On September 13, 2024 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported four abstracts were accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, which convenes in Barcelona, Spain, from September 13-17, 2024 (Press release, Tempus, SEP 13, 2024, View Source [SID1234646595]).

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"ESMO provides a great platform to share our recent research and advancements with the global oncology community, foster further collaboration, and drive forward the mission of improving patient outcomes," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "At Tempus, we are committed to leveraging AI and data to transform cancer care and research, and this is a great opportunity to showcase the impact of our innovative approaches to both."

This year, Tempus will share a few of its latest scientific and clinical research findings via one oral presentation and three poster presentations, including:

Oral Presentation (#CN13): Impact of AI Clinical Trial Program on Screening, Matching, and Enrollment of Patients Over 6 Months
Session Date & Time: Monday, September 16, 2024; 11:05-11:15 a.m. CEST
Location: Fira Barcelona Gran Via; Hall 7
Overview: In collaboration with Cleveland Clinic, Tempus’ TIME initiative streamlined large-scale patient screening and clinical trial matching, enhanced patient enrollment and access, and achieved an average of more than one consent per day over a six-month period. Utilizing AI for patient matching and accelerating trial activation is recommended to maximize clinical trial success.

Poster Presentation (#113P): The association of changes in circulating tumor fraction and in actionable variant allele frequencies with clinical outcomes in real world diverse cohort of advanced patients treated with Tyrosine Kinase inhibitors
Session Date & Time: Sunday, September 15, 2024; 9:00 a.m.-17:00 p.m. CEST
Location: Fira Barcelona Gran Via; Hall 6
Overview: This study evaluates the use of circulating tumor DNA (ctDNA) for monitoring treatment response in advanced solid tumor patients treated with tyrosine kinase inhibitors (TKIs). Using the Tempus xM ctDNA assay, patients were classified as molecular responders (MRs) or non-responders (nMRs) based on changes in ctDNA tumor fraction (TF). The majority of patients ( 69%) had targetable SNV/indels; 13 were MRs and 18 were nMRs. MRs had longer overall survival (no deaths during follow-up) than nMRs. Among patients with decreasing variant allele frequencies (VAF, n=21), patients that were MRs (n=12) had significantly longer survival compared to nMRs (n=9). The study suggests that ctDNA TF monitoring may be used clinically to monitor response to TKI therapy beyond targeted VAF monitoring alone and warrants further validation.

Poster Presentation (#79P): Comprehensive Genomic Profiling provides patients access to novel matched therapies in a diverse real world cohort of advanced lung cancer patients
Session Date & Time: Sunday, September 15, 2024; 9:00 a.m.-17:00 p.m. CEST
Location: Fira Barcelona Gran Via; Hall 6
Overview: This study assessed adherence with guideline-recommended targeted therapy recommendations and the time from genomic sequencing to the initiation of targeted treatment in a diverse, real-world dataset of advanced NSCLC patients. Findings show that most oncologists utilized comprehensive genomic profiling (CGP) to identify and treat patients with guideline-recommended, variant matched targeted therapy, with adherence rates varying according to the variant. Notably, even patients that received CGP results prior to FDA approval of novel therapies, received matched therapy once they were included in guidelines.

Poster Presentation (#580P): Impact of RAS and BRAFV600E mutations on tumor immune microenvironment and associated genomic alterations in patients with microsatellite instability (MSI) or DNA Mismatch Repair Deficient (dMMR) colorectal cancers
Session Date & Time: Monday, September 16, 2024; 9:00 a.m.-17:00 p.m. CEST
Location: Fira Barcelona Gran Via; Hall 6
Overview: This study aimed to understand the impact of RAS and BRAF mutations on prognosis and treatment effects in MSI/dMMR patients in both localized and metastatic settings. These data suggest that MSI/dMMR colorectal cancers (CRC) with RAS mutations are less immunogenic and exhibit a lower tumor inflammatory profile in the tumor immune microenvironment (TIME) compared to those with RAS wild-type (RASwt) or BRAF V600E mutations. Further analysis and validation are required to confirm these findings.

On September 13, 2024 Ascendis Pharma A/S reported initial data showing signs of clinical activity in heavily pre-treated patients with platinum-resistant ovarian cancer (PROC) treated with TransCon IL-2 β/γ in combination with chemotherapy in its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ (Press release, Ascendis Pharma, SEP 13, 2024, View Source [SID1234646562]). First results will be shared in Poster 762P at ESMO (Free ESMO Whitepaper) 2024, the annual meeting of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) being held in Barcelona from September 13-17, 2024.

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Of the 18 patients (median age 64 years) included in the initial data, 14 were efficacy evaluable patients who had 1 or more post-baseline tumor assessment(s), plus an additional 4 who discontinued treatment before the first post-baseline tumor assessment due to disease progression or death. Anti-tumor clinical responses were observed in 29% (4/14) of the efficacy evaluable patients (2 confirmed and 2 unconfirmed partial responses in patients who had received three to seven prior lines of treatment – including patients whose disease had previously progressed on Elahere, also called mirvetuximab soravtansine-gynx), suggesting clinical activity in heavily pre-treated patients. The data suggest that TransCon IL-2 β/γ was generally well-tolerated: the most common treatment-emergent adverse events related to combination therapy with TransCon IL-2 β/γ plus chemotherapy were fatigue, thrombocytopenia, neutropenia, and anemia. Most TransCon IL-2 β/γ-related TEAEs were grade 1 or 2.

"Building on results announced at ASCO (Free ASCO Whitepaper) 2024 in melanoma, we are excited now to see meaningful signs of anti-tumor activity in combination with chemotherapy in our second indication-specific cohort of heavily pretreated patients who have exhausted standard-of-care options," said Stina Singel, M.D., Ph.D., Executive Vice President, Head of Clinical Development, Oncology, at Ascendis Pharma. "We look forward to providing further updates as patients continue on study treatment."

About TransCon IL-2 β/γ & IL-Believe
TransCon IL-2 β/γ is a novel prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 analogue (IL-2 β/γ). IL-2 β/γ is transiently attached to an inert carrier by a TransCon linker, which under physiological conditions releases active IL-2 β/γ in a predictable, sustained manner. This results in lower Cmax and longer half-life, which is expected to widen the therapeutic index.

TransCon IL-2 β/γ is being investigated in IL Believe, a multicenter Phase 1/2, multi-cohort study in adult patients with locally advanced or metastatic solid tumors. As of the July 29, 2024, data cut off, 42 patients whose disease had progressed within six months after completing platinum-based chemotherapy were enrolled in the PROC dose expansion cohort (Cohort 3 in the trial). Treatment for patients in Cohort 3 included intravenous TransCon IL-2 β/γ at the recommended Phase 2 dose of 120 μg/kg every 3 weeks in combination with the physician’s choice of paclitaxel, docetaxel, or pemetrexed. Disease response was assessed every 9 weeks using RECIST v1.1. and safety, efficacy, and biomarkers were evaluated.

On September 13, 2024 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place September 13-17, 2024, in Barcelona, Spain (Press release, ESSA, SEP 13, 2024, View Source [SID1234646580]). Masofaniten is a first-in-class N-terminal domain androgen receptor ("AR") inhibitor that suppresses androgen activity through a novel mechanism of action and is being developed for the treatment of prostate cancer. The poster presentation is available on the "Publications" section of the Company’s website at www.essapharma.com.

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"We are pleased to be sharing more mature data from the Phase 1 dose escalation study evaluating masofaniten in combination with enzalutamide today at ESMO (Free ESMO Whitepaper) 2024. The combination continues to be well tolerated with prolonged reductions in circulating prostate-specific antigen ("PSA") levels in patients with metastatic castration-resistant prostate cancer ("mCRPC"). After 15.2 months of follow up, neither median time to PSA progression nor radiographic progression free survival have been reached. These data compare favorably to historical data for single agent enzalutamide treatment in the mCRPC patient population," said David Parkinson, MD, President and CEO of ESSA. "We continue to focus on the enrollment of the Phase 2 dose expansion study evaluating masofaniten in combination with enzalutamide, with 33 sites activated in the US, Canada and Australia and an additional 22 sites anticipated in Europe. We look forward to providing further updates in 2025."

Poster presentation details:

Title: Phase 1/2 trial of oral EPI-7386 (masofaniten) in combination with enzalutamide (Enz) compared with Enz alone in subjects with metastatic castration-resistant prostate cancer (mCRPC): Phase 1 results and Phase 2 design
Presenting Author: Christos Kyriakopoulos, MD, University of Wisconsin-Madison Carbone Cancer Center
Presentation #: 1641P
Date and time: Sunday, September 15, 2024; 12:00-1:30 p.m. CEST/ 6:00-7:30 a.m. ET

Data summary: This Phase 1/2 multicenter, open-label clinical trial enrolled patients with mCRPC who have received androgen deprivation therapy and who are naïve to second-generation antiandrogens but may have been treated previously with one line of prior chemotherapy in the metastatic hormone-sensitive prostate cancer setting. The data presented today includes 18 patients across four cohorts in the Phase 1 dose escalation portion of the study. Masofaniten has no effect on enzalutamide exposure, thus allowing the use of full dose per label (160mg) of enzalutamide in combination. Enzalutamide reduces masofaniten exposure but twice daily dosing of masofaniten appears to mitigate the reduction and maintains clinically relevant drug exposures.

In patients evaluable for safety (n=18), masofaniten combined with enzalutamide, continues to be well-tolerated at the dose levels tested through 32 cycles of dosing in some patients. Most frequent adverse events were Grades 1 and 2, related to either AR inhibition or gastrointestinal tract irritation. In Cohort 4, one patient experienced a Grade 3 rash, which was observed immediately following administration of masofaniten combined with enzalutamide and deemed probably related, resulting in the expansion of the cohort from four to seven patients. No additional dose-limiting toxicities (DLTs) were observed, therefore the maximum tolerated dose (MTD) was not reached. The recommended Phase 2 combination doses (RP2CDs) were identified as masofaniten 600 mg twice daily (BID) in combination with enzalutamide 160 mg once daily (QD).

In the patients evaluable for efficacy (n=16), rapid, deep and durable reductions in PSA were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg). Across all dose cohorts, 88% of patients (14 of 16) achieved PSA50, 88% of patients (14 of 16) achieved PSA90, 69% of patients (11 of 16) achieved PSA90 in less than 90 days, and 63% of patients (10 of 16) achieved PSA <0.2ng/mL. With a current median follow up of 15.2 months, the median time to PSA progression and radiographic progression free survival have not yet been reached.

The randomized, open-label, two arm, Phase 2 dose expansion portion of the study is underway and is designed to evaluate the combination of masofaniten and enzalutamide versus single agent enzalutamide in patients with mCRPC naïve to second generation anti-androgens. The study is currently enrolling at approximately 33 sites in the USA, Canada and Australia, and an additional 22 sites anticipated in Europe.

About Masofaniten

Masofaniten (formerly known as EPI-7386) is a first-in-class investigational, highly selective, oral, small molecule inhibitor of the N-terminal domain ("NTD") of the androgen receptor ("AR"). Masofaniten’s unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth, by selectively binding to the NTD, a region of the AR that is not currently targeted by other therapies. Masofaniten is currently being studied in an open-label, randomized Phase 2 clinical trial (NCT05075577) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens. ESSA is also conducting a Phase 1 monotherapy study (NCT04421222) in patients with mCRPC whose tumors have progressed on standard-of-care therapies. The U.S. Food and Drug Administration has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to masofaniten worldwide.

On September 13, 2024 OS Therapies, a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported the development and in vitro concept data for two novel ADC therapeutic candidates leveraging the Company’s proprietary SiLinker technology (Press release, OS Therapies, SEP 13, 2024, View Source;Based-Therapeutic-Candidates [SID1234646596]). The Company has completed target engagement tests for both therapeutic candidates and confirmed their therapeutic potential. These new constructs will target Breast, Lung and Gastric Cancer; and Ovarian, Fallopian Tube and Primary Peritoneal Cancer, respectively.

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The Company is advancing its tADC platform through successive product development de-risking milestones and intends to out-license certain therapeutic candidates and components that are strategic to potential partners’ pipelines – particularly the ph-sensitive SiLinker. The Company’s first tADC asset OST-tADC-FRα-H has achieved proof of concept in animal models of ovarian cancer. With the additional two constructs now added to the pipeline, the Company is positioning itself to become a key provider of intellectual property for new therapeutic product development to partners. All while continuing to focus its internal resources on bringing to market the OST-HER2 off-the-shelf immunotherapy cancer vaccine platform for canines with osteosarcoma, and for humans with osteosarcoma and other HER2 positive cancers such as breast cancer and colorectal cancer.

On September 13, 2024 Aurinia Pharmaceuticals Inc. reported that the Company’s management team will attend the 2024 Cantor Fitzgerald Global Healthcare Conference in New York City, September 17-19, 2024 (Press release, Aurinia Pharmaceuticals, SEP 13, 2024, View Source [SID1234646563]).

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Aurinia management will host one-on-one meetings with investors and will participate in a fireside chat and Q&A session on Tuesday, September 17th, at 3:05 PM EDT. A live webcast of the session will be available on the Investor section of Aurinia’s website, which can be found here.