- WuXi Biologics is having a busy year, announcing on Monday it inked yet another development and manufacturing partnership. This time it's with Immune Pharmaceuticals for the late-stage production of bertilimumab, the biotech's anti-eotaxin-1 monoclonal antibody.
- WuXi will scale-up bertilimumab's manufacturing process to 2,000 liters, providing for both clinical trial and commercial needs, and will also provide fill and finish services. No financial details have been released.
- The immediate plans are to start current good manufacturing practice (cGMP) production in the second quarter of 2019 and release supplies for clinical use in the third quarter of that year.
It's evidently WuXi's year for deals. So far in 2018, the contract development and manufacturing organization (CDMO) has partnered with Adagene to develop preclinical-stage antibodies; signed a manufacturing deal with Bioasis Technologies over the biotech's preclinical cancer biologic xB3-001; expanded a biologics manufacturing collaboration with Aravive Biologics; signed a memorandum of understanding with Tsinghua University Innovation Center for Immune Therapy (ICIT); and most recently, hooked up with Harbour BioMed to develop, manufacture and supply Harbour's leading heavy-chain antibody for clinical trials.
What's more, Wuxi is planning new production facilities in the U.S., Ireland and Singapore, and to expand its footprint and capabilities in China. It also has the money to make these kinds of investments: 2017 annual results showed revenues up 63.7% to an all-time high of RMB 1.62 billion (around $244.8 million), while net profit was up 85.1%.
Though financials weren't disclosed, Wuxi's bottom line surely benefits too from the company's latest deal.
In 2011, Immune Pharmaceuticals signed a deal with Lonza to produce bertilimumab for Phase 2 clinical trials using Lonza’s system of cell lines and vectors. Immune has moved from Lonza to WuXi for further clinical trial materials and commercial supply.
Bertilimumab is Immune Pharmaceuticals' lead product candidate. It targets inflammation in a number of diseases, and has completed a Phase 2a study in moderate-to-extensive bullous pemphigoid, with a pivotal study planned for 2019. A Phase 2 trial in ulcerative colitis is also ongoing.
"This is an extremely important milestone for the bertilimumab program, as we have secured clinical manufacturing not only for our planned pivotal Phase 2/3 trial in bullous pemphigoid, but for future trials in ulcerative colitis, asthma and other indications," said Tony Fiorino, Immune's chief medical officer and chief operating officer, in the July 9 statement.