ImmunoGenesis, Inc.’s Post

𝐂𝐢𝐫𝐜𝐥𝐞 𝐏𝐡𝐚𝐫𝐦𝐚 𝐒𝐮𝐛𝐦𝐢𝐭𝐬 𝐈𝐍𝐃 𝐀𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐂𝐈𝐃-𝟎𝟕𝟖, 𝐚 𝐍𝐨𝐯𝐞𝐥 𝐂𝐲𝐜𝐥𝐢𝐧 𝐀/𝐁 𝐈𝐧𝐡𝐢𝐛𝐢𝐭𝐨𝐫 Circle Pharma Circle Pharma, Inc. announced the submission of its first Investigational New Drug (IND) application to the FDA for CID-078, a first-in-class cyclin A/B RxL inhibitor. This marks a significant advancement in the development of novel drug candidates from Circle’s proprietary MXMO™ platform for difficult-to-drug targets in oncology and other serious illnesses. CID-078, an orally bioavailable macrocycle, has shown preclinical efficacy across multiple tumor types with high E2F expression, including small cell lung cancer, triple-negative breast cancer, ER-low breast cancer, and HR-positive breast cancer following CDK 4/6-inhibitor treatment. The IND submission includes comprehensive preclinical data demonstrating CID-078's safety, efficacy, and pharmacokinetic profile to support the proposed phase 1 trial. Designed to selectively inhibit key protein interactions involving cyclins A and B, CID-078 targets proteins implicated in cancer cell proliferation and survival. This novel mechanism of action offers a new therapeutic approach for patients with advanced solid tumors who have limited treatment options. “I am proud that we have reached this critical milestone in the development of CID-078,” said David J. Earp David J. Earp, JD, PhD, CEO of Circle Pharma. “The IND filing represents a major step forward in our mission to harness the power of macrocycle therapies for cancer and other serious illnesses.” Pending regulatory approval, Circle Pharma plans to initiate a phase 1 clinical trial of CID-078 in patients with advanced solid tumors to evaluate safety, tolerability, pharmacokinetics, and anti-tumor activity. #CirclePharma #Oncology #CancerResearch #MacrocycleTherapies #DrugDevelopment #INDSubmission

$LTRN "Receiving a second #FDA #FastTrack Designation for LP-184 reinforces the significant potential of this drug candidate to address critical unmet needs in aggressive cancers, especially those like TNBC where patients have limited therapeutics options," stated Panna Sharma, President and CEO of Lantern Pharma (NASDAQ: LTRN). "Recent data presented at the Immuno-Oncology Summit demonstrated LP-184's ability to sensitize TNBC tumors that are non-responsive to checkpoint inhibitors, potentially expanding treatment options for patients with limited therapeutic choices." About TNBC and the Need for Novel Therapies #TNBC represents approximately 20% of all #breastcancers, affecting nearly 29,000 patients annually in the US. The prognosis for TNBC patients is considerably worse than hormone receptor-positive breast cancers, with over 50% of patients relapsing in the first 3-5 years. https://lnkd.in/gSw5P--s

Imugene Limited (ASX:IMU, OTC:IUGNF) is ready to begin combination dosing #SolidTumour patients with CD19 targeting drug #blinatumomab as part of a Phase 1 clinical trial of CD19 oncolytic #virotherapy drug candidate onCARlytics (on-CAR-19, CF33-CD19 HOV4). The combination arm of the study treatment will see onCARlytics combined with CD19 targeting bispecific monoclonal antibody blinatumomab (marketed as Blincyto® by Amgen which currently is specifically approved only for liquid blood cancers). Progression to this phase follows onCARlytics clearing its first cohort within the intratumoural monotherapy arm of the study. More at #Proactive #ProactiveInvestors #ASX #OTC #IMU #IUGNF #Biotech #Biopharmaceutcials #Oncology #OncolyticVirus #BloodCancer http://ow.ly/BTLW105lp3Y

Shanghai Henlius Biotech, Inc. has announced that the first subject was dosed for a phase 1 clinical trial of HLX42 (NCT06210815), an investigational EGFR-targeting antibody-drug conjugate (ADC), for the treatment of advanced/metastatic solid tumors. HLX42 was developed by the company based on the collaboration with MediLink Therapeutics. HLX42 is a novel EGFR-targeting ADC, comprised of a high-affinity humanised IgG1 mAb targeting EGFR conjugated with a novel cytotoxic payload through cleavable linkers, with the drug-to-antibody ratio is about 8. The cytotoxic payload is a novel DNA topoisomerase-I inhibitor. In December 2023, FDA granted Fast Track Designation to HLX42 for the treatment of advanced/metastatic non-small cell lung cancer patients with disease progression on EGFR targeted therapies. https://lnkd.in/eU5qmtid

$LTRN "Receiving a second #FDA #FastTrack Designation for LP-184 reinforces the significant potential of this drug candidate to address critical unmet needs in aggressive cancers, especially those like TNBC where patients have limited therapeutics options," stated Panna Sharma, President and CEO of Lantern Pharma (NASDAQ: LTRN). "Recent data presented at the Immuno-Oncology Summit demonstrated LP-184's ability to sensitize TNBC tumors that are non-responsive to checkpoint inhibitors, potentially expanding treatment options for patients with limited therapeutic choices." About TNBC and the Need for Novel Therapies #TNBC represents approximately 20% of all #breastcancers, affecting nearly 29,000 patients annually in the US. The prognosis for TNBC patients is considerably worse than hormone receptor-positive breast cancers, with over 50% of patients relapsing in the first 3-5 years. https://lnkd.in/gSw5P--s

"Receiving a second #FDA #FastTrack Designation for LP-184 reinforces the significant potential of this drug candidate to address critical unmet needs in aggressive cancers, especially those like TNBC where patients have limited therapeutics options," stated Panna Sharma, President and CEO of Lantern Pharma (NASDAQ: LTRN). "Recent data presented at the Immuno-Oncology Summit demonstrated LP-184's ability to sensitize TNBC tumors that are non-responsive to checkpoint inhibitors, potentially expanding treatment options for patients with limited therapeutic choices." About TNBC and the Need for Novel Therapies #TNBC represents approximately 20% of all #breastcancers, affecting nearly 29,000 patients annually in the US. The prognosis for TNBC patients is considerably worse than hormone receptor-positive breast cancers, with over 50% of patients relapsing in the first 3-5 years and metastatic TNBC patients having a median overall survival of less than one year. Currently available treatment options are limited, particularly for patients who develop resistance to existing therapies. https://lnkd.in/gSw5P--s

The cover story of RISFAX this morning is an insightful report on the progress of CAR-T therapies in the treatment of solid tumors. Few days ago, I was listening Dr. Michel Sadelin on the radio (https://lnkd.in/g3icxjxv); a pioneer of CAR-T therapy for years, and recently awarded for his research with the Breakthrough Prize 2024, Dr. Sadelin was sharing that solid tumor treatment, unlike hematology, continued to be a real challenge in term of efficacy and safety for CAR-T. The article reports that at ASCO this year, US venture AfiImmune Therapeutics achieved the first complete response (CR) against solid tumors, with the CR seen in one out of nine patients in a Phase I trial targeting thyroid cancer. The company's "AIC100" targets "ICAM-1," which is strongly overexpressed in thyroid cancer, while adjusting the affinity so that it does not bind to normal cells. The overall response rate (ORR), including this one CR case, was 22% of the nine cases evaluated for efficacy analysis, and the disease control rate, including stable disease (SD), was 56%. At ASCO, positive results were obtained for CAR-T cell therapy for other solid tumors, with C-CAR031, a drug jointly developed in China by AstraZeneca and AbelZeta Pharma, showing an ORR of 50% and a disease control rate of 90.9% in 22 evaluable cases. The development of CAR-T cell therapy is gaining momentum in China, with early clinical data released for Immunofuoco's two drugs, Immunopharma's IM96, and Chongqing Precision Biotech's product targeting CEA. Takeda Pharmaceutical announced Phase I results for TAK-102, which is being developed by Takeda Pharmaceutical to target GPC3. After administering the drug to 11 patients, one case showed antitumor effects and tumor shrinkage over a six-month period. However, following a review of its development strategy, the company has decided to return the rights to US company Noile-Immune Biotech and discontinue the development of several CAR-T cell therapies. So Chinese pharma is moving in but Japanese pharma is holding back or so it seems in this newly emerging field of oncology. #asco2024 #innovativetherapy #oncology #medicalresearch

Oxford’s Accession Therapeutics Limited files to begin phase 1 clinical trials 🥼✍️ Accession Therapeutics, which is developing novel immunotherapies targeted at tumour sites and administered systemically, has filed a clinical trial application (CTA) with regulatory agency MHRA. This will be the first clinical trial showcasing the Oxford firm’s TROCEPT-01 lead programme and will enrol patients with a variety of solid tumour carcinomas, including non-small cell lung, bladder, pancreatic, head and neck, cholangiocarcinoma and endometrial cancers. TROCEPT-01 encodes an immune checkpoint inhibitor transgene as a payload. Once cancer cells are infected, they will start producing and secreting the drug payload. Continue reading... https://lnkd.in/epxFsxX7 #science #technology #innovation #therapeutics #launch #trial #oxonnews #oxonhour #businessnews #businessintelligence

New initial dose escalation clinical data has been released for masked (conditionally activated) T-cell engagers, specifically on CX-904 in advanced metastatic solid tumor types known for expressing EGFR, such as pancreatic cancer, CRC, NSCLC, HNSCC, and others: https://lnkd.in/dYmUjZU3 . Developed by CytomX Therapeutics, CX-904 is an investigational PROBODY T-cell engager designed to target EGFR and CD3 within the tumor microenvironment. No CRS of any grade was observed in step-dosing cohorts and no grade >1 CRS was observed overall. Among the patients with pancreatic cancer, 2 of 6 patients (33%) had a confirmed partial response (PR), while no responders were observed in other tumor types. It is interesting to compare these results with data published in February by Janux Therapeutics on their EGFR/CD3 masked TCE JANX008 in CRC, NSCLC, SCCHN, RCC. Similar to CX-904, no CRS greater than grade 1 was reported, and only one patient with NSCLC had a confirmed PR. https://lnkd.in/d7CCSM4R

"Receiving a second #FDA #FastTrack Designation for LP-184 reinforces the significant potential of this drug candidate to address critical unmet needs in aggressive cancers, especially those like TNBC where patients have limited therapeutics options," stated Panna Sharma, President and CEO of Lantern Pharma (NASDAQ: LTRN). "Recent data presented at the Immuno-Oncology Summit demonstrated LP-184's ability to sensitize TNBC tumors that are non-responsive to checkpoint inhibitors, potentially expanding treatment options for patients with limited therapeutic choices." About TNBC and the Need for Novel Therapies #TNBC represents approximately 20% of all #breastcancers, affecting nearly 29,000 patients annually in the US. The prognosis for TNBC patients is considerably worse than hormone receptor-positive breast cancers, with over 50% of patients relapsing in the first 3-5 years and metastatic TNBC patients having a median overall survival of less than one year. Currently available treatment options are limited, particularly for patients who develop resistance to existing therapies.