Latest news with #ParabilisMedicines
Business Wire
6 days ago
- Business
- Business Wire
Parabilis Medicines to Present Overview of Ongoing Phase 1/2 Study of FOG-001, a β-catenin
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Parabilis Medicines, a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, today announced the presentations of trial-in-progress posters on the Company's first-in-human clinical trial evaluating FOG-001, the first and only direct inhibitor of β-catenin TCF4, at the ASCO Annual Meeting, which begins on May 30 in Chicago, Illinois, and the ESMO Gastrointestinal Cancers Congress 2025, which begins on July 2 in Barcelona, Spain. FOG-001 is being evaluated in a Phase 1/2 trial (NCT05919264). The multicenter, open-label, non-randomized trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of FOG-001 in patients with solid tumors with Wnt pathway activating mutations (WPAM+), including colorectal cancer (CRC) and desmoid tumors. More than 65 patients with locally advanced or metastatic tumors have been dosed with FOG-001 to date, and early clinical data demonstrate monotherapy antitumor activity and in-tumor target engagement. Phase 1/2 data are expected to be shared publicly in 2025. The trial is currently enrolling patients with desmoid tumors in its monotherapy arm. It is also enrolling multiple cohorts of microsatellite-stable CRC (MSS-CRC) patients to evaluate combination regimens of FOG-001, supported by strong scientific rationale: Combinations with FOLFOX+bevacizumab and trifluridine/tipiracil+bevacizumab: Paired biopsy data from the ongoing FOG-001 trial indicate that FOG-001 drives reduction in markers of stemness and upregulation of the angiogenesis pathway, pointing to potentially greater susceptibility to both chemotherapy and bevacizumab. Preclinical studies employing patient-derived xenograft (PDX) mouse models indicate FOG-001 can significantly deepen and extend the benefit of both chemotherapy backbone agent 5-FU and bevacizumab. A second combination regimen, pairing FOG-001 with PD-1 checkpoint inhibitors, is supported by paired biopsy data from the ongoing trial indicating that FOG-001 induces the Merck tumor inflammation signature in otherwise immunologically 'cold' tumors. Preclinical studies in MC38 mouse models suggest this potential, demonstrating synergistic combination efficacy between FOG-001 and PD-1 checkpoint inhibitors. These observations indicate that FOG-001 could improve CRC responses to immunotherapy, which currently has minimal to no monotherapy efficacy in MSS-CRC. ASCO poster information: Title: 'A Phase 1/2 study of FOG-001, a first-in-class direct β-catenin:TCF inhibitor, in patients with colorectal cancer (CRC) and other locally advanced or metastatic solid tumors' Abstract Number: TPS3169 Date and Time: June 2, 2025, 1:30-4:30 p.m. CDT Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Location: Hall A – Posters and Exhibits ESMO GI poster information: Title: 'FOG-001 – a first-in-class direct β-catenin:TCF inhibitor, in patients with colorectal cancer (CRC) and other locally advanced or metastatic solid tumors: Phase 1/2 study design' Presentation Number: 145TiP Date and Time: July 3, 2025, 3:30-4:30 p.m. CET Session: Poster display session Location: Foyer About FOG-001 FOG-001 is an investigational first-in-class competitive inhibitor of β-catenin interactions with the T-cell factor (TCF) family of transcription factors, and is currently in clinical development. By directly targeting the β-catenin TCF4 protein-protein interaction, FOG-001 is intended to block the Wnt signaling pathway irrespective of the various APC and beta-catenin mutations that typically drive disease. FOG-001 combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: FOG-001 acts inside the cell where it binds directly to the key oncogenic driver β-catenin; and FOG-001 blocks the Wnt pathway at the most downstream node, disrupting the interaction between β-catenin and the transcription factor TCF, thereby abrogating the signal transmission by which Wnt pathway mutations are believed to drive oncogenesis. FOG-001 is currently being evaluated in a first-in-human Phase 1/2 clinical trial in patients with locally advanced or metastatic solid tumors. About Parabilis Medicines Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer. Through its Helicon discovery platform, Parabilis is engineering precisely tuned, stabilized helical peptide therapeutics that have the potential to unlock a large number of traditionally undruggable targets. This versatile platform enables applications for Helicons across three main areas: functional inhibitors of intracellular protein-protein interactions, targeted protein degraders, and targeted radiopharmaceuticals. Parabilis is advancing a pipeline of first-in-class programs across these three domains, led by FOG-001, its clinical-stage β-catenin TCF4 inhibitor. Parabilis is headquartered in Cambridge, Mass., and is well-capitalized, with more than $500 million raised to date from leading life sciences investors. For more information, please visit:
Business Wire
25-04-2025
- Business
- Business Wire
Parabilis Medicines Reports Positive Proof-of-Mechanism Data for Groundbreaking ERG Degrader Program
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Parabilis Medicines (formerly Fog Pharmaceuticals), a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, is presenting preclinical data demonstrating first-in-industry targeted degradation of ERG at the 2025 American Association for Cancer Research (AACR) Annual Meeting, which begins today in Chicago, Illinois. ERG has been a long-recognized high-value target in prostate cancer, where ERG fusions have been implicated in 40-50% of all cases. In metastatic castrate-resistant prostate cancer (mCRPC) specifically, the TMPRSS2-ERG gene fusion is associated with more aggressive disease and may predict resistance to certain therapies, such as PARP inhibitors. However, ERG has been undruggable by conventional inhibitors or first-generation degraders because it lacks small molecule binding pockets. Potent and specific degradation of ERG has been achieved with Helicon™ peptide degraders both in vitro and in vivo, leading to substantial tumor growth inhibition in multiple mouse models of prostate cancer. The data represent the first pharmacological proof-of-concept for ERG dependency in preclinical models of ERG-fusion prostate cancer. 'Parabilis's Helicon peptide degraders have thrilling potential to expand the reach of targeted protein degradation to traditionally 'undruggable' targets,' said Mathai Mammen, M.D., Ph.D., Chairman and CEO of Parabilis Medicines. 'These first compelling data from our ERG program validate our novel approach to degradation. The data also support the continued progress of our ERG degrader toward clinical trials, where it has the potential to be a meaningful therapeutic for patients with metastatic prostate cancer.' Highlights of the data presented at AACR include: In mice implanted with prostate cancer cell-derived xenograft (CDX) tumors, administration of the ERG degrader produced >90% tumor ERG degradation through 7 days post dose. This corresponded to suppression of ERG's downstream effects on target gene ARHGDIB. In both patient- and cell-line derived xenograft (PDX and CDX) models of TMPRSS2-ERG fusion prostate cancer, Parabilis's ERG degrader significantly inhibited tumor growth. RNA sequencing expression analyses indicated that Parabilis's ERG degrader downregulated Myc target genes. Parabilis's ERG degrader uses Helicon technology to bind directly to the ERG protein and, through its attached E3 ligand, directs the ERG protein to the ubiquitin-proteasome pathway for degradation. The company anticipates entering IND-enabling toxicology studies in 2025. Parabilis's prostate cancer franchise additionally includes a selective degrader of active androgen receptor (AR), which binds at a different site from approved drugs, and circumvents known resistance mechanisms that arise in response to AR antagonist therapies. Together, Parabilis's degraders of ERG and AR could potentially provide novel therapeutic approaches for patients with mCRPC. About Parabilis Medicines (Formerly Fog Pharmaceuticals) Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer. Through its Helicon discovery platform, Parabilis is engineering precisely tuned, stabilized helical peptide therapeutics that have the potential to unlock a large number of traditionally undruggable targets. This versatile platform enables applications for Helicons across three main areas: functional inhibitors of intracellular protein-protein interactions, targeted protein degraders, and targeted radiopharmaceuticals. Parabilis is advancing a pipeline of first-in-class programs across these three domains, led by FOG-001, its clinical-stage β-catenin TCF4 inhibitor. Parabilis is headquartered in Cambridge, Mass., and is well-capitalized, with more than $500 million raised to date from leading life sciences investors. For more information, please visit:
Yahoo
23-04-2025
- Business
- Yahoo
Parabilis Medicines to Present First Preclinical Data on ERG Degrader Program at AACR Annual Meeting
- First-in-class ERG degrader is designed to treat the 40-50% of prostate cancers displaying ERG-TMPRSS2 fusions - - Degrader leverages ability of Helicons™ to potently bind and degrade challenging targets with no small-molecule binding sites - CAMBRIDGE, Mass., April 23, 2025--(BUSINESS WIRE)--Parabilis Medicines (formerly Fog Pharmaceuticals), a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, today announced the presentation of preclinical data on its first-in-class targeted protein degrader of ERG at the upcoming American Association for Cancer Research (AACR) Annual Meeting, being held April 25–30, 2025, in Chicago, Illinois. The transcription factor ERG has been a long-recognized high-value target in prostate cancer, where ERG fusions have been implicated in 40-50% of all cases. Despite its relevance, ERG has remained undrugged by conventional inhibitors or first-generation degraders because the protein lacks small molecule binding pockets. Parabilis's ERG degrader overcomes this challenge by using the company's proprietary Helicon peptide technology, which enables intracellular targeting of "flat" protein surfaces. The company's prostate cancer franchise also includes a selective degrader of androgen receptor (AR) targeting a site outside the canonical androgen-binding site on the protein, thereby addressing a common resistance mechanism that arises in response to AR antagonist therapies. Together Parabilis's degraders of ERG and AR could potentially provide meaningful and differentiated therapeutic approaches to treat patients with metastatic castrate-resistant prostate cancer (mCRPC). Full details of the poster are as follows: Title: "Degradation of the ETS transcription factor ERG by stabilized helical peptide (Helicon™) degraders enables pharmacological validation in ERG-fusion prostate cancer models"Abstract Number: 4246/3Presentation Date and Time: Tuesday, April 29, 9:00 a.m. – 12:00 p.m. CDTSession: New and Emerging Cancer Drug TargetsLocation: Poster Section 17 About Parabilis Medicines (Formerly Fog Pharmaceuticals)Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer. Through its Helicon discovery platform, Parabilis is engineering precisely tuned, stabilized helical peptide therapeutics that have the potential to unlock a large number of traditionally undruggable targets. This versatile platform enables applications for Helicons across three main areas: functional inhibitors of intracellular protein-protein interactions, targeted protein degraders, and targeted radiopharmaceuticals. Parabilis is advancing a pipeline of first-in-class programs across these three domains, led by FOG-001, its clinical-stage β-cateninTCF4 inhibitor. Parabilis is headquartered in Cambridge, Mass., and is well-capitalized, with more than $500 million raised to date from leading life sciences investors. For more information, please visit: View source version on Contacts Media Contact Ten Bridge CommunicationsLisa Raffenspergerlisa@ Sign in to access your portfolio
Business Wire
23-04-2025
- Business
- Business Wire
Parabilis Medicines to Present First Preclinical Data on ERG Degrader Program at AACR Annual Meeting
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Parabilis Medicines (formerly Fog Pharmaceuticals), a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, today announced the presentation of preclinical data on its first-in-class targeted protein degrader of ERG at the upcoming American Association for Cancer Research (AACR) Annual Meeting, being held April 25–30, 2025, in Chicago, Illinois. The transcription factor ERG has been a long-recognized high-value target in prostate cancer, where ERG fusions have been implicated in 40-50% of all cases. Despite its relevance, ERG has remained undrugged by conventional inhibitors or first-generation degraders because the protein lacks small molecule binding pockets. Parabilis's ERG degrader overcomes this challenge by using the company's proprietary Helicon peptide technology, which enables intracellular targeting of 'flat' protein surfaces. The company's prostate cancer franchise also includes a selective degrader of androgen receptor (AR) targeting a site outside the canonical androgen-binding site on the protein, thereby addressing a common resistance mechanism that arises in response to AR antagonist therapies. Together Parabilis's degraders of ERG and AR could potentially provide meaningful and differentiated therapeutic approaches to treat patients with metastatic castrate-resistant prostate cancer (mCRPC). Full details of the poster are as follows: Title: 'Degradation of the ETS transcription factor ERG by stabilized helical peptide (Helicon™) degraders enables pharmacological validation in ERG-fusion prostate cancer models' Abstract Number: 4246/3 Presentation Date and Time: Tuesday, April 29, 9:00 a.m. – 12:00 p.m. CDT Session: New and Emerging Cancer Drug Targets Location: Poster Section 17 About Parabilis Medicines (Formerly Fog Pharmaceuticals) Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer. Through its Helicon discovery platform, Parabilis is engineering precisely tuned, stabilized helical peptide therapeutics that have the potential to unlock a large number of traditionally undruggable targets. This versatile platform enables applications for Helicons across three main areas: functional inhibitors of intracellular protein-protein interactions, targeted protein degraders, and targeted radiopharmaceuticals. Parabilis is advancing a pipeline of first-in-class programs across these three domains, led by FOG-001, its clinical-stage β-catenin TCF4 inhibitor. Parabilis is headquartered in Cambridge, Mass., and is well-capitalized, with more than $500 million raised to date from leading life sciences investors. For more information, please visit:
