On October 3, 2022 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that new data which demonstrates the potential of its second focal adhesion kinase (FAK) inhibitor AMP886 for the treatment of acute myeloid leukemia (AML) (Press release, Amplia Therapeutics, OCT 3, 2022, View Source;[email protected] [SID1234621638]). AML makes up about 1% of all cancer diagnoses and is a heterogeneous cluster of cancers that affect blood and bone marrow, with around 900 new cases diagnosed in Australia each year, about 50 of which are in children. Adults over 60 are the most commonly affected and have the poorest prognosis. Optimal treatment for AML depends on the disease subtype for each patient as well as their age/fitness but typically requires use of relatively toxic chemotherapies. Poorer response rates in older patients and high rates of relapse after treatment are also typical of AML.

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!

Amplia’s drug candidate AMP886 potently inhibits both FAK and Fms-like tyrosine kinase 3 (FLT3). FLT3 is mutated in around a third of AML patients and is a clinically validated target for chemotherapy. There is a poor duration of response to current FLT3 inhibitors which often leads to an aggressive disease relapse and very poor patient outcomes. Emerging research supports combing inhibition of FLT3 and FAK to overcome disease rebound following to FLT3 monotherapy, 1 and that this approach may have a beneficial impact in AML patients.

2 Amplia has now shown that AMP886 inhibits AML in an industry-standard MV4-11 disease model recognised to carry the FLT3 mutation. Figure 1 shows that 21 days after inoculation with MV4-11 cells, oral doses of AMP886 significantly reduced the tumour burden in mice Figure 1: Dose dependent reduction in tumour growth measured via bioluminescence of AML MV4-11 cells following treatment with AMP886 Vehicle (0 mg/kg AMP886) AMP886 37.5 mg/kg AMP886 75 mg/kg 1 Allert, C. et al. Protein tyrosine kinase 2b inhibition reverts niche-associated resistance to tyrosine kinase inhibitors in AML. Leukemia (2022). View Source 2 Carter BZ, et al. Focal Adhesion Kinase as a Potential Target in AML and MDS. Mol Cancer Ther. (2017). View Source

In a second experiment, we measured the efficacy of AMP886 combined with venetoclax, a B-cell lymphoma 2 (BCL-2) inhibitor that is approved as part of combination therapy, typically for older patients with AML. Our rationale for adding AMP886 to venetoclax was based on recent reports showing that combination of FLT3 inhibitors and venetoclax may have clinical potential in patients with relapsed or refractory AML.

3 The data show (Figure 2a) that AMP886 is more effective in reducing AML cell growth than venetoclax alone. Figure 2b shows that while both AMP886 and venetoclax improve survival in the MV4-11 model of AML, the combination of the two drugs tended to further enhance survival. A

B Figure 2: (A) Inhibition of MV4-11 AML in mice treated with AMP886, venetoclax or combined AMP886 and venetoclax; (B) Kaplan-Meier survival curves of mice bearing MV4-11 AML when treated with AMP886, venetoclax or combined AMP886 and venetoclax Amplia’s CEO, Dr John Lambert, commented that "The impressive results we are reporting today tell us that there may be a clinical rationale to include AMP886 as part of new treatment regimens for unmet needs in AML. With an eye to expanding Amplia’s clinical development pipeline, further experiments are already underway with AMP886 to build on this data and establish a scientifically solid foundation for initiation of formal development of AMP886."

This ASX announcement has been approved and authorised for release by the Board of Amplia Therapeutics.

On October 3, 2022 Alexion, AstraZeneca Rare Disease, reported that it has entered a definitive agreement to acquire Lexington, Mass.-based LogicBio Therapeutics, Inc. (NASDAQ: LOGC), a pioneering genomic medicine company (Press release, Alexion, OCT 3, 2022, View Source [SID1234621637]). The proposed acquisition aims to rapidly accelerate Alexion’s growth in genomic medicines through LogicBio’s unique technology, experienced rare disease R&D team, and expertise in pre-clinical development.

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 proposed acquisition of LogicBio is a significant development for our growing research in genomic medicine," said Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease. "LogicBio’s people, experience and platforms provide new scientific capabilities by adding best-in-class technology and expertise to our genomic medicine strategy. The scientific collaboration between Alexion and AstraZeneca has been a substantial area of focus since last year’s acquisition and the addition of LogicBio will expand this foundational work."

LogicBio has developed technology platforms for the delivery and insertion of genes to address genetic diseases, as well as a platform designed to improve viral vector manufacturing processes. These platforms, coupled with LogicBio’s highly experienced team and Alexion’s advancements with AstraZeneca, will drive future scientific possibilities and next generation medicines to treat rare genetic diseases.

Fred Chereau, President and Chief Executive Officer, LogicBio, said: "We are excited about the opportunity to bring our science and expertise in genetic medicine to Alexion, which shares our commitment to discovering treatments for rare conditions and improving the lives of patients. Through this acquisition, we strive to accelerate our research in gene editing and AAV capsid development and together move the field of genomic medicine forward."

Under the terms of the agreement, Alexion, through a subsidiary, will initiate a cash tender offer to acquire all outstanding shares of LogicBio for $2.07 per share. Both boards have unanimously approved the transaction. Alexion plans to close the deal in four to six weeks, subject to the tender of at least a majority of the outstanding shares of LogicBio common stock and satisfaction of other closing conditions, and plans to retain LogicBio employees at their current location.

On October 3, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) for the treatment of unresectable, recurrent/metastatic human papilloma virus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC) (Press release, PDS Biotechnology, OCT 3, 2022, View Source [SID1234621636]).

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 very pleased with the guidance received from FDA on key elements of the clinical program that will support the submission of a Biologics License Application (BLA) for our lead asset PDS0101," said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "The interim safety and efficacy data we presented to the FDA has allowed us to move into a registrational trial ahead of our projected schedule. This, along with the recent capital raise, allows us to efficiently advance our clinical programs."

Earlier this year, the FDA granted Fast Track designation to the combination of PDS0101 and KEYTRUDA (pembrolizumab) for the treatment of HPV16-positive HNSCC. The FDA’s Fast Track designation program is designed to aid in the development and to expedite the review of drug candidate applications that could potentially treat serious or life-threatening conditions. Treatments granted this designation are given the opportunity to have more frequent meetings and interactions with the FDA throughout the entire drug development and review process, with the goal of moving promising new drugs more rapidly through the process.

Dr. Frank Bedu-Addo further commented, "PDS0101 represents a potentially transformative treatment approach for HPV16-positive HNSCC patients. We are committed to providing physicians and patients a possibly more effective and safer treatment option to address this debilitating and deadly disease."

On October 3, 2022 Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, reported the appointment of Alex Martin as Chief Executive Officer (Press release, Abcuro, OCT 3, 2022, View Source [SID1234621635]). He brings to Abcuro more than 30 years of leadership experience in the biopharmaceutical industry.

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 excited to welcome Alex Martin as CEO of Abcuro, as he brings extensive experience in building and leading biopharmaceutical companies as well as a track record of delivering value for patients, the clinical community, and investors," said John Edwards, Executive Chair of Abcuro. "I look forward to working with Alex as we accelerate Abcuro’s growth and advance our clinical programs in the areas of autoimmune disease and cancer."

Mr. Martin brings over 30 years of experience building companies and closing transactions in the biopharmaceutical industry. He was most recently Chief Executive Officer of Palladio Biosciences, a clinical stage biopharmaceutical company which was acquired by Centessa Pharmaceuticals (CNTA), and previously served as Chief Executive Officer of Realm Therapeutics (RLM) which was acquired by ESSA Pharma (EPIX). Prior to this, he was the Chief Operating Officer of Intercept Pharmaceuticals (ICPT), and Chief Finance Officer of BioXell (BXLN) which was acquired by Cosmo Pharmaceuticals (COPN). Mr. Martin began his career at SmithKline Beecham Pharmaceuticals where he held roles of increasing responsibility in marketing and business development and later joined Novartis as Vice President, Global Business Development & Licensing. He holds a BA from Cornell University and an MBA from Harvard.

"It’s an honor to join the team at Abcuro, a company built on an unmatched ability to selectively target highly cytotoxic T cells in diseases and conditions with high unmet need, and a strong commitment to delivering novel, life-changing therapies for patients," said Mr. Martin. "I look forward to working with the highly talented team at Abcuro and building on the company’s momentum and promising clinical data from the lead program ABC008, to make a positive impact on the lives of patients."

About ABC008
ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory and central memory T cells. ABC008 has been designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and other mature T cell malignancies. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to ABC008 for the treatment of IBM.

On October 3, 2022 Celularity Inc. (Nasdaq: CELU) (Celularity), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, reported that Adrian Kilcoyne, M.D., M.P.H., M.B.A., has been appointed Executive Vice President, Chief Medical Officer (CMO) and Head of Global Medical Affairs, Patient Safety and Patient Affairs, effective today (Press release, Celularity, OCT 3, 2022, View Source;utm_medium=rss&utm_campaign=celularity-appoints-adrian-kilcoyne-m-d-m-p-h-m-b-a-as-chief-medical-officer [SID1234621634]). Dr. Kilcoyne brings over 15 years of clinical experience to Celularity, having previously served in R&D, medical affairs, and commercialization roles, primarily focused on oncology. He has a track record of advancing early-stage clinical programs through commercialization and will provide senior leadership to advance Celularity’s clinical pipeline toward U.S. Food and Drug Administration (FDA) approval.

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!

"It is with great pleasure that we welcome Dr. Kilcoyne to Celularity’s leadership team during this critical stage of our growth trajectory," said Robert Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity. "Dr. Kilcoyne will play a fundamental role in advancing our clinical pipeline, including our three Phase 1 studies in acute myeloid leukemia, glioblastoma multiforme and gastric cancer, and one IND-pending program in B-cell malignancies, all of which utilize our next-generation placental-derived cellular therapeutic candidates. I am confident Dr. Kilcoyne’s expertise and deep industry knowledge will help to accelerate Celularity’s achievement of key clinical development milestones and to establish Celularity as a leader in cellular immunotherapies."

"I am excited to be joining such a talented and experienced group of professionals, and look forward to working as part of the leadership team to support and execute on Celularity’s vision," commented Dr. Kilcoyne. "Natural killer cells, especially those derived from placental cells, are scalable and have potential to confer greater safety and efficacy, the latter due to their inherent stemness. I am optimistic that by leveraging this unique class of cells, Celularity will be successful in advancing therapies for the unmet clinical need in cancer, infectious and degenerative diseases."

Most recently, Dr. Kilcoyne served as the Chief Medical Officer of Humanigen, where he was responsible for building its oncology and immunology portfolio focused on the cytokine pathway, CAR-T therapy related toxicity, and antibody drug conjugates (ADCs) in solid tumors. Before that, he served as an integral member of the executive team at AstraZeneca as the Vice President of Global Oncology Evidence Generation and External Alliances. During his time at AstraZeneca, he was responsible for the creation, development, and delivery of the fully integrated Global Evidence strategy. Dr. Kilcoyne holds an M.D. from Trinity College in Dublin, an M.P.H. from the University of London, and an M.B.A. from Warwick Business School. Along with multiple publications in peer review journals, he co-authored the Oxford Specialist Handbook of Pharmaceutical Medicine.