical development including several undergoing Phase 3 registration trials. The company’s proprietary pipeline includes GX-188E (tirvalimogene teraplasmid) for head and neck cancer and cervical cancer, GX-I7 (efineptakin alfa) for multiple cancers, GX-H9 (eftansomatropin alfa) for Pediatric Growth Hormone Deficiency and GX-E4 for CKD-induced anemia, among others. Genexine has established multiple partnerships with global companies in order to expedite product development and commercialization and create significant value. Genexine is listed on the Korean exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea. Genexine is committed to the well-being and care of patients worldwide. For more information about Genexine, please visit at www.genexine.com.

About EPD Bio

EPD Bio is an early-stage biotech company dedicated on developing novel engineered protein degraders that selectively degrade the most undruggable disease-causing proteins that cannot be targeted by current small molecule-based PROTAC (PROteolysis TArgeting Chimera). The company was founded in 2021 and is based in Seoul, South Korea.

Contacts

Investor Contact:
Genexine Inc.

Jongsoo Lee, Investor Relations

jongsoo.lee@genexine.com

Kyuri Kim, Investor Relations

kyuri.kim@genexine.com

AriBio Licenses Exclusive Marketing Rights for AR1001 for Alzheimer’s Disease in China for $770 Million USD

SEONGNAM-SI, South Korea–(BUSINESS WIRE)–AriBio Co., Ltd. (AriBio), announces signing of exclusive marketing rights for AR1001, an investigational drug for early Alzheimer’s disease, in China for up to $770 million USD.

The term consists of a non-refundable upfront payment of 120 billion KRW (approximately 90 million USD), with the total deal summing up to 5.59 billion RMB (approximately 770 million USD) inclusive of milestone payments with additional royalties. The upfront payment will be paid starting from mid-2024.

In response to the increasing Alzheimer’s disease population in China, prominent pharmaceutical companies have sought to develop safe and effective oral treatments for Alzheimer’s disease. To date, AriBio has partnered for exclusive marketing rights in South Korea with Samjin Pharmaceutical for 100 billion KRW. And now, the partnership has expanded to China, cumulating to 1.12 trillion KRW (approximately 840 million USD). Considering the market competition for Alzheimer’s drugs in China and the sales strategy, the licensee requested not to be disclosed until an agreed upon time.

The global Phase 3 clinical trial for AR1001 in early Alzheimer’s disease patients (Polaris-AD) is on-going in the United States, United Kingdom, and South Korea. Furthermore, the clinical trial is awaiting regulatory approval in China and the European Union. This study will be conducted across 180 global sites. The first patient enrollment began in the United States in December 2022, and the rest of the regions are actively enrolling.

Matthew (Jai Jun) Choung, CEO and Chairman of AriBio, stated, “This deal demonstrates our unwavering commitment to developing meaningful treatments for Alzheimer’s disease, and our partners will help position AR1001 for success in the major Asian territories. We are building momentum in our AR1001 program, as we continue to discuss with other potential partners in Asian countries, the Middle East, South America, as well as Europe and the United States.”

About AR1001

AR1001 is a PDE5 inhibitor being developed as an investigational oral agent for the treatment of Alzheimer’s disease. Pre-clinical studies have confirmed neuroprotective effects of AR1001 via inhibiting neuron apoptosis and restoring synaptic plasticity. AR1001 has also demonstrated robust reduction of hyperphosphorylated tau proteins in pre-clinical models as well as in a Phase 2 trial.

About AR1001-ADP3-US01

AR1001-ADP3-US01 (NCT05531526) is a Phase 3 double-blind, randomized, placebo-controlled, multi-center trial to evaluate the efficacy and safety of AR1001 over 52 weeks in participants with early Alzheimer’s disease. The study aims to assess the efficacy and safety of AR1001 in slowing the progression of Alzheimer’s disease through various cognitive and functional assessments. The details of the clinical trial are available at ClinicalTrials.gov.

About AriBio

AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with offices in both South Korea and the United States. The company focuses on the development of novel therapies for neurodegenerative diseases. The company continues to expand its partnerships to accelerate the development of meaningful treatment options for neurodegenerative diseases.

Contacts

Fred Kim

fredkim@aribiousa.com

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