Seyoum Ayehunie’s Post

Congratulations to Tubulis GmbH! The company announced that the U.S. Food and Drug Administration has granted Fast Track designation to its lead antibody-drug conjugate (ADC) TUB-040 for the treatment of patients with platinum-resistant ovarian cancer. TUB-040 is a NaPi2b-targeting Exatecan ADC based on Tubulis’ proprietary P5 technology with superior biophysical properties that demonstrated effective and durable responses in a range of preclinical models, including ovarian cancer. The candidate is currently being evaluated in a multicenter Phase I/IIa study (NAPISTAR 1-01, NCT06303505) in patients with platinum-resistant high-grade ovarian cancer or relapsed/refractory adenocarcinoma non-small cell lung cancer, who have exhausted other available treatment options. #mabs https://lnkd.in/ePUNUgkZ

Biohaven Initiates Phase I/II Clinical Trial for BHV-1510 Targeting Advanced Epithelial Cell Tumors Biohaven has commenced a Phase I/II clinical trial to assess BHV-1510, an antibody-drug conjugate (ADC) specifically directed at Trop-2 for treating advanced or metastatic epithelial cell tumors. This trial comprises two phases: the first is focused on establishing safety and recommended doses, while the second will evaluate the drug's preliminary efficacy in later stages. BHV-1510 is distinguished by its unique drug-antibody ratio (DAR) of four and incorporates a stable linker, displaying encouraging results in preclinical studies. These findings include heightened efficacy and potential synergy with anti-PD-1 therapy. Furthermore, Biohaven has established a clinical supply agreement with Regeneron Pharmaceuticals to access the PD-1 inhibitor Libtayo for combination studies. The company's chief medical officer has voiced optimism regarding the potential of BHV-1510 to present improved treatment options for cancer patients. # Thank you Elena Vargas for your submission!

Fulgent Pharma, a subsidiary of Fulgent Genetics, is set to present exciting Phase 1 clinical data on FID-007, its lead therapeutic candidate for head and neck cancer, at the American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago on June 2, 2024. FID-007, a nanoparticle formulation of paclitaxel, has been designed to improve drug delivery and tolerability. The formulation utilizes a PEOX polymer excipient, allowing the drug to remain in solution and preferentially target tumor cells through hyperpermeable blood vessels. Fulgent Pharma emerged from Fulgent LLC in 2016 and has since been acquired by Fulgent Genetics. Today, the company focuses solely on developing innovative cancer therapeutics, collaborating with leading institutions such as the University of Southern California, Moffitt Cancer Center, and ANP Technologies. Don't miss out on the opportunity to learn more about FID-007's promising clinical data, which will be presented in a poster session on June 2, 2024, from 9:00 a.m. to 12:00 p.m. Central Time at ASCO. The presentation title is "Efficacy from the phase 1 study of FID-007, a novel nanoparticle paclitaxel formulation, in patients with head and neck squamous cell carcinoma." The abstract number is 6042, and the poster board number is 345. Mike Nohaile #FulgentPharma #ASCO2024 #cancertherapeutics #clinicaldata #headandneckcancer #FID007 #nanoparticleformulation #paclitaxel #PEOXpolymerexcipient #drugdelivery #tumorcells #hyperpermeablebloodvessels

🔍 Interested in the Intratumoral Cancer Therapy Market? Connect with us to delve deeper into the latest insights and advancements. Let's engage in meaningful discussions! 🚀 #Healthcare #oncology #intratumoral #cancertherapy #marketresearch #businessanalysis

Initial dose escalation results from its ongoing Phase 1 KisMET-01 study evaluating the investigational ‘next generation’ cMET-targeting Antibody-drug Conjugates (#ADC), #MYTX-011, in patients with previously treated, locally advanced or metastatic non-small cell lung cancer (#NSCLC) were presented at the annual meeting of the American Society of Clinical Oncology (#ASCO), held May 31st – June 4th, 2024. MYTX-011 is being developed by clinical-state biotech #Mythic Therapeutics. MYTX-011 is a novel #cMET-targeted Drug-to-antibody ratio (DAR) of 2 #vcMMAE* ADC with an #antibody that has been engineered to have pH-dependent binding, which results in higher internalization and #payload delivery to tumor cells with a range of cMET expression. ChemExpress provide #vcMMAE, #MMAE and many other payloads with high GMP quality. #ADCs #Payloads #Linkers #Linker-payload #GMP #Preclinical #Clinical #CDMO #FFS

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

Jacobio Pharma (SEHK: 1167) presented the preclinical data of the SHP2 inhibitor JAB-3312 in combination with the KRAS G12C inhibitor glecirasib in the form of a poster at the Fifth RAS Initiative Symposium 2024. The data showed that glecirasib and JAB-3312 demonstrate potent anti-tumor effects both in vitro and in vivo, with JAB-3312 enhancing the anti-tumor effect of glecirasib. Representative patient cases were also included in the poster. The clinical data for the combination of JAB-3312 and glecirasib further validated the above preclinical conclusions. The poster released by Jacobio at ESMO 2024 showed that the confirmed objective response rate (cORR) of glecirasib and JAB-3312 as first-line treatment for non-small cell lung cancer was 70.6% (N=102), and the median progression-free survival (mPFS) remained stable at 12.2 months. #CancerResearch #SHP2Inhibitor #KRAS #Glecirasib #NonSmallCellLungCancer #ClinicalTrial #Oncology #ESMO2024 #RASInitiative #Pharmaceuticals #Biotechnology Read More: https://lnkd.in/g7wv7BH9

Exciting New Portfolio Development for Lantern Pharma: ADC advancement in 2024!    Lantern Pharma Inc. (Nasdaq: LTRN), in collaboration with Bielefeld University, is proud to announce an important milestone in the development of a promising new class of ADCs for the treatment of cancer. ADCs are a promising and emerging class of cancer therapy that are expected to generate over $24 billion in revenue by 2030. 📍What is the advancement? Our novel, Cryptophycin-linked ADC (CpADC) shows potent picomolar activity against 6 types of solid tumors 📍What does this mean?  We have further expanded our portfolio of drug-candidates and this molecule has the potential to benefit patients with drug resistant solid tumors. 📍How did we do it? By utilizing our AI Platform RADR® for target selection and payload characterization and working with our team of collaborators at Bielefeld University 📍Why does this matter?  We expect to advance this molecule towards an Investigational New Drug (IND) application! Bringing our unique ADC closer to the clinic and patients! We will continue to share advancements across our portfolio of drug-candidates and clinical trials: LP-300, LP-184, LP-284 and our ADC program. Make sure to follow us for updates on our groundbreaking research at the forefront of AI powered drug development!  To learn more in detail of our findings take a look at the Article Linked Below and checkout Bielefeld University’s LInkedin! Press Release: https://lnkd.in/eeQvxHJW Bielefeld University’s ADC consortium - Magic Bullet: https://lnkd.in/eKT3hy3d #TogetherWeCan #ADC #CancerResearch #LanternPharma #PersonalizedMedicine #LP300 #LP184 #LP284 

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

This review article just published on Nature Reviews Clinical Oncology is interesting to us. This work summarized the role of bispecific and multispecific antibodies in patients with cancer, including history and development. Maria-Elisabeth Goebeler and colleagues from University Hospital Würzburg, Germany, also discussed novel alternative bispecific antibody constructs, such as those targeting two antigens expressed by tumour cells or cells located in the tumour microenvironment. The full article can be access at: https://lnkd.in/epX5ZsZH By the way, Antibody Therapeutics (2022 CiteScore: 6.4), the officially journal of Chinese Antibody Society, published by Oxford University Press, calls for paper in “Cell Therapies and Cell Engagers against Cancer”. You are welcome to submit your manuscripts for this special collection by December 24, 2024. You may know more detailed information from the link below to the website of call for papers announcement. https://lnkd.in/esh6_s2h #antibodies #antibody #bispecific #bispecificantobody #bispecificantibodies #mabs #mab #antibodytherapeutics #antibodydiscovery #biologics #antibodydiscovery