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

On September 5, 2021 AffaMed Therapeutics ("AffaMed"), a global clinical stage biopharmaceutical company dedicated to addressing critical unmet medical needs in ophthalmic, neurological and psychiatric disorders, reported that during the recent "China International Trade in Services Fair 2021" a strategic cooperation partnership with Beijing Tiantan Hospital of Capital Medical University ("Beijing Tiantan Hospital") and Beijing Infinite Brain Technologies ("IBT") (Press release, AffaMed Therapeutics, SEP 5, 2021, View Source [SID1234587264]). The three parties will cooperate to promote the application and development of digital therapy in neurological diseases.

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"Digital therapy offers new possibilities in the treatment of different diseases as a novel therapeutic approach and has demonstrated encouraging clinical performance in the fields of cognitive behavior, biofeedback and neural oscillations, as distinguished from the existing mobile health applications and remote diagnosis and treatment", said Dr. Dayao Zhao, CEO of AffaMed, "AffaMed focuses on neurological and psychiatric disorders, and is committed to continuing to discover innovative therapies. The Beijing Municipal Government recently published the ‘Action Plan for Accelerating Collaborative Innovation in Medicine and Health’, with the aim to advance the new digital medical industry and support the research and development of digital medical products targeting areas such as mental disease and neurodegenerative disorders. With this clear regulatory support, I believe our strong alliance with Tiantan Hospital and IBT will further drive technological research, clinical application and commercial development, and support our ambition to lead and accelerate the innovation and implementation of digital therapy in China."

Dr. Wang Yongjun, President of Beijing Tiantan Hospital said: "As the problem of aging population in society worsens, the prevalence of cerebrovascular diseases and cognitive impairment continues to increase yearly, putting pressure on both the patient and the medical system. For example, the incidence of post-stroke cognitive impairment is high, along with known issues like low cognitive screening rates and identification rate, with limited post-disease intervention options available, together with challenges in intervention and management. In close collaboration with AffaMed and IBT, we will develop highly effective digital assessment and intervention products. Through refined clinical studies and real-world research, we will further improve early screening rates for relevant indications, while bridging the gap in clinical resources and providing digital interventions that are more relevant to patients’ living environments and easier to use and comply with."

Dr. Sun Wei, Founder and Chairman of Beijing Infinite Brain Technologies, said: "With the rich neuroscience data and big data models accumulated over decades, we have been focusing on using proprietary technologies and artificial intelligence to not only accelerate the development of innovative digital therapeutics for multiple neurological diseases but also provide patient-centered digital medical solutions covering the full intervention processes. With this strategic cooperation, we will tap into AffaMed and Beijing Tiantan Hospital’s strong capabilities in clinical development and application, to further promote the development and innovation of digital therapeutics and offer benefit to domestic as well as global patients with better solutions and lower medical costs."

The strategic cooperation between AffaMed, Beijing Tiantan Hospital and IBT will focus on the application of digital therapies in neurological disorders, pooling the three parties’ resources and experience in technology development, clinical design and operation, and clinical practice to verify the safety and efficacy of digital therapies in clinical trials, and jointly promote the development process and application of digital therapies in China.

On September 5, 2021 GeneQuantum Healthcare (Suzhou) Co.,Ltd. (hereinafter referred to as "GeneQuantum") and BrighGene Biomedical (Suzhou) Co.,Ltd. (hereinafter referred to as "BrighGene ") reported that it signed a co-development agreement for antibody immune agonist conjugate (AIAC), GQ1007 (Press release, GeneQuantum Healthcare, SEP 5, 2021, https://www.prnewswire.com/news-releases/genequantum-and-brighgene-sign-agreement-for-development-of-antibody-immune-agonist-conjugates-301369524.html [SID1234587263]).

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GQ1007 is a new type of antibody-drug conjugate. It is an antibody conjugated to a potent immune agonist. In recent years, immunotherapeutic antibody drugs targeting PD-1 and PD-L1 (representing immune checkpoint inhibitors) have revolutionized cancer therapy. Even though the superior efficacy of immune checkpoint inhibitor treatment has shown great benefit, many cancer patients do not respond to such treatment. These non-responsive tumors are referred to as "cold" tumors. Compared with other immunotherapies, such as anti-PD1 / PD-L1 and anti-CD40 etc., GQ1007 not only can precisely reach tumor site but also enhance innate and adaptive immune responses. It activates dendritic cells and macrophagesand increases T cell infiltration into tumor tissue through immune agonists, thus "cold" tumors becomes "hot" tumors and immune system is mobilized to suppress tumors. Ultimately, GQ 1007 achieves strong and lasting anti-tumor effect, overcomes the low response rate of PD-1 antibody in immunotherapy, and has great clinical value and market potential.

Dr. Paul Song, Chief Scientific Officer of GeneQuantum comments: "BrighGene has extensive experience in small molecule drug development, they hold a unique and competitive advantage in TLR7/8 agonists. We are incredibly pleased to work with R&D team led by Dr. Jiandong Yuan, CEO of BrightGene. By working together, we expect to achieve IND filing for GQ 1007 soon."

Dr. Gang Qin, Founder, Chairman and Chief Executive Officer comments: "Seamless integration of small molecule platform of BrighGene and iLDC technology platform of GeneQuantum will enhance our R&D capability for world competitive innovation conjugates, this collaboration fully demonstrate high effectivity of resource and expertise integration among China biomedical companies, which significantly improve new drug development. Based on our in-house iLDC technology, GeneQuantum continues to establish in-depth collaborations with domestic and international biopharmaceutical companies to develop more innovative drugs."

Dr. Jiandong Yuan, CEO of BrightGene, comments, "GeneQuantum’s enzymatic site-specific conjugation technology and unique linker technology effectively improve current issues of chemical conjugation, such as high heterogeneity, low stability, narrow treatment windowand difficult manufacturing challenges for ADC drug products. Linker stability is extremely important in the field of antibody immune agonist conjugates. GeneQuantum’s unique stable linker technology can decrease or even avoid random shedding of immune agonists in circulation and significantly reduce the likelihood of general (non-specific) immune activation, it ensures this AIAC molecule with best-in-class potential. BrighGene and GeneQuantum will keep close collaboration relationship, fully leverage our individual core strengths to develop more globally competitive first-in-class or best-in-class drugs in near future."

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."

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