German radiopharma forms another China joint venture; Urovant's Gemtesa passes blood pressure study
German biotech ITM is forming a joint venture with Chinese radiopharma player Chengdu Gaotong Isotope.
This venture follows a strategic partnership between ITM and the China Isotope and Radiation Corporation (CIRC) which was initially formed in 2010 and further extended in November 2019.
The newly formed company is scheduled to start operations by the end of the year and will be located in Chengdu, China. This will be ITM’s second location in China after opening its first subsidiary in Shanghai earlier this year.
“We are committed to further expanding our successful, long-term partnership with CIRC and are looking forward to increasing our global footprint in China,” said ITM CEO Steffen Schuster.
Further details of the agreement were not disclosed. — Paul Schloesser
Urovant’s overactive bladder drug Gemtesa passes safety test
California biotech Urovant’s Gemtesa has no clinically relevant effect on blood pressure and heart rate, according to the biotech.
Urovant showed data from an outpatient study at the yearly meeting of the American Urological Association showing blood pressure and heart rate being similar between two groups of patients: one with a placebo for 28 days, and the other on daily Gemtesa.
“We are delighted to present these important additional data confirming the efficacy and safety profile of Gemtesa,” said Urovant CMO Cornelia Haag-Molkenteller in a statement.
According to the study, systolic blood pressure, diastolic blood pressure, and heart rate were generally similar between the two groups. There were no statistically significant or clinically relevant differences in mean daytime or mean 24-hour ambulatory systolic blood pressure, diastolic blood pressure, or heart rate after 28 days of treatment with Gemtesa compared with placebo.
Part of Vivek Ramaswamy’s family of companies, the biotech’s overactive bladder drug Gemtesa hit the market late last year as Urovant’s first approved product. — Paul Schloesser
MiMedx shows mixed results in mdHACM clinical studies
Georgia regenerative medicine biotech MiMedx has results from two late-stage clinical trials on its treatment (micronized dehydrated Human Amnion Chorion Membrane, or mdHACM) for knee osteoarthritis and plantar fasciitis.
The trials, in Phases IIb and III, respectively, did not hit the primary endpoints in either study. The osteoarthritis study did reveal varied efficacy signals between patients evaluated pre- and post-study, which will lead MiMedx to attempt confirmatory studies. As for the study on plantar fasciitis, MiMedx will not pursue a BLA with the FDA.
“We look forward to further discussions with the FDA under the Regenerative Medicine Advanced Therapy process, and reviewing our next steps for continued clinical study of Purion processed mdHACM as a platform for regenerative medicine,” said MiMedx CEO Timothy Wright in a statement.
MiMedx was in hot water late last year after the CEO and the COO at the time were respectively convicted of securities fraud and conspiracy. This happened after the FBI alleged that the company was fraudulently boosting its sales. — Paul Schloesser
Adaptimmune sees 36% response rate in Phase I #ESMO21 tease
Fresh off a $3 billion deal with Roche to develop off-the-shelf T cell therapies, Adaptimmune is capitalizing on the momentum with a new data release it expects to present at #ESMO21 this weekend.
In a Phase I study looking at 22 evaluable patients with MAGE-A4+ tumors “in the context of HLA-A*02,” Adaptimmune saw seven partial responses and one complete response, good for an overall response rate of 36.4%. The responses spanned five different indications including ovarian, head and neck, esophagogastric junction and bladder cancers, as well as synovial sarcoma.
“It is no longer a question of whether our SPEAR T-cells are effective against a range of MAGE-A4 expressing tumors — they undoubtedly are,” CEO Adrian Rawcliffe said in a statement. “Now, our focus is on turning them into approved therapies.”
Another 11 patients saw their disease stabilized on the therapy, while three saw disease progression. Adaptimmune reported that the data cutoff was August 2, saying 25 total patients had received the therapy at that point while 22 of the 25 made up Monday’s data readout.
The biotech also noted it was encouraged by the initial durability results. Of the eight responders, five remain progression-free after a minimum of 24 weeks. — Max Gelman