Alpha fetoprotein targeted T-cell therapy(Adaptimmune Ltd.)

- Confirmed complete response in ovarian cancer, and confirmed partial responses in ovarian, head and neck, esophagogastric junction, bladder, and synovial sarcoma cancers - - Majority of patients experienced antitumor activity with a disease control rate of 86% - - ADP-A2M4CD8 cell therapy shows improved tumor cell killing and engagement of the broader immune system to fight cancer - PHILADELPHIA and OXFORD, U.K., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, announced updated data from its Phase 1 SURPASS trial in multiple solid tumors to be presented in a digital poster at the upcoming European Society for Medical Oncology (ESMO) annual meeting. The poster will be displayed on the ESMO congress web site on Thursday, September 16th. The Company has also released a video of Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer (CEO), and Elliot Norry, Adaptimmune’s Chief Medical Officer, describing these data in more detail that can be accessed here: . “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. Now, our focus is on turning them into approved therapies. This begins with ongoing recruitment in this SURPASS trial for people with lung, bladder, gastroesophageal, head and neck, and now ovarian cancer, and continues with the recently initiated SURPASS 2 trial in esophageal and EGJ cancers,” said Adrian Rawcliffe, Adaptimmune’s CEO. “These data bring us closer to identifying further indications to take into late-stage development and confirm our expertise in developing and enhancing cell therapies. ADP-A2M4CD8 does exactly what we designed it to do — kill cancer cells and more effectively engage the broader immune system to deliver improved potency and clinical benefit.” Dr. David Hong, Professor, Deputy Chairman in the Department of Investigational Cancer Therapeutics (Phase I Program) at The University of Texas MD Anderson Cancer Center said, “We are encouraged by these promising early data from the SURPASS trial. Having previously seen strong responses with afami-cel, this next-generation cell therapy appears safe and demonstrated antitumor activity for a majority of patients across many cancer indications.” Topline results from the Phase 1 SURPASS trial (data cut-off August 2, 2021)Emerging efficacy and durability data are promising with responses in five solid tumor indications * Of 25 patients who received ADP-A2M4CD8, 3 were not evaluable at the time of data cut-off: 2 patients (ovarian or esophageal cancers) did not have post-baseline scans; 1 patient (EGJ) had a post-baseline scan that did not meet the ≥4-week duration for evaluation of stable disease** One PR in head and neck cancer and one PR in EGJ cancer were reported previously at SITC 2020 ADP-A2M4CD8 demonstrated an acceptable safety profile ADP-A2M4CD8 was designed to be more potent than the first-generation product Initial translational data confirm that ADP-A2M4D8 is more potent and better engages the immune system, compared to the first-generation product Conclusions from the Phase 1 SURPASS Trial Data at ESMO Overview of Phase 1 SURPASS trial design About AdaptimmuneAdaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Forward-Looking StatementsThis release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 9, 2021 and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances. Adaptimmune Contacts: Media Relations: Sébastien Desprez — VP, Corporate Affairs and CommunicationsT: +44 1235 430 583M: +44 7718 453 176Sebastien.Desprez@adaptimmune.com Investor Relations: Juli P. Miller, Ph.D. — VP, Investor RelationsT: +1 215 825 9310M: +1 215 460 8920Juli.Miller@adaptimmune.com

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 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 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 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