On September 6, 2021 TB Alliance reported that it has granted global pharma major Lupin Limited (Lupin), a non-exclusive license to manufacture the anti-TB drug pretomanid as part of the three-drug "BPaL" regimen (Press release, Lupin, SEP 6, 2021, View Source [SID1234587269]). Lupin intends to commercialize the anti-tuberculosis (TB) medicine in approximately 140 countries and territories, including many of the highest TB burden countries around the world.

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"TB Alliance is committed to ensure its products are widely available and affordable to those who need them," said Mel Spigelman, President and CEO, TB Alliance. "Partnering with Lupin, a well-established manufacturer with experience delivering high quality TB therapies, will help further enable widespread access to our novel regimen while promoting a competitive market to drive affordability."

Nilesh Gupta, Managing Director, Lupin added, "As a global leader in anti-TB medicines, Lupin is committed to enhancing access to bridge unmet needs in countries where it is needed the most. This collaboration with TB Alliance leverages our strength and expertise to contribute to better global health."
"Tuberculosis is one of humanity’s oldest, deadliest, and most persistent diseases. Lupin is the largest supplier of first-line anti-TB drugs in the world, and we are excited to partner with TB Alliance to help bring new therapies for highly drug-resistant TB to reach individuals and countries where access to these medicines is so urgently needed," said Naresh Gupta, President API Plus, Lupin.

About Tuberculosis
TB, in all forms, must be treated with a combination of drugs; the most drug-sensitive forms of TB are typically treated for six months using four anti-TB drugs. An estimated 1.5 million people died of TB in 2020, according to the World Health Organization (WHO), although the precise numbers are not known and recent research suggests that TB could have killed as much as half a million more people in that same year.

Drug-resistant TB develops when the long, complex, decades-old TB drug regimen is improperly administered, or when people with TB stop taking their medicines before the disease has been fully eradicated from their body—highlighting the urgent need to develop better and shorter treatment regimens. Once a drug-resistant strain has developed, it can be transmitted directly to others through the air, just like drug-sensitive TB. There are over half a million cases of drug-resistant TB each year and its spread undermines efforts to control the TB pandemic.

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.

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."