On October 11, 2022 Pacylex reported that the US Department of Defense (DOD) awarded The University of Texas MD Anderson Cancer Center $1.4 million to treat Acute Myeloid Leukemia (AML) patients with PCLX-001, a first-in-class N-myristoylation inhibitor in clinical development by Pacylex (Press release, Greenfire, OCT 11, 2022, View Source [SID1234624499]). PCLX-001 is being studied in non-Hodgkin lymphoma (NHL) and solid tumor cancer patients at 4 clinical sites in Canada. This investigation will be the first of an N-myristoyl transferase (NMT) inhibitor, PCLX-001, in AML patients.

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 clinical study is being undertaken because PCLX-001 showed promise in preclinical testing in AML cell lines and patient blast cells where it induced apoptosis at concentrations that spared a majority of normal, healthy peripheral blood lymphocytes and monocytes and PCLX-001 monotherapy had dose-dependent anticancer activity in AML MV-4-11 cell line derived xenografts (CDXs) and AML patient derived xenografts (PDXs) and produced complete remissions in subcutaneous AML CDX. In tail-vein injected PDX models, PCLX-001 treatment resulted in up to 95% reduction of human CD45+ cells in peripheral blood and bone marrow.

"This clinical study is the culmination of work we have been doing in AML models for several years," said Luc Berthiaume, CSO of Pacylex. "It combines insights on the role myristoylation may play in cancer with an NMT inhibitor Pacylex licensed for exclusive development".

Dr. Naveen Pemaraju will be the principal investigator for the AML clinical study at MD Anderson. It will enroll AML patients whose disease has progressed despite other cancer therapies. "We look forward to seeing PCLX-001 tested in AML patients given how responsive this cancer is in other non-clinical studies", said Dr. John Mackey, CMO of Pacylex. "In our ongoing dose-escalation clinical study, 16 patients have received PCLX-001 without observing dose limiting toxicities and the drug levels delivered are in the range we think can help AML patients."

Four clinical sites are involved in the ongoing clinical study in NHL and solid tumor patients in Canada; the University of Alberta Cross Cancer Institute, Princess Margaret Hospital in Toronto, Centre Hospitalier de l’Université de Montréal (CHUM) and the BC Cancer Agency in Vancouver. That study has dosed 16 patients and will include approximately 15-20 more in the initial phase and is registered at ClinicalTrials.gov Identifier: NCT04836195.

PCLX-001
PCLX-001 (aka DDD86481) is a first-in-class, small molecule NMT inhibitor originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness, funded by Welcome Trust. Pacylex is developing PCLX-001 in the form of a once-a-day pill initially to treat leukemia and lymphoma. PCLX-001 has also been shown to inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the levels of NMT2 is correlated with survival, suggesting an important biological role in these cancers. In tests using cultured cancer cells in vitro, PCLX-001 is at least ten times as potent as ibrutinib (Imbruvica) and dasatinib (Sprycel), two clinically approved drugs currently used to treat hematologic malignancies.

On October 11, 2022 2A Pharma reported that Preben and Jeanette will attend the 23rd World Vaccine Congress Europe, which will be held in Barcelona from October 11-14 (Press release, 2A Pharma, OCT 11, 2022, View Source [SID1234622162]).
Poster
During the congress, Preben and Jeanette will share more details about the preliminary proof-of-concept studies and the development of our active vaccine against EpCAM+ cancers, which was developed using phage display and next generation sequencing to identify innovative epitopes that mimics the target protein.

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!

About World Vaccine Congress Europe
World Vaccine Congress Europe is one of the largest conferences. The conference brings together experts from all over the world to encourage collaboration and share knowledge. People working in manufacturing, clinical trials, as well as immune profiling will attend.

On October 11, 2022 Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, reported an executive leadership transition (Press release, Seneca Biopharma, OCT 11, 2022, View Source [SID1234622025]). Effective October 10, 2022, Thomas Hallam, Ph.D., ceased his duties as chief executive officer (CEO). The company’s board of directors has appointed JD Finley, current chief financial officer (CFO), as interim CEO, and Mr. Finley has assumed the duties of Dr. Hallam effective October 10, 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!

"On behalf of my fellow directors, I would like to thank Tom for his dedication to Palisade Bio over the last nine years," said James R. Neal, chairman of the board of Palisade Bio. "Tom was instrumental in the development LB1148. We thank him for his contributions to the company and wish him the best in his future endeavors."

Mr. Neal continued, "During this time of transition, the board of directors believes that JD Finley is uniquely qualified to lead Palisade Bio and its continued advancement of LB1148. JD has served as Palisade’s CFO since 2017, during which time he led multiple financings and played a key role in the execution of the company’s 2021 merger with Seneca Biopharma, Inc., which resulted in Palisade Bio’s public listing on Nasdaq. We are pleased to name JD as interim CEO and we look forward to his continued contributions to the company."

"I have long been committed to the success of Palisade Bio and the clinical advancement of LB1148, and I am honored to assume this leadership role for the company," said JD Finley, interim CEO of Palisade Bio. "I am a strong believer in the promise of LB1148 for the potential treatment of acute and chronic gastrointestinal complications, and I, along with our dedicated team, will continue the important work of advancing our programs for the benefit of our shareholders and patients worldwide."

Mr. Finley is an experienced financial executive, having played instrumental roles in raising nearly $1 billion in capital for companies as both an internal CFO and an independent investment banker. Prior to joining Palisade Bio, Mr. Finley was the chief executive officer, president and CFO for PointAcross, Inc., a software company providing business messaging and communications services. Mr. Finley previously co-founded Proteus Capital Partners, Inc., a firm specializing in providing financing for a variety of businesses, and was CFO at Phillips Capital, a broker/dealer firm specializing in private debt and equity capital raises. During his career, he also served as executive vice president and CFO of MetroGolf, Inc., where he successfully completed MetroGolf’s initial public offering and was instrumental in growing the start-up company to over 125 employees.

In order to ensure a smooth and timely transition, the company will focus its near-term resources on the internal reorganization. Accordingly, the company will no longer presenting at, the American College of Surgeons (ACS) Clinical Congress 2022, being held October 16 – 20, 2022.

On October 11, 2022 Seventure Partners, a worldwide leading microbiome venture capital, and Clinical Microbiomics A/S, a pioneering microbiome research company, reported the completion of a financing in the Danish growth company (Press release, Biosortia Pharmaceuticals, OCT 11, 2022, View Source [SID1234621981]).

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 transaction confirms Seventure Partners position as leading investor in the fast-developing microbiome field, where they have backed growth companies with funding through "Health for Life I" and "Health for Life II" since 2013.

Microbiome science is widely proposed as the next frontier in addressing our most urgent health challenges. Organisations worldwide are exploring the potential for microbiome science to help people live better lives; from novel nutritional products and next-generation probiotics to new ways to diagnose, treat and prevent disease. However, the complexity of microbiome science remains a challenge in bringing new solutions to market.

Since its foundation in 2015, Clinical Microbiomics has been innovating at the forefront of microbiome science. The company is working with the world’s leading food and consumer health companies and is supporting the pharmaceutical industry in phase 3 clinical trials through its GCP-compliant microbiome research services. Importantly Clinical Microbiomics hosts the richest data-warehouse on the market with 30k+ samples linking 3M+ bacterial strains to clinical phenotypes. Clinical Microbiomics is a premium quality microbiome analysis company, particularly known for its pioneering work on clonal-level microbiome profiling that is recognized as the most sensitive, precise, and comprehensive in the field.

Together with researchers from the world’s most prominent academic institutions and innovative companies, microbiome scientists at Clinical Microbiomics are constantly pushing the boundaries of science to find the answers needed to impact health and disease.

Isabelle de Cremoux, CEO and managing partner at Seventure Partners, commented: "Incredible progress has been made in understanding the link between the microbiota and our health in the past years, but there is still much more to be accomplished. There is a lot of data available, but we need better tools to get more insights and standards for how to put it to practice. Clinical Microbiomics has a track-record of developing tools that can untangle the complexity of the microbiome and help researchers worldwide understand the mechanisms that impact health and disease. Our investment will enable Clinical Microbiomics to invest even further to lead the way with innovative concepts and services at pharma standards for this field, and we believe their work will play a critical role in unleashing the potential of microbiome science".

The funds raised will be invested to further advance Clinical Microbiomics’ leading microbiome profiling and systems biology platform, and to expand the service offering within multi-omics data integration, as well as to build further presence in key markets starting with the US.

Anders Grøn, CEO at Clinical Microbiomics, commented: "Our vision is a world where people are healthier because we understand how to improve our inner ecology – the microbiome. We challenge the idea that the complexity of the microbiome prevents us from exploring its potential to tackle the most pressing health questions of our time. Seventure Partners brings valuable experience across the microbiome field that will help us identify and address challenges across the sector, and their investment will enable us to expand our innovation programs, quality management systems, and strategic collaborations at a high pace to help researchers worldwide to bring new products and treatments to market."

Clinical Microbiomics’ is located in Medicon Valley, one of the largest centres for microbiome research in the World, but the Company’s microbiome analysis services are offered worldwide to clients across sectors such as pharma, biotech, nutrition, food, feed, personal care, and consumer testing.

On October 11, 2022 Biogen Inc. (Nasdaq:BIIB) reported it will report third quarter 2022 financial results Tuesday, October 25, 2022, before the financial markets open (Press release, Biogen, OCT 11, 2022, View Source [SID1234621957]).

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!

Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at investors.biogen.com. Following the live webcast, an archived version of the call will be available on the website.