On September 14, 2021 Seneca Therapeutics, Inc. ("STI"), a clinical-stage biopharmaceutical company dedicated to the development of targeted oncolytic immunotherapeutics for cancer based on Seneca Valley Virus (SVV-001), reported the successful development of a novel SVV-001 Patient Screening Test (Press release, Seneca Therapeutics, SEP 14, 2021, View Source [SID1234587680]). The test uses a unique set of genes to predict sensitivity to SVV-001 in tumor cells obtained from patient samples. The SVV-001 Patient Screening Test can be used on Formalin-Fixed-Paraffin-Embedded (FFPE) tumor blocks allowing for patient screening using previous biopsies. The SVV-001 Patient Screening Test will identify which cancer patients will benefit from SVV-001 treatment either as monotherapy or in combination with other immune therapies like checkpoint inhibitors. The SVV-001 Patient Screening Test can also be used to identify types of cancer patients that will benefit from SVV-001. The test can be used to screen patients for products in the SVV-001 based Armed Construct Cancer Gene Therapy Portfolio currently in development. The selection of patients using the SVV-001 Patient Screening Test will be applicable whether the patient is treated with either the Intra-tumoral or Intravenous route of administration. The SVV-001 Patient Screening Test will be available through CLIA laboratories.

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!

"Using the SVV-001 Patient Screening Test to select patients, it will be possible to identify and select cancer patients that will benefit from SVV-001 therapy either as monotherapy, combination therapy with check point inhibitors or therapy using SVV-001 Armed Constructs," said Dr. Paul Hallenbeck, CSO, President and Founder of Seneca Therapeutics. "We are excited that this pre-screening test offers the ability to selectively identify which patients will likely benefit from SVV-001."

Seneca Therapeutics is also using the SVV-001 Patient Screening Test to identify relevant cancer patient populations that could benefit from SVV-001 therapy. The company recently screened nearly 300 sarcoma samples and determined that more than 94% were sensitive to SVV-001 therapy. The work to screen other cancers for SVV-001 sensitivity is ongoing.

On September 14, 2021 Vipergen, a leading provider of small-molecule drug discovery services based on DNA-encoded library (DEL) technologies, reported the signing of a multi-target drug discovery agreement with PhoreMost (Press release, PhoreMost, SEP 14, 2021, View Source [SID1234587697]). Under the terms of the agreement, Vipergen will apply its high-fidelity DEL technology platforms to identify novel small-molecule compounds that bind to selected PhoreMost protein targets. PhoreMost will select hits for development into novel therapeutics for oncology. PhoreMost will retain exclusive rights to globally commercialize any products resulting from the collaboration. Financial details of the agreement 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!

"Applying Vipergen’s suite of leading technologies for DNA-encoded library synthesis and screening, we aim to optimize our success rate for discovering novel, high-quality small drug molecules for several oncology targets that were previously considered undruggable," said Rich Boyce, Vice President of Drug Discovery at PhoreMost. "We look forward to collaborating with the Vipergen team in our mission to deliver a diverse range of more effective and safe therapies for cancer patients."

"We are delighted to partner with PhoreMost in its unique mission to develop a pipeline of transformative new therapies for cancer patients by identifying novel drug molecules for binding sites that have eluded conventional target discovery," said Nils Hansen, PhD, Chief Executive Officer of Vipergen. "In particular, Vipergen’s newest platform—which enables screening DNA-encoded small-molecule libraries inside living cells, under physiologically relevant conditions—significantly expands our ability to discover novel small molecules against challenging targets."

On September 14, 2021 Nucleai, a leader in AI-powered spatial biology, and Jefferson Health, a leading cancer center, reported that they have entered into a strategic collaboration to discover spatial immunotherapy biomarkers, leveraging Nucleai’s ATOM platform and Jefferson’s repository of pathology and clinical data (Press release, Nucleai, SEP 14, 2021, View Source [SID1234587793]). The mutual collaboration will help advance AI-based solutions in discovering histological biomarkers and patient selection in clinical trials and clinical settings. The Israeli Innovation Authority supports the collaboration as part of the International Health-Tech Pilot Program.

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!

Nucleai’s ATOM platform analyzes pathology images using computer vision and machine learning methods to model the tumor and the immune system’s spatial characteristics, creating unique and specific histological biomarkers that may predict patient response to therapy. These biomarkers hold the potential to provide a better understanding of cancer biology, enable further stratification of responder/non-responder patient populations, and improve the success rate of clinical trials and patient care. Nucleai leverages proprietary multimodal datasets of pathology images and clinical data from leading hospitals and Health Maintenance Organizations (HMOs) in the U.S and Israel to develop its platform.

As part of the collaboration between Nucleai and Jefferson, the two parties will test the utility of AI-based predictive biomarkers in a real-world clinical setting and assess the clinical benefit that the novel platform could provide for cancer patients treated with immunotherapy.

"It is now clear that analysis of digital pathology through computational approaches opens access to "hidden" information that is beyond the resolution of a pathologist’s examination through a microscope. We look forward to working with Nucleai to "unlock" such information to learn new disease mechanisms and using it to help our patients," said Stephen Peiper, Peter A. Herbut Professor and Chair Department of Pathology, Anatomy and Cell Biology at Thomas Jefferson University and Senior Vice President for the Enterprise Pathology and Laboratory Medicine Service Line of Jefferson Health System.

"Jefferson is dedicated to providing the highest-quality, compassionate clinical care for patients, preparing tomorrow’s professional leaders for 21st century careers, and discovering new treatments to define the future of care. The collaboration with Nucleai epitomizes this vision," said Zvi Grunwald, the Director of the Jefferson Israel Center.

"We are thrilled to launch this collaboration with Jefferson Health and are honored to be included in the Israeli Innovation Authority pilot program. Nucleai brings a unique spatial biology perspective into precision medicine, and we are eager to apply our platform to support novel biomarker discovery, diagnostics development, and clinical decision support," Nucleai CEO Avi Veidman said in a statement.

On September 14, 2021 AbbVie reported that faced no shortage of criticism and questioning over its decision to abandon its proposed $55 billion Shire buyout back in 2014 (Press release, FiercePharma, SEP 14, 2021, View Source [SID1234587941]). But after years of legal back-and-forth, the company has escaped one high-profile case from hedge funds that alleged the company misled them about its true intentions .

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!

When AbbVie unveiled its proposed Shire deal in July 2014, the company cited a "strong strategic rationale" for the move—not just the tax benefits of acquiring an Irish drugmaker. But shortly after the U.S. Treasury Department rolled out new rules in September 2014 to crack down on controversial so-called tax inversions, the company gave up on the merger.

That sequence of events led to some big losses at hedge funds, which later sued AbbVie alleging fraud. In their lawsuits, the hedge funds said they bought Shire shares hoping the deal would close but that they suffered losses when AbbVie walked away from the deal in October 2014. They said AbbVie’s public statements didn’t match with its private intentions for pursuing Shire.

In a decision Monday, Cook County Circuit Judge Margaret A. Brennan ruled in AbbVie’s favor, granting summary judgement and tossing the hedge funds’ claims. The plaintiffs were "kind of rolling the dice, hoping to make some money" by buying Shire shares after the buyout announcement, the judge said. They "had to do their own analysis" and "had to be aware that there were possibilities that this may not come through," she added.

Representing AbbVie, Gabor Balassa of law firm Kirkland Ellis said the company’s statements about the merger talks—both before and after the July 14, 2014, announcement—contained cautionary language and opinions about the proposed deal, not statements of fact.

RELATED: Hedge fund sues AbbVie for scuttling $55B Shire buyout

The hedge funds saw things differently. Representing the plaintiffs, Robert B. Tannenbaum of Bartlit Beck said AbbVie "repeatedly" told its clients the deal was "not driven by the tax benefits" but that it was "strategically and financially compelling well beyond the tax benefits." That didn’t match with the company’s behind-the-scenes beliefs, Tannenbaum told the court, as evidenced by the company’s decision to walk away from the deal after the U.S. Treasury Department rolled out its anti-inversion rules.

Even after the U.S. Treasury Department issued those rules, AbbVie’s CEO Richard Gonzalez said in a memo to Shire employees that he was "more confident than ever about the potential of our combined organizations," Tannenbaum pointed out.

Behind the scenes, AbbVie’s execs sought the deal primarily for tax purposes, Tannenbaum said. At the time, tax inversions were "extremely controversial and nearly universally unpopular." In that environment, AbbVie developed a "messaging strategy," he said, to talk up more favorable aspects of the deal.

"AbbVie pursued this false messaging strategy to minimize government scrutiny of the deal, avoid long-term reputational harm as a tax avoider and to avoid losing essential Shire shareholder support for the deal," Tannenbaum said.

SPECIAL REPORT: Biopharma’s top broken, unfulfilled or abandoned promises | AbbVie, Rick Gonzalez

In 2016, hedge fund Elliott Management sued AbbVie over the failed merger, and other funds followed with their own lawsuits over subsequent years. Discovery in the litigation has spanned years, with lawyers taking nearly 100 depositions.

In a separate case, AbbVie settled with Shire shareholders in 2019 for an undisclosed amount.

After AbbVie and Shire parted ways on their talks, Takeda ended up buying the Irish drugmaker in 2018 for $62 billion. AbbVie, for its part, scored another megamerger with its massive Allergan buyout. AbbVie and Allergan merged last May in a deal worth $63 billion.

On September 14, 2021 Pacylex Pharmaceuticals, Inc. reported that it initiated a Phase 1 clinical trial of PCLX-001, a first-in-class, orally bioavailable small molecule inhibitor of N-myristoyltransferase 1 and 2 (NMT1, NMT2), at the University of Alberta Cross Cancer Institute (Press release, Pacylex Pharmaceuticals, SEP 14, 2021, View Source [SID1234645062]). This open label, dose escalation study will examine the safety and tolerability of PCLX-001 and determine the dose to be used in initial efficacy studies. Pacylex received a No Objection Letter from Health Canada on March 8, 2021, authorizing the planned Phase 1 Trial of PCLX-001 in relapsed/refractory B-cell Non-Hodgkin’s Lymphoma and advanced solid malignancies. PCLX-001 is believed to be the first NMT inhibitor that will be clinically tested.

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!

PCLX-001 is the first clinical candidate sponsored by Pacylex Pharmaceuticals to reach the clinical stage. "We are excited to see PCLX-001 transition to helping serious refractory cancer patients," said Michael Weickert, CEO of Pacylex Pharmaceuticals. "Our mission is to bring this new potential cancer breakthrough to patients, and we are especially privileged to be working with the Cross Cancer Institute on this clinical program."

"We are genuinely excited to initiate a new therapeutic candidate for these very challenging patients," said Dr. John Mackey, the Chief Medical Officer of Pacylex Pharmaceuticals. "Based on its unique mechanism of action and preclinical results, we hope this therapy will provide at least some patients with relief from their disease."

Dr. Randeep Sangha is the principal investigator for the study of PCLX-001 at the Cross Cancer Institute in Edmonton. "We plan to test PCLX-001 on patients who have tried everything else. Testing something really new is the goal of every cancer researcher since it may open the door for new treatments for patients" said Dr. Sangha.

Patient enrollment and dosing will also begin soon at Princess Margaret Hospital in Toronto and the BC Cancer Agency in Vancouver. The study will enroll 20-30 patients in the initial phase. Three principal investigators will oversee the clinical study at the three clinical sites in Canada: Dr. John Kuruvilla at Princess Margaret Cancer Centre in Toronto, Dr. Randeep Sangha at the Cross Cancer Institute in Edmonton, and Dr. Laurie Sehn at the British Columbia Cancer Center in Vancouver.

This study is registered at ClinicalTrials.gov Identifier: NCT04836195.

About Non-Hodgkin’s Lymphoma

Non-Hodgkin’s Lymphoma (NHL) is the most common hematologic malignancy and the eleventh most common cancer worldwide, with nearly 510,000 new cases diagnosed in 2018. It accounted for nearly 249,000 deaths worldwide in 2018. The most prevalent form of NHL, accounting for about 40% of newly diagnosed NHL cases, is an aggressive form called diffuse large B-cell lymphoma (DLBCL), that comes with a life expectancy of weeks or months if left untreated.

PCLX-001

PCLX-001 is a small molecule, first-in-class N-myristoyltransferase (NMT) inhibitor, originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness funded by Wellcome Trust. Pacylex is developing PCLX-001, which has excellent oral bioavailability, to treat leukemia and lymphoma. PCLX-001 selectively kills cancer cells and completely regresses (eliminates) tumors in animal models of acute myeloid leukemia (AML), diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma (BL). PCLX-001 has also been shown to strongly inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the level 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.