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 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 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 3, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Morgan Stanley 19th Annual Global Healthcare Conference on Tuesday, September 14, 2021 (Press release, Eli Lilly, SEP 3, 2021, View Source [SID1234587229]). Michael Mason, senior vice president, president of Lilly Diabetes, will participate in a virtual fireside chat at 1:15 p.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On September 3, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, reported that the company has received Human Research Ethics Committee (HREC) clearance to commence the Phase II combination trial of olinvacimab, PharmAbcine’s anti-VEGFR2 antibody, and KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 molecule, for the treatment of metastatic Triple-Negative Breast Cancer (mTNBC) in Australia (Press release, PharmAbcine, SEP 3, 2021, View Source [SID1234587247]).

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The Phase II clinical trial is an open-label and multicenter trial that will enroll 36 immuno-oncology drug naïve mTNBC patients regardless of their PD-L1 expression level. The study will evaluate the clinical efficacy, safety, pharmacodynamics, and the expression level of VEGFR-2 and PD-L1 after the administration of 16mg/kg of olinvacimab, and 200mg of pembrolizumab. PharmAbcine will sponsor the clinical trial that will take place in Australia, and MSD will supply pembrolizumab.

PharmAbcine and MSD decided to enter this collaboration based on the promising clinical data obtained from the Phase Ib olinvacimab and pembrolizumab study in mTNBC which is still ongoing in Australia. According to the interim result presented at San Antonio Breast Cancer Symposium (SABCS) 2020, olinvacimab in combination with pembrolizumab showed a clear safety profile and certain encouraging efficacy data, including 50% Overall Response Rate (ORR) and 67% Disease Control Rate (DCR) in the high-dose olinvacimab (16mg/kg) cohort (n=6pts). In addition, one patient in Partial Response (PR) showed Complete Response (CR) in the target lesion and another PR patient showed CR in a non-target lesion.

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 15-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

"This is a significant milestone for the company, as we strongly believe that olinvacimab could be a new therapeutic option for mTNBC patients," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We are excited to initiate this study and expect the first patient enrollment to take place in October 2021.

About Olinvacimab

PharmAbcine’s leading pipeline, olinvacimab is an anti-VEGFR2 neutralizing fully human IgG. It is currently in a Phase II study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients in both US and Australia. In addition to the ongoing Phase Ib olinvacimab and pembrolizumab combo trial in mTNBC, another olinvacimab plus pembrolizumab Phase Ib trial for rGBM is ongoing in Australia.