FAP

BOTHELL, WA, USA I October 29, 2024 I Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, recently presented promising preclinical data for IM-1021 and the associated proprietary ADC payload HC74. The results were presented in a poster entitled “Preclinical evaluation of IM-1021, a ROR1-targeted antibody-drug conjugate with a novel topoisomerase I linker payload” at the 36 th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona on October 24, 2024. The poster included preclinical results for IM-1021 in both liquid and solid tumors while also highlighting the enhanced ADME properties of HC74: Immunome expects to submit an IND for the IM-1021 program to the FDA in the first quarter of 2025. “We believe that transformative ADCs require matching the target with the right combination of antibody, linker, and payload. Based on this data, we continue to believe that IM-1021 is a promising preclinical candidate,” said Immunome’s Chief Scientific Officer Jack Higgins, Ph.D. “HC74’s differentiated profile, including substantial potency in chemo-resistant cell lines, provides intriguing opportunities for clinical development. We look forward to submitting the IM-1021 IND and starting clinical trials upon IND clearance to further validate these findings.” A copy of the poster is available in the “Events & Presentations” portion of Immunome’s website. About Immunome, Inc. Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. For more information, visit www.immunome.com . SOURCE: Immunome

Oct. 21, 2024 – Avacta Therapeutics (AIM: AVCT), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today announces the initiation of an artificial intelligence (AI)-focused collaboration with Tempus AI, Inc. (Nasdaq: TEM), a technology company leading the adoption of artificial intelligence to advance precision medicine and patient care. The strategic collaboration will provide Avacta access to Tempus’ multimodal datasets comprising primary tumor samples and associated clinical data from over 200,000 patients across a broad range of cancer indications. The collaboration is designed to leverage these data to characterize the deep biology of the tumor microenvironment and fibroblast activation protein (FAP) activity upon which its pre|CISION® technology is based. In addition, Avacta has recently expanded its pre|CISION® platform with the addition of two new preclinical programs: AVA6103 and AVA7100. AVA6103 is a novel pre|CISION®-enabled peptide drug conjugate comprising exatecan, a potent topoisomerase I inhibitor, designed to deliver its powerful anti-tumor effects directly to the tumor while minimizing exposure to healthy tissues. AVA7100 is a first-in-class Affimer® drug conjugate, aimed at cancers with varying levels of FAP expression, including low FAP. Together, these programs reflect the versatility of the pre|CISION® platform and its potential to address a broad range of cancer indications. Avacta plans to leverage these insights to further enhance its pre|CISION® platform reach through the identification of the full addressable patient populations for its clinical programs. Tempus’s analytical support and computational biology experts will collaborate in the data analysis with the Avacta team. Christina Coughlin, MD PhD, CEO of Avacta, said, “Our pipeline of pre|CISION® oncology programs will benefit greatly from an extensive understanding of the tumor microenvironment, FAP biology and both high- and low-FAP expression across solid tumor settings. The Tempus AI real-world database and industry-leading AI capabilities will enable us to better assess the specific patient population most likely to respond to our pre|CISION® therapies, enabling faster, smarter clinical development with the highest probability of success.” Kate Sasser, PhD, Chief Scientific Officer at Tempus AI added, “A powerful use of AI in drug development is leveraging real-world data to have a deeper understanding of the patient populations that would benefit from a specific mechanism of action. Tempus was created to build one of the world’s largest libraries of multimodal data and an operating system to make those data accessible and useful. This collaboration with Avacta is another example of our execution of that vision, and we are thrilled to partner with Avacta in support of their efforts to bring game-changing new therapies to patients in need.” The pre|CISION® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION® platform harnesses this tumor specific protease to cleave pre|CISION® peptide drug conjugates and pre|CISION® antibody/Affimer® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for patients. The lead pre|CISION® program AVA6000, a peptide drug conjugate form of doxorubicin, is in Phase 1 studies. It has shown an improvement in safety and tolerability in clinical trials to date compared with standard doxorubicin and preliminary signs of clinical activity in multiple patients.To register for news alerts by email go to https://avacta.com/investors/investor-news-email-alerts/. Avacta Group is a UK-based life sciences company focused on improving healthcare outcomes through targeted cancer treatments and diagnostics. Its clinical stage oncology biotech division Avacta Therapeutics is harnessing the proprietary pre|CISION® platform technology to develop novel, highly targeted cancer drugs. Avacta Diagnostics focuses on supporting healthcare professionals and broadening access to diagnostics. To register for news alerts by email go to https://avacta.com/investors/investor-news-email-alerts/. The content above comes from the network. if any infringement, please contact us to modify.

Avacta Group plc ("Avacta" or "the Group" or "the Company") Avacta Reports Pipeline Advances with Two Novel Programs at the EORTC-NCI-AACR Molecular Targets Symposium in Barcelona LONDON – Oct. 24, 2024 – Avacta Therapeutics (AIM: AVCT), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today announces scientific presentations of two novel programs in its pipeline at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain. The presentations include data from two preclinical oncology assets, AVA6103 and AVA7100, from Avacta’s pipeline of pre|CISION® product candidates. Both presentations take place today in the Antibody Drug Conjugate (ADC) poster session at the Symposium. Avacta’s pre|CISION® product candidates are designed to be activated specifically in the tumor microenvironment (TME), thereby enabling improved antitumor activity while reducing systemic toxicities. Each peptide drug conjugate (PDC) in the Company’s pipeline is comprised of an active antitumor drug (known as a payload) linked to the pre|CISION peptide, which renders the payload inert and is cleaved only within the tumor by the action of Fibroblast Activation Protein, or FAP, expressed in the cancer associated fibroblasts in the TME. The pre|CISION® technology addresses key limitations of ADCs, namely (1) non-specific payload release that results in significant off target toxicities, and (2) the complexity of the bystander effect, which is necessary to target antigen-negative tumor cells and thus to treat antigen-low populations. The pre|CISION platform addresses these limitations by releasing payload only in the tumor microenvironment and optimizing the bystander mechanism of action. AVA6103 is a pre|CISION-enabled PDC comprised of the pre|CISION peptide linked to exatecan, the most potent topoisomerase I (topo I) inhibitor in clinical development. AVA7100 is a part of a new class of pre|CISION®-enabled Affimer® drug conjugates with potential applications in multiple cancer types, including those with lower levels of FAP in the tumor. AVA6103 and AVA7100 are expected to enter IND-enabling studies in late 2024 and 2H 2025, respectively. The details of these advances in the pre|CISION® technology are presented below. Christina Coughlin, MD PhD, CEO of Avacta, commented: “We are encouraged by the preclinical data from AVA6103 demonstrating that FAP-enabled exatecan induces DNA damage and drives cancer cell death and we look forward to advancing this promising therapy toward the clinic. The preliminary data from AVA7100 demonstrating that exposure to Affimer® Drug Conjugates (AffDCs) results in drug cleavage, release of the payload and tumor cell kill as a bystander function are exciting for this entirely new class of therapies. “These presentations showcase the evolution of our pre|CISION® platform technology to selectively deliver highly potent payloads directly to the TME, while minimizing exposure in normal tissues and optimizing patients’ outcomes. Our first program, AVA6000, demonstrates a four- to six-fold increase in the therapeutic index in the clinic and in preclinical models. With the advances in the platform, we are now seeing a 75-fold increase in therapeutic index with our recently announced exatecan program, AVA6103 in preclinical models, suggesting that AVA6103 could have an unprecedented safety profile in the clinic. Potent topoisomerase I inhibitors are the payloads of ADC therapies in the clinic, although the non-specific release of these payloads can lead to severe off-target toxicities. Given the lack of these toxicities in our first program and the broad reach of the topoisomerase I inhibitor class, we see our next programs as having great potential for true impact in patients with high unmet need.” AVA6103 Results In a poster titled “The novel peptide drug conjugate AVA6103 is a FAP-enabled pre|CISION® medicine which targets Topoisomerase I to the tumor microenvironment via FAP cleavage” in vivo data were presented that demonstrate the ability to target and accumulate the active warhead in the tumor microenvironment, resulting in tumor growth inhibition with AVA6103. Specifically, the key findings from the poster demonstrate: The therapeutic index of exatecan is significantly increased by pre|CISION enabling, specifically the maximum tolerated dose of pre|CISION exatecan (AVA6103) observed is 75 times that of conventional exatecan in a daily dosing regimenAVA6103 optimizes the bystander effect where the conjugate is only cleaved by FAP-positive fibroblasts, and released exatecan can enter FAP-negative cancer cellsHigh intratumoral warhead concentrations are seen at 4hr and 24hr timepoints for several pre|CISION exatecan compounds, with up to 50-fold higher warhead concentrations in the tumor versus plasma in a patient-derived xenograft model, AVA6103 inhibits tumor growth, with complete responses noted in a preclinical treated model engineered with human FAP expression (HEK-FAP) tumors. Increased survival was also shown in this model treated with AVA6103 compared with other models with vehicle-treated tumors. AVA7100 Results A poster titled “Affimer® Drug Conjugates (AffDC) targeting Fibroblast Activation Protein-α deliver highly toxic warheads to the tumor microenvironment by leveraging the pre|CISION® release mechanism” include data demonstrating that exposure of tumor cell line or fibroblast cell co-cultures to AffDCs results in drug cleavage, release of the warhead and tumor cell kill as a bystander function. Specifically, the key findings from the poster demonstrate: With non-internalizing Affimer protein binding and extracellular warhead release by FAP, the AffDC optimizes the bystander effect, leading to effective killing of antigen-positive and antigen-negative tumor cellsAffDCs have an antigen-binding region of 14kDa (single-domain) or 28 kDa (two-domain) that is 10-20% of the size of an antibody, optimizing tumor penetration. AffDCs may be rapidly engineered for optimal biophysical and functional characteristics.The FAP AffDC molecules exhibit a broad range of FAP binding (including potency up to single-digit picomolar, pM) combined with highly tumor-specific warhead release by leveraging the preCISION linker to release warhead directly in the tumor microenvironment and target that delivery to tumors with low FAP expression For further information from Avacta Group plc, please contact: Avacta Group plcMichael Vinegrad, Group Communications Directorhttps://avacta.com/Peel Hunt (Nomad and Broker)James Steel / Chris Golden / Patrick Birkholmwww.peelhunt.comICR Consilium Mary-Jane Elliott / Jessica Hodgson / Sukaina Virjiavacta@consilium-comms.com About the pre|CISION® Platform The pre|CISION® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION® platform harnesses this tumor specific protease to cleave pre|CISION® peptide drug conjugates and pre|CISION® antibody/Affimer® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for patients. About AVA6000: FAP-enabled doxorubicin The lead pre|CISION® program AVA6000, a peptide drug conjugate form of doxorubicin, is in Phase 1 studies. It has shown an improvement in safety and tolerability in clinical trials to date compared with standard doxorubicin and preliminary signs of clinical activity in multiple patients.To register for news alerts by email go to https://avacta.com/investors/investor-news-email-alerts/. AVA6103: FAP-enabled PDC targeting Topoisomerase I AVA6103 is a pre|CISION-enabled PDC comprised of the pre|CISION peptide linked to exatecan, the most potent topoisomerase I inhibitor in clinical development. Exatecan has demonstrated clinical activity in breast, gastric, lung and pancreatic cancers; however, it is associated with severe dose-limiting toxicities and a short half-life in patients that led to discontinuation of its monotherapy development. AVA6103 is designed to enable patients to obtain the therapeutic benefit associated with exatecan, while limiting the systemic exposure associated with its poor tolerability. AVA7100: pre|CISION® FAP Affimer Drug Conjugate (AffDC) AVA7100 is a pre|CISION®-enabled Affimer® drug conjugate, a new class of therapies being developed by Avacta with potential applications in a variety of cancer types, including those with lower levels of FAP in the tumor. Affimer® molecules are small proteins that are engineered to bind to a target molecule in the same way that an antibody does, but with several advantages, including smaller molecule size and a broad range of binding affinity. AVA7100 consists of a novel FAP-Affimer conjugated to a pre|CISION-peptide linker with multiple options for the payload. About Avacta Group plc - https://avacta.com/ Avacta Group is a UK-based life sciences company focused on improving healthcare outcomes through targeted cancer treatments and diagnostics. Its clinical stage oncology biotech division Avacta Therapeutics is harnessing the proprietary pre|CISION® platform technology to develop novel, highly targeted cancer drugs. Avacta Diagnostics focuses on supporting healthcare professionals and broadening access to diagnostics. To register for news alerts by email go to https://avacta.com/investors/investor-news-email-alerts/.