Multitude Therapeutics, Inc.

The FDA's approval for Yuhan's J&J-partnered Lazcluze, Merck and Kelun's revised ADC deal, and U.S. lawmakers' scrutiny of clinical trials run at Chinese military hospitals made our news this week. Yuhan's Lazcluze, licensed by Johnson & Johnson, has made history as the first Korea-developed novel cancer drug to be approved by the FDA. Merck has optioned in on one Kelun Biotech antibody-drug conjugate but returned another. A few U.S. lawmakers have asked the FDA to examine clinical trials involving sites at Chinese military hospitals. And more. 1. Targeting AZ's Tagrisso, Johnson & Johnson's Rybrevant combo wins key FDA nod in first-line lung cancerThe FDA has approved Johnson & Johnson’s Rybrevant and Lazcluze for newly diagnosed EGFR-mutant non-small cell lung cancer. The combo will compete with AstraZeneca’s Tagrisso. J&J in-licensed Lazcluze, a third-generation EGFR tyrosine kinase inhibitor, from Korea’s Yuhan in 2018. The drug is now the first Korea-developed novel anti-cancer therapy to be approved by the FDA.2. Merck & Co. bags one Kelun ADC for $37.5M, boots out another asset as pipeline tinkering continuesMerck and Kelun Biotech have reworked their multi-asset ADC deal. The New Jersey pharma has decided to return the CLDN18.2-directed SKB315. Although no reason was offered, the CLDN18.2 space has become very crowded with multiple firms exploring various modalities. Merck also agreed to pay $37.5 million to take up an option on a new candidate, a bispecific ADC coded SKB571, although the exact drug target remains unclear.3. Lawmakers urge FDA to investigate clinical trials run in tandem with China's militaryLawmakers on the House Select Committee on the CCP are asking the FDA to scrutinize clinical trials conducted at Chinese military hospitals. The lawmakers questioned the trustworthiness of data generated at those sites and potential risks for U.S. intellectual property. Trials of Eli Lilly’s Alzheimer’s disease drug Kisunla and Pfizer’s cancer med Inlyta were raised as examples. 4. Despite looming BIOSECURE threat, pharma contracting giant WuXi Bio scoops up new projectsMeanwhile, as the House is reportedly gearing up for a vote on the BIOSECURE Act in September, WuXi Biologics said it had added 61 new projects in the first six months of 2024, half of which came from the U.S. Fifty-two of the new projects are for preclinical candidates and five for early clinical work. The number of new projects compares favorably to the company’s haul during the same period last year.5. FDA allows BioNTech-MediLink ADC trial to resume with lower, safer dosesAfter a safety scare in mid-June, the FDA has allowed MediLink Therapeutics to restart a phase 1 trial of its BioNTech-partnered HER3-directed ADC. Before the halt, the trial had recorded three deaths across two dose cohorts. Now, BioNTech said it will focus solely on doses no higher than 3mg/kg as MediLink “had observed a dose level-dependent trend of treatment-related adverse events.”6. Denmark's Adcendo signs $1B biobuck deal for Multitude’s anti-TF ADCDenmark’s Adcendo has signed a $1 billion biobucks deal to get ex-China rights to a preclinical ADC from Sino-American biotech Multitude Therapeutics. The candidate, coded ADCE-T02, targets tissue factor. A phase 1 trial of the drug is scheduled to start in Australia in the fourth quarter, and Adcendo is planning to get FDA’s green light to launch a U.S. study “in the near future.”7. Eisai, Biogen's Leqembi nabs UK nod, but reimbursement remains elusiveThe U.K. has approved Eisai and Biogen’s Leqembi for early-stage Alzheimer’s disease but excluded patients with two copies of the ApoE4 gene out of safety concerns. Still, the National Institute for Health and Care Excellence has tentatively denied coverage of the drug under Britain’s taxpayer-funded insurance program. The drug cost watchdog cited Leqembi’s “relatively small benefits” and high costs.Other News of Note: 8. Astellas employee held in China indicted by China’s prosecutors9. Insulet unveils $200M insulin delivery device production site in Malaysia10. Pathalys raises $105M series B to prepare Japan-approved kidney disease drug for FDA11. FDA rebukes another troubled Eugia production site with a warning letter12. Korea’s Bridge Biotherapeutics, China’s HitGen sign drug discovery pact for cancer (release)13. Pfizer pulls smoking cessation drug Champix from Korean market (Korea Biomedical Review)

In the field of pharmaceutical innovation, a little-known Chinese ADC company has quietly risen, causing widespread concern in the industry. The company, Multitude Therapeutics, with its innovative technology and excellent research and development capabilities, has recently successfully won a global licensing deal of more than $1 billion, which has impressed the industry.   Multitude Therapeutics' roots can be traced back to 2007, when its founders Chen Changzheng and Meng Xun co-founded Abmart, a company focused on antibody customization and related services. After years of technology accumulation and business expansion,Abmart has accumulated a rich "antibody technology ecosystem" in the fields of plant science, aquatic science and animal science. In 2019,Abmart further expanded its business with the establishment of Multitude Therapeutics, an early stage drug development company, to apply its core technology accumulated over the years to the pharmaceutical field.   Starting from a CRO company,Multitude Therapeutics has gradually entered the field of ADC innovative drug research and development with its own innovative advantages. Multitude Therapeutics has grown rapidly, driven by both market trends and technology developments, and has performed well with this latest transaction.   On August 20,Multitude Therapeutics and Danish biotechnology company Adcendo ApS announced a licensing agreement under which Adcendo will receive ADCE-T02(Multitude Therapeutics R&D code AMT-754 has exclusive global development and commercialization rights outside of Greater China. Under the agreement,Multitude Therapeutics will receive an initial payment of tens of millions of dollars and will receive a total of more than $1 billion in milestone payments and global sales commissions over subsequent development, regulatory and commercial milestones.   The success of this transaction not only highlights the technical strength of Multitude Therapeutics, but also arouses widespread concern in the industry. In the past, the company has kept a relatively low profile, but with this "Big Deal", its strength and potential are gradually emerging.   The founding team of Multitude Therapeutics has extensive entrepreneurial and management experience. Its co-founders, Chen Changzheng and Meng Xun, had previously founded Abmart together, laying the foundation for this pharmaceutical company transformation. In addition,Multitude Therapeutics has attracted the favor of many well-known investment institutions in multiple rounds of financing, fully demonstrating the capital market's recognition of its technology and development prospects.   With the success of this transaction,Multitude Therapeutics is set to play an even more important role in the future pharmaceutical innovation circuit. This cutting-edge ADC company will surely become a new star in the development of China's pharmaceutical innovation industry.

COPENHAGEN, Denmark and SHANGHAI, Aug. 20, 2024 /PRNewswire/ -- Adcendo ApS ("Adcendo") and Multitude Therapeutics Inc. ("Multitude") jointly announced today that they have signed a licensing agreement for the development of a novel, highly differentiated antibody-drug conjugate (ADC) targeting Tissue Factor (TF) with the development code ADCE-T02. Under this agreement, Adcendo will obtain the exclusive development and commercialization rights for the asset globally, except for the Greater China region (Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan) where Multitude will retain development and commercialization rights. According to the financial terms of the agreement, Multitude would receive upfront and milestone payments upon achieving development, regulatory, and commercial milestones totally over $1 billion, as well as single-digit to low double-digit tiered royalties on potential future product sales. TF is a clinically validated ADC target that is highly expressed in indications such as non-small cell lung cancer, colorectal cancer, cervical cancer, oesophageal cancer, head and neck cancer, bladder cancer and certain gastrointestinal cancers, but its expression is limited in normal tissues. ADCE-T02 is a highly differentiated anti-TF ADC, and the first ADC with a Topoisomerase I inhibitor-based linker/payload, to enter into clinical development in Australia, US and Europe. Its unique antibody design minimizes the impact on the coagulation pathway, while the T1000-exatecan linker-payload technology platform has been shown to amplify the bystander effect, improve linker stability, and has the potential to overcome potential resistance mechanisms. These differentiated features promise to translate into a superior therapeutic window, a better safety profile, enhanced response rates and longer response durations through reduced toxicity driven treatment terminations, interruptions or dose reductions. Clinical Trial Notification for ADCE-T02 has been submitted in Australia, and an IND application in the United States is planned in the near future. The start of the Phase I study in Australia is expected in Q4 2024. Michael Pehl, Chief Executive Officer of Adcendo, stated: "We are highly impressed by the deep science behind Multitude Therapeutics' linker/payload platforms and are delighted about our licensing agreement on ADCE-T02, which perfectly complements our existing unique first-in-class ADC pipeline and allows Adcendo to become a clinical-stage biotech company in Q4 2024. TF is an excellent ADC target with ample opportunity in high unmet need indications, as was recently reported at the annual ASCO congress. The highly differentiated profile of ADCE-T02 will enable a full capture of the potential of this target and will hopefully bring tangible progress to cancer patients in need". Dr. Xun Meng, Chief Executive Officer of Multitude, stated: "We are delighted to collaborate globally with Adcendo. The successful cooperation demonstrates that the T1000-exatecan linker-payload platform has played a significant role in multiple successful ADC pipelines. We look forward to Adcendo's experienced global clinical development team bringing ADCE-T02 to cancer patients in need as soon as possible." About Adcendo ApS: Adcendo ApS is developing breakthrough antibody-drug conjugates for the treatment of underserved cancers. In 2024, the company completed a Series A extension financing round, increasing the total funds raised to 98M EUR to advance, broaden, and accelerate the development of its first-in-class ADC pipeline assets. Investors include Novo Holdings, Ysios Capital, Pontifax Venture Capital, RA Capital Management, HealthCap, Gilde Healthcare and Dawn Biopharma, a platform controlled by KKR. For further information, please visit About Multitude Therapeutics Inc. : Multitude Therapeutics is a clinical-stage company focused on the development of ADC drugs. Multitude Therapeutics has two technology platforms: MabArray™— an antibody platform for discovering novel cell surface tumor targets to construct first-in-class targets, and T1000 — a new linker-payload technology for developing ADCs, which allows ADCs prepared with this platform to achieve a better balance of the bystander effect, efficacy, and safety. The combination of MabArray™ and T1000 generates significant synergistic effects, enabling Multitude Therapeutics to build an ADC "atlas" that is expected to treat malignant tumors with high unmet medical needs and achieve higher and more durable responses. Based on the above technology platforms, Multitude Therapeutics currently has several ADCs in development, including three first-in-class target ADCs. Moreover, several ADCs, including all-new target ADCs, have entered the clinical stage, where they have demonstrated good safety and efficacy and provided preliminary validation of the company's platform technology. For further information, please visit SOURCE Adcendo