On June 1, 2022 Jubilant Therapeutics Inc. a clinical stage precision therapeutics Company advancing small molecule therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported data to be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Jubilant Therapeutics, JUN 1, 2022, View Source [SID1234615394]). The data report on the pharmacokinetic and in vitro and in vivo anti-cancer properties of JBI-2174, the Company’s lead oral, brain penetrant PD-L1 inhibitor, which is in IND-enabling studies for the treatment for solid tumors. The poster will be presented by Luca Rastelli, Ph.D., Company’s Chief Scientific Officer, during the Developmental Therapeutics — Immunotherapy session at 8:00 a.m. CDT on June 05, 2022. The abstract is available here.

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"Checkpoint inhibitors, such as anti-PD-1 and anti-PDL1 antibodies, have revolutionized cancer treatment by enabling the immune system to attack tumor cells," said Luca Rastelli. "However, these antibodies have poor brain penetrance and shown limited efficacy in brain cancers. Employing our structure-based drug design and computational algorithms, we have designed oral small molecule checkpoint inhibitors that address this limitation. We are focused on completing our IND-enabling studies and hope to initiate shortly the clinical trials with JBI-2174 in patients with specific brain tumors." he further added.

The potency, pharmacokinetics and in vivo activity of rationally designed small molecule inhibitors of PD-L1 were evaluated. The Company’s lead anti-PD-L1 candidate, JBI-2174, demonstrated strong affinity for PD-L1 with an IC50 of approximately 1 nM. In selectivity assays for immune-oncology targets, JBI-2174 was highly selective for PD-L1 and also inhibited PD-L1/PD-1 mediated signaling essential for T-cell modulation. In multiple animal models where tumor cells were injected in the brain, JBI-2174 demonstrated sustained brain exposure, efficacy equivalent to an anti-PD-L1 antibody and increased survival compared to control. The results suggest an orally administered brain penetrant small molecule PD-L1 inhibitor could achieve efficacy in brain tumors that do not usually respond to immune-checkpoint antibodies

On June 1, 2022 NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology drug development company, reported the successful completion of the first stage of a Simon 2 stage Phase 2a clinical trial of naptumomab estafenatox (NAP), in combination with docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have been previously treated with chemotherapy and checkpoint inhibitors (CPIs) (Press release, NeoTX, JUN 1, 2022, View Source [SID1234615393]). The patients were treated with NAP (10 μg/kg/day x 4, days 1-4) and with docetaxel 75mg/m2, on day 5. The first stage of this trial required a minimum of two responses out of ten patients and the second stage is now enrolling.

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"These early observations are encouraging as patients with advanced disease previously treated with chemotherapy and checkpoint inhibitors have limited treatment options and new alternatives are needed. In addition, this clinical milestone occurs just as the acquisition of InterX has been recently completed, adding a computer-aided drug discovery arm (CADD) to the pre-clinical and clinical capabilities of NeoTX. So, this has been a crucial time for us" said Asher Nathan, CEO of NeoTX. "NeoTX’s drug discovery capabilities are strengthened by a world-class team that includes three Nobel Laureates. InterX technologies have the potential to significantly increase the speed of drug discovery. InterX also provided a pipeline that includes an oral PD-L1 inhibitor, which aligns with our current development plan of investigating NAP in combination with CPIs in various indications."

On June 1, 2022 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that management will present at the following investor conferences (Press release, Compugen, JUN 1, 2022, View Source [SID1234615392]):

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Event: Jefferies Healthcare Conference, New York City
Date: Wednesday June 8, 2022
Fireside Chat Time: 1:30PM ET

A live webcast will be accessible on the Investor Relations section of the Compugen website at www.cgen.com. A replay will also be available following the live event.

Event: JMP Securities Life Sciences Conference, New York City
Date: Wednesday, June 15, 2022
Fireside Chat Time: 9:00AM ET

A live webcast will be accessible on the Investor Relations section of the Compugen website at www.cgen.com. A replay will also be available following the live event.

On June 1, 2022 Iterion Therapeutics, Inc., a venture-backed, clinical-stage biotechnology company developing novel cancer therapeutics, reported that results from a Phase 1 study of tegavivint in patients with desmoid tumors will be featured in a poster presentation and discussion session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2022) (Press release, Iterion Therapeutics, JUN 1, 2022, View Source [SID1234615391]). ASCO (Free ASCO Whitepaper) 2022 is being held June 3-7, 2022, in Chicago, Illinois.

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Tegavivint is a potent and selective first-in-class small molecule inhibitor of Transducin Beta-like Protein One (TBL1), a novel downstream co-factor in the Wnt/beta-catenin signaling pathway. Increased expression of beta-catenin and TBL1 are associated with metastasis and poor prognosis in a broad range of tumor types. Tegavivint’s targeting of TBL1 prevents TBL1/beta-catenin complex formation, specifically inhibiting beta-catenin’s oncogenic transcriptional activity without disrupting key cell membrane functions that have been linked to toxicity common to other drugs in this pathway.

The poster, titled, "Results of a phase I dose escalation study of a tegavivint (BC2059), a first-in-class TBL1 inhibitor for patients with progressive, unresectable desmoid tumors," will be presented on Sunday, June 5, 2022, at 11:30 a.m., CDT, during the Sarcoma session (poster number 428; abstract number 11523) by Lee D. Cranmer, M.D., Ph.D., F.A.C.P., principal investigator of the trial. The poster details results from the Phase 1 trial in adult patients with progressive, unresectable desmoid tumors. The primary objectives of the study were to evaluate safety and to determine the maximum tolerated dose (MTD), the recommended Phase 2 dose (RP2D), and exploratory efficacy. No dose-limiting toxicities were observed and a maximum tolerated dose (MTD) was not determined. Treatment related adverse events were mostly Grade 1-2 with none resulting in treatment discontinuation. The RP2D was declared at 5 mg/kg based on pharmacologically relevant plasma concentrations and preliminary efficacy. Responses were observed at all dose levels with an overall response rate of 25% at the RP2D. Additionally, the 9 month progression free survival rate was 79% among those treated at the RP2D. Overall, these data demonstrated that tegavivint is well tolerated, does not appear to have the toxicity historically associated with WNT inhibition, and has promising clinical activity.

"The data presented at ASCO (Free ASCO Whitepaper) complements research presented earlier this year at AACR (Free AACR Whitepaper), which cumulatively demonstrate the safety, tolerability and clinical activity of tegavivint in the treatment of desmoid tumors," said Rahul Aras, PhD, CEO of Iterion. "We are particularly excited to present these results at ASCO (Free ASCO Whitepaper), the world’s preeminent oncology conference, because the data also serve to highlight the potential of our ongoing tegavivint programs in AML, non-small cell lung cancer, and pediatric solid tumors. These cancer indications, like desmoid tumors, are associated with nuclear beta-catenin overexpression, which has historically been considered undruggable. We believe tegavivint’s unique mechanism of action provides an opportunity to selectively disrupt the interaction of beta-catenin and TBL1, which in turn, allows for the specific degradation of nuclear beta-catenin without impacting key cell membrane functions that have been linked to previously reported toxicity."

On June 1, 2022 MyOme, a clinical whole genome platform analysis company, reported new data on a cross ancestry polygenic risk score (caPRS) for breast cancer that will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, MyOme, JUN 1, 2022, View Source [SID1234615390]). Using a proprietary informatics approach to PRS that provides benefit across multiple ancestries, MyOme showed a significant association between their caPRS and breast cancer in a study including more than 130,000 women across multiple ancestries

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"Only 5 to 10% of breast cancer is thought to be caused by single gene mutations. Polygenic risk scores aggregate hundreds or potentially thousands of variants into a single measure of disease risk. PRS has the potential to inform the 90-95% of women without rare breast cancer genetic mutations of their risk for breast cancer," said Akash Kumar, MD, PhD, chief medical officer of MyOme.

Key findings from the study include:

caPRS was highly correlated with odds of breast cancer across ancestries.
caPRS performed better across multiple ancestries than when applying a widely used European-based PRS across the same ancestries. For example, caPRS demonstrated a 5% increase in odds ratio for African/Black women (1.24 [1.08-1.4] to 1.30 [1.15-1.48])
"Polygenic risk scores have primarily shown benefit in Caucasian women due to limited data on individuals of non-European ancestry. However, our data highlights the opportunity to use cross ancestry PRS to better predict breast cancer risk for women across multiple ancestries who may be missed otherwise," said Kate Im, PhD, head of research at MyOme and author on the study. "Our cross ancestry PRS sets the foundation for a more inclusive risk assessment tool."

Breast cancer is the most common cancer among women and a leading cause of cancer mortality. According to the American Cancer Society, it is estimated there will be 287,850 new cases of breast cancer diagnosed in the U.S. and around 43,250 deaths in 2022.

Abstract #: 10540
Title: Cross-ancestry polygenic risk score for breast cancer risk assessment
Authors: Tshiaba, P., et al.
Session Title: Prevention, Risk Reduction, and Hereditary Cancer
Session Date & Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT