On August 24, 2022 Galapagos NV (Euronext & NASDAQ: GLPG) reported that management will participate in the following upcoming investor conferences (Press release, Galapagos, AUG 24, 2022, View Source [SID1234618620]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Citi’s 17th Annual Biopharma Conference. September 8, 2022 in Boston
Morgan Stanley 20th Global Healthcare Conference. September 12-14, 2022 in New York
Bank of America Merrill Lynch Global Healthcare Conference. September 15, 2022 in London
KBC Securities Virtual Life Sciences Conference. September 16, 2022
JP Morgan CEO Call Series. September 28, 2022
Credit Suisse 31st Annual Healthcare Conference. November 8-10, 2022 in Rancho Palos Verdes, CA
Bryan Garnier Virtual Conference on Cell Therapy Innovation. November 14, 2022
Jefferies 2022 Global Healthcare Conference. November 16-17, 2022 in London
Kepler Cheuvreux Virtual Life Science Days. November 21, 2022
Deutsche Bank 2022 Call Series. November 30, 2022

Additional information regarding these events will be available on the investor section of the Galapagos website at glpg.com/events.

On August 24, 2022 Almac Discovery, a research driven biotech company and member of the Almac Group, reported that is delighted that its novel AKT kinase inhibitor (known as VAD044) is being advanced into a proof-of-concept Phase 1b clinical study for patients suffering from Hereditary Haemorrhagic Telangiectasia (HHT) (Press release, Almac, AUG 24, 2022, View Source [SID1234618588]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This patent-protected, allosteric subtype selective AKT kinase inhibitor, which was discovered and taken into early pre-clinical development by Almac Discovery, was out-licensed for all uses, worldwide, to Vaderis Therapeutics AG in May 2020.

After Vaderis’s successful Phase 1a, VAD044 will now be studied by Vaderis Therapeutics AG in their INSIGHT proof-of-concept trial, which aims to provide a thorough understanding of the safety of a once daily, orally administered, AKT inhibitor medication in HHT patients. A total of 80 HHT patients across North America and Europe will be randomised in a double-blind, controlled trial comparing two doses of the medication to placebo. Initiation of the INSIGHT trial follows Health Authority approvals including FDA, Health Canada and key European agencies.

Professor Tim Harrison, Vice President Drug Discovery, commented: "This excellent news from our out-licensing partner, Vaderis Therapeutics AG, represents a further example of Almac Discovery’s mission to discover new, innovative drug candidates for development through external partnerships and collaboration. We look forward, with great anticipation, to monitoring the findings of the INSIGHT trial and wish Vaderis every success as they emerge from stealth mode and progress through the next phase of clinical development for the benefit of HHT patients across the globe."

About Almac Discovery

Almac Discovery is a research driven biotech company dedicated to the discovery and development of First in Class therapeutics across a range of therapeutic areas including neuroscience, muscle-wasting, oncology and inflammation. Almac Discovery focuses on the discovery to preclinical stage, seeking to licence programmes and/or collaborate with a pharmaceutical partner for further development and commercialisation.

On August 24, 2022 GNS, the leader in the use of "Digital Twins" and Causal AI & biosimulation technology for biopharmaceutical drug discovery and development, and Servier, a global pharmaceutical group, reported a collaboration to advance drug discovery, translational, and clinical development efforts in Multiple Myeloma (MM) (Press release, Servier, AUG 24, 2022, View Source [SID1234618605]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This collaboration furthers Servier’s goal to accelerate its drug discovery and clinical development efforts through AI and biosimulation and other digital initiatives," said Claude Bertrand, EVP of Research and Development at Servier. "We believe GNS’ Digital Twin and unique causal AI models will help our research and early development group improve our understanding of MM disease biology and, ultimately, transform our drug discovery and clinical development process".

"We are delighted to collaborate with Servier to help advance research in MM and leverage our Gemini Digital Twin patient models to help uncover novel insights and reveal the hidden biological circuity of this disease," said Joe Donahue, Chief Business Officer at GNS. "Working together with the outstanding Servier team, we hope to make a difference in the lives of patients with MM."

The collaboration will address key questions about how MM progresses in different patient subpopulations, including discovering what are the most synergistic pathways for new combination therapies and will help Servier gain insights that can advance their translational and clinical development efforts. This work will initially leverage the GNS Gemini Digital Twin for MM developed using the rich clinico-genomic data from the Multiple Myeloma Research Foundation (MMRF) CoMMpass study.

GNS’ MM Digital Twin leverages the rich patient multi-modal data generated by MMRF to create a transparent, accurate, quantified representation of complex biological mechanisms, revealing new circuitry of human disease. By conducting biosimulations, which are essentially computational experiments, one can discover new drug targets and disease mechanisms, and can also determine which drug candidates are more effective than others and why certain molecular profiles of patients lead to better and more durable response. Ultimately, the MM Digital Twins will radically change how Pharma R&D is conducted by helping to accelerate the identification of new targets and target combinations, new biomarkers, and enabling the in silico design of better trials.

On August 24, 2022 Alpha Biopharma, a developer of innovative drugs, reported the completion of last patient last visit (LPLV) in its international, multicenter EVEREST phase II/III clinical study of Zorifertinib, a next-generation EGFR-TKI, in first line patients with advanced EGFRm+ non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases (Press release, Alpha Biopharma, AUG 24, 2022, View Source [SID1234618621]). Topline data from this MRCT study are expected around the end of 2022, at which time Alpha Biopharma could submit a New Drug Application (NDA) to the National Medical Products Administration (NMPA).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As the international leading principal investigator (PI) of EVEREST study, Professor Yilong Wu, President of the Chinese Thoracic Oncology Group (CTONG), said: "EVEREST study is an international, multicenter, phase II/III randomized clinical study. It is also the only large-scale prospective international multicenter clinical study worldwide for first line EGFRm+ NSCLC patients with CNS metastases to date. It was carried out in 55 study sites located in Chinese mainland, Taiwan, South Korea, and Singapore, with a total enrollment of 492 patients. The clinical and preclinical data of Zorifertinib have shown its high blood-brain barrier (BBB) penetration, anti-tumor activity in metastatic CNS lesions, overall efficacy in both CNS and extra-cranial diseases, and similar safety profile as other EGFR-TKI drugs. If approved, it is expected to provide a valuable choice for treatment of EGFRm+ NSCLC patients with CNS metastases. As the name EVEREST suggests, the study sponsor and investigators are dedicated to solving important unmet clinical needs."

Professor Jie Wang, Director of Oncology Department of Cancer Hospital Chinese Academy of Medical Sciences, and co-leading PI of EVEREST study, said: "Lung cancer with CNS metastases has always been a challenging problem and leading cause of death for these patients. Zorifertinib is a next-generation, high-potent EGFR-TKI drug targeting sensitive mutations of exon 19 deletion or L858R in EGFR gene with good exposure in CNS lesions. It is not a substrate of efflux transporter P-gp and BCRP, thus not only capable of fully passing through BBB, but also maintaining high drug exposure in the brain tissue and cerebrospinal fluid. It was intentionally designed to optimize its physicochemical and biochemical properties meet the requirements of CNS penetration, which has been proven to be the case in this and prior clinical studies. We look forward to the finale data readout and if positive, a direly needed treatment for these patients."

Dr. Ruilin Song, Executive President of China Pharmaceutical Innovation and Research Development Association, said: "In the past three years, the COVID-19 pandemic in some regions of China has brought great challenges to innovative biotech companies. Many clinical study sites faced challenges in terms of regional lockdown, logistics, and clinical operations. However, the clinical development team at Alpha Biopharma and investigators worked together to overcome difficulties to achieve the key milestones of the EVEREST study. They diligently communicated with study sites to come up with solutions, paid full attention to the safety of the subjects and the quality of the trial data while ensuring the uninterrupted treatment of the subjects. In recognizing this pivotal milestone of EVEREST study completion, we would like to express sincere respect for the efforts of all relevant personnel involved in the study and wish Zorifertinib a smooth NDA submission. We are a step closer to bringing new hope to patients with CNS metastases of EGFRm+ NSCLC."

About Zorifertinib

Zorifertinib is a potent, oral, reversible inhibitor of the tyrosine kinase activity of the epidermal growth factor receptor (EGFR-TKI) activating mutation (L858R and Exon19Del). EGFR is widely expressed in human epidermal cells and stromal cells and is highly expressed in a variety of human malignancies, such as NSCLC. EGFR gene mutation will cause excessive epidermal growth factor receptors on the cell membrane surface, accelerate the abnormal growth and division of cells, and eventually lead to tumorigenesis. CNS metastases is common in EGFRm+ NSCLC patients and accompanied with poor prognosis of earlier disease progression, shorter survival, and lower quality of life. The BBB significantly increases the difficulty of drug penetration into CNS, which allows the CNS to be a refuge for lung cancer cells. Zorifertinib is a new-generation EGFR-TKI specifically designed to fully penetrate the BBB to target brain metastases. Zorifertinib is in late-stage clinical studies and has global intellectual property protection.

On August 24, 2022 LumaBridge (formerly known as Cancer Insight), a clinical research organization (CRO) dedicated to discovering, developing, and testing emerging biotechnologies related to cancer therapies, and the Parker Institute for Cancer Immunotherapy (PICI), the largest network of immuno-oncology expertise in the world, reported a new strategic partnership aimed at accelerating breakthrough immunotherapies from bench to bedside with greater ease (Press release, Cancer Insight, AUG 24, 2022, View Source [SID1234618589]). The new collaboration offers affiliated scientists and organizations a one-stop shop to advance research studies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The two organizations are collaborating to provide PICI Affiliated Partners—PICI Network institutions and investigators, affiliated companies, and nonprofit collaborators—direct access to the full suite of clinical trial services from LumaBridge. Offerings range from clinical trial design through regulatory strategy support, including patient accrual, clinical operations, quality assurance, data management, medical writing and biostatistics, pharmacovigilance, and beyond.

"PICI was founded to clear the path from scientific idea to best possible clinical outcomes," said Ute Dugan, MD, PhD, chief medical officer of PICI, based in San Francisco. "By combining our focus with additional expertise in clinical trial design and oversight, we aim to streamline the development process and ultimately accelerate novel immunotherapies to patients."

PICI’s first valued CRO partner, LumaBridge also is focused on accelerating the development of immunological cures for cancer through innovative science, advanced technologies, and new modes of research collaboration. Through this mission-focused alliance, PICI Affiliated Partners gain preferred access to and pricing for an array of clinical trial services and expertise, including early consulting on clinical trial design and development, protocol development, regulatory support, and full-service clinical trial support.

"Patients awaiting new therapies deserve an effective, efficient process," said George E. Peoples, MD, FACS, founder and chief medical officer of San Antonio-based LumaBridge. "Through this partnership, we will harness our pioneering experience in immuno-oncology research alongside the expertise of academic, clinical, and industry partners to reduce turnaround time and safely test the most promising novel therapies for our cancer patients."

More specifically, available LumaBridge services include:

Regulatory support for pre-investigational new drug meetings and investigational new drug (IND) preparation, publishing, filing, and maintenance
Clinical trial design, execution, and support such as medical monitoring, clinical operations, data management, and quality assurance
Medical writing and biostatistics support such as statistical analysis, US Food and Drug Administration (FDA) application writing, and abstract or journal publication preparation
Guidance in navigating government/military contracts and funding
Clinical development and commercialization strategies for Cancer Prevention and Research Institute of Texas (CPRIT) applicants
The partnership advances PICI’s focus on bringing together top researchers, nonprofits and industry collaborators, providing resources and eliminating barriers to get treatments to patients faster.

"Collaboration is critical to achieving our mission," said Tarak Mody, PhD, chief business officer of PICI. "By offering access to LumaBridge’s services and expertise to our PICI Affiliated Partners, we intend to accelerate breakthrough scientific discoveries, moving them into the clinic sooner to deliver patient impact."