Latest news with #tripleNegativeBreastCancer
National Post
28-05-2025
- Business
- National Post
ProteinQure Raises Series A Financing to Advance First AI-Designed Peptide Therapeutic into Clinical Trials
Article content TORONTO — ProteinQure Inc., a biotechnology company pioneering computational peptide therapeutics, announced today the close of an $11 million Series A financing round. The proceeds will support the initiation of the company's first clinical trial for PQ203, a first-in-class peptide-drug conjugate for triple-negative breast cancer (TNBC), and the advancement of additional pipeline programs in neurology and nephrology. The financing round was led by Tom Williams of Heron Rock Fund, with participation from Golden Ventures, Kensington Capital, and select returning investors. This brings ProteinQure's total funding to $16 million across seed and Series A rounds. Article content Article content 'With this financing, we're advancing what we believe to be the first AI-designed peptide therapeutic into the clinic. It's a defining moment for ProteinQure and for the field,' said Lucas Siow, CEO and co-founder of ProteinQure. 'The support from new and returning investors allows ProteinQure to advance a new class of medicines that underscores the strength of our platform. With this foundation in place, we're ready to generate clinical validation of how our next-generation peptide design platform can unlock previously unreachable targets and tissues.' Article content ProteinQure's lead candidate, PQ203, is a first-in-class peptide-drug conjugate designed to target the sortilin receptor, which is overexpressed in many solid tumors, including TNBC. The drug is being developed for tumors resistant to topoisomerase I inhibitors (e.g., antibody-drug conjugates like Trodelvy ®), based on robust preclinical evaluation in patient-derived xenograft models. Article content The upcoming multicenter phase 1 clinical trial is anticipated to open in the third quarter of 2025 with planned enrollment of 70-100 patients across Canada and the United States at world-renowned cancer centers, including Princess Margaret Cancer Centre, MD Anderson Cancer Center, and Yale Cancer Center. Article content 'We're witnessing the birth of a new drug class – AI-engineered peptide therapeutics – and ProteinQure is at the forefront,' said Mr. Williams. 'Ever since leading the pre-seed round of ProteinQure, I believed that ProteinQure's approach to building both proprietary data libraries and learning models would advantage the Company in a world where AI played a significant role in the drug discovery process. Heron Rock's decision to lead the Series A was an easy one: ProteinQure has demonstrated true platform capabilities for designing non-canonical peptide therapeutics with exceptional specificity and drug-like properties and they've gone from concept-to-clinic with remarkable capital efficiency.' Article content About ProteinQure Article content ProteinQure is redefining peptide therapeutics with a drug discovery platform that goes beyond the limits of traditional drug design. At the core is ProteinStudio™, a proprietary platform that integrates machine learning, structural biology, and atomic-level simulations to design therapeutic peptides using thousands of non-natural amino acids, enabling tissue-specific delivery and access to novel target classes. From cytotoxic payloads to RNA delivery, our precision-designed peptides deliver diverse payloads and unlock previously inaccessible targets with broad potential across oncology, neurology, nephrology, and rare disease. Headquartered in Toronto, ProteinQure is advancing a robust internal pipeline and partnering with global biopharma to accelerate the future of programmable peptide medicines. For more information, visit Article content Article content Article content Article content Article content
Medscape
19-05-2025
- Health
- Medscape
New High-Risk TNBC Subgroup Identified
New data support integrating tumor-infiltrating lymphocyte levels with nodal status to improve risk stratification in women with triple-negative breast cancer (TNBC) and pathological complete response (pCR) following neoadjuvant treatment. Specifically, patients with lower levels of tumor-infiltrating lymphocytes had a higher risk for relapse and worse overall survival than those with higher levels, said Davide Massa, MD, medical oncologist, University of Padua, Padua, Italy. 'For every 5% increase in [tumor-infiltrating lymphocytes], we saw a 10% reduction in the risk of distant relapse-free survival and an 11% reduction in the risk of death,' he reported in an oral presentation at the ESMO Breast Cancer 2025 meeting. And when combining tumor-infiltrating lymphocytes and nodal status, 'we could identify a previously unrecognized high-risk subgroup — patients with low tumor-infiltrating lymphocytes and positive nodal involvement,' Massa noted. These data may help guide post-neoadjuvant strategies for patients otherwise considered to have favorable long-term outcomes, he added. Refining Risk Stratification In TNBC, pCR after neoadjuvant treatment is associated with favorable outcomes, but a subset of patients remains at risk for relapse. Massa and his colleagues wanted to find out if they could identify these patients. Stromal tumor-infiltrating lymphocytes in TNBC are a strong independent prognostic biomarker associated with improved outcomes, yet their role in risk stratification within the pCR subgroup has been underexplored. The retrospective study included 1532 patients with stage I-III TNBC who received neoadjuvant therapy between 2000 and 2023 at 12 European centers. Of these patients, 733 (48%) had a pCR. Tumor-infiltrating lymphocyte levels, assessed in treatment-naive biopsies, were available for 613 patients with a pCR (84%), which comprised the study cohort. The median follow-up was 4.2 years. In multivariate analyses, both tumor-infiltrating lymphocytes and nodal status were independent prognostic factors for distant relapse-free survival and overall survival in patients with a pCR. Patients with positive nodal status had significantly worse distant relapse-free survival (adjusted hazard ratio [aHR], 2.38) and overall survival (aHR, 3.45) compared with those with negative nodal status. When evaluating tumor-infiltrating lymphocytes at a predefined cutoff of 30%, patients with higher tumor-infiltrating lymphocyte levels demonstrated better survival outcomes. Patients with tumor-infiltrating lymphocyte levels ≥ 30% had a 5-year distant relapse-free survival elapsed survival rate of 96.3% compared with 89.5% in patients with levels < 30% (aHR, 0.42). Similarly, in patients with higher tumor-infiltrating lymphocyte levels, 5-year overall survival was 98.1% compared with 91.5% in those with lower levels (aHR, 0.33). When combining tumor-infiltrating lymphocyte and nodal status information, patients with low tumor-infiltrating lymphocyte levels and positive nodal involvement had significantly worse 5-year distant relapse-free survival compared with all other subgroups (82.6% vs at least 94.7%; aHR, 3.17). This finding held for 5-year overall survival (84.3% vs at least 97%; aHR, 5.09). Sensitivity analyses confirmed the study findings for both distant relapse-free survival and overall survival. 'This is a simple, cost-effective, and universally applicable stratification tool that relies only on hematoxylin and eosin-stained slides and no proprietary technology, which can be implemented in treatment-tailoring trials,' Massa said. Massa noted that a prospective study to validate these findings is ongoing. Kevin Kalinsky, MD, with Winship Cancer Institute, Emory University, Atlanta, who served as study discussant, called the results 'intriguing' and 'hypothesis-generating.' Kalinsky said it will be important to validate whether low tumor-infiltrating lymphocytes are associated with worse outcomes regardless of pCR. And, if so, what is the role of antibody-drug conjugates with or without immunotherapy — a question that may be answered in the ongoing OptimICE-pCR trial, he added. Another question is whether patients with stage I TNBC and high tumor-infiltrating lymphocytes can opt out of systemic therapy, as is being explored in the OPTImaL and ETNA trials. Finally, Kalinsky said it will be worth exploring the use of tumor-infiltrating lymphocytes and other markers to tailor the selection of chemotherapy in TNBC, something the NeoTRACT trial is investigating.
Yahoo
11-05-2025
- Business
- Yahoo
LTRN: IND Clearance for LP-184 in TNBC
By John Vandermosten, CFA NASDAQ:LTRN A May 5th press release indicated that the FDA cleared Lantern Pharma, Inc.'s (NASDAQ:LTRN) LP-184 trial in triple negative breast cancer (TNBC). Lantern will now run a Phase Ib/II clinical trial evaluating LP-184 both as a monotherapy and in combination with olaparib. The trial will evaluate Lantern's candidate in recurrent, advanced-stage TNBC patients with the BRCA1 or BRCA2 mutation. Endpoints will include safety and efficacy with the goal to support design and execution of registrational studies. Clinical Trial Design The Phase Ib/II trial for LP-184 will enroll approximately 30 patients in the monotherapy arm with advanced stage TNBC. This arm will focus on identifying the optimal dose to maximize safety and potential efficacy for TNBC patients. The combination trial will evaluate LP-184 with olaparib in second-line settings for patients with advanced stage TNBC with BRCA1 or BRCA mutations. The primary endpoints for the study include safety and efficacy sufficient to support regulatory studies. The trial will be run at several centers in the United States and academic centers and institutions in India and Nigeria. The sites overseas have access to populations with a higher incidence of TNBC and leverage collaborative research networks in these countries. LP-184 LP-184 is a novel, clinical-stage small molecule drug which belongs to the acylfulvene class of molecules and functions as a prodrug. The candidate is designed to be preferentially activated in cancer cells that overexpress a specific enzyme, Prostaglandin Reductase 1 (PTGR1). Once activated by PTGR1, LP-184 becomes a potent alkylating agent. It works by binding to the DNA of cancer cells, creating DNA adducts which triggers cell apoptosis. Lantern is developing LP-184 in several cancer indications including pancreatic, glioblastoma, atypical teratoid rhabdoid tumors, ovarian, bladder, prostate, lung and TNBC. LP-184 has received multiple expedited designations from the FDA including Orphan Drug, Fast Track and Rare Pediatric Disease. Olaparib Olaparib (branded Lynparza) is a poly ADP-ribose polymerase (PARP)[1] inhibitor that is used to bring about synthetic lethality in mutated breast cancer cells. Olaparib is a targeted therapy used in patients whose cancer is associated with an inherited mutation in the breast cancer (BRCA)1 or BRCA2 genes. The drug also works with other homologous recombination deficiencies (HRD) and prevents these cells from repairing their DNA, leading to cancer cell death. First approved in 2024, olaparib is used in ovarian, prostate and pancreatic cancer. It is also approved in HER2 negative breast cancer with BRCA mutations. Treatment begins after surgery and chemotherapy for high-risk early-stage disease or for metastatic disease that has progressed after other treatments. Triple Negative Breast Cancer (TNBC) TNBC is a type of breast cancer that lacks three receptors: estrogen (ER), progesterone (PR) and human epidermal growth factor 2. The lack of these receptors means that these TNBC patients will not benefit from therapies that use these receptors to fight cancer. This includes drugs like tamoxifen and aromatase inhibitors, which target ER or PR, medications such as trastuzumab and pertuzumab, which target the HER2 protein. Many targeted therapies that have shown success in other breast cancer types have failed in TNBC clinical trials, largely due to the lack of actionable molecular targets and the heterogeneity of TNBC.[2] TNBC accounts for ~15% of the 320,000 annual breast cancer cases in the United States.[3] The incidence of TNBC has shown a steady increase over time, with over two million cases reported globally in 2018.[4] This subtype of breast cancer has the worst prognosis of breast cancers, especially if metastatic.[5] Lantern notes that nearly 70% of TNBCs harbor deficiencies in homologous recombination pathways, which make the tumors sensitive to LP-184 and suggests that olaparib will work well in combination. It also notes that average survival for newly diagnosed, metastatic TNBC is about 18 months, highlighting the severity of the unmet need. To demonstrate the efficacy of LP-184 in TNBC, Lantern included the results of preclinical work that shows how its candidate is able to shrink tumors in both PARPi resistant and PARPi sensitive tumors. Lantern conducted further LP-184 animal studies using a patient-derived xenograft (PDX) model where tumor tissue from human breast cancer is implanted into a mouse. The implanted tumor was resistant to the PARP inhibitor and produced evidence of re-sensitization in combination with LP-184 as shown in Exhibit II. Lantern's continued advancement of LP-184 in a variety of cancer types and its arsenal of expedited pathways make it an attractive asset in the company's pipeline. The indication in TNBC joins other clinical assets including other LP-184 indications, STAR-001 in CNS indications, LP-284 in recurrent non-Hodgkin's lymphoma and LP-300 in non-small cell lung cancer for never smokers. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer . ________________________ [1] PARP is an enzyme that helps repair damaged DNA in cells. [2] Salimbeni, B.T., et al. The triple negative breast cancer drugs graveyard: a review of failed clinical trials 2017-2022. [3] American Cancer Society. Cancer Statistics, 2025. [4] Singh S., et al. Role of Immune Checkpoint Inhibitors in the Revolutionization of Advanced Melanoma Care. International Immunopharmacology. 2020 [5] National Cancer Institute. Cancer Stat Facts: Female Breast Cancer Subtypes. Sign in to access your portfolio
