'Novel drugs·CDMO competitiveness↑'

K-bio to win global orders

BIO USA was held between 3-6th of June…discussions about the technology transfer of novel drugs and CDMO orders

Samsung Biologics, Lotte Biologics, and ST Pharm introduced their technological capacities…to take the place of China’s absence

Anticancer agents, ADC, and obesity pipelines have gathered attention…discussed technology transfers

Major biotech companies in Korea participated in the BIO International Convention (BIO USA 2024) and introduced their in-house competitiveness.

 

Over 50 Korea-based companies attended the BIO USA 2024, held between June 3-6 in San Diego, United States.

 

They sought opportunities to expand partnerships along with discussions for technology transport.

 

Samsung Biologics showcased its new platform, showing a strong directive to expand the company’s growth related to intensified cell-culture with improved manufacturing capacity.

 

Lotte Biologics, ST Pharm, and Prestige Biologic introduced their contract development and manufacturing organization (CDMO) capacities and held partnering meetings for contract orders.

 

Korean companies have made significant achievements in novel drug development.

 

VaxCell Biotherapeutics showcased positive results of its novel candidate under a phase 2 clinical trial for hepatocellular carcinoma.

 

Genome & Company won a technology transport contract for its antibody-drug conjugate (ADC), confirming its competitiveness.

 

China absent from the BIO USA…all eyes on K-bio According to industry sources on June 9th, 47 Korean companies ran booths during the BIO USA, which was 6 more companies than last year.

 

BIO USA is the world’s largest biopharmaceutical convention, with more than 20,000 leaders in the biopharmaceutical industry participating.

 

Continuing from last year, Korean CDMO companies have gathered attention this year.

 

Notably, due to the introduction of the Biosecure Act by the United States, all eyes were drawn to the Korean companies in the absence of WuXi Biologics, China’s largest CDMO.

 

The United States aims to limit the business with the Chinese biotech companies.

 

Therefore, the analysis suggests that along with Swiss-based Lonza and Japan-based Fujifilm, Korean CDMO companies will have more opportunities.

 

The Korea booth at the BIO International Convention (BIO USA 2024) (photo=KoreaBio).

Samsung Biologics launched a new CDO platform called S-Tensify, bolstering CDO competitiveness.

 

S-Tensify supports high-intensity biomedicine development with the latest cell-culture technology.

 

The company shared that S-Tensify’s adoption of N-1 perfusion technology has increased its cell-culture concentration by 30-fold, significantly boosting manufacturing capacity during inoculation at the seed stage (N-1).

 

ST Pharm has started CDMO of CRISPR/Casx, used in gene editing technology.

 

Gene editing is a biomolecular tool for editing precise locations within DNA using zinc finger nucleases, TALEN, or CRISPR/Cas9.

 

CRISPR/Casx is an innovative technology for precisely editing DNA sequences, enabling deletion, addition, or correction of genetic material.

 

Novel drug development using gene editing is currently underway.

 

The U.S.

 

FDA approved exa-cel (U.K.-authorized product name: Casgevy), a CRISPR/Cas9 gene-edited therapy developed by the United States biotech company Vertex Pharmaceuticals and SWISS-based CRISPR Therapeutics.

 

ST Pharm showcased its manufacturing process of sgRNA, which precisely targets the genome.

 

More than 100 mer high-purity sgRNA production is needed to develop medicines, and this manufacturing technology is more difficult than ASO or siRNA oligonucleotides ingredients.

 

During the event, Prestige Biologics shared new CDMO business opportunities due to the imminent passing of the Biosecure Act by the United States.

 

According to the company, over 30 companies have requested meetings, and 6 offers have been received.

 

Prestige Biologics emphasized that the company is equipped with cost competitiveness and quality for a single-use approach.

 

K-bio showcased novel drug development competitiveness In addition to CDMO orders, Korean biopharmaceutical companies also showcased their capabilities in the development of novel drugs.

 

VaxCell Biotherapeutics presented the outcomes of Phase 2a ‘Vax-NK/HCC’ clinical trials for hepatocellular carcinoma.

 

This trial evaluated the efficacy of Vax-NK/HCC plus HAIC combination therapy involving 16 patients with advanced hepatocellular carcinoma who did not respond to conventional treatments.

 

The clinical results demonstrated that Vax-NK/HCC plus HAIC combination therapy had an objective response rate (ORR) of 68.8% and a progression-free survival (PFS) of 16.8 months.

 

Genome & Company has confirmed the competitiveness of its ADC candidate.

 

Earlier this month, the company signed a technology transfer contract with Swiss-based Debiopharm for its ADC candidate, GENA-111.

 

Including the upfront payment of approximately KRW 6.9 billion, the contract size amounts to a maximum of KRW 586.4 billion.

 

GENA-11 is an ADC candidate with a novel mechanism for targeting CD239.

 

CD239 is known to be highly expressed in cancer cells than in healthy cells, and no ADC has been commercialized for targeting this.

 

Genome & Company is considering targeting GENA-111 to treat gynecologic cancer.

 

After assessing which payload would be more effective, the company stated that the final target indication would be decided.

 

Bridge Biotherapeutics shared directives for developing novel drug candidates to treat idiopathic pulmonary fibrosis (IPF).

 

BBT-887 is an innovative new candidate under development in a phase 2 trial.

 

It is a selective inhibitor of autotaxine enzyme.

 

Autotaxine is a protein known to bind to receptors in cells and induce various physiological activities, such as sclerosis and tumorigenesis.

 

Bridge Biotherapeutics presentation (photo=Bridge Biotherapeutics).

Last month, Bridge Biotherapeutics received authorization from the Independent Data Monitoring Committee (IDMC) to continue the clinical trial.

 

After evaluating the efficacy and safety data of 75 clinical subjects, there were no concerns related to the drug safety or effects.