On April 22, 2024 Hyundai Bioscience (KOSDAQ 048410) reported the positive results from its preclinical study on triple-negative breast cancer, investigating combination therapy of ‘Niclosamide-based oral anti-cancer drug’ jointly developed with CNPharm and Docetaxel, one of widely-used chemical anticancer agents (Press release, Hyundai Bioscience, APR 22, 2024, View Source [SID1234642222]). As a result, the combination therapy was found to be more effective than Docetaxel alone. The anti-cancer efficacy of the combination therapy group was 67% better than the Docetaxel-treated group.

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This preclinical study results will be published through an SCI-level paper.

Hyundai Bioscience has succeeded in repurposing Niclosamide as an oral anticancer drug. Niclosamide had been found effective in treating various cancers by acting on the metabolic process of cancer cells, evidenced by decades of in vitro studies.

Metabolic anticancer drugs inhibit the growth and survival of cancer cells by disrupting the unique metabolic mechanisms of cancer cells as well as blocking the cell signaling pathways. Metabolic anticancer agents exhibit higher antitumor activity when treated with the existing anticancer drugs as a combination therapy.

From the in vitro test, Niclosamide successfully inhibited the proliferation and survival of cancer cells by disrupting their metabolism, preventing the anticancer drug-resistance by blocking the cell signaling pathways of tumor cells and recurrence and metastasis of cancer by inhibiting cancer stem cells. Niclosamide is found to be an antitumor agent that blocks metabolism, and Niclosamide-based anticancer drugs can solve the resistance and metastasis problems simultaneously.

Due to its anticancer mechanism, Niclosamide is effective against multiple cancers, including lung cancer, breast cancer, prostate cancer, colon cancer, liver cancer, kidney cancer, and head and neck cancer. It has also been found to be highly effective against cancers that are resistant to current anticancer treatments such as triple-negative breast cancer, lung cancer, prostate cancer, ovarian cancer, colon cancer, pancreatic cancer, and head and neck cancer.

Although Niclosamide was known for excellent anticancer efficacy, it has not been clinically used on humans for over 60 years because of its ‘low bioavailability’ and ‘short half-life to maintain effective drug concentration in the blood.’

Through its proprietary ‘drug delivery technology’ technology, Hyundai Bioscience, in collaboration with CNPharm, has developed a niclosamide-based oral anticancer drug formulation that enables a drug concentration at IC50 level or higher to inhibit the proliferation of cancer cells even with a non-toxic Niclosamide dose. Their 3-month-long in vivo toxicity tests demonstrated that the Niclosamide blood concentration level of no-observed-adverse-effect level (NOAEL) dose was 7,888 ng/mL. Considering the IC50 of various cancer cells is mostly 65~654 ng/mL, Niclosamide can effectively inhibit cancer cell proliferation even when administered at a dose less than one-tenth of the NOAEL.

Hyundai Bioscience’s in vivo efficacy study on combination therapy of a niclosamide-based anticancer agent with Docetaxel was conducted on animals implanted with triple-negative breast cancer cells. The results confirmed that Niclosamide significantly increased the anticancer efficacy.

Dr. Jin Geun-Woo, leading Hyundai Bioscience R&D, highlighted the significance of these preclinical results, stating, "This is the first case that is statistically proven in vivo that the oral Niclosamide-based anticancer treatment has a remarkable effect on triple-negative breast cancer, a type of cancer that is challenging to treat. Niclosamide-based metabolic anticancer drugs could potentially address the problems of drug resistance and metastasis that make cancer treatment difficult." He added, "Clinical phase 1/2a trials will be conducted in Korea for various difficult-to-treat cancers, including triple-negative breast cancer, pancreatic cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and metastatic prostate cancer."

Mr. Oh Sang-gi, the CEO of Hyundai Bioscience, announced, "The Niclosamide-based oral anticancer drug project will be carried out by a new subsidiary of Hyundai Bioscience, ADM KOREA," and added, "Hyundai Bioscience therefore plans to transfer its Niclosamide-based oral anticancer technology to its new subsidiary."

On April 22, 2024 ImmPACT Bio USA Inc. (ImmPACT Bio), a clinical-stage biopharmaceutical company developing a new generation of cellular therapies that have the potential to bring transformational benefits to patients, reported that it will present new ex vivo preclinical data for ImmPACT Bio’s bispecific Claudin 18.2 (CLDN18.2)/TGF-β chimeric antigen receptor (CAR) T program for the treatment of solid tumors that express CLDN18.2, including gastric and gastroesophageal junction cancer, as part of a poster presentation at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting, taking place in Baltimore, MD from May 7-11, 2024 and virtually (Press release, ImmPACT-Bio, APR 22, 2024, View Source;car-t-program-at-the-american-society-of-gene–cell-therapy-27th-annual-meeting-302123539.html [SID1234642221]).

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"There is a significant unmet medical need in patients with gastric cancer, which is among the top three deadliest cancers globally. CLDN18.2 has emerged as a promising target due to its elevated expression in tumor cells but not healthy cells. Previous CAR T-cell therapies targeting CLDN18.2 have demonstrated promise but lacked durability, likely due to poor T-cell persistence and function in solid tumors," said Sumant Ramachandra, M.D., Ph.D., chief executive officer of ImmPACT Bio. "We are using a novel bispecific approach designed to enhance CAR T-cell activity in solid tumors by overcoming immune suppression in the tumor microenvironment. We will present new ex vivo preclinical data at ASGCT (Free ASGCT Whitepaper) which demonstrated the ability of our bispecific CAR targeting CLDN18.2 and TGF-β to convert the immunosuppressive TGF-β signal into a T-cell activation signal to ultimately enhance T-cell fitness, reduce regulatory T-cell conversion, and decrease phenotypic exhaustion."

Details for the presentation are as follows:

Title: Engineering a Bispecific Claudin 18.2/TGF-β CAR to Target Claudin 18.2 Positive Tumors and Overcome the Tumor Microenvironment
Abstract Number: 832
Presenter: Jessica Reyes, ImmPACT Bio
Poster Session Date/Time: Wednesday, May 8, 2024 at 12:00 – 7:00 PM ET
Author Reception Date/Time: Wednesday, May 8, 2024 at 5:30 – 7:00 PM ET
Poster Session: Immune Targeting and Approaches with Genetically Modified Cells and Cell Therapies

Abstracts and additional details can be found at the ASGCT (Free ASGCT Whitepaper) 27th Annual Meeting website.

On April 22, 2024 SalioGen Therapeutics, a biotechnology company developing next-generation genetic medicines based on its novel Gene Coding technology, reported that four abstracts, including one oral presentation, will be presented at the upcoming annual meetings of the Association for Research in Vision and Ophthalmology (ARVO) and the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) (Press release, SalioGen Therapeutics, APR 22, 2024, View Source;cell-therapy-asgct-302123770.html [SID1234642220]).

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The presented findings will highlight preclinical data supporting the tolerability and in vivo efficacy of SGT-1001, a development candidate for the one-time treatment of Stargardt disease, a genetic condition that causes progressive vision loss. A separate program under development for cystic fibrosis will show success in targeting integration of the CFTR gene into the native CFTR intron 1, a major step forward in targeted delivery of a large genetic cargo. SalioGen will also share genomic profiling data on its novel Gene Coding technology, which uses transposition to integrate large DNA constructs (up to 100kb) into the genome and promises to overcome key safety risks and limitations of other approaches to genetic medicine.

ARVO will take place in Seattle, Washington, from May 5 to 9, 2024, and ASGCT (Free ASGCT Whitepaper) will take place in Baltimore, Maryland, from May 7 to 11, 2024.

ARVO Presentation Details
Title: ABCA4 gene replacement in a mouse model of Stargardt disease using a mammalian transposon system
Format: Poster Presentation (#A0065)
Location: Exhibit Hall
Date/ Time: Monday, May 6 at 4:00-5:45 MDT

ASGCT Presentation Details
Title: Efficacy and Integration of a Non-Viral ABCA4 Transposon in Treating Stargardt Disease: Evidence from Mice and Primate Studies
Format: Oral presentation (abstract #11)
Location: Ballroom 1
Date/Time: Tuesday, May 7 at 1:30 PM – 1:45 EST

Title: Comprehensive Genomic Profiling of Human CD19 CAR T-cells Engineered with a Mammalian Transposon
Format: Poster presentation (#1212)
Location: Exhibit Hall
Date/Time: Thursday, May 9 at 12:00 EST

Title: A Programmable Mammalian Transposon Achieves Accurate Integration of a CFTR2-27 Superexon in Human Bronchial Epithelial Cells
Format: Poster presentation #1677
Session Room: Exhibit Hall
Date/Time: Friday, May 10, 2024 at 12:00 EST

On April 22, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported selection of a move-forward Phase 2 expansion dose for IDE397 monotherapy in MTAP-deletion squamous non-small cell lung cancer (NSCLC), based on adverse event profile and preliminary clinical efficacy observed, including multiple partial responses by RECIST 1.1 (Press release, Ideaya Biosciences, APR 22, 2024, View Source [SID1234642219]).

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"We are excited to select a move-forward Phase 2 expansion dose for IDE397 monotherapy in MTAP-deletion squamous NSCLC, based on AE profile and multiple responses observed at this dose. We believe MTAP-deletion squamous NSCLC is an area of high unmet medical need, and we are excited to further evaluate clinically our potential first-in-class MAT2A inhibitor IDE397 in this tumor setting, while in parallel advancing multiple rational combinations with our pharma collaborators and internal wholly owned pipeline," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

"We believe IDE397 is well positioned as a potential first-in-class MAT2A inhibitor and encouraged to see preliminary translation of our preclinical activities to the clinic in the MTAP-deletion squamous NSCLC setting. Next, through this year we look forward to the potential to clinically validate several important preclinical hypotheses we have generated on several mechanistically high conviction rational combinations in the MTAP-deletion setting," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. The Company continues to focus on evaluating IDE397 in two trials, including as monotherapy and in multiple clinical combinations:

IDE397-001 (NCT04794699) is a Phase 2 monotherapy expansion of IDE397 in MTAP-deletion solid tumors
Phase 1/2 trial of IDE397 + AMG 193 in MTAP-Deletion NSCLC (Amgen-sponsored study, NCT05975073)
Phase 1 trial of IDE397 + Trodelvy in MTAP-deletion bladder cancer (IDEAYA-sponsored, NCT04794699)

On April 22, 2024 OSR Holdings, a global healthcare holding company, reported that it has signed a memorandum of understanding (MOU) with SillaJen, a Kosdaq-listed biotech firm with a pipeline of immuno-oncology drug candidates, to share technology and clinical development resources and launch a strategic collaboration between the two companies (Press release, OSR Holdings, APR 22, 2024, View Source [SID1234642218]). Through the MOU, the two companies will explore various ways to collaborate to create synergies between current platform technologies and new drug candidates.

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OSR Holdings was established in 2019 in South Korea as a "hub-and-spoke" business model, which has become more visible in the biopharma space over the past decade. The "hub-and-spoke" model, exemplified by companies like Roivant Sciences, PureTech Health and BridgeBio Pharma, enables centralized management of drug development strategies, clinical plans, and resource allocation by the holding company. The model allows the holding companies’ subsidiaries to concentrate on the advancement of new drug assets and technological innovations. The model’s scalability and resource efficiency are notably enhanced, especially as clinical phases of drug development progresses.

OSR Holdings’ current portfolio includes Vaximm AG, a Swiss entity developing immuno-oncology therapeutics; Darnatein, a South Korean drug developer of osteoarthritis therapeutics; and RMC, a distributor of specialized medical devices. Vaximm AG, a venture spun out from Merck KGaA, has completed Phase 2a clinical trials for glioblastoma. Darnatein, established by Dr. Seung-Hyun Choi, a former researcher at one of the leading research institutes in the U.S., Salk Institute for Biological Studies, boasts a robust platform for cartilage and bone regeneration and is developing new drugs for other diverse disease indications based on this foundational technology.

SillaJen boasts a diverse pipeline of new drugs, including the SJ-600 series and BAL0891, and is leading the way in developing anti-cancer viruses based on its GEEV platform. Known for its immune-evasion capabilities, GEEV enables anti-cancer viruses to efficiently target affected areas. The SJ-600 series is an anti-cancer pipeline based on SillaJen’s GEEV platform. BAL0891, a mitotic checkpoint inhibitor, has advanced to Phase 1 clinical trials targeting solid tumors and will be conducted in the United States.

Sung Jae "Alex" Yu, COO of OSR Holdings, stated, "the signing of this MOU marks the two companies transitioning into strategic partners for the development of innovative drug technologies in the global immuno-oncology market. We eagerly anticipate exploring a variety of opportunities to further our relationship and collaborations with SillaJen, particularly in the U.S., the largest pharmaceutical market in the world."

A representative of SillaJen stated, "We can anticipate synergies by collaborating between a company that possesses original anti-cancer drug development technology and a company with global business expertise," and added, "Aside from our cooperation with existing partners, we will have the opportunity to present SillaJen’s exceptional pipeline in the U.S. market."