On May 26, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Dr. Shakeel Modak, MD from Memorial Sloan Kettering ("MSK") will present results from the naxitamab-based chemoimmunotherapy trial in patients with chemoresistant high-risk neuroblastoma ("HR-NB"), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting to be held June 3-7, 2022 (Press release, Y-mAbs Therapeutics, MAY 26, 2022, View Source [SID1234615108]).

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This clinical trial studied the combination of Humanized anti-GD2 antibody naxitamab, Irinotecan, Temozolomide and Sargramostim (GM-CSF), ("HITS") protocol, and included cohort of patients that were treated at MSK in a phase 2 protocol, and at Hospital Sant Joan de Déu ("HJSD") per protocol on compassionate use basis. Health authorities have not established the safety and efficacy of the HITS protocol, as it is investigational and has not been approved by health authorities.

Eligibility criteria included evaluable or measurable chemoresistant disease. Prior anti-GD2 or irinotecan/temozolomide therapy was permitted. Each cycle, administered 3-5 weeks apart, comprised irinotecan, temozolomide, naxitamab and GM-CSF. The primary endpoint of the phase 2 trial at MSK was complete response ("CR") and partial response ("PR") after 4 cycles.

Of 90 previously heavily treated patients, (38 at MSK in the phase 2 trial, and 52 at HJSD), eight had HR-NB refractory to induction chemotherapy and 82 had up to six prior relapses.

The primary endpoint was reached in the MSK phase 2 trial: Objective Response Rate ("ORR") according to the International Neuroblastoma Response Criteria ("INRC") of 30.6 %, with a lower boundary of 20.4%. In the entire cohort, responses were 26% for CR, 11% for PR, 9% for mixed response, 27% for stable disease and 27% for progressing disease ("PD"). In the MSK phase 2 trial, the ORR was 64% for all patients, with soft tissue (48%) and skeletal MIBG uptake (66%). CR in bone marrow was seen in 57% of the patients. The ORR in patients with MYCN-amplification was 25%, in patients with refractory disease 100%, and in patients with relapsed disease 61%. Moreover, in patients who had previously received irinotecan/temozolomide or naxitamab, the ORR was 64% and 68%, respectively. In patients who had previously received dinutuximab/irinotecan/temozolomide, the ORR was 42% (five out of 12 patients).

Toxicities included myelosuppression and diarrhea as expected with irinotecan/temozolomide, pain and hypertension as expected with naxitamab, plus febrile neutropenia. No other >grade 2 unexpected toxicities occurred, and the treatment was outpatient. In this trial, human anti-human antibody did not develop in any of the 50 patients providing samples for testing.

"We are very pleased to present data for the HITS protocol," stated Thomas Gad, Founder, President and Interim CEO. "Responses in patients with relapsed or progressive high-risk neuroblastoma are challenging, as chemo-resistant disease is considered an obstacle, so we are excited to see this study met its primary endpoint. This further demonstrates the potential role for DANYELZA in HR-NB. No other GD2 antibody has been studied in such a heavily pre-treated patient population."

Researchers at Memorial Sloan Kettering Cancer Center MSK developed naxitamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

On May 26, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, will participate in two upcoming investor conferences (Press release, Veracyte, MAY 26, 2022, View Source [SID1234615107]). Veracyte will present at the William Blair 42nd Annual Growth Stock Conference on Wednesday, June 8, and will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Monday, June 13 .

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Event: William Blair 42nd Annual Growth Stock Conference
Date: Wednesday, June 8, 2022
Time: 10:40 a.m. PT / 1:40 p.m. ET

Event: Goldman Sachs 43rd Annual Global Healthcare Conference
Date: Monday, June 13, 2022
Time: 2:40 p.m. PT / 5:40 p.m. ET

Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source Replays of the webcasts will be available for 90 days following the conclusion of each live presentation broadcast.

On May 26, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data from a large, population-based study reinforce the clinical utility of the Decipher Prostate genomic classifier (Press release, Veracyte, MAY 26, 2022, View Source [SID1234615106]). The findings, which will be shared for the first time at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, suggest that the Decipher Prostate tests are helping to guide prostate cancer treatment decisions and improve patient care.

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"This is the first study linking patient data from SEER, the most commonly used cancer database in the United States, and the Decipher Prostate genomic classifier, to explore the association between Decipher Prostate test results and prostate cancer treatment decisions," said Elai Davicioni, Ph.D., Veracyte’s medical director for urology and an author on the study. "The resulting data are exciting, because they demonstrate that population-based prostate cancer treatment patterns are independently associated with Decipher classifier scores."

Researchers identified 10,528 patients with a primary prostate cancer diagnosis from 2010 to 2018 in the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database who had undergone testing with either Decipher Prostate Biopsy (n=5,015) or Decipher Prostate RP (n=5,513) between 2014 and 2020. They then evaluated the association between these patients’ Decipher scores (range 0-1) and risk groups (low, intermediate and high), and the use of active surveillance and watchful waiting (AS/WW) as well as adverse pathology at the time of radical prostatectomy (RP).

Results show that use of AS/WW was highest among those men with low risk Decipher Prostate Biopsy results (41%), as compared to men who had intermediate (32%) or high risk (17%) Decipher scores. Conversely, RP usage increased based on individuals’ Decipher test risk group (19% of low, 25% of intermediate, and 34% of high risk). Researchers observed a similar association and trend by Decipher risk group in the use of radiation therapy (13% of low, 19% of intermediate, and 29% of high Decipher risk).

"These findings provide a powerful demonstration that the Decipher Prostate genomic classifiers are giving physicians and patients valuable information to help them make important and often challenging treatment decisions. In other words, the test is positively impacting patient care, as intended," said Dr. Davicioni. "We are thrilled to be collaborating with the National Cancer Institute’s SEER program and academic researchers from leading comprehensive cancer centers and believe that these data will substantially enrich SEER’s prostate cancer registry and provide a valuable resource for oncology researchers."

About Decipher Prostate

Decipher Prostate is a 22-gene, microarray-based genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis (Decipher Prostate Biopsy) and after surgical removal of the prostate (Decipher Prostate RP). The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

On May 26, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data from a clinical research study demonstrating the ability of its Immunoscore Immune Checkpoint (IC) assay to predict which patients with metastatic non-small cell lung cancer (NSCLC) may benefit from immune checkpoint inhibitors (ICIs) (Press release, Veracyte, MAY 26, 2022, View Source [SID1234615105]). The findings will be shared in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on June 6 at 1:15 p.m. CDT.

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"Immune checkpoint inhibitors have revolutionized therapeutic management of patients with metastatic non-small cell lung cancer," said Jérôme Galon, Ph.D., of Inserm, the National Institute of Health and Medical Research in France, and Veracyte. "Unfortunately, current biomarkers are limited for identifying responders as only a handful of these patients benefit from ICIs. Our findings are exciting because they underscore the Immunoscore IC assay as a tool for predicting which patients may benefit from ICIs, potentially avoiding the use of costly drugs and unnecessary additional toxicity for non-responder patients."

For the study, researchers evaluated the Immunoscore IC assay in two independent cohorts totaling 265 patients who were treated with anti-PD1 or anti-PD-L1 antibodies (immune checkpoint inhibitors). The Immunoscore IC assay provided a risk score that was significantly associated with patients’ progression-free survival and overall survival. Within the two cohorts, all patients (100 percent) with a "high-risk" Immunoscore IC result relapsed in less than 18 months. In contrast, 34 percent and 33 percent of patients with a "low-risk" Immunoscore IC result did not relapse for a period of at least 36 months, in each cohort.

"These findings suggest that the Immunoscore IC assay may help biopharmaceutical companies select the right patients, helping to improve the success rate of their clinical trials, notably in combination trials including ICIs," said Corinne Danan, general manager for Veracyte’s Biopharma business unit. "Further, we believe the test’s use could help enable patients who are unlikely to respond to ICIs to enter into novel, combination-immunotherapy trials."

About Immunoscore IC

Immunoscore IC is a novel assay designed to help predict a patient’s response to immune checkpoint inhibitors. The assay measures the densities of PD-L1+ and CD8+ cells, as well as the proximity among these cells on a single tissue section using imaging tools, and then produces a risk score based on a proprietary algorithm. The Immunoscore IC assay is available as a service for biopharmaceutical companies and is part of the Immunoscore family of assays. These assays measure the immune reaction in and around the tumor and help to determine drugs’ mechanisms of action and their impact on the tumor microenvironment (TME). The Immunoscore Colon Cancer test is available clinically and analyzes T lymphocyte infiltration at the tumor site to help guide treatment decisions in localized colon cancer.

On May 26, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing therapies that combine both targeted and immune-mediated mechanisms, reported positive results from its Phase 1 clinical trial of TPST-1120, a first-in-class1 PPARα antagonist, as a single agent and in combination with nivolumab in patients with advanced solid tumors (Press release, Tempest Therapeutics, MAY 26, 2022, View Source [SID1234615104]). The results will be presented in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL, by Mark Yarchoan, M.D., associate professor of oncology at Johns Hopkins School of Medicine.

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Dr. Yarchoan commented, "The anti-cancer activity observed in these late-stage solid tumor patients is encouraging, particularly in light of their treatment history and the difficult nature of the tumor types. Based on the clinical activity observed with monotherapy, and the responses observed with combination therapy in patients with prior progression on checkpoint inhibitor therapy, a tolerable safety profile and distinct mechanism of action, I see significant potential in multiple tumor types and look forward to the ongoing development of TPST-1120."

Sam Whiting, chief medical officer of Tempest, added, "We are excited to see these positive TPST-1120 results in Tempest’s first presentation of clinical data, especially given the advanced stage and treatment histories of these patients. We look forward to presenting these data at ASCO (Free ASCO Whitepaper) and the continued development of TPST-1120 in the ongoing first-line randomized study in patients with hepatocellular carcinoma."

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1 If approved by the FDA

TPST-1120 Monotherapy Results

In the monotherapy portion of the trial, 19 patients with late-line treatment-refractory solid tumors, including pancreatic, cholangiocarcinoma (CCA), and colorectal cancers, were treated with oral twice-daily TPST-1120. The results showed that 53% (10/19) of patients experienced clinical benefit in the form of disease control, including tumor shrinkage in 21% of the patients. Two patients with late-line CCA, an aggressive tumor type and disease setting usually unresponsive to therapy, including IO therapies, achieved durable stable disease and one of the patients achieved durable tumor shrinkage.

TPST-1120 and Nivolumab Combination Therapy Results

In the combination therapy portion of the trial, 15 patients with heavily-pretreated renal cell carcinoma (RCC), hepatocellular carcinoma (HCC) and CCA were treated with oral twice-daily TPST-1120 and the anti-PD-1 therapy, nivolumab. All of the HCC and RCC patients had received an approved anti-PD-1 therapy in at least one prior line of therapy and discontinued that treatment due to disease progression. Promising objective responses (RECIST v1.1) were observed in two patients with late-line RCC who had previously progressed on anti-PD-1 therapy without an objective response (ORR 50%, n=2/4, in evaluable RCC patients). A third RECIST response was observed in a patient with late-line, heavily pre-treated CCA, a tumor type generally not responsive to anti-PD-1 alone.

Notably, all three responders were treated at the two highest doses of TPST-1120 (ORR 30%, 3/10).

Safety

TPST-1120 was well tolerated as both a monotherapy and in combination with nivolumab. The majority of the treatment-related adverse events were Grade 1 and 2, and included nausea, fatigue and diarrhea. No dose-limiting toxicities were reported during dose escalation.

ASCO Events

Presentations Details

Title: A phase 1 study of TPST-1120 as a single agent and in combination with nivolumab in subjects with advanced solid tumors

Session Typer/Title: Oral Abstract Session, Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Tuesday, June 7, 2022; 9:45 a.m. – 12:45 p.m. CDT
Abstract Number: 3005

Title: A phase 1 study of TPST-1495 as a single agent and in combination with pembrolizumab in subjects with solid tumors

Session Type/Title: Poster Session, Developmental Therapeutics – Immunotherapy
Session Date and Time: Sunday, June 5, 2022; 8:00 a.m. – 11:00 a.m. CDT
Abstract Number: TPST2696

Tempest Investor Event

Tempest will host and webcast an investor event in conjunction with the ASCO (Free ASCO Whitepaper) Annual meeting on Sunday, June 5, 2022 at 6:30 a.m. CDT. Company management will be joined by key thought leaders:

Mark Yarchoan, M.D.
Associate Professor of Oncology
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Susanna V. Ulahannan, M.D., MMEd
Assistant Professor of Medicine
Associate Director, Oklahoma TSET Phase 1 Program
Stephenson Cancer Center at the University of Oklahoma

Jason Luke, M.D.
Associate Professor of Medicine
Director – Immunotherapy and Drug Development Center
UPMC Hillman Cancer Center

Toni K. Choueiri, M.D.
Director, Lank Center for Genitourinary Oncology, Dana Farber Cancer Institute
Jerome and Nancy Kohlberg Chair and Professor of Medicine,
Harvard Medical School

To access the live or archived recording of the investor event, please visit the investor section of the Tempest website at View Source

About TPST-1120

TPST-1120 is a first-in-class2 oral selective PPAR⍺ antagonist with a dual mechanism designed to target both tumor cells directly and suppressive immune cells in the tumor microenvironment. Both types of targeted cells are dependent on fatty acid metabolism, which is regulated by the PPAR⍺ transcription factor. In extensive non-clinical studies, TPST-1120 as a monotherapy and in combination with other anti-cancer drugs resulted in significant reductions in tumor growth and stimulation of durable anti-tumor immunity. In addition to the study being presented at ASCO (Free ASCO Whitepaper), in collaboration with F. Hoffmann La Roche, TPST-1120 is also advancing through a randomized, first-line, global, Phase 1b/2 clinical study in combination with the standard-of-care regimen of atezolizumab and bevacizumab in patients with advanced or metastatic hepatocellular carcinoma.