On September 7, 2021 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported that it has entered into a strategic collaboration and license agreement with Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) to develop and commercialize allogeneic cell therapies to treat multiple oncology indications (Press release, Adaptimmune, SEP 7, 2021, View Source [SID1234587282]).

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"We are proud to partner with Genentech, given their commitment to patients and science in the cancer immunology field. This collaboration broadens Adaptimmune’s leadership position in developing allogeneic cell therapies building on our in-depth knowledge gained from our autologous clinical programs," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "Through this collaboration, our platform will form the basis of a personalized allogeneic cell therapy vision, where any patient can receive a T-cell product for their cancer; a significant step towards our goal of making cell therapies both curative and mainstream."

"We believe allogeneic cell therapies could be a game-changing approach for developing personalized therapy platforms based on individual cancer patients’ unique needs," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "This partnership, which combines Adaptimmune’s allogeneic platform with Genentech’s expertise in developing personalized therapies, complements our other efforts to discover and develop personalized cell therapies. It holds the promise to change how we treat cancer and brings us another step closer to making personalized healthcare a reality."

The collaboration has two components:

Development of allogeneic T-cell therapies for up to five shared cancer targets
Development of personalized allogeneic T-cell therapies
For each component, Adaptimmune will be responsible for developing clinical candidates using its induced pluripotent stem cell (iPSC) derived allogeneic platform to produce T-cells (iT cells). Genentech will be responsible for the input TCRs and subsequent clinical development and commercialization.

Under the terms of the agreement, Adaptimmune will receive an upfront payment of $150 million and additional payments of $150 million over five years, unless the agreement is earlier terminated. In addition, Adaptimmune may be eligible to receive research, development, regulatory and commercial milestones payments potentially exceeding $3 billion in aggregate value.

Adaptimmune will also receive tiered royalties on net sales in the mid-single to low-double digits.

Adaptimmune has the right to opt in to a 50/50 U.S. profit/cost share on "off-the-shelf" products. If Adaptimmune elects to opt in, then Adaptimmune will be eligible to share 50 percent of profits and losses from U.S. sales on such products and is eligible to receive ex-U.S. regulatory and sales-based milestone payments, as well as royalties on ex-U.S. net sales.

The effectiveness of the agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

Virtual update on Adaptimmune’s allogeneic platform
Thursday, September 9, 2021 at 08:00 a.m. EDT
The Company will host a live virtual update to discuss its allogeneic platform and future development plans at 08:00 a.m. EDT (01:00 p.m. BST), on Thursday, September 9. You can join the event with this link: https://bit.ly/3jHI4KP. More details, as well as a replay of the event, can be found on the Investor Relations tab of the Company’s website: https://bit.ly/2WRDa4C.

On September 6, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that the Company’s ordinary shares, which trade on The Stock Exchange of Hong Kong Limited ("HKEX"), are included in the Shanghai-Hong Kong Stock Connect and Shenzhen-Hong Kong Stock Connect programs, effective on September 6, 2021, according to announcements issued by the Shanghai Stock Exchange and the Shenzhen Stock Exchange (Press release, Hutchison China MediTech, SEP 6, 2021, View Source [SID1234587383]).

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The Stock Connect programs allow international and Mainland Chinese investors to trade securities in each other’s markets through the trading and clearing facilities of HKEX, Shanghai and Shenzhen Stock Exchanges. Qualified Mainland Chinese investors can access eligible Hong Kong shares (Southbound), while Hong Kong and overseas investors can trade eligible A shares (Northbound), subject to specified daily quotas.

Christian Hogg, CEO of HUTCHMED commented: "We are pleased to be included in the Stock Connect programs and that qualified Mainland Chinese investors will now have direct access to our shares through the Shanghai and Shenzhen Stock Exchanges."

Hang Seng Indexes Company Limited announced on August 20, 2021, that HUTCHMED would be included as a constituent of several indexes including the Hang Seng Composite Index from September 6, 2021. Inclusion in the Hang Seng Composite Index is a key requirement for the Stock Connect scheme.

On September 6, 2021 JW Therapeutics (HKEx: 2126), an innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (hereafter abbreviated as relma-cel, R&D code JWCAR029) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, and has released the drug registration certificate (Press release, JW Therapeutics, SEP 6, 2021, View Source [SID1234587276]). Relma-cel is the first CAR-T product approved as a Category 1 biologics product in China, and sixth approved CAR-T product globally.

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Relma-cel, JW Therapeutics’ first CAR-T product, was independently developed based on a CAR T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company) to meet the needs of the Chinese market. Currently, it is the only approved CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review (in r/r LBCL) and breakthrough therapy designations (in follicular lymphoma). To date, over 100 patients have been dosed with relma-cel in clinical studies, marking relma-cel a most studied anti-CD19 CAR-T product in China.

This approval is based on the results of a single-arm, multi-center, pivotal study (RELIANCE study) to evaluate the efficacy and safety of relma-cel in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) in China. RELIANCE study results show that relma-cel demonstrated high rates of durable disease response and low rates of CAR-T associated toxicities, and may provide a best-in-class CAR-T therapy profile.

Professor Zhu Jun, the lead investigator of RELIANCE study, Chief of Internal Medicine Department and Lymphoma Department at Peking University Cancer Hospital, said, "The RELIANCE study is a registrational clinical study completed with high quality, and I’m very proud of that. Based on the outstanding efficacy and safety profiles it demonstrated in RELIANCE study, I believe that relma-cel will provide healthcare professionals in China with an additional treatment option and bring hope for long-term remission and even cure for lymphoma patients."

Edward Hu, Vice Chairman and Global Chief Investment Officer at WuXi AppTec, said, "Congratulations to JW Therapeutics for the approval of its first product. WuXi AppTec will continue to enable more companies to deliver advanced therapies for patients globally. Cell and gene therapy is on

On September 6, 2021 Median Technologies (Paris:ALMDT) (ALMDT:PA) reported that outstanding performance based on a large-scale lung cancer screening (LCS) patient cohort to characterize malignant vs benign lung nodules based on a deep learning algorithm on low-dose chest computed tomography (Press release, MEDIAN Technologies, SEP 6, 2021, View Source [SID1234587275]). Median plans to demonstrate how the potential of its iBiopsy AI powered Computer Aided Diagnosis (CADx) product for LCS could significantly impact the accuracy, consistency, and adoption of LCS worldwide. The Median Technologies iBiopsy Lung Cancer Development Plan was launched in February 2021, as part of the Company’s strategic positioning in early-stage disease diagnosis.

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Lung cancer is the number one cancer killer globally, with an estimate of 1.8m deaths, accounting for 25% of all cancer deaths in 2018. This is largely due to late-stage diagnosis of the disease associated with poor 5-year survival. Major international studies have shown that LDCT lung cancer screening can reduce mortality by 44% (NELSON Trial, 2018). Despite being included in US screening guidelines and the increased adoption by the medical community, screening efforts still suffer from low rates of adoption. The low patient enrollment is commonly attributed to the difficulty to characterize malignant from benign nodules leading to high rates of false positives, unnecessary follow up procedures and raising concerns on the economic viability of screening programs.

The study was based on a cohort of 1,696 patients from the National Lung Screening Trial cases (NLST) consisting of a total of 15,608 lung nodules. The training set was based on 1,224 patients with 11,392 nodules and the test set was based on 472 patients having a total of 4,216 nodules.

The performance of iBiopsy CADx for the characterization of lung nodules shows an AUC of 0.991 and an outstanding sensitivity of 95.2% for a specificity of 95.7% and is a major progress for Lung Cancer Screening worldwide.

"We have achieved an outstanding performance with our innovative deep learning algorithm for lung nodule characterization. This promising and powerful digital biomarker could have a profound impact on lung cancer screening and help to dramatically reduce the 1.8m lung cancer deaths per year by diagnosing lung cancer patients at a stage that could save their lives.", highlights Fredrik Brag, CEO and founder of Median. "Our plan in the coming months is to perform an additional large-scale study for an end-to-end lung cancer screening digital biomarker. Results of this study including both nodule detection (CADe) and characterization (CADx) are expected in Q4, 2021", Brag added.

Median’s AI digital biomarker could significantly contribute to eliminate barriers to widespread LCS adoption. It could have a huge impact on saving patients’ lives for the deadliest form of cancers as well as providing substantial savings by eliminating unnecessary healthcare spendings.

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of AI digital biomarkers, to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on Lung Cancer, Liver Cancer (HCC) and Liver Disease (NASH)

Since 2020, Median’s iBiopsy development program has been supported by the European Investment Bank (EIB) through a financial loan of €35 million under the Juncker Plan, the European Fund for Strategic Investments for research and innovation projects developed by companies with high growth potential.

On September 6, 2021 Alliance Pharma plc (AIM: APH), the international healthcare group, reported that it will announce its results for the six months ended 30 June 2021 on Tuesday 21 September 2021 (Press release, Alliance Pharma, SEP 6, 2021, View Source;aph-/rns/notification-of-half-year-results/202109060700077459K/ [SID1234587273]).

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A link to a recorded presentation of the half year results, by Peter Butterfield, Chief Executive Officer, and Andrew Franklin, Chief Financial Officer, will be included in the results announcement.

The recorded presentation will also be made available at the investor section of Alliance’s website, View Source .

A Q&A call for analysts will be held at 10.00am on the day of the results, 21 September 2021; analysts who require joining details should contact Buchanan at [email protected] .

For any further information, please contact Buchanan at the details below.