On September 27, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AL102 for the treatment of progressing desmoid tumors. AL102 is a potent, selective, oral gamma-secretase inhibitor (Press release, Ayala Pharmaceuticals, SEP 27, 2022, View Source [SID1234621451]).

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!

"We are pleased to receive FDA Fast Track designation for AL102 in progressing desmoid tumors, which we believe reinforces the large unmet medical need for patients with this serious disease. This designation holds important advantages that may expedite the development and regulatory review of AL102," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "We are very encouraged by the emerging body of clinical data supporting AL102 and, if approved, believe that this product could have a meaningful impact on patients’ lives."

The FDA grants Fast Track designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A therapeutic that receives Fast Track designation can benefit from early and frequent communication with the agency, in addition to a rolling submission of the marketing application, with potential pathways for expedited approval that have the objective of getting important new therapies to patients more quickly.

AL102 is being evaluated in the ongoing RINGSIDE pivotal Phase 2/3 clinical trial in desmoid tumors. Positive interim results from Part A, the Phase 2 segment of this study, were presented at ESMO (Free ESMO Whitepaper) 2022, showing efficacy across all cohorts, with early tumor responses that deepened over time. AL102 was well tolerated. The company has initiated Part B of RINGSIDE (Phase 3), and is enrolling patients in an open label extension study.

About the RINGSIDE study
The RINGSIDE pivotal Phase 2/3 study is a randomized global multi-center trial. Part A of the study is evaluating the efficacy, safety, tolerability, and tumor volume by MRI after 16 weeks of AL102 in patients with desmoid tumors. It enrolled 42 patients and is evaluating 3 doses of AL102. Patients who participated in Part A are eligible to enroll into an open-label extension study at the Part B selected dose of 1.2 mg daily, and long-term efficacy and safety will be monitored.

Part B of the study, the Phase 3 segment, has been initiated. This is a double-blind, placebo-controlled segment enrolling up to 156 patients with progressive disease, comparing AL102 at 1.2 mg once daily to placebo. The primary endpoint for Part B is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), tumor volume reduction, and patient-reported Quality of Life (QOL) measures. For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).

About Desmoid Tumors
Desmoid tumors also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root, and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to a high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

On September 27, 2022 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that the company will participate in the RBC Global CDMO Conference (Press release, Avid Bioservices, SEP 27, 2022, View Source [SID1234621450]). Nick Green, president and chief executive officer, will be the featured speaker in a fireside chat at the conference, which will take place October 3-4, 2022.

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!

Details of the company’s participation are as follows:

RBC Global CDMO Conference
Conference Date: October 3-4, 2022
Fireside Chat Time/Date: 12:15 – 12:45 p.m. Eastern on Monday, October 3, 2022
Format: Virtual conference; webcast available
To listen to the webcast of the RBC fireside chat please visit: View Source

On September 27, 2022 Race Oncology Limited ("Race") reported that it has contracted the Monash Fragment Platform (MFP) at Monash University to complete a fragment-based screening program aimed at discovering novel drugs that inhibit the m6 A RNA demethylases FTO and ALKBH5 (Press release, Race Oncology, SEP 27, 2022, View Source [SID1234621447]). Eminent medicinal chemist and Director of the MFP, Professor Martin Scanlon, will lead the project.

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!

All intellectual property developed in the project will be owned exclusively by Race.

RNA Epitranscriptomics Important scientific discoveries made over the last decade have identified dysregulation (loss of control) of RNA epigenetics (epitranscriptomics) as a key driver of cancer and other complex diseases1. Two of the major players in this dynamic regulatory system are the Fatso/FaT and Obesity associated (FTO) and ALKBH5 proteins. FTO and ALKBH5 are the only m6 A RNA demethylases found in humans and are major global regulators of the m6 A RNA levels in cells2.

Changes in the expression of FTO or ALKBH5 has a profound impact on cancer growth, spread and resistance to treatment. Inhibiting FTO or ALKBH5 activity is able to kill or slow the growth of a wide range of cancers, including leukaemia, breast, lung, ovarian, gastric, brain, melanoma, pancreatic, kidney and many more. Race Oncology’s most advanced asset Zantrene (bisantrene dihydrochloride) is a potent inhibitor of FTO (IC50 142nM)3 and is the only m6 A RNA demethylase inhibitor and RNA epitranscriptomic drug in the clinic.

NMR Fragment Based Drug Screening To build on our success in the RNA epitranscriptomics space, Race is aiming to discover new, potent and selective inhibitors of FTO and ALKBH5 for use in cancer and other indications. To advance this program, Race has contracted the Monash Fragment Platform to complete a fragment screening campaign using the latest techniques in Race Oncology Ltd ABN 61 149 318 749 Registered office: L36, 1 Macquarie Place, Sydney NSW 2000 www.raceoncology.com nuclear magnetic resonance spectroscopy (NMR). In this approach, a library of diverse small molecules (‘fragments’) will be tested by NMR for their ability to bind to the FTO and ALKBH5 proteins. Molecules that are found to bind to the proteins will be transformed into drug leads and ultimately clinical drug candidates in a follow-up medicinal chemistry campaign. This screening program will start immediately with results reported over the coming 12 months. The total cost of the project is $286,786 and is expected to be eligible for the ATO 43.5% R&D Tax Rebate.

Race Principal Scientist, Professor Mike Kelso said: "Race is extremely pleased to be working with Professor Scanlon and his experienced team on this important project. The discovery and patenting of new FTO and ALKBH5 inhibitors will greatly strengthen Race’s drug development pipeline and add valuable assets to our expanding IP portfolio. Drawing on my career in medicinal chemistry, I relish the downstream challenge of evolving molecules discovered in this campaign into clinic-ready FTO and ALKBH5 inhibitors as innovative new treatments for cancer and other diseases." Professor Scanlon said: "Developing next-generation medicines requires outstanding discovery science. The Monash Fragment Platform was established to help researchers accelerate this long and complex journey. We are delighted to be working with Race to use our established Fragment-Based Screening technology to identify novel inhibitors for FTO and ALKBH5."

Race Chief Executive Officer, Phil Lynch said: "Addition of new FTO inhibitors to Race’s drug pipeline creates major value as it grows Race ‘Beyond Zantrene’ and positions us as a world leading RNA epitranscriptomics pharma company." 1. Sun, T., Wu, R. & Ming, L. The role of m6A RNA methylation in cancer. Biomed Pharmacother 112, 108613 (2019). 2. You, Y. et al. Recent Advances of m6A Demethylases Inhibitors and Their Biological Functions in Human Diseases. Int J Mol Sci 23, 5815 (2022). 3. Su R et al. Targeting FTO Suppresses Cancer Stem Cell Maintenance and Immune Evasion. Cancer Cell 38:1–18 (2020).-ENDSAbout Professor Martin Scanlon and the Monash Fragment Platform The Monash Fragment Platform (MFP) is part of the Monash University Technology Research Platform Network (MTRP). The aim of MFP is to facilitate access to the transformative technology of Fragment-Based Drug Design through its multidisciplinary technology network. MFP supports Australian academic groups and pharma companies to accelerate their drug discovery R&D programs using a fee-for-service model. Martin Scanlon is Scientific Director of the MFP and Professor of Medicinal Chemistry at the Monash Institute of Pharmaceutical Sciences. He has published over 100 papers in highranking international journals, and has led more than 30 successful fragment-based discovery campaigns at MFP for academic and industry clients since its inception in 2015.

On September 27, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report third quarter 2022 financial results on Thursday, October 20, 2022, before the market opens (Press release, Quest Diagnostics, SEP 27, 2022, View Source,-2022 [SID1234621446]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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 conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 888-566-0462 for domestic callers or 203-369-3609 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on October 20, 2022 until midnight Eastern Time on November 3, 2022.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On September 27, 2022 Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), reported that it has completed a minority investment in LeeO Precision Farming B.V. (LeeO) (Press release, Merck & Co, SEP 27, 2022, View Source [SID1234621445]). Merck Animal Health also will assume distribution of LeeO’s digital swine traceability solution in selected markets over the coming months. Merck Animal Health joins LeeO’s existing founders and shareholders, Prairie Systems, Inc., a strategic investment of United Animal Health, Inc., and MIQ B.V. Specific terms of the minority investment were not disclosed.

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!

LeeO, a privately held company located in Deventer, the Netherlands, provides a cloud-based, real-time digital swine traceability solution for farmers, producers and retailers to continuously track and analyze swine from birth throughout their lifecycle. The cloud-based technology platform provides users with the capability to record and track major life events in swine production, including genetics, insemination, birth registration, vaccination, age, weight, weaning, location and transportation. The platform is supported by an ecosystem of RFID-based hardware technology, such as ear tags, readers and weigh scales.

"Through this agreement, we are linking Merck Animal Health’s breadth and depth in animal health intelligence technology solutions with LeeO’s innovative digital swine traceability platform, which can help to change the way all phases of swine production interact and make decisions," said Jeroen van de Ven, lead, Animal Health Intelligence, Merck Animal Health. "Our animal health solutions, including our identification, traceability and monitoring capabilities, and investment in LeeO will help accelerate this technology development and advance the health and well-being of animals. We look forward to our partnership with LeeO and to continue to build the future of livestock traceability solutions, which can further create a connected and integrated ecosystem for the global livestock market."

LeeO Chief Executive Officer Peter ter Linde said, "This investment from Merck Animal Health is an exciting development for LeeO and will be used to fuel our growth and investment in our leading digital animal traceability solution for swine. It also signals Merck Animal Health’s ongoing commitment to swine health, well-being and management and laser focus on accelerating animal traceability solutions in livestock to improve animal health. We believe Merck Animal Health’s investment will further accelerate the growth and value of our company."

"Adding Merck Animal Health to the ownership of LeeO will certainly allow for growth at a faster pace, which is great for the swine industry," said Doug Webel, Ph.D., president and chief executive officer of United Animal Health, Inc., a strategic partner of LeeO for food chain visibility and analytics. "We view this agreement as a key step to advancing this technology and animal traceability for better animal health."

Evidence-based animal traceability solutions have helped to safeguard and strengthen the integrity of the food supply chain. Traceability solutions, such as LeeO’s digital traceability platform, provides customers with information that identifies and traces the origin, history, production and distribution throughout the lifecycle of the pig to validate sustainability claims by detailing how animals are raised and processed.