On November 26, 2024 Anocca AB, a leading T-cell receptor-engineered T-cell (TCR-T) cellular therapeutics company, reported the submission of its first Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for a Phase I/II multi-asset umbrella trial, VIDAR-1 (Press release, Anocca, NOV 26, 2024, View Source [SID1234655346]). The VIDAR-1 programme will begin with ANOC-001, which targets mutant KRAS G12V, in patients with advanced pancreatic cancer. Subject to approval of the CTA, Anocca aims to initiate the study in Q2, 2025. ANOC-001 is the lead product from Anocca’s robust preclinical pipeline of TCR-T cell therapies.

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Reagan Jarvis, co-founder and Chief Executive Officer, commented, "This is an important milestone for Anocca, affirming the value of our unique cell biology R&D engine. Our approach integrates the systematic generation of validated TCR-T target maps from tumour-selective genetic sequences and supports the delivery of libraries of potent and highly specific therapeutic TCRs to leverage the diverse cancer target space. With our in-house cGMP facilities and gene-edited autologous TCR-T manufacturing capability we can efficiently and cost effectively develop new investigational products at scale. Our ambition is to grow our pipeline rapidly across the immense untapped target space for TCR-T cell therapies in solid tumours."

Hugh Salter, Chief Scientific Officer at Anocca, elaborated, "KRAS is an immensely important target in many cancer types, but has to date been challenging to address. KRAS mutations are a hallmark of PDAC, which is among the most difficult to treat cancers, and we believe TCR-T cell therapies and, in particular, our VIDAR-1 assets can be effective in addressing this target and providing a new solution in an indication with high unmet medical need".

About the VIDAR-1 clinical programme

VIDAR-1 is designed as a multi-asset umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product, where each product is specific for a different combination of HLA and mutation, in a set of phase I/II studies. Phase I is planned for eight sites in four countries with additional countries and sites in phase II. Subject to approval of the CTA, the company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enroll if they have a HLA and KRAS mutation matching an available product.

About KRAS and PDAC

Mutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect ~90% of pancreatic cancer patients. The five-year survival rate of patients with PDAC is less than 10% (1). Despite recent advances there are no definitive treatments for advanced patients at present.

On November 26, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that it will be highlighting its positive overall survival and clinical benefit data in metastatic breast cancer (MBC) patients including those with CNS metastasis (not shown on the abstracts) who were treated with the Bria-IMT plus immune checkpoint inhibitor (CPI) combination in its "Spotlight" poster presentation session, at the 2024 San Antonio Breast Cancer Symposium (SABCS ) held at Henry B. Gonzalez Convention Center, San Antonio, TX (Press release, BriaCell Therapeutics, NOV 26, 2024, View Source [SID1234649125]).

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"In the Phase 2 study, the Bria-IMT combination regimen significantly increased overall survival versus comparable published benchmarks. Additionally, objective response rate and clinical benefit rate data, support the potential benefit of Bria-IMT plus CPI in patients with this difficult-to-treat cancer," stated Saranya Chumsri, MD, Principal Investigator, and Professor of Oncology, Mayo Clinic. "We plan to confirm the impressive clinical data in the BriaCell pivotal Phase 3 study as we continue to explore the use of Bria-IMT regimen across all breast cancer subtypes."

"At BriaCell, we are committed to finding therapeutic options for difficult-to-treat metastatic breast cancer patients," stated Dr. William V. Williams, BriaCell’s President & CEO. "BriaCell’s clinical data demonstrating impressive overall survival in all patient subsets including very difficult to treat patient populations, such as those who have failed prior checkpoint inhibitor and/or antibody-drug conjugate therapy, reinforces our confidence in the potential use of the combination regimen in MBC patients. Additionally, clinical benefit was seen across metastatic breast cancer subtypes including HER2+, HR+/HER2-, and even in triple-negative breast cancer (TNBC) patients. Bria-IMT may provide a significant contribution to the lives of patients and their families fighting this incurable disease."

The details about the submitted abstracts are as follows:

Abstract Number: SESS-1071 (Selected as Spotlight Poster)
Title: Overall survival results of Bria-IMT allogenic whole cell-based cancer vaccine
Time: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CST
Presentation ID: PS3-06

Abstract Summary:

54 patients were enrolled with 22 patients in phase 1 and 32 patients in phase 2.
11 patients were treated with pembrolizumab and 44 patients with retifanlimab (1 patient received pembrolizumab and later retifanlimab).
The Bria-IMT combination regimen was well tolerated.
The Bria-IMT regimen demonstrated promising results across all subtypes of breast cancer with favorable safety profiles.
Patients receiving the pivotal Phase 3 Bria-IMT combination regimen (n=37) showed significantly higher median overall survival (OS) (13.4), an objective response rate (ORR) of 9.5% and a clinical benefit rate (CBR) of 55%.
Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive.
mong 36 patients with post-dose cancer-associated circulating tumor cell (CTC) data, patients with post-dose CTC count < 5 had a significantly better OS compared with a CTC count > 5 (13.4 vs. 5.5 months, P 0.01).
Patients with positive delayed type hypersensitivity (DTH), an inflammatory marker to measure the response to Bria-IMT immunization, had significantly better OS.
"Our clinical findings support the use of the current Phase 3 formulation," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We plan to confirm the potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT plus CPI ongoing pivotal Phase 3 study ( NCT06072612 ) in metastatic breast cancer."

Abstract Number: SESS-1431
Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccines
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-06-02

Abstract Number: SESS-2217
Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysis
Time: Wednesday, December 11, 2024 12:00 – 2:00 PM CST
Presentation ID: P1-01-17

Abstract Number: SESS-1068
Abstract Title: ASTRO-VAC CNS: Bria-IMT in the management of tumor agnostic metastatic CNS lesions
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-10-24

Abstract Number: SESS-1069
Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn "Cold" tumor "Hot" in metastatic breast cancer
Time: Friday, December 13, 2024 12:00 PM – 2:00 PM CST
Presentation ID: P5-10-12

Following presentations, the posters can be viewed at the following: View Source

On November 26, 2024 Vir Biotechnology, Inc. (NASDAQ:VIR) reported it will host a virtual investor event to discuss initial data from the dual-masked Phase 1 T-cell engagers VIR-5818 targeting a variety of HER2-expressing solid tumors and VIR-5500 targeting PSMA in metastatic castration-resistant prostate cancer (mCRPC) along with updates on the PRO-XTEN platform on January 8, 2025, at 5:00 a.m. PT / 8:00 a.m. ET (Press release, Vir Biotechnology, NOV 26, 2024, View Source [SID1234648674]).

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A live webcast will be available on View Source and will be archived on www.vir.bio for 30 days.

On November 26, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence company transforming oncology drug development, and its wholly-owned subsidiary Starlight Therapeutics, focused exclusively on CNS and brain cancers, reported the presentation of new preclinical data and Phase 1b trial design for LP-184 (to be developed as STAR-001 for CNS indications) in glioblastoma at the Society for Neuro-Oncology (SNO) 2024 Annual Meeting in Houston, Texas (Press release, Lantern Pharma, NOV 26, 2024, View Source [SID1234648673]).

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The poster presentation highlighted LP-184’s unique mechanism of action, brain penetrance properties, and potential enhanced therapeutic effect when combined with spironolactone in glioblastoma multiforme (GBM). LP-184 is currently under investigation in a Phase 1a dose-escalation safety study (NCT05933265) in adult patients with advanced solid tumors including GBM.

"The data and trial design presented at SNO2024 further validate and progress LP-184’s potential as a promising new treatment option for glioblastoma patients," said Panna Sharma, President and CEO of Lantern Pharma. "Through our subsidiary Starlight Therapeutics, we are positioned to advance LP-184 as STAR-001 specifically for brain cancers and CNS indications, where treatment options are limited and often ineffective. The combination with spironolactone represents an innovative approach, which has been developed with the aid of our AI platform RADR, to potentially enhance therapeutic response in this devastating disease."

The key highlights from the poster presented by Dr. Schreck from Johns Hopkins Medicine and Dr. Kulkarni from Lantern Pharma at SNO2024 include:

LP-184 shows favorable brain penetrance with a brain tumor/plasma concentration ratio of 0.2 compared to 0.1 for the existing standard of care, temzolomide.
Preclinical studies show spironolactone increases GBM cell sensitivity to LP-184 up to 6-fold through ERCC3 degradation – which induces NERD (nucleotide excision repair deficiency) making the cancer cells both more sensitive to LP-184/STAR-001 and largely unable to repair themselves after exposure to the drug-candidate.
Multiple time point and dose level experiments show that GBM cells treated with spironolactone showed significant depletion of ERCC3 – including at 25μM of spironolactone which showed up-to 95% depletion of ERCC3 by 24h.
LP-184 is effective in temozolomide-resistant GBM models and is agnostic to MGMT methylation status.
PTGR1 expression analysis from GTEX normal brain and TCGA GBM highlights that PTGR1 levels are higher in brain tumor tissue (median 5.15) as compared to normal brain tissue (median 3.95).
ERCC3-dependent TC-NER activity was identified as a determinant of LP-184 synthetic lethality predicting that LP-184’s therapeutic potential will be enhanced in patients with intrinsic or spironolactone-induced NER deficient tumors.
Phase 1b trial being considered will evaluate LP-184 as both monotherapy and in combination with spironolactone using Simon’s 2-stage optimal design in patients with IDH wild type GBM at first progression.
Following determination of the Maximum Tolerated Dose and/or Recommended Phase 2 Dose from the ongoing Phase 1a study, Starlight Therapeutics plans to initiate a Phase 1b trial evaluating LP-184/STAR-001 in two cohorts of recurrent GBM patients: one arm which anticipates administration of STAR-001 as monotherapy and the other arm which anticipates administration of STAR-001 in combination with spironolactone (200 mg daily).

The trial, as currently anticipated and designed, will assess safety, pharmacokinetics, and objective response using RANO 2.0 criteria. Additionally, the study will evaluate biomarkers including PTGR1 expression, ERCC3 levels, and DNA damage markers to help identify patients most likely to respond to treatment. Lantern has previously reported on achieving significant development milestones in the creation of a molecular diagnostic using quantitative PCR to assess PTGR1 levels from clinical patient samples.

LP-184 (to be developed as STAR-001 for CNS indications) is a fully synthetic small molecule that belongs to the acylfulvene class of alkylating agents. It induces DNA double-strand breaks and has shown promise across a range of solid tumors, including in preclinical GBM models. LP-184 is activated by PTGR1, which is over-expressed in approximately 80% of recurrent GBM tumors. The FDA has granted LP-184 both Orphan Drug and Fast Track designations for the treatment of malignant gliomas / glioblastoma.

On November 26, 2024 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that it will participate in and present at the 7th Annual Evercore HealthCONx Conference and Citi’s 2024 Global Healthcare Conference, both being held in Miami. Our management team will participate in fireside chats surrounding the development of our innovative investigational bispecific antibody, ivonescimab, at the Evercore HealthCONx Conference on Tuesday December 3, 2024 at 8:45am ET, and the Citi Global Healthcare Conference on Wednesday December 4, 2024 at 8:45am ET (Press release, Summit Therapeutics, NOV 26, 2024, View Source [SID1234648672]).

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Presentations from both conferences will be available live from our website: www.smmttx.com. An archived version of both presentations will be available on our website following the presentation.