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 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 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that its CEO, Gil Beyen, will present at the H.C. Wainwright 23rd Annual Global Investment Conference (Press release, ERYtech Pharma, SEP 6, 2021, https://erytech.com/erytech-to-present-at-the-h-c-wainwright-23rd-annual-global-investment-conference/ [SID1234587270]). The Conference will be held virtually with all participants joining remotely from September 13th – 15th, 2021.

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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 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."