Skills Alliance’s Post

Great achievement of the #Innovent team and hope for pancreatic cancer patients just announced. IBI343, a recombinant TOPO1i human anti-Claudin 18.2 monoclonal antibody-drug conjugate (ADC), just received Fast Track Designation by FDA for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy. This development comes after impressive initial efficacy results in the Phase I trial just reported at ASCO2024 with ORR of IBI343 monotherapy reaching 40% in r/r PDAC patients. #pancreatic cancer #PDAC #ADC #Claudin #FDA https://lnkd.in/ebpwTK7Z

https://lnkd.in/gf2RXecS Enhertu belongs to a class of therapies called antibody-drug conjugates (ADC) and comprises a monoclonal antibody - in this case trastuzumab (also known as Herceptin) - chemically linked to a cell-killing chemotherapy drug. The drug, sold under the brand name #Enhertu, originally won U.S. approval in late 2019 as a third-line treatment for HER-2-positive breast #cancer patients, and the fresh approval opens the treatment across multiple HER2-expressing solid tumors #monoclonalantibodies #Oncology

Regeneron is one of the leading companies actively developing CD28 T-cell engagers. In their Q2 2023 earnings report, Regeneron disclosed two immune-mediated deaths in a patient cohort receiving nezastomig (PSMA×CD28) in combination with cemiplimab. These deaths led Regeneron to halt patient enrollment for the full dose regimen of cemiplimab. In their Q2 2024 earnings report, Regeneron revealed that nezastomig is now being studied with REGN4336 (PSMA×CD3). They did not provide an update on the combination therapy with cemiplimab.

🔬 Important Update on Allarity Therapeutics' Strategic Focus We have refined our focus to concentrate exclusively on the development of stenoparib for advanced recurrent ovarian cancer. This decision comes after careful analysis and the encouraging data observed in our ongoing Phase 2 monotherapy trial of stenoparib. Our aim is to expedite the process toward regulatory approval, dedicating our resources to this critical endeavor.   Key Points:   The ongoing Phase 2 trial of stenoparib shows significant clinical benefit, with patients experiencing extended treatment durations: - Clinical benefit has now exceeded 20 weeks for each of the five patients originally mentioned in the December release. - The Complete Responder, referenced in the December release, has confirmed continued response through multiple additional scans and remains on therapy. We are committed to advancing stenoparib as swiftly and safely as possible, believing in its potential to make a meaningful difference for patients. #AllarityTherapeutics #OvarianCancer #ClinicalTrials #Oncology #Pharmaceuticals Image: a molecular model of stenoparib

#News: Roche has performed a little light spring cleaning, sweeping a pair of #phase1 #solid tumor drugs and an early-stage #psychiatricdisorder prospect out of the door as part of its update for the first quarter. The culls are part of a broader refocusing that has removed 20% of #newmolecules from the pipeline in recent quarters. The spring #cancer clearout affected #belvarafenib and #RG6286. Belvarafenib, also known as RG6185 and HM95573, is an oral #RAFkinaseinhibitor that Roche’s Genentech licensed from #HanmiPharmaceuticals for $80 million upfront in 2016. The candidate was in phase 1 at the time of the deal. Hanmi began a phase 1b study to test belvarafenib in combination with either cobimetinib or cetuximab in 2017. Read more from.Fierce Biotech 👇🏽 https://lnkd.in/ekQWsUJu

If you are attending the AACR 2024 conference in San Diego, CA from April5-10, visit us for a fruitful discussion. We will present a poster on “Novel organotypic patient derived primary tumor tissues for oncology drug safety and efficacy studies”. Our poster presentation at AACR will on April 7th 1:30-5:00pm in Section 9 under session PO.TB05.04 - Organoid Models of Cancer 1. MatTek/BICO has recently developed In vitro cancer models from human primary tumors that can play a key role in drug development. The creation of tumoroids in their cancer microenvironment will serve as efficient screening tools for drug discovery, help researchers test compounds and assess their effects on specific cancer types, create high-throughput screening platforms and accelerate the identification of novel drug candidates, and help to prevent candidate drugs with insufficient antitumor activity from progressing to preclinical animal testing. The models can also assist scientists to study cancer cells in a controlled environment outside the body, unravel molecular mechanisms underlying tumor growth, metastasis, and drug resistance and contribute to personalized medicine by enabling patient-oriented treatment approaches.  MatTek, BICO, in vitro, Tumoroid tissue model, Drug development

The FDA granted #Fast #Track designation to Phanes Therapeutics, Inc.'s PT217 for the treatment of patients with extensive-stage small cell #lung #cancer. Previously in 2022, PT217 was also granted orphan drug designation by the FDA 🔶 PT217, a first-in-class native IgG-like bispecific #antibody (bsAb) targeting DLL3 and CD47. It is being developed for the treatment of patients with small-cell #lung #cancer, large-cell #neuroendocrine #carcinoma of the lung, and extrapulmonary #neuroendocrine #carcinoma 🔶A multi-center Phase I #clinical #trial of PT217 (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in patients with advanced or refractory #cancers expressing DLL3 Source: https://lnkd.in/gj43MWkf

MacroGenics, Inc. has shared data from the Phase 2 TAMARACK study of vobramitamab duocarmazine (vobra duo, previously known as MGC018) in patients with metastatic castration-resistant prostate cancer (mCRPC). Early interim safety data from the Phase 2 TAMARACK study (NCT05551117), including comparison to retrospective analysis from a Phase 1 study (as submitted in an ASCO abstract that was not accepted), is included in the press release. Overall conclusions are: Preliminary safety data from TAMARACK suggest that reducing the dose and frequency of vobra duo improves its safety and tolerability in men with mCRPC. The company plans to provide updated interim data, including safety and preliminary efficacy, by May 31. #mabs #adcs https://lnkd.in/eE57D7mu

I'm excited to share our latest publication: The drug efficacy testing in 3D cultures platform identifies effective drugs for ovarian cancer patients, in npj precision oncology. This paper was part of my postdoctoral work at Karolinska Institutet/SciLifeLab in the Kallioniemi group with the supervision of Brinton Seashore-Ludlow. Here we describe the development and use of the image based drug screening platform DET3CT with a combination testing capability. This platform enables identification of effective therapies for individual patients in a clinically relevant timeframe. Our findings indicate the promising potential of the DET3CT platform, which in the future could be useful for identifying existing and emerging drugs and drug combinations for repurposing in ovarian cancer. #precisionmedicine #ovariancancer #functionalprecisionmedicine #drugscreening https://lnkd.in/eH6mzj_4

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