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iPSC-Derived Cell Therapies Summit to Feature Discussion on Trailblazing Therapies for Immuno-Oncology-Panelists Include Exacis Biotherapeutics CEO

On October 12, 2022 Dr. Gregory Fiore, Co-Founder, President and CEO of Exacis Biotherapeutics reported that it will participate in an industry leader fireside chat focused on "Taking a Look at the Current Learnings from iPSC-Derived Cell Therapies and Determining Future Outlook and Developments" at the 2nd iPSC-Derived Cell Therapies Summit (Press release, Exacis Biotherapeutics, OCT 12, 2022, View Source [SID1234621926]). Dr. Fiore will join an expert panel that will reflect on current learnings from therapy development to drive focus and motivation while highlighting the demands of the future. Discussion will include validating iPSCs as starting material for immuno-oncology and regenerative medicine therapies to drive further investment and efforts in the space.

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"These cutting-edge therapies are the future of medicine" said Dr. Fiore. "I am excited to be part of this forum where industry leaders can share their expertise on what is happening with iPSC-derived cell therapies and where the industry is heading."

The discussion will take place at 9 am ET on Tuesday, December 6, 2022.

Held December 6-7 in Boston, the 2nd iPSC-Derived Cell Therapies Summit will focus on the creation of safe and effective iPSC-derived therapies for immuno-oncology and regenerative medicine. Participants will include iPSC drug developers working from discovery to CMC and will cover topics such as optimizing directed differentiation, enhancing expansion, advancing next-generation gene engineering approaches to improve safety, and defining the critical quality attributes to develop best-in-class iPSC-based therapies.

Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit to Include Presentation by Exacis Biotherapeutics CEO

On October 12, 2022 Dr. Gregory Fiore, Co-Founder, President and CEO of Exacis Biotherapeutics reported that it will present "Strategies to Develop Safe Cell Therapies Without Compromising Efficacy" at the 3rd Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit (Press release, Exacis Biotherapeutics, OCT 12, 2022, View Source [SID1234621925]). Dr. Fiore has gained a deep understanding of the complexity of developing cell-based therapies as CEO. CMO and C-suite advisor of multiple pharmaceutical and biotechnology companies.

"Patient safety is essential in developing new therapies," said Dr. Fiore. "Finding the optimal benefit-risk balance where a therapy is as effective as possible, while limiting the risk to patients requires thorough exploration and is crucial for success."

The panel will take place at 5:00 pm CET on Wednesday, November 16, 2022.

The 3rd Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit will be November 16-17, in Vienna, Austria and online. The meeting will focus on the unique challenges related to CMC, analytical, process development, automation, manufacturing, facility design, aseptic processing, supply chain and others that developers of gene and cell therapies must resolve.

Major Grant Awarded to Study PCLX-001 in Acute Myeloid Leukemia Patients

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.

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.

2A Pharma is attending the 23rd World Vaccine Congress Europe

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.

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.

Palisade Bio Announces Executive Leadership Transition Board Appoints JD Finley to Interim Chief Executive Officer

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.

"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.