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19:49 EDT Natera announces data from ProActive study - Natera announced new data on its Prospera test being presented at the American Transplant Congress 2023 taking place June 3-7, 2023. The presentations include several interim analyses from ProActive, a prospective donor-derived cell-free DNA study evaluating Natera's Prospera test for the detection of rejection in kidney transplant patients, as well as additional presentations that showcase the utility of Prospera in kidney and heart transplantation. The company's presence at ATC includes three oral presentations, several posters, and a symposium led by medical experts in kidney transplantation. Prospera Kidney dd-cfDNA predicted ABMR up to four months, and TCMR up to two months, in advance of biopsy-proven rejection, underscoring the value of Prospera. 86.9% of stable kidney transplant recipients had dd-cfDNA persistently below 1%, further supporting Prospera as a reliable indicator of allograft stability. Patients with biopsy-proven rejection showed a 60X median elevation in dd-cfDNA% vs baseline, compared to just 1.3X median elevation in the non-rejection group, indicating that Prospera may allow for real-time prediction of rejection risk through continuous monitoring of dd-cfDNA level changes.

09:08 EDT Puma presents biomarker findings from Phase II study in HR+, TN breast cancer - Puma Biotechnology announced the presentation of biomarker findings from a Phase II study of alisertib plus paclitaxel versus paclitaxel alone in metastatic hormone receptor positive, or HR+, and triple negative, or TN, breast cancer at the 2023 American Society of Clinical Oncology Annual Meeting held June 2-6 in Chicago and online. The Phase II trial was conducted through The U.S. Oncology Network. The results of this trial were published by Joyce O'Shaughnessy et al. and showed that the addition of alisertib to paclitaxel improved progression-free survival among enrolled patients compared with paclitaxel alone. Archival tissue samples from patients enrolled in the clinical study were analyzed at TGen. Of the 140 patients enrolled in the trial, 45 from the alisertib plus paclitaxel arm and 51 from the paclitaxel arm had sufficient tissue available for next generation sequencing, and 31 from the alisertib plus paclitaxel arm and 35 from the paclitaxel arm had enough for RNA sequencing/gene set enrichment analysis. The most frequently mutated genes were PIK3CA and TP53. No mutations were significantly associated with response or resistance to alisertib plus paclitaxel, including those in PIK3CA, TP53, AKT1, HER2, and CDH1. Increased MYC RNA expression was observed in tumors from patients who did not derive clinical benefit from paclitaxel alone compared to those with benefit from paclitaxel alone. Increased MYC RNA expression was not observed in patients who did not appear to benefit from alisertib plus paclitaxel. Elevated expression of genes involved in MYC activation and in unfolded protein response were enriched in alisertib plus paclitaxel responders compared to paclitaxel responders and were associated with poor response to paclitaxel alone. In 12 patients with exceptional response to alisertib plus paclitaxel, increased expression of genes involved in MYC activation and in epithelial to mesenchymal transition was observed in comparison to cancers from patients whose disease progressed within 6 months of initiating alisertib + paclitaxel or those with exceptional response to paclitaxel alone.

08:45 EDT Bristol-Myers presents follow-up results from Phase 3 CheckMate -9LA trial - Bristol-Myers Squibb announced four-year follow-up results from the Phase 3 CheckMate -9LA trial demonstrating durable, long-term survival benefits with Opdivo, or nivolumab, plus Yervoy, or ipilimumab, with two cycles of chemotherapy compared to four cycles of chemotherapy alone in previously untreated patients with metastatic non-small cell lung cancer, or NSCLC. With a minimum follow-up of 47.9 months, the dual immunotherapy-based combination continued to enhance overall survival, the trial's primary endpoint, with 21% of patients treated with Opdivo plus Yervoy with two cycles of chemotherapy alive compared to 16% of patients treated with chemotherapy alone at four years. With extended follow-up, the clinically meaningful efficacy benefit of Opdivo plus Yervoy with two cycles of chemotherapy was maintained across secondary endpoints and key subgroups of patients, with benefits more pronounced amongst high unmet need patients with tumor PD-L1 expression less than1% and squamous histology. Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase 3 clinical trials in five tumors to date: metastatic NSCLC, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and esophageal squamous cell carcinoma.

08:28 EDT Summit presents data for investigational bispecific antibody ivonescimab - Summit Therapeutics announced data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that was presented at the 2023 American Society of Clinical Oncology Annual Meeting in Chicago, IL. AK112-201 is an open-label Phase II study evaluating ivonescimab plus chemotherapy for 174 patents across three cohorts of patients. The poster features data from 135 patients in Cohort 1 of this study: patients who are treatment-naive with advanced or metastatic non-small cell lung cancer, or NSCLC, whose tumors do not have actionable genomic alterations. Notably, this Phase II data set summarizes results to date from 63 patients with squamous histology. These patients experienced a median progression-free survival of 11.0 months and an overall response rate of 67%. After a median follow-up time of 13.3 months, median overall survival was not reached; although, estimated 9-month OS was 93.2%. The frequency of Grade greater than or equal to3 treatment-related adverse events was 41%. The most frequent treatment-emergent adverse events were anemia, decreased neutrophil counts, and alopecia. Summit has begun clinical development activities on the Phase III HARMONi-3 study, which intends to evaluate ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients. Summit intends to treat patients in the HARMONi-3 trial during the second half of 2023. Ivonescimab had an acceptable safety profile in combination with platinum-doublet chemotherapy for patients with advanced or metastatic NSCLC who had progressed following an EGFR-TKI, as well as in combination with chemotherapy for patients who had progressed following treatment with a PD-(L)1 inhibitor plus platinum-doublet chemotherapy in this clinical study. In May 2023, the first patient was treated in Summit's license territories in the Phase III HARMONi clinical trial. HARMONi intends to evaluate ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor. Ivonescimab, known as SMT112 in the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. There is higher expression of both PD-1 and VEGF in tumor tissue and the tumor microenvironment as compared to normal, healthy tissue in the body. Ivonescimab's tetravalent structure enables higher avidity with over 10 fold increased binding affinity to PD-1 in the presence of VEGF in vitro in tumor cells. This tetravalent structure, the intentional design of the molecule, and bringing these two targets into a single bispecific antibody have the potential to steer ivonescimab to the tumor tissue versus healthy tissue, which is intended to improve side effects and safety concerns associated with these targets and has the potential to focus the antitumor activity of both targets. Over 750 patients have been treated with ivonescimab across multiple clinical studies in different indications in China and Australia.

07:28 EDT G1 Therapeutics presents data from Phase 2 study of trilaciclib in TNBC - G1 Therapeutics presented results from 24 patients enrolled in its Phase 2, single arm mechanism of action study of trilaciclib administered as a single agent to patients with early-stage triple-negative breast cancer, or TNBC, prior to receiving trilaciclib and neoadjuvant therapy. The company said that these results highlight the potential for trilaciclib to enhance long term immune surveillance by increasing T cell function and generation of certain memory T cells and demonstrate gene expression profiles that may be associated with improved clinical outcome. The data also support earlier findings from this Phase 2 trial demonstrating an increase in the ratio of CD8+ T cells to regulatory T cells; a high ratio of CD8+ T cell to Tregs is predictive of overall survival and is associated with pathologic complete response. As expected, high rates of pCR were observed in patients with PD-L1(+) tumors and in patients with inflamed tumor immune microenvironments. Data generated across multiple preclinical and clinical studies to date show that trilaciclib has the greatest effect on longer term endpoints including OS rather than earlier efficacy measures such as objective response rate, pCR, and progression free survival, consistent with other immunotherapies like checkpoint inhibitors. These results suggest that this is likely due to trilaciclib's immune-mediated mechanism of action that protects the immune system from damage caused by cytotoxic therapy and enhances long-term immune surveillance by increasing the generation of certain memory T cells. This dual benefit may provide important longer-term benefits for patients by improving their ability to generate robust immune responses, particularly when treated with future subsequent therapies. Trilaciclib continues to show a strong tolerability profile. Trilaciclib in combination with anthracycline/ cyclophosphamide/paclitaxel (AC/T) +/- pembrolizumab +/- carboplatin in the neoadjuvant setting for early-stage TNBC has a similar safety and tolerability profile as standard neoadjuvant regimens. There were no adverse events leading to discontinuation of trilaciclib.