FDA Grants Orphan Drug Designation to Mabwell’s Treatment of Small Cell Lung Cancer

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The FDA has granted Orphan Drug Designation to Mabwell’s 7MW3711, a novel B7-H3-targeting antibody-drug conjugate (ADC) for the treatment of patients with small cell lung cancer. According to the company, 7MW3711, which features an antibody molecule, a novel linker, and the new payload Mtoxin (TOP1i), binds to tumor cell membrane antigens, being internalized and transported to the lysosome, releasing a cytotoxic drug, and inducing tumor cell apoptosis.

According to preclinical studies, 7MW3711 offers greater tumor-killing effects compared to similar ADCs and shows a favorable safety profile and pharmacokinetic properties, with controlled on- and off-target toxicities in animal models.¹

“IDDC is a next generation ADC site-specific conjugation technology platform independently developed by Mabwell, consisting of multiple systematic core patented technologies including the site-specific conjugation process DARfinity, the site-specific linker IDconnect, the novel payload Mtoxin, and the conditional release structure LysOnly,” reports Mabwell, in a press release. “The next generation ADCs developed based on the above systematic patented technologies have better structural uniformity, quality stability, efficacy, and tolerability. The novel payload Mtoxin (MF6) demonstrates good pharmacodynamics, bystander killing efficacy, and anti-multidrug resistance.”

Last year, the ADC market was estimated to be worth around $9.7 billion, with the expectation that it will reach $19.8 billion by 2028, growing at a compound annual growth rate of 15.2% from 2023 to 2028, according to MarketsandMarkets. This can be credited to a growing number of collaborations and partnerships among stakeholders in the market, a higher focus on the development of new ADCs, and regular approvals by the FDA, according to the report. Specifically, the Asia Pacific region is expected to experience rapid growth in the coming years, influenced by a growing number of ADCs among the patent population.²

“The antibody drug conjugates market is competitive, with a small number of players competing for market shares. F. Hoffmann-La Roche Ltd (Switzerland), Daiichi Sankyo Company, Limited (Japan), Seagen Inc. (US), Gilead Sciences, Inc. (US), Takeda Pharmaceutical Company Limited (Japan), Pfizer Inc. (US), Astellas Pharma Inc (Japan), AstraZeneca (UK), ADC Therapeutics SA (Switzerland), ImmunoGen, Inc. (US), and Zydus Group (India), among others are some of the leading players in this market,” reports Marketsandmarkets, in a press release. “Most companies in the market focus on organic and inorganic growth strategies, such as product launches, expansions, acquisitions, partnerships, agreements, and collaborations, to increase their product offerings, cater to the unmet needs of customers, increase their profitability, and expand their presence in the global market.”

For years, tumors have been treated through chemotherapy and radiotherapy, which can cause damage to healthy tissue in the process. Puja Sapra, SVP, biologics engineering, oncology targeted delivery, AstraZeneca, stated that ADCs offer promise in treating cancer tumors, suggesting that they can act as a guided missile through delivering a powerful payload directly into cancer cells.³

“These molecules consist of an antibody attached via a chemical linker to a chemotherapy payload,” said Sapra, in an article published by AstraZeneca. “When administered, the antibody part of the molecule homes in on tumor cells that express a specific tumor associated or overexpressed protein on their surface. The ADC is then taken into the cancer cell, where appropriate cleavage mechanisms release the cytotoxic payload. This process kills the cancer cell in a more targeted way than traditional chemotherapy, sparing healthy cells.”

References

1. FDA Grants Orphan Drug Designation to 7MW3711. PR Newswire. July 16, 2024. Accessed July 18, 2024. https://www.prnewswire.com/news-releases/fda-grants-orphan-drug-designation-to-7mw3711-302198021.html

2. Antibody Drug Conjugates (ADC) Market worth $19.8 billion | MarketsandMarkets. PR Newswire. October 5, 2023. Accessed July 18, 2024. https://www.prnewswire.com/news-releases/antibody-drug-conjugates-adc-market-worth-19-8-billion--marketsandmarkets-301948054.html

3. Engineering novel cancer treatments: ADCs and radioconjugates. AstraZeneca. October 18, 2023. Accessed July 18, 2024. https://www.astrazeneca.com/what-science-can-do/topics/next-generation-therapeutics/engineering-novel-cancer-treatments.html