On October 23, 2024 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that it will host a conference call and webcast on October 25, 2024 at 8:00 am ET to share interim clinical results of TYRA-300 from the SURF301 Phase 1/2 study in metastatic urothelial cancer (mUC) (Press release, Tyra Biosciences, OCT 23, 2024, https://www.prnewswire.com/news-releases/tyra-biosciences-to-host-conference-call-on-interim-clinical-data-of-tyra-300-from-surf301-phase-12-study-on-october-25-2024-at-8am-et-302285111.html [SID1234647350]). These data will be presented in a late-breaking oral presentation at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium on Molecular Targets and Cancer Therapeutics, being held October 23-25, 2024, in Barcelona, Spain.

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Gary Steinberg, MD, Professor of Urology, Department of Urology, Rush University Medical Center, will be joining members of TYRA’s management team on the call and will be available during Q&A.

Conference Call Information

TYRA is hosting a conference call and webcast on October 25, 2024, at 8am ET to review the interim clinical data demonstrated with TYRA-300 in mUC. Participants may access a live webcast of the call and the associated slide presentation on the "For Investors" page of the TYRA website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 90 days.

On October 23, 2024 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported early results from the REFLECTION study, which aims to understand the real-world experience of the Galleri multi-cancer early detection (MCED) test in routine clinical settings (Press release, Grail, OCT 23, 2024, View Source [SID1234647349]). The Galleri test is recommended for adults with an elevated risk for cancer, such as those age 50 or older. In this study, a diverse population of veterans from U.S. Department of Veterans Affairs (VA) sites with toxic exposure but with no symptoms suggestive of cancer were included in study enrollment. Initial results showed that among study participants, the veteran cohort had a cancer signal detection rate consistent with other populations that have received the MCED test. The findings were presented during a presentation at the 2024 Early Detection of Cancer Conference (EDCC).

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Overall, the cancer signal detection rate in this veteran cohort was 1.30% (37/2854 participants; 95% CI: 0.94% – 1.78%), which is consistent with other populations that have received the MCED test (0.88%1 and 0.95%2). Among the 37 participants with a Cancer Signal Detected (CSD) at the time of analysis, 28 completed 180 days of follow-up, and of these, 12 cancer diagnoses were confirmed. More than half of the cases were identified at early stages (I-III) and the most common cancer signal of origin prediction was lung cancer (7). A positive predictive value (PPV), meaning that the test accurately detects a signal for cancer in someone that has cancer, was 42.9%, which is consistent with PPVs from previous Galleri testing datasets.1,3 Additional cancers could be diagnosed during the remainder of the one-year follow-up period.

"While today doctors screen individually for five specific cancers, nearly 70% of cancers have no recommended screening tests. With 50,000 veterans diagnosed with cancer every year, these initial findings from REFLECTION showing a consistent cancer signal detection rate among the veteran cohort suggest that when added to recommended screenings, MCED tests like Galleri may address an unmet medical need," said Charles Atwood, M.D., pulmonologist and lead researcher on the REFLECTION study at VA Pittsburgh. "We look forward to longer-term data that will provide veteran-reported experience with MCED testing and cancer outcomes that may provide additional insights for veterans with service-related toxic exposures."

The REFLECTION study (NCT05205967) is a multi-center, prospective, non-interventional, cohort study designed to understand the real-world experience of Galleri in clinical settings. This initial analysis included data from seven VA sites with 180 days of post-test follow-up. A total of 2,924 veterans were enrolled in the study at the time of the analysis and 2,854 are analyzable in these initial study data. Within the veteran cohort with data, 70% of participants had been exposed to one or more toxic environmental or occupational hazards during their service, including open burn pits/airborne hazards, Gulf War-related exposures, Agent Orange, radiation and others. The study included recruitment of veterans aged ≥22 years. The mean age of the cohort was 60 years old and the cohort was 79% male.

"With many veterans at elevated risk of developing cancer, the initial results from the REFLECTION study provide important insights into the impact of MCED testing to help transform early cancer detection in a real-world setting," said Josh Ofman, MD, MSHS, President at GRAIL. "We’re honored to be working with the VA, the largest national integrated health system in the U.S., to evaluate how Galleri can screen for many of the deadliest cancers before they become symptomatic, when there may be more treatment options."

About the REFLECTION Study
REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 17,000 individuals who have opted to be screened with the Galleri, multi-cancer early detection (MCED) test in routine clinical settings. The purpose of the study is to understand the real-world experience of Galleri in clinical settings. Patients who have been prescribed the Galleri test as part of medical care by their healthcare provider will have the opportunity to consent for participation into this data collection study and will be actively followed for 12 months from the time of enrollment through data capture from electronic health records and periodic self-report questionnaires.

On October 23, 2024 J INTS BIO, a leader in oncology drug development, reported that it has revealed interim preclinical results of its second-generation synthetic HSP90 inhibitor, JIN-001, at the ENA (EORTC-NCI-AACR) (Free EORTC-NCI-AACR Whitepaper) Symposium held in Barcelona, Spain, from October 23-25, 2024 (Press release, J INTS BIO, OCT 23, 2024, View Source [SID1234647347]). The findings demonstrate JIN-001’s potential as a new therapeutic option for cancer patients who have developed drug resistance after treatment, representing a significant advancement in addressing this critical challenge.

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JIN-001: A Novel Approach to Overcoming Chemotherapy Resistance in Ovarian Cancer

Ovarian cancer remains one of the most aggressive and lethal gynecological malignancies, with approximately 70% of patients diagnosed at an advanced stage. While many patients initially respond to standard chemotherapy, drug resistance eventually develops, leading to disease progression and cancer relapse. JIN-001 was designed to address this issue and by targeting heat shock protein 90 (HSP90), a molecular chaperone that plays a crucial role in enabling cancer cells to adapt to therapeutic stress and survive.

By inhibiting HSP90, JIN-001 disrupts the ability of cancer cell to evolve and acquire resistance to the chemotherapy, thereby maintaining the effectiveness of existing standard treatment options. The preclinical studies presented at the symposium specifically explored the drug’s efficacy when used in combination with established chemotherapeutic agents, offering new hope for patients with drug-resistant cancer.

A New Therapeutic Hope for Cancer Patients

The preclinical study was designed to evaluate the efficacy of JIN-001 in ovarian cancer cell lines, including those resistant to common chemotherapies such as paclitaxel and cisplatin. Researchers treated both normal ovarian cancer cell lines and chemo resistant strains with various concentrations of JIN-001, either alone or in combination with paclitaxel (PTX) or cisplatin (Cis).

Study Highlights:

Cell Lines Tested: Ovarian cancer cell lines (OV90, TOV21G, OVCAR3) and chemo resistant cell lines (OV90/PTX200, TOV21G/PTX100, OVCAR3-CisR) were used to assess the drug’s efficacy.
Methods: The researchers measured cell viability, comparing outcomes between monotherapy with JIN-001 and combination therapy with standard chemotherapy agents.
JIN-001: A Game-Changer in the Treatment of Cancer

Combination Therapy with Chemotherapeutics: The most notable results emerged when JIN-001 was combined with conventional chemotherapy agents. When JIN-001 was used alongside paclitaxel, the IC50 value of paclitaxel in the resistant OV90/PTX200 cell line decreased from 0.204 μM to 0.043 μM, demonstrating a substantial improvement in therapeutic efficacy. Similarly, in the cisplatin-resistant OVCAR3-CisR cell line, the combination of JIN-001 with cisplatin reduced the IC50 of cisplatin from 9.643 μM to 0.142 μM.

JIN-001: A Breakthrough for Treatment-Resistant Ovarian Cancer

The interim results strongly suggest that JIN-001 has the potential to serve as a breakthrough companion therapy for patients with ovarian cancer. By inhibiting HSP90, JIN-001 enhances the efficacy of existing chemotherapies by limiting the adaptability and heterogeneity of cancer, thereby removing their ability to overcome the therapies.

"The synergy observed between JIN-001 and standard chemotherapy agents is extremely promising. It represents a new treatment paradigm for cancer patients," commented the J INTS BIO research team. "We are committed to further clinical development of JIN-001 to validate its efficacy and safety, and we believe this drug could offer a transformative option in limiting chemotherapy resistance."

JIN-001: Leading the Way in Innovative Cancer Therapies

JIN-001 has shown considerable promise as a novel therapeutic agent, particularly for chemotherapy resistance. J INTS BIO is committed to accelerating the clinical development of JIN-001, with plans to advance its use not only in ovarian cancer but also in other cancers, such as glioblastoma. Collaborative research with MD Anderson Cancer Center on JIN-001’s potential in glioblastoma has already yielded positive preclinical results, with a Phase 1 trial anticipated in 2025.

On October 23, 2024 Oncotelic Therapeutics, Inc (OTCQB:OTLC) reported its presentation at Precision in Drug Discovery & Preclinical Summit. Dr. Wen-Han Chang, Nanomedicine Sr. Manager, and Dr. Tara Zand, Research Scientist, presented Sapu Bio pipeline of TGFB2 therapeutics (Press release, Oncotelic, OCT 23, 2024, View Source [SID1234647345]). For additional information please go to: View Source

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Dr. Chang and Dr. Zand are experienced nanomedicine and precision drug development dedicated to finding the cure for pancreatic and brain cancers. View Source

View Source

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On October 23, 2024 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported the company presented a poster highlighting certain best-in-class properties of ORIC-114, a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor, to treat EGFR exon 20 insertions and other atypical mutations at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (Press release, ORIC Pharmaceuticals, OCT 23, 2024, View Source [SID1234647344]).

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"Preclinical data presented today underscore ORIC-114’s superior potency and selectively across EGFR mutational classes compared to other EGFR inhibitors," said Lori Friedman, PhD, chief scientific officer. "These results build on clinical findings that highlight ORIC-114’s potential best-in-class profile, showing notable systemic and CNS responses, along with a favorable safety profile, even in heavily pre-treated NSCLC patients. We are continuing to evaluate ORIC-114 in multiple Phase 1b expansion cohorts for NSCLC patients with EGFR exon 20, HER2 exon 20, and atypical EGFR mutations, with updated data expected in the first half of 2025."

Poster presentation details:

ORIC-114, a highly selective, brain penetrant EGFR and HER2 inhibitor, demonstrates best-in-class properties against exon 20 insertions and other atypical EGFR mutations

ORIC-114 previously demonstrated systemic and intracranial clinical responses in heavily pre-treated patients with EGFR and HER2 exon 20 insertion mutations. Key findings of this poster presentation:

Demonstrates regressions in all EGFR mutant in vivo models tested, including cell-derived xenografts, patient-derived xenografts and intracranial models that encompass exon 20 insertion and atypical mutant models. An in vivo model with complex atypical mutant EGFR dosed with ORIC-114 notably shows 100% tumor regressions and all tumors experienced a complete response.

In an expanded preclinical comparative analysis of exon 20 insertion, atypical PACC and other mutations, overall ORIC-114 is the most potent across EGFR mutational classes whilst displaying comparative wild-type selectivity in cell-based assays​, relative to firmonertinib, zipalertinib, lazertinib and BDTX-1535.

In head-to-head comparisons with firmonertinib, zipalertinib, lazertinib and BDTX-1535, ORIC-114 has superior kinome selectivity with no off-target kinase liabilities identified.

Shows complete molecular responses in ctDNA from patients with EGFR exon 20 insertion and PACC mutations from Phase 1 dose escalation study. Evidence of molecular responses observed across dose escalation cohorts supports broad therapeutic window for ORIC-114.

ORIC-114 is a promising therapeutic candidate with best-in-class potential for patients with non-small cell lung cancer harboring exon 20 insertions and atypical mutations in EGFR, including those presenting with active CNS metastases, and is being evaluated in a global clinical trial (NCT05315700).

About ORIC-114
ORIC-114 is a highly selective, brain penetrant, orally bioavailable, irreversible inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, making it a promising therapeutic candidate to address the unmet medical need of having both meaningful systemic as well as CNS antitumor activity.