HUTCHMED Announces Selection of Its Shares in the Shanghai-Hong Kong and
Shenzhen-Hong Kong Stock Connect Programs

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.

Scandion Oncology receives approval for initiating the CORIST part 2 trial

On September 6, 2021 Scandion Oncology A/S, the Cancer Drug Resistance Company, reported that the company has obtained approval from the Danish Medicines Agency and the Ethics Com-mittee in Denmark of the amendment of part 2 of the CORIST Phase II study (Press release, Scandion Oncology, SEP 6, 2021, View Source,c3410221 [SID1234587265]). This means that the company can commence the inclusion of patients. To increase the recruitment rate, Scandion Oncology is expanding the number of sites in Denmark from 2 to 5 and will further add additional sites in the EU.

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"With this approval, we can now commence part 2 of this seminal study. This next step in our journey will target a clear proof-of-concept to create clarity in order to make a difference for patients and create value for our shareholders. To accelerate the recruitment rate, we are opening additional sites and expect a read-out in Q2-Q3, 2022. We will communicate more about our plans and strategy at our upcoming Capital Markets Day on September 8," said Bo Rode Hansen, President and CEO of Scandion Oncology.

On June 24, Scandion Oncology reported positive results from the dose-finding part 1 of the CORIST Phase II study. A well tolerated dose of SCO-101 in combination with the chemotherapy regimen FOLFIRI was determined and the treatment resulted in notable potentiation of FOLFIRI. Scandion Oncology also identified the oncogene RAS as a predictive biomarker, which led the company to making an amendment to the clinical protocol, optimizing the inclusion of patients and de-risking the study.

The design for part 2 of the study (the proof-of-concept arm) is a standard single arm Phase II study with the aim of assessing preliminary effect and further evaluating safety and tolerability of SCO-101 in combination with FOLFIRI. The primary efficacy objective is assessment of response (tumor reduction) and secondary objectives include assessment of Clinical benefit (The duration of Stable Disease, Progression Free Survival (PFS), Overall Survival (OS)) as well as biomarker assessment and correlation to treatment tolerability and outcome. Part 2 of the CORIST Phase II study will include up to 25 patients.

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on September 6, 2021, at 8:30 CET

Selvita will develop a platform to produce focused libraries of bioactive compounds with the use of machine learning and AI methods

On September 6, 2021 Selvita, one of the largest preclinical contract research organizations in Europe, reported that it had received a grant funding of 1 M EUR to create a novel technological platform which will accelerate the drug discovery process (Press release, Selvita, SEP 6, 2021, View Source;utm_medium=rss&utm_campaign=selvita-will-develop-a-platform-to-produce-focused-libraries-of-bioactive-compounds-with-the-use-of-machine-learning-and-ai-methods [SID1234587267]). The grant came from the National Centre of Research and Development with a total of 1.7 M EUR dedicated to the project. The project will enable Company to implement new services for biotech and pharma clients.

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The aim of the project is to significantly improve the early stages of the drug discovery process, leading to the identification of the first active substance which will undergo further development. Usually, this is done by searching large libraries of randomly selected chemicals, which are mostly inactive and not novel. This, however, results in a low probability of finding a compound with the desired biological profile worth pursuing further. It is also a very time-consuming and expensive process. In order to mitigate these problems, Selvita will create a service platform, called ProBiAI, that will use much smaller libraries of compounds with targeted biological properties using novel structures. This platform will integrate structure design, parallel synthesis and automatic compound purification, all of which will be optimized using artificial intelligence methods. What distinguishes this type of libraries is a much greater probability of identifying biologically active substances with better patentability, faster and cheaper.

Development of innovative compounds with therapeutic potential and a good IP position, which can be executed within an optimal time and budget, is one of the greatest challenges that biotechnology and pharmaceutical companies are currently facing. The aim of our project is to optimize the initial stages of the drug discovery process, including the design of compound structures with therapeutic potential, as well as the effective synthesis and purification of the designed target compound libraries.

To achieve our goal, we intend to create a platform that integrates the design of structures and the planning of parallel synthesis and automatic purification, based on the available scientific data, using artificial intelligence methods. Our platform will not only help to accelerate the process of discovering new drugs but will also increase the likelihood of discovering effective therapies, which may be of particular interest to our clients – comments Mirosława Zydroń, PhD Eng, Member of the Management Board and Director of the Chemistry Department at Selvita S.A.

Adaptimmune Updates Data from its Phase 1 Trial for Liver Cancer at ILCA Showing Clinical Benefit

On September 5, 2021 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported that updated data from its Phase 1 ADP-A2AFP trial for patients with liver cancer at ILCA (Press release, Adaptimmune, SEP 5, 2021, View Source [SID1234587253]).

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"We have seen significant antitumor activity with this first-generation product targeting AFP that is encouraging for the potential of cell therapy for the treatment of liver cancer in these heavily pre-treated patients with late-stage disease," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "We reported a complete response in one patient, and tumor reductions with stable disease that has lasted more than 16 weeks in two patients as well as disease control in most patients at the target dose. We are continuing the expansion phase and will update when new data becomes available."

"Despite the recent advances, we need more and better systemic therapies for liver cancer," said Dr. Bruno Sangro of Clinica Universidad de Navarra. "The first results from this cell therapy trial are of great interest since they indicate obvious antitumor activity in some patients. This treatment has generally been safely applied even to cirrhotic patients."

Oral Presentation Today at ILCA
Dr. Bruno Sangro presented data from Cohort 3 and the expansion phase of the ADP-A2AFP Phase 1 trial during an oral presentation today at ILCA. A replay will be available through the congress web site.

Topline results from the ADP-A2AFP Phase 1 trial as of the April 5, 2021 data cutoff
Efficacy

Thirteen patients with advanced hepatocellular carcinoma (HCC) received ADP-A2AFP in Cohort 3 and expansion
The best overall responses in Cohort 3 and expansion (per RECIST v1.1) included 1 complete response (reported in 2020), 6 stable disease and 4 progressive disease. 2 patients did not have scan results at the time of data cut-off
The disease control rate for patients with at least one scan was 7/11 (64%) and 2 patients had stable disease lasting beyond 16 weeks
Safety

ADP-A2AFP has an acceptable safety profile with no reports of significant T-cell related hepatotoxicity and no protocol-defined dose limiting toxicities
Adverse events (AEs) reported in 2 or more patients and considered related to T-cell infusion included neutropenia, leukopenia, lymphopenia, pyrexia, anemia, cytokine release syndrome, febrile neutropenia, thrombocytopenia, aspartate aminotransferase increased, and alanine aminotransferase increased
Two patients reported a total of 3 treatment-related serious AEs including cytokine release syndrome (Grade 1), infusion-related reaction (Grade 2), and febrile neutropenia (Grade 3)
Conclusions

Antitumor activity, with one complete response, sustained decreases in serum AFP, and best overall response of stable disease observed in 6 patients, indicate that ADP-A2AFP is an active product in HCC
ADP-A2AFP up to doses of 10 billion transduced cells has been associated with an acceptable safety profile
Overview of Trial Design

This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and anti-tumor activity of ADP-A2AFP in patients with liver cancer (hepatocellular carcinoma) or other AFP-expressing tumors, who are not amenable to transplant, resection, or loco-regional therapy, and who failed or were intolerant to or refused standard-of-care treatment
Dose escalation is complete, and this trial is intended to treat up to 25 patients with doses up to 10 billion transduced cells in the expansion phase

Kintor Pharma Included in Hong Kong Stock Connect Program

On September 5, 2021 Kintor Pharmaceutical Limited ("Kintor Pharma," HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, reported that the company’s stock has been included in the Hong Kong Stock Connect program (the "Hong Kong Stock Connect"), effective September 6, 2021 (Press release, Suzhou Kintor Pharmaceuticals, SEP 5, 2021, View Source [SID1234587262]).

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Dr. Youzhi Tong, Founder, Chairman, and Chief Executive Officer of Kintor Pharma, commented, "We are excited to be included in the Hong Kong Stock Connect. Since Kintor Pharma was officially listed on the Hong Kong Stock Exchange on May 22, 2020, the company’s development has received long-term support from investors. We expect that the inclusion in the Stock Connect program will facilitate further expansion of our investor base and enhance the liquidity of our stock. We continue to advance the progress of our research and development, clinical operations, and commercialization efforts to innovate therapeutics for patients with unmet medical needs, help advance human health, and maximize value for our shareholders."