On September 23, 2022, Syndax Pharmaceuticals, Inc. (the "Company") reported made a prepayment of $21.5 million to satisfy in full all of the Company’s principal and interest obligations and related fees under that certain Loan and Security Agreement, dated February 7, 2020, by and among the Company and its subsidiaries, the several banks and other financial institutions or entities from time to time parties thereto, and Hercules Capital, Inc. ("Hercules"), in its capacity as administrative agent and collateral agent (collectively, the "Lender"), as amended (as amended, the "Loan Agreement") (Filing, 8-K, Syndax, SEP 23, 2022, View Source [SID1234621399]). The payoff amount paid by the Company in connection with the termination of the Loan Agreement was pursuant to a payoff letter with Hercules and included payment of (a) $1.0 million as an end-of-term fee and (b) $0.4 million pre-payment fee. Hercules released all security interests held on the assets of the Company and its subsidiaries.

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On September 23, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that John Climaco, Chief Executive Officer of CNS Pharmaceuticals, will present at the Virtual Investor Innovations in Oncology – Ongoing Pivotal Global Study for Treatment of Glioblastoma Multiforme (GBM) Event on Wednesday, September 28, 2022 at 1:00 PM ET (Press release, CNS Pharmaceuticals, SEP 23, 2022, View Source;ongoing-pivotal-global-study-for-treatment-of-glioblastoma-multiforme-gbm-301631776.html [SID1234621398]).

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As part of the virtual event, the Company will discuss its ongoing potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV1) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival (OS), which is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. The recently amended protocol expands eligibility for the study to patients who have received additional treatments as part of the first line therapy for their disease considering advancements in this area. This change was made due to the complexity of new agents introduced as a component of first line therapy, which allows an additional group of patients that can enroll on the study after what may constitute multiple procedures as their initial treatment.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

In addition to the moderated portion of the event, investors and interested parties will have the opportunity to submit questions. The Company will answer as many questions as possible during the event.

A live video webcast of the Virtual Investor Innovations in Oncology – Ongoing Pivotal Global Study for Treatment of Glioblastoma Multiforme (GBM) Event will be available on the Events page in the Investors section of the Company’s website (www.cnspharma.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On September 23, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported that management will participate in a fireside chat at 1:30 p.m. ET on Friday, September 30, 2022 at the upcoming Jefferies Cell & Genetic Medicine Summit set to take place in New York City (Press release, Wugen, SEP 23, 2022, View Source [SID1234621397]).

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On September 23, 2022 Massive Bio, which uses its proprietary artificial intelligence-based platform to match cancer patients to clinical trials regardless of where they live or their financial circumstances, reported that it is expanding its operations in Europe (Presentation, Massive Bio, SEP 23, 2022, View Source [SID1234621396]). With support from Series B investments received in the first half of this year, Massive Bio announced the hiring of three new team members who will help expand the company’s global operations, intensify its marketing activities, develop new data sets and products, and expand its M&A efforts. The new recruits are Toygun Onaran, who will serve as Head of Strategy; Mert Sarı, who will be Regional Manager; and Sinan Fındık, who comes on board as Clinical Research and Data Manager.

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Massive Bio’s expanding presence in Europe will allow the company to continue its mission of ensuring that all cancer patients receive treatment under fair and favorable conditions, said Çağlar Demirbağ, Director of International Partnerships, which manages the company’s operations outside of the United States, adding that "there are about 4 million patients diagnosed with cancer annually in Europe. With the steps we have taken in the last two years, we have been ensuring that thousands of cancer patients in Spain, Italy, France, Germany, Romania, Poland, and Greece are matched to appropriate clinical trials. This is also enabling that these patients receive the best treatment free of charge."

"The current changes we are making today will help us better reach and support more cancer patients in the future," added Erkan Terzi, Massive Bio’s Vice President of Global Marketing. Terzi said, "At Massive Bio, we work on three continents in 32 different functional areas in our marketing efforts. Our recent updates, newsletters, infographics, new video production, digital-asset improvements, content writing, and advertising management continue to help us create a more comprehensive and effective patient-use case. The technologies we use and the integrated studies we create with different units enable us to work more effectively in the business focus."

On September 23, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported the publication of a study in the Journal of the American Academy of Dermatology validating the performance of DecisionDx-Melanoma’s proprietary algorithm, i31-ROR. i31-ROR is designed to integrate a patient’s tumor biology with clinicopathologic factors to provide the patient’s personalized risk of melanoma recurrence (Press release, Castle Biosciences, SEP 23, 2022, View Source [SID1234621395]). The study, accessible here, found that DecisionDx-Melanoma’s integrated algorithms (i31-ROR and i31-SLNB) provide more precise risk-stratification and individualized risk estimates, compared to those based on clinicopathologic factors alone, and can ultimately improve treatment decisions.

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As expected in the study, the most significant factor in predicting melanoma-specific survival (MSS) was the tumor biology risk as identified by DecisionDx-Melanoma’s 31-gene expression profile (GEP) (multivariate hazard ratio (HR)=20.00). Additionally, DecisionDx-Melanoma, including both algorithms (i31-SLNB and i31-ROR), identified 44% of patients who could potentially forego the sentinel lymph node biopsy (SLNB) surgical procedure while maintaining high survival rates (>98% for recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and MSS) or were re-stratified as being at a higher or lower risk of recurrence or death than initially staged using the American Joint Committee on Cancer 8th edition (AJCC8) staging criteria.

"Current staging practices use key characteristics of a patient’s melanoma tumor to determine how aggressive it is as a means to inform important cancer management decisions, such as intensity of follow-up, surveillance imaging and the need for adjuvant therapy," said first author Abel Jarell, M.D., dermatologist and dermatopathologist at Northeast Dermatology Associates, PC, Portsmouth, New Hampshire. "DecisionDx-Melanoma takes many of these same characteristics and combines them with the biology of a patient’s tumor to provide patients and clinicians with personalized – instead of population-based – risk estimates that can allow for tailored treatment plans aligned to the patient’s individual risk."

Integrating Clinicopathologic Factors with Tumor Biology for Precise, Personalized Risk Estimates

DecisionDx-Melanoma is Castle’s molecular risk stratification GEP test that analyzes the expression of 31 genes (31-GEP) within tumor tissue. DecisionDx-Melanoma’s 31-GEP has been shown to be a significant predictor of recurrence and metastatic risk, independent of other clinical factors.1 In addition to the 31-GEP class score (low risk (Class 1A), increased risk (Class 1B/2A) or high risk (Class 2B) of recurrence or metastasis), the test now provides results from two proprietary algorithms, i31-SLNB and i31-ROR, that combine a patient’s 31-GEP score with his/her clinicopathologic factors to provide precise, personalized risk assessments that inform two clinical questions in the management of cutaneous melanoma:

1) A patient’s individual risk of sentinel lymph node (SLN) positivity (i31-SLNB algorithm, previously validated);2 and

2) A patient’s personal risk of recurrence and/or metastasis (i31-ROR algorithm).

The paper, titled "Optimizing treatment approaches for patients with cutaneous melanoma by integrating clinical and pathologic features with the 31-gene expression profile test," discusses the development and validation of the i31-ROR algorithm and its use in conjunction with the i31-SLNB algorithm for more comprehensive and refined patient prognoses.

i31-ROR Highlights:

DecisionDx-Melanoma’s i31-ROR algorithm integrates a patient’s 31-GEP score with his/her clinicopathologic factors, including Breslow thickness, ulceration, mitotic rate, SLN status, age and tumor location. The most significant factor in predicting MSS was the tumor biology risk as identified by the 31-GEP (multivariate HR=20.00).
With these inputs, i31-ROR provides personalized, not population-based, predictions of five-year MSS, and two additional endpoints not available in AJCC8, RFS and DMFS.
Study highlights:

In the study, DecisionDx-Melanoma’s i31-ROR algorithm identified patients at the highest and lowest risk for recurrence or metastasis; patients with a low-risk i31-ROR result had significantly higher RFS (91% vs. 45%, P<0.001), DMFS (95% vs. 53%, P<0.001) and MSS (98% vs. 73%, P<0.001) than patients with a high-risk i31-ROR result.
Additionally, i31-ROR correctly reclassified patient risk as being higher or lower than predicted by AJCC8 for MSS, demonstrating the ability of the algorithm to further refine patient risk and help inform more individualized melanoma management plans.
The i31-ROR also had higher sensitivity and higher negative predictive value (NPV) for RFS, DMFS and MSS than SLN status alone (sensitivity of i31-ROR vs. SLN status alone: RFS (66% vs. 46%), DMFS (78% vs. 49%) and MSS (71% vs. 57%); NPV of i31-ROR vs. SLN status alone: RFS (93% vs. 89%), DMFS (97% vs. 93%) and MSS (98% vs. 97%)).
When patients with an i31-SLNB estimated likelihood of SLN positivity of ≥5% (n=298) were analyzed by the i31-ROR algorithm, those with a negative SLN but high-risk i31-ROR result had lower RFS, DMFS and MSS rates than patients with a negative SLN and a low-risk i31-ROR result. Among this same subset of patients, those with a positive SLN but a low-risk i31-ROR result had higher RFS, DMFS and MSS rates than patients with a high-risk i31-ROR result.
Moreover, the study showed that the number of patients undergoing SLNB could potentially be reduced as a subset of patients with an i31-SLNB predicted risk of <5% all received a low-risk i31-ROR result and had RFS, DMFS and MSS rates >98%.
Study conclusions:

Overall, the study demonstrated that DecisionDx-Melanoma, with integrated algorithms that combine the 31-GEP score with a patient’s clinicopathologic factors, provides personalized and accurate survival prognoses, which can help guide risk-aligned patient management.
Further, the study showed that using DecisionDx-Melanoma test results in conjunction with current staging guidelines can help refine patient risk, reduce unnecessary procedures and ultimately improve patient care.
As the National Comprehensive Cancer Network (NCCN) guidelines recommend risk-aligned decisions for individual patients, the use of DecisionDx-Melanoma test results could aid in identifying patients with more or less aggressive cases of melanoma to align treatment decisions more accurately with patient risk and help ensure a more appropriate allocation of healthcare resources.
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 9,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 35 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com