On April 18, 2023 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vector immunotherapies, reported new translational and biomarker data obtained from the ongoing Phase 1b trial evaluating NOUS-PEV in patients with metastatic melanoma (Press release, NousCom, APR 18, 2023, View Source;utm_medium=rss&utm_campaign=nouscom-presents-new-positive-translational-phase-1b-data-of-nous-pev-a-personalized-neoantigen-cancer-immunotherapy-in-a-late-breaking-abstract-at-aacr-2023 [SID1234630250]). The data will be presented today in a Late-Breaking session at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

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Dr. Elisa Scarselli, Chief Scientific Officer and Co-Founder of Nouscom, said: "These translational data presented at AACR (Free AACR Whitepaper) demonstrate NOUS-PEV, in combination with pembrolizumab, induces long-lasting, tumor-infiltrating memory T cells and anti-tumor activity in metastatic melanoma patients, further supporting the mechanism of actions driving clinical efficacy. Our results further validate the immunogenic potency of our viral vector platform targeting shared and personalized neoantigens. We look forward to advancing the clinical development of NOUS-PEV and reporting complete Phase 1 results later this year."

The abstract reports a greater than 90% success in manufacturing feasibility with a median vaccine release of 8 weeks from biopsy. NOUS-PEV was demonstrated to be safe, well tolerated and highly immunogenic, inducing potent neoantigen-specific CD4 and CD8 T cell responses that were detected for greater than six months in all evaluable patients. Biomarker analysis demonstrated neoantigen-specific increased T cell migration and infiltration in tumors in patients with durable clinical responses. Current clinical efficacy data from six melanoma patients with 11 months median follow up demonstrated 4 partial responses, 1 durable stable disease and 1 progressive disease.

Poster Presentation Details:

Title: NOUS-PEV, a Personalized Cancer Immunotherapy targeting neoantigens, induces long lasting, tumor infiltrating memory T cells

On April 18, 2023 Notable Labs, Inc. ("Notable"), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, reported clinical data regarding its Predictive Precision Medicine Platform (PPMP) at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held in Orlando, Florida from April 14-19, 2023 (Press release, Notable Labs, APR 18, 2023, View Sourcenbl-validation-aacr-2023/" target="_blank" title="View Sourcenbl-validation-aacr-2023/" rel="nofollow">View Source [SID1234630249]).

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"Together with our collaborators at Washington University, today we are reporting on the fourth successful validation study of our Predictive Precision Medicine Platform (PPMP)," said Thomas Bock, M.D., Chief Executive Officer of Notable. "The study assessed our platform’s accuracy in predicting whether a patient will clinically respond to their induction chemotherapy for acute myeloid leukemia (AML). We are excited about these clinical results as they not only corroborate, but expand upon, those of our three other validation trials. Using a specially designed approach to training our machine learning algorithm, PPMP achieved 100% accuracy in its predictions for response to venetoclax plus decitabine (VenDec). That is, all patients predicted to respond clinically actually did while those patients predicted not to respond, did not. These results add further validation and promise to Notable’s strategy of de-risking precision medicines and developing them selectively in patients predicted to clinically respond."

Abstract title: Predictive precision medicine platform accurately predicts individual patient response to AML treatments to maximize outcomes.

This study assessed the capacity of Notable’s Predictive Precision Medicine Platform to accurately predict newly diagnosed AML patients’ response to treatment with cytarabine plus idarubicin (7+3) or VenDec. Employing two different training methods, the predictive algorithm assessed pre-induction blood samples from 31 patients, 18 of whom received 7+3 and 13 of whom received VenDec. The "original" training approach bases predictions on the number of live blasts remaining after treatment with the induction therapies, while the enhanced PPMP approach employs a novel machine learning method and is explicitly designed to maximize the accuracy of predictions for VenDec. The study assessed the correlations between predictive and actual outcomes using four metrics: positive predictive value (PPV/predictive precision, the proportion of predicted responders who actually responded), the negative predictive value (NPV, the proportion of predicted non-responders who, in fact, did not respond), the area under the curve (AUC) of the Receiver Operating Characteristic (ROC) curve (the probability that the predictor correctly ranks a randomly chosen responder higher than randomly chosen nonresponder), and accuracy (the proportion of correct predictions out of all predictions).

For both 7+3 and VenDec, PPMP trained using the original method achieved a PPV of 100%, i.e., all predicted responders actually responded. A PPV of 100% indicates, for example, that a clinical trial selectively enrolling predicted clinical responders would result in a 100% response rate. The NPV was 67% for 7+3 and 57% for VenDec (i.e., 67% of patients on 7+3 and 57% on VenDec who were predicted not to respond, did not). Trained using the original method AUC was 0.91 for 7+3 and 0.81 for VenDec, and the accuracy of this approach was 94% for 7+3 and 77% for VenDec.

To further increase the accuracy on VenDec, a machine learning algorithm integrated the behavior of malignant and non-malignant cell populations and examined responses to the therapeutics along multiple biological dimensions. This novel enhanced method resulted in 100% PPV, 100% NPV and 100% accuracy on VenDec. These compelling results highlight the platform’s potential as a tool for guiding the identification of, the decision-making regarding, and the clinical development of optimal AML therapies for the individual patient. Additional meeting information can be found on the AACR (Free AACR Whitepaper) website, View Source The poster will be available on the Company’s website at View Source shortly after the event.

On April 18, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in the brain cancer space, reported that the Protocol for the Phase 2 clinical trials was submitted to the FDA for review and approval (Press release, Nascent Biotech, APR 18, 2023, https://www.nascentbiotech.com/nascent-submits-phase-2-clinical-research-protocol-to-fda-for-review-and-approval/ [SID1234630248]). The review is required for approval to commence the next phase in the development of Pritumumab ("PTB"). Data related to Phase 1 Clinical Research evaluating safety and tolerance for PTB as a treatment for Primary and Metastatic Brain Cancers has also been submitted to the FDA. The Company anticipates initial comments from the FDA approximately 30 days from the date of filing.

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PTB is a natural human antibody that binds to Cell surface Vimentin (also referred to as ectodomain vimentin), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy and seek out only cancer cells without damaging healthy cells.

On April 18, 2023 Mythic Therapeutics, a clinical-stage biotechnology company focused on the development of next-generation antibody-drug conjugate therapies for the treatment of a wide range of cancers, reported preclinical data highlighting the potential of MYTX-011, its investigational cMET-targeting ADC, for treating a broader range of cMET+ cancers than other cMET-targeting ADCs in development (Press release, Mythic Therapeutics, APR 18, 2023, View Source;utm_medium=rss&utm_campaign=mythic-therapeutics-presents-preclinical-data-on-investigational-cmet-targeting-antibody-drug-conjugate-adc-mytx-011-at-american-association-for-cancer-research-aacr-annual-meeting [SID1234630247]). These data were presented today as a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

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"We are excited by the findings of this study, which demonstrate the potential of MYTX-011 to not only expand the use of ADCs to patients who have not been eligible for treatment due to their level of target expression or tumor type, but also increase ADC efficacy as compared to current cMET-targeting ADCs in development," said Gilles Gallant, BPharm, PhD, FOPQ, Chief Development Officer at Mythic Therapeutics. "These data reinforce the continued evaluation of MYTX-011, not only through our ongoing Phase 1 KisMET-01 clinical trial in NSCLC, where cMET overexpression occurs in up to 70% of cases,[1],[2] but also for patients with other cMET-expressing cancers who are still in need of targeted treatment options."

Details of the poster presentation are as follows:

Title: MYTX-011: A novel cMET-targeting antibody-drug conjugate (ADC) engineered to increase on-target uptake in and efficacy against cMET expressing tumors
Presenter: Nimish Gera, Ph.D., Vice President, Biologics at Mythic Therapeutics
Session Title: Targeting Protein Kinases and Phosphatases for Therapy 1
Session Date and Time: Today, April 18, 2023, from 1:30 PM – 5:00 PM
Location: Poster Section 17
Poster Board Number: 13

Published Abstract Number: 5000

MYTX-011 was designed using Mythic’s FateControl platform by introducing an optimized set of mutations into an anti-cMET antibody. This engineering is designed to allow MYTX-011 to bind cMET on the surface of cancer cells and be selectively freed once inside of cancer cells, increasing the delivery of a potent chemotherapy, MMAE, inside of cancer cells.

In this study, the efficacy of MYTX-011 was evaluated on 62 different cancer cell lines grown in vitro, including NSCLC, head and neck, gastric, pancreatic and other cancer types which are known to express cMET. The efficacy of MYTX-011 was also evaluated in mouse models of NSCLC that expressed moderate and high levels of cMET, as measured by an immunohistochemistry (IHC) test.

MYTX-011 demonstrated higher internalization in cMET+ tumor cells and broader, more potent efficacy, including a greater than 3-fold increase in efficacy in mouse models of NSCLC, as compared to other cMET-targeting ADCs. MYTX-011 also exhibited favorable pharmacokinetics in monkeys including increased half-life, reduced target-mediated drug disposition, and reduced release of free MMAE payload, as compared to other cMET-targeting ADCs. The toxicity profile of MYTX-011 in monkeys was consistent with other vcMMAE-based ADCs. No MYTX-011-related clinical toxicities were found, and the only findings included MMAE-related neutropenia and mild bone marrow toxicity, both of which were reversible.

Mythic recently announced that the first subject was dosed with MYTX-011 in its Phase 1 KisMET-01 multi-center, dose escalation and dose expansion clinical trial in subjects with NSCLC. More information about the clinical trial is available at clinicaltrials.gov (identifier: NCT05652868).

About MYTX-011

MYTX-011, a cMET-targeting ADC, leverages Mythic’s innovative FateControl technology, which allows ADCs to actively navigate inside of cells to potentially increase delivery of anti-cancer agents to tumor cells with less impact on healthy cells. This breakthrough approach takes the next step beyond linker-payload technologies and is designed to improve ADC efficacy against a broad set of molecular targets and patient profiles.

On April 18, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in Stifel 2023 Targeted Oncology Days (Press release, Kura Oncology, APR 18, 2023, View Source [SID1234630246]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at 1:00 p.m. ET / 10:00 a.m. PT on April 25, 2023.

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A live audio webcast of the fireside chat will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay following the event.