On October 6, 2023 Circle Pharma, a biopharmaceutical company advancing the discovery and development of intrinsically cell-permeable macrocycles, reported an upcoming poster presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place from October 11-15, 2023, in Boston, MA (Press release, Circle Pharma, OCT 6, 2023, View Source [SID1234635705]).

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Details of the presentation are as follows:

Title: Novel orally bioavailable macrocycles that target cyclin A and B elicit antitumor activity in breast cancer patient-derived xenograft models
Presenter: Mariana Paes Dias, Vall d’Hebron Institute of Oncology, Barcelona, Spain
Abstract Number: LB_C04
Session: Poster Session C
Date/Time: Saturday Oct 14 12:30-4:00pm

On October 6, 2023 IngenOx Therapeutics, the Oxford-based biopharmaceutical company reported that it had received separate grants of applications from the Chinese (CNIPA); and European Patent Office for compounds and methods useful in the treatment of protein arginine methyl-transferase mediated proliferative disorders such as cancers (Press release, IngenOx Therapeutics, OCT 6, 2023, View Source [SID1234635681]).

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IngenOx is developing oral medicines which inhibit protein arginine methyltransferase 5 (PRMT5), an enzyme that is instrumental in driving the malignant properties of cancer cells. The enzyme methylates key targets which lead to uncontrolled cell growth and division, and inhibitors of PRMT5 are effective at blocking cancer cell proliferation. IngenOx has developed broad intellectual property and has received granted patents covering the PRMT5 enzyme and its inhibitors and is advancing them to clinical trials.

IngenOx’s granted China patent (No ZL201880031972.3) covers a range of tricyclic compounds suitable for use in the treatment of proliferative disorders. Its European patent (EP3596061) covers compounds useful in the treatment or prevention of a PRMT5-mediated disorder.

Nick La Thangue, CEO of IngenOx, and Professor of Cancer Biology at the University of Oxford commented:

"We are delighted that the Chinese and European Patent Offices have granted patents on our applications, providing us with wide chemistry cover. The patents add to and extend our significant intellectual property and patent portfolio and strengthen our competitive position in this increasingly interesting area for cancer drug development. Combined with our precision medicine biomarker approach, we have a very powerful platform for delivering new and effective cancer drugs".

On October 5, 2023 Molecular Targeting Technologies, Inc. (MTTI), reported that it is presenting at BioFuture 2023 on Thursday 2:45 PM, Oct 5th, at Lotte New York Palace hotel. This year, registered, in-person attendees can view MTTI’s presentation live, and get advance access to a recorded version beginning September 1, five weeks prior to the actual event (Press release, Molecular Targeting Technologies, OCT 5, 2023, View Source [SID1234635704]).

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Jianwei Xu, PhD, Chief Business Officer will introduce MTTI’s EvaThera, the first long-acting, targeted peptide receptor radionuclide therapy (PRRT) platform.

PRRT delivers killing radiation directly to cancer cells using unique peptides to target biomarkers on those cancers. This class of therapeutics has seen explosive growth since 2018, projected to continue at 34% CAGR over the next decade.

Chris Pak, founder and CEO of MTTI noted, "EvaThera provides next-generation efficacy for many hard-to-treat cancers. We’re excited to expose the broad BioFuture audience to our high value, long-acting PRRT platform."

Sara Demy, CEO of Demy-Colton commented, "We are delighted that Molecular Targeting Technologies, Inc. will be presenting. BioFuture gathers today’s very best innovators, investors and business leaders to discuss the future of healthcare and potential game-changing technologies, like EvaThera, that will drive that future."

On October 5, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported a new study demonstrating DecisionDx-Melanoma outperforms a nomogram developed at the Memorial Sloan Kettering Cancer Center (MSKCC) in predicting the risk of sentinel lymph node (SLN) positivity in patients with cutaneous melanoma (CM) (Press release, Castle Biosciences, OCT 5, 2023, View Source [SID1234635703]). The study is available online in Anticancer Research.

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"Nearly 90% of patients receive a negative result after undergoing the sentinel lymph node biopsy (SLNB) procedure,1-2 indicating there is a significant need for more precise methods to identify which patients can safely forego the surgery and still experience good outcomes," said Michael Tassavor, M.D., study author, board-certified dermatologist and fellowship-trained Mohs surgeon currently practicing in New Jersey. "By providing an accurate prediction of a patient’s likelihood of having a positive SLN, DecisionDx-Melanoma test results can inform important conversations between clinicians and patients and provide added confidence in decisions to proceed without the surgery if a patient’s risk is low."

The study evaluated the performance of two tools used to identify patients at low and high risk of SLN positivity:

Castle’s DecisionDx-Melanoma test, which uses advanced algorithms to integrate a patient’s clinical and pathologic factors with his/her tumor biology to provide a personalized prediction of the risk of SLN positivity, and melanoma recurrence and metastasis.
The MSKCC nomogram, which uses logistic regression and only clinical and pathologic factors to predict a patient’s SLN positivity risk.
Patients from previously published multicenter cohorts with T1-T2 tumors who had undergone the SLNB procedure (n=465) were analyzed using both DecisionDx-Melanoma and the MSKCC nomogram. Following current National Comprehensive Cancer Network (NCCN) guidelines, a risk prediction of less than 5% in the study was considered low risk for SLN positivity, where patients could safely forego the SLNB procedure. A true-to-false-negative ratio was evaluated using this 5% risk threshold. A 5% threshold represents 19 truly negative nodes for one positive SLN missed (19:1 ratio; 1/20 [5%]), meaning that for every 100 patients who avoided SLNB based on NCCN criteria, 5 would have had a missed positive SLN.

The DecisionDx-Melanoma test resulted in a 36:1 true-to-false-negative ratio (108/3), meaning that for every 100 patients who avoided SLNB based on the test’s results, only 2.7 would have had a positive SLN. This is well below the 5% low-risk threshold established by NCCN. DecisionDx-Melanoma’s performance was better than that of the MSKCC nomogram, which resulted in a 9:1 true-to-false-negative ratio, suggesting that for every 100 patients avoiding SLNB using the MSKCC nomogram, 10 would have had a positive SLN. DecisionDx-Melanoma also demonstrated better accuracy in predicting SLN positivity, including higher sensitivity (95% vs. 81%) and negative predictive value (97% vs. 90%) than the MSKCC nomogram.

Importantly, in patients with T1 tumors, for whom the decision to perform SLNB is least clear, using the DecisionDx-Melanoma test to help guide decision-making could have reduced the number of SLNBs by 43.7%, compared with standard NCCN SLNB guidance using American Joint Committee on Cancer staging, while maintaining a low false-negative rate.

DecisionDx-Melanoma has been validated to identify patients who have less than a 5% risk of a positive SLN, indicating that these patients may consider avoiding the SLNB surgical procedure.3-4 The results of this study support these findings and demonstrate that DecisionDx-Melanoma outperforms the MSKCC nomogram in identifying patients at low risk of SLN positivity. The study provides further evidence that using DecisionDx-Melanoma to help guide decisions regarding the SLNB procedure could improve patient selection, reduce unnecessary surgical procedures and ultimately improve the care of patients with melanoma.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2023, DecisionDx-Melanoma has been ordered more than 137,200 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.

On October 5, 2023 CEL-SCI Corporation (NYSE American: CVM) reported it has filed a request with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss a pathway for approval of Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed head and neck cancer (Press release, Cel-Sci, OCT 5, 2023, View Source [SID1234635702]).

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At the meeting, CEL-SCI will present MHRA with new results that demonstrate pre-surgical response rates and overall survival advantages that are superior to those published by CEL-SCI previously. These new results arose from an improved selection algorithm of the Multikine target population. The improvements in the selection algorithm were based on discussions and feedback from regulators and consultants. This improved selection algorithm is able to more accurately predict the patients who would benefit most from the Multikine therapy.

A statistical validation of outcomes in the new target population, based on the Phase 3 study data, was recently concluded and will be presented at the Conference of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) which takes place October 20-24, 2023 in Madrid, Spain.

CEL-SCI is seeking a pathway towards approval of Multikine throughout the UK. CEL-SCI’s goal is to apply for marketing authorization in the UK as soon as possible, based on the data already generated. Just two weeks ago CEL-SCI filed a similar submission with the European Medicines Agency (EMA).

"We have a comprehensive global regulatory approval strategy," stated CEL-SCI’s CEO Geert Kersten. "Having received encouraging submission guidance from Health Canada, we plan to file for a NOC/C conditional approval there. This pathway would allow CEL-SCI to request immediate approval based on the data generated to date, and any additional studies if needed would be done post-market. With the European Medicines Agency and the MHRA, we hope to do the same. We are extremely excited about the results seen in the newly defined Multikine target population."

CEL-SCI’s pivotal Phase 3 study tested Multikine in newly diagnosed locally advanced head and neck cancer patients. The study demonstrated a nearly 4-year median overall survival benefit for Multikine treated patients who were treated with surgery and radiotherapy versus the control group who did not receive Multikine. The dire need for a new and effective treatment for newly diagnosed locally advanced primary head and neck cancer is widely recognized in the medical community.