Hoth Therapeutics and WuXi strike API and drug product deal for cancer therapeutic
WuXi will use its new modality platform to provide an end-to-end solution for oligonucleotide peptide
China's WuXi STA has signed two contracts with Hoth Therapeutics, a clinical-stage biopharmaceutical company, for the process development and manufacturing of the API and formulation of drug product for the continued development and commercialisation of HT-KIT.
HT-KIT is Hoth's a new molecular entity (NME) morpholino oligonucleotide therapy in development for targeting mast cell-derived cancers and anaphylaxis.
Through the agreements, the two companies expect to accelerate the development of this new modality therapy with rapid and efficient PMO manufacturing scale-up from feasibility batches to GMP material.
WuXi STA will utilise its integrated CRDMO (contract research development and manufacturing organisation) new modality platform to provide an end-to-end solution for oligonucleotide peptide as well as their conjugates for both API and formulation under one roof.
The company has already begun the HT-KIT API process development for manufacturing and expects to yield small-scale material during the first quarter of 2022.
API manuacturing will be immediately followed by initiation of formulation development for HT-KIT, which Hoth intends to develop as a parenteral formulation for injection.
Hoth has said it intends to pursue a pre-IND meeting with the FDA after completion of formulation development.
Related News
-
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Pharma Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain. -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
News BIOSECURE Act continues to loom over Chinese pharma manufacturers
With the US BIOSECURE Act on its way to passing into legislation, Chinese companies are facing declining revenues within the first half of 2024 as US pharmaceutical and healthcare companies pull their businesses from the country. -
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance