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 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

On September 4, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s"), reported that it has entered into a definitive agreement with Citius Pharmaceuticals, Inc. ("Citius") pursuant to which it sold all of its rights to E7777 (an engineered IL-2-diphtheria toxin fusion protein) and certain related assets (Press release, Dr Reddy’s, SEP 4, 2021, View Source [SID1234587243]).

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Under the terms of agreement, Dr. Reddy’s will receive $40 million upfront upon the closing of the transaction, followed by approval milestone payment of up to $40 million related to the CTCL (cutaneous T-cell lymphoma) indication approval and up to $70 million for additional indication approvals. Further, Dr. Reddy’s will receive certain sales-based milestones and tiered earn-out payments.

In March 2016, Dr. Reddy’s had acquired the exclusive global rights (excluding Japan and Asia) to the investigational anti-cancer agent E7777 from Eisai Co. Ltd.

Erez Israeli, Chief Executive Officer, Dr. Reddy’s, said: "Addressing unmet patient needs in oncology remains a prime focus area for us. E7777 has significant potential as an important component of systemic therapy for CTCL and other cancers. Post acquiring from Eisai, significant progress was made on the CTCL development front. We are confident of Citius’ ability to realize the full potential of E7777 in the treatment of CTCL as well as in their ability to develop this promising drug for additional oncology and immuno-oncology indications."

On September 4, 2021 AmerisourceBergen (NYSE: ABC), Cardinal Health (NYSE: CAH) and McKesson (NYSE: MCK) reported that, under the previously announced proposed settlement agreement and process designed to resolve the opioid claims of state and local governmental entities, they have determined that enough states have agreed to settle to proceed to the next phase (Press release, Cardinal Health, SEP 4, 2021, View Source [SID1234591442]). Under the proposed settlement agreement and process, all U.S. States, territories, and Washington DC were given 30 days to join the settlement, except West Virginia which settled previously with the companies. As of August 21, 2021, 42 out of 49 states, all 5 territories and Washington DC had affirmatively signed on to the agreement.

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This next phase is notice to the subdivisions, and the subdivision sign-on period. During this phase, each participating state will offer its political subdivisions, including those that have not sued, the opportunity to participate in the settlement for an additional 120-day period, which ends January 2, 2022. After the conclusion of the political subdivision sign-on period, each company will independently determine whether a sufficient number of political subdivisions have joined for the settlement to proceed to implementation.

If the conditions are satisfied, the settlement would become effective 60 days after the distributors determine that there is sufficient participation to proceed. During this 60-day period, the participating states and the distributors would cooperate to obtain consent judgments in each participating state embodying the terms of the settlement. The companies will make their first annual settlement payment into escrow on or before September 30, 2021, and the payment will be disbursed following the effective date or returned to distributors if the settlement does not become effective. The final payment amount will depend on several factors, including the final participation rate of states and political subdivisions.

The companies believe that this settlement framework will allow them to focus their attention and resources on the safe and secure delivery of medications and therapies while expediting the delivery of meaningful relief to affected communities.

On September 3, 2021 Molecular Partners AG (SIX: MOLN, NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that its Chief Executive Officer, Patrick Amstutz, Ph.D., will present at two upcoming virtual healthcare investor events in September 2021 (Press release, Molecular Partners, SEP 3, 2021, View Source [SID1234587260]).

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Conference Presentation Details:

Event: Morgan Stanley 19th Annual Global Healthcare Conference
Date/Time: Friday, September 10, 11:00 AM – 11:45 AM ET (5:00 PM – 5:45 PM CET)
Event: H.C. Wainwright 23rd Annual Global Investment Conference
Date/Time: September 13-15, 2021; Presentation available on demand from Sept. 13, 7:00 AM ET (1:00 PM CET)
All webcasted presentations will be made available on the Molecular Partners website.