The Michael J. Fox Foundation for Parkinson's Research’s Post

2024 is set to be a pivotal year for MC2 Therapeutics with significant milestones in our three Phase 2 stage clinical programs within Immunology and Inflammation. Next week in San Francisco, I am representing our dedicated MC2 Therapeutics team at the J.P. Morgan Healthcare Conference to provide an update on our progress and plans and to discuss collaborations with investors and industry partners.   Our two novel drug candidates (an oral HSP90 Inhibitor and a topical Iso-cyanate scavenger) are first-in-class with new mode of action and multiple indications potential, including Hidradenitis Suppurativa, CKD-associated Pruritus (CKD-aP) and Vulvar Lichen Sclerosus. Addressing the unmet needs of millions of patients and a testament to our commitment to pioneer novel treatment paradigms within I&I.   I look forward to engaging.   #JPM2024 #HealthcareInnovation #MC2Therapeutics #ClinicalAdvancement #Networking  

Don't forget to join Vigeo Therapeutics COO Dr. Jing Watnick updating the Fifth Annual Glioblastoma Drug Development Summit TODAY at 1:30 PM EDT today (March 28) in Boston, MA. Dr. Watnick will give an overview of #VT1021 in our Ph1/2 program in GBM as well as the future use of #VT1021 in attacking the roots of Neuro-inflammatory disease #GBM #Glioblastoma #NeurodegenerativeDisease #NeuroInflammatoryDisease #GBMSummit

At Artax Biopharma, we are developing first-in-class Nck modulators to treat T cell mediated autoimmune disease such as #psoriasis, #atopicdermatitis, and more. We're excited by the progress we've been making in the development of our first novel mechanism, AX-158, as we rapidly approach phase 2 trials for psoriasis treatment with first results expected in Q4 2024. We are simultaneously developing additional Nck modulator candidates for #autoimmunediseases with AX-194 undergoing preclinical testing to enter Phase 1 trials. Learn more about our candidate pipeline on our recently updated website here: https://lnkd.in/eqq3eSTK #clinincaltrials #immunology

[Clinical Trials] NeuroSense Therapeutics reports phase 2b trial results of PrimeC in ALS indicating reduced risk of disease complications and slower progression https://lnkd.in/gntGVcH8 CymaBay Therapeutics' phase 3 trial of seladelpar yields significant efficacy in primary biliary cholangitis endpoints https://lnkd.in/gu_sAxbc SynAct Pharma reports phase 2b trial of AP1189 reveals efficacy endpoints met in Rheumatoid Arthritis patients with elevated baseline CRP https://lnkd.in/g4KMythz [Deals] Immunocore Holdings and 브리스톨마이어스스큅 Collaborate on phase 3 Clinical Trial for IMC-F106C in Cutaneous Melanoma Treatment https://lnkd.in/gUchXuzB

FDA posted separate draft FDA guidances 4/25/24, highlighting the importance of Cancer Clinical Trial Eligibility Criteria, for Industry, IRBs, and Clinical Investigators in 3 Key Areas: = Laboratory Values = Performance Status = Washout Periods and Concomitant Medications Below are the links to the 3 FDA guidances: https://lnkd.in/eMesADPr https://lnkd.in/eWYuUu8K https://lnkd.in/e4_eApmH --end--

[Clinical Trials] Vicore Pharma AB's phase 2a trial of Digital therapy Almee shows a 2.7-point improvement in anxiety symptoms in Anxiety with Pulmonary Fibrosis https://lnkd.in/gY3DpKM3 Soligenix, Inc.'s phase 2a trial of SGX302 demonstrates positive outcomes in treating psoriasis https://lnkd.in/g5S5ce7i Theravance Biopharma US, Inc.'s phase 4 study of YUPELRI reveals no significant difference from Spiriva HandiHaler in COPD https://lnkd.in/gbe-e-6a Jiangsu Simcere Pharmaceutical's phase 3 trial of BD0801 met primary endpoint in ovarian cancer, fallopian tube cancer, and peritoneal cancer patients https://lnkd.in/gRcDwvt5 Stayble Therapeutics' phase 2b trial of STA363 for chronic disc-related back pain did not achieve primary objective https://lnkd.in/g9jTpNY7

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). Namodenoson granted Orphan Drug and Fast track status from the FDA. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. Chemenu has been working to develop more compounds for drug discovery. Here comes the building blocks we can provide: https://lnkd.in/gtC2PYBK #Namodenoson #2-CL-IB-MECA #A3AR #buildingblocks

Sinaptica Therapeutics (#LSIAlumni) is developing a totally new way of treating Alzheimer's disease with a drug free, noninvasive, neuromodulation approach. During this #LSIEurope23 interview, Ken Mariash, CEO of Sinaptica Therapeutics, provides an update on the company’s recent developments and shares a glimpse of what we can anticipate in 2024 and beyond. Sinaptica’s positive Phase II trial results published in October 2022, showed an unprecedented reduction in cognitive decline and improved function in mild-to-moderate Alzheimer’s disease patients. The results showed greater than 80% disease slowing on all four gold-standard cognitive and functional endpoints. What’s next for Sinaptica Therapeutics? They’re full steam ahead towards their pivotal trial. You can watch the rest of this interview with Ken Mariash, and a second interview with Sinaptica Co-Founder and Scientific Advisor, Emiliano Santarnecchi, on our website and YouTube channel. 🔗 Full Interview with Ken Mariash: https://lnkd.in/g-qNgk42 🔗 Full Interview with Emiliano Santarnecchi: https://lnkd.in/gGNNJeED

The @USFDA has issued three draft guidance documents that aim to promote greater participation & diversity in oncology clinical trials by expanding eligibility criteria.  The documents address three areas: laboratory values, washout periods & concomitant medicines, and patient’s performance status. The deadline for commenting on the guidance is June 25. Washout period and concomitant medications https://lnkd.in/gNiHAyVA Laboratory values https://lnkd.in/gErQcG3Z Performance status https://lnkd.in/gyE4tgbM https://lnkd.in/g_fEMGDP  

This is a great example of immunophenotyping on clinical trials. This is from Candel Therapeutics's June 2024 presentation (https://lnkd.in/g9DmSu2i), parts of which were shown at ASCO this weekend. For the uninitiated, in the first slide, you can see the injections generate an immune response at the right times. In the second slide, using multi-parameter cytometry, you can see the detail. The second slide compares changes in immune cells between the first and second CAN-2409 injections in patients who survived less than 24 months versus those who survived 24 months or more. Using multi-parameter cytometry, you can see that patients with a stronger immune activation after the second injection (the top right quadrant) tended to live longer.