On October 12, 2022 Tavros Therapeutics, Inc., a precision oncology platform company leading the new frontier of targeted therapies exploiting tumors’ genetic vulnerabilities, and Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders, and a wholly owned and independently operated subsidiary of Bayer AG, reported the companies have entered into a collaboration agreement to discover or target four oncology targets across an initial five-year term (Press release, Tavros Therapeutics, OCT 12, 2022, View Source [SID1234621928]).

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Tavros leverages its functional and computational genomics technologies to uncover unique vulnerabilities within tumors to discover novel targets and biomarkers in areas of high unmet clinical need and identify novel clinical positioning strategies for existing molecules.

Under the terms of the agreement, Tavros will receive $17.5 million in a cash upfront payment from Vividion, and is eligible to receive up to $430.5 million in potential future payments based on the achievement of prespecified preclinical, clinical development, and commercial milestones, as well as low-single-digit royalties on sales of certain potential programs. Vividion has options to pursue up to five additional targets with up to $482 million in potential additional future payments.

"The future of cancer treatment lies in the precision targeting of therapies in the optimal clinical settings. This partnership allows Tavros to expand the actionability of our platform into a new target space by pairing our precision oncology platform with Vividion’s unmatched ability to drug the traditionally undruggable," said Tavros CEO and co-founder Eoin McDonnell, Ph.D. "We’re thrilled to launch our work with Vividion and harness our combined expertise to reach patients with difficult-totreat cancers by uncovering and drugging the next generation of high-value targets and augmenting the efficacy of emerging compounds." RESTRICTED

"Despite decades of effort, many targets remain inaccessible to traditional small molecule drugs, and many others have uncertain relevance to disease," said Vividion Therapeutics CEO Jeffrey Hatfield. "This collaboration brings together two orthogonal, highly innovative and synergistic approaches to drug discovery that will address both of these challenges. Vividion has the ability to find and drug previously unknown, or cryptic, functional binding pockets on oncology and immunology targets of high interest, while Tavros has the potential to uncover previously unknown synthetic vulnerabilities or dependencies in deadly tumor cells. We believe this powerful combination of leading-edge technologies has the potential to deliver multiple breakthrough discoveries for cancer patients in need."

On October 12, 2022 Dr. Gregory Fiore, Co-Founder, President and CEO of Exacis Biotherapeutics reported that it will discuss strategies for funding RNA-based cell therapies as a panel member at the RNA Cell Therapies Summit (Press release, Exacis Biotherapeutics, OCT 12, 2022, View Source [SID1234621927]). The panel discussion, "The Science Speaks for Itself – But What Else is Required to Secure an Investment," will include both medical and venture capital experts. Panelists will reveal what investors look for when investing in RNA-based cell therapies and share insights into how best to work holistically with scientists, investors, and lawyers to secure investments. Discussion will also include the role a founders legacy plays in investment opportunities.

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With experience as CEO and CMO of multiple pharmaceutical and biotechnology companies and C-suite advisor for several early-stage biotechnology companies, Dr. Fiore is uniquely qualified to provide his expert knowledge in raising capital to advance new therapeutics.

"While scientific discovery is vital to the development of novel treatment options, securing financial support is a critical requirement in progressing new therapeutics all the way through to patient delivery," said Dr. Fiore.

The panel will take place at 2:30 pm ET on Thursday, January 26, 2023.

The RNA Cell Therapies Summit will take place January 24-26, in Boston. The meeting will focus on specific challenges associated with RNA cell therapy development and how to accelerate these promising therapies through the value chain.

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.

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.

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"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.

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.

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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.