On January 23, 2023 NovAccess Global Inc., a Colorado corporation ("NovAccess" or the "company"), reported previously entered into three securities purchase agreements dated August 20, 2021, February 15, 2022, and May 5, 2022 (collectively, the "Agreements"), with AJB Capital Investments, LLC ("AJB") (Filing, 8-K, NovAccess Global, JAN 23, 2023, View Source [SID1234626477]). Pursuant to the Agreements, NovAccess issued promissory notes to AJB representing loans provided by AJB to the company totaling $1.75 million. Also pursuant to the Agreements, NovAccess paid AJB commitment fees totaling 1,575,000 unregistered shares of the company’s common stock (the "commitment fee shares"). If AJB is unable to sell the commitment fee shares for amounts specified in the Agreements, then AJB may require NovAccess to issue additional shares or pay cash in the amount of the shortfall (the "make-whole rights"). However, AJB may only exercise its make-whole rights within time frames following the loan dates specified in the Agreements (the August 20, 2021 and February 15, 2022 make-whole rights each have a term of 18 months and the May 5, 2022 make-whole rights have a term of 36 months). The August 20, 2021 make-whole rights expire on February 20 of this year. To avoid forcing AJB to sell the commitment fee shares in order to take advantage of its make-whole rights, on January 20, 2023 NovAccess entered into a letter agreement with AJB extending the exercise period for the make whole-rights to 72 months. As amended by the letter agreement, the make-whole rights now expire on August 20, 2027, February 15, 2028, and May 5, 2028. The letter agreement makes additional less material revisions to AJB’s make-whole rights and harmonizes the make-whole rights among the Agreements.

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The letter agreement with AJB is filed as an exhibit to this Current Report on Form 8-K. The description above is qualified in its entirety by reference to the full text of the agreement.

On January 23, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME) (Paris:ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported a clinical update on survival of first-line glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, the CXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab (Press release, TME Pharma, JAN 23, 2023, View Source [SID1234626476]).

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With a median follow-up to date of 10 months in this arm of the trial median overall survival (mOS) has not yet been reached, and five of six patients (83%) remain alive. The 10-month timepoint is an important landmark for assessment since this is the expected survival for patients with MGMT unmethylated tumors and incomplete resection1.

"The data presented in November 2022 at the SNO conference demonstrated the ability of NOX-A12 in combination with radiotherapy and bevacizumab to durably shrink brain tumors in glioblastoma patients with 100% radiographic response and an 83% rate of mRANO response, which is twice as high as the mRANO response rate reported from comparable studies with bevacizumab and standard of care2," said Aram Mangasarian, CEO of TME Pharma. "We are pleased to see the data continuing to support our approach with each update, and we are keen to understand the extent of survival benefit that these patients will obtain. We will continue to provide clinical updates as the data mature."

On January 23, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that the Company’s medical director, Matthew Goldberg, M.D., F.A.A.D., board-certified dermatologist and dermatopathologist, will present at the Precision Medicine World Conference (PMWC) 2023, being held Jan. 25-27 in Santa Clara, California (Press release, Castle Biosciences, JAN 23, 2023, View Source [SID1234626475]).

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Dr. Goldberg’s presentation, titled "Using Molecular Diagnostics to Inform Cancer Management Decisions," will take place on Wednesday, Jan. 25, at 2:30 p.m. Pacific time as part of Track 3: Diagnostics and Molecular Profiling in the Clinic. Dr. Goldberg will highlight several tests within Castle’s skin cancer and gastroenterology portfolios, including DecisionDx-Melanoma, DecisionDx-SCC and the TissueCypher Barrett’s Esophagus test, and demonstrate how the personalized information the tests provide can help clinicians make more informed treatment decisions in the care of their patients to potentially improve patient outcomes.

"Castle Biosciences is a leading company in the precision medicine space that is committed to transforming disease management for skin cancers and Barrett’s esophagus," said Dr. Goldberg. "By focusing on disease states with significant unmet clinical need, we leverage our innovative in-house testing platforms to provide meaningful improvements to diagnostic or risk stratification approaches across the various disease states where we offer molecular testing.

"While there is much discussion about the promise of personalized medicine, Castle’s tests have the potential to improve patient outcomes and reduce costs to the healthcare system. I am looking forward to sharing concrete examples during my discussion of how molecular testing technologies can be clinically accessed for the benefit of patient care today."

Dr. Goldberg has served as Castle’s medical director since 2020 and supports Castle’s commercialized and pipeline tests. He graduated summa cum laude from Princeton University and received his medical degree from the Icahn School of Medicine at Mount Sinai. Dr. Goldberg completed his dermatology residency at the University of California, San Francisco, and completed a dermatopathology fellowship at the University of Texas Southwestern.

Conference presentation content will be available to registered attendees only. Visit View Source for more information and registration details.

About Precision Medicine World Conference

PMWC, the "Precision Medicine World Conference," is the largest and original annual conference dedicated to precision medicine. PMWC’s mission is to bring together recognized leaders, top global researchers and medical professionals, and innovators across healthcare and biotechnology sectors to showcase practical content that helps close the knowledge gap between different sectors, thereby catalyzing cross-functional fertilization and collaboration in an effort to accelerate the development and spread of precision medicine.

Since 2009, PMWC has been recognized as a vital cornerstone for all constituents of the health care and biotechnology community, providing an exceptional forum for the exchange of information about the latest advances in technology, in clinical implementation, research and in all aspects related to the regulatory and reimbursement sectors.

On January 23, 2023 Agilent Technologies Inc. (NYSE: A) reported an agreement with Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services (Press release, Agilent Technologies, JAN 23, 2023, View Source [SID1234626474]). The alliance will enable providers and patients throughout the United States to access the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test. Healthcare providers can order the test beginning today.

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The agreement between Quest and Agilent will enable broad adoption for ctDx FIRST, a single-site premarket approved (ssPMA) test performed at the Resolution Bioscience CLIA laboratory in Kirkland, Washington. ctDx FIRST is the first liquid biopsy test approved by the U.S. Food and Drug Administration (FDA) as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients who may benefit from treatment with KRAZATI. KRAZATI (adagrasib) received accelerated approval as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. ctDx FIRST is also FDA-approved for tumor profiling of the epidermal growth factor receptor (EGFR) gene in accordance with professional guidelines in oncology for patients with advanced non-small cell lung cancer (NSCLC).

As a professional service, the ctDx FIRST test report* includes comprehensive genomic profiling on 109 genes across four types of alterations: single nucleotide variants, indels, copy number amplifications, and fusions.

"We are looking forward to the Quest Diagnostics alliance facilitating broad access to ctDx FIRST, our liquid biopsy solution," said Paul Beresford, vice president and general manager of Agilent’s Companion Diagnostics Division. "This expands the testing options available for NSCLC patients as patients don’t always have tissue available for molecular analysis."

"The addition of the ctDx FIRST test to our oncology menu underscores our commitment to providing access to precision medicine innovations to improve care for patients with cancer," said Kristie Dolan, vice president and general manager, Oncology Franchise, at Quest Diagnostics. "It also reflects our ability to optimize our national physician and patient access network to extend access to important medical innovations with the potential to improve patient outcomes."

Under the terms of the agreement, Quest will offer ctDx FIRST to healthcare providers in the United States seeking a minimally invasive liquid biopsy test option as a CDx for KRAZATI. Healthcare providers can order the test electronically through the Quest connectivity platform, which connects to hundreds of electronic medical records (EMRs). Healthcare providers may direct patients to provide specimens at one of Quest’s 2,100 patient service centers across the United States. Integrating Quest’s electronic health record (EHR) platform and access to its national patient center network will make it easier for healthcare providers to incorporate ctDx FIRST as part of regular clinical care.

Agilent and Quest have previously collaborated on Ki-67 IHC MIB-1 pharmDx and PD-L1.

* CLIA validated, not FDA approved

About NSCLC

There are two primary types of lung cancer, non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Named initially for how the cancer cells look under the microscope, these two account for 230,000 newly diagnosed cases of lung cancer in the U.S. each year. The vast majority (85 percent) of lung cancers fall into the non-small cell lung cancer category. Though this form of lung cancer progresses more slowly than SCLC, 40 percent of NSCLCs will have spread beyond the lungs by the time it is diagnosed.

On January 23, 2023 Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound mocravimod reported that the first patients have been enrolled in the pivotal MO-TRANS global Phase 2b/3 study evaluating mocravimod in AML patients undergoing allogeneic hematopoietic cell transplant (HCT) (Press release, Priothera, JAN 23, 2023, View Source [SID1234626473]).

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Mocravimod, a sphingosine 1 phosphate (S1P) receptor modulator which has been previously tested in multiple autoimmune indications, is being developed to enhance the curative potential of allogeneic HCT. Mocravimod has shown a clinically relevant benefit in an early clinical study in patients with hematologic malignancies undergoing allogeneic HCT.

Priothera is initiating the pivotal MO-TRANS global Phase 2b/3 study in Europe, Israel, the US and in additional Asian and Latin American countries, to assess the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in AML patients undergoing allogeneic HCT. The double-blind, placebo-controlled study assesses relapse-free and overall survival of two dose levels of mocravimod in comparison to placebo. Topline data from this study are expected in 2025.

Marcos de Lima, M.D., is the Principal Investigator for the MO-TRANS global Phase 2b/3 trial. Dr. de Lima is professor of medicine at The Ohio State University College of Medicine and a hematologist-oncologist at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

Prof de Lima said: "We are excited to be part of the important MO-TRANS global Phase 2b/3 study to investigate mocravimod, a potential new adjunctive and maintenance therapy for patients with Acute Myeloid Leukemia undergoing allogeneic Hematopoietic Cell Transplant. Maintenance therapy is fast becoming the new frontier in the treatment of AML and we are committed to bringing forth new innovative therapies to AML patients."

Elisabeth Kueenburg, M.D., Chief Medical Officer at Priothera, commented: "This MO-TRANS global Phase 2b/3 study builds on pre-clinical and clinical proof of concept studies which demonstrated mocravimod’s ability to improve survival outcomes for patients with hematological malignancies requiring allogeneic HCT. The mode of action has been well-established in autoimmune indications, but never in hematology. Mocravimod has the potential to be a first-in-class therapy in maintaining the graft-versus-leukemia effect, while preventing graft-versus-host disease, one of the most serious complications of allogeneic HCT. We expect this trial to deliver important clinical data supporting the registration of mocravimod in this indication."

Florent Gros, Co-Founder and CEO of Priothera, said: "Having successfully enrolled the first AML patients undergoing allogeneic HCT in our MO-TRANS global study represents a significant milestone for Priothera as we believe mocravimod has the potential to address a significant unmet need. Furthermore, we anticipate a strong uptake in patient enrollment with a significant number of patients currently being identified. We look forward to seeing topline results in 2025."

About mocravimod

Mocravimod (also known as KRP203) is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers and the improvement of CAR-T cell therapy.

Mocravimod is currently being investigated as an adjunctive and maintenance treatment in a Phase 2b/3 study for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic cell transplantation (HCT). Allogeneic HCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages mocravimod’s unique mode of action to maintain the beneficial graft-versus leukemia (GVL) activity, while reducing tissue damage resulting from graft-versus-host disease (GVHD), both a consequence of allogeneic HCT. This novel treatment approach – mocravimod being the only S1PR modulator treating blood cancers – tackles a high unmet medical need and aims to improve patients’ quality of life.