Paul Audhya

In 2024, 5 emerging BTK inhibitors are undergoing late-phase clinical investigation for #multiplesclerosis. Most clinicians are likely unaware of the clinical data regarding their use in MS. Dive into the data and earn free #CME here: https://bit.ly/4gViIVp #MedEd #FOAMed

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Don't miss our co-founder and Managing Partner, Jason Robart, on the Cambridge Associates podcast! "Precision oncology represents an exciting shift in cancer treatment from a one-size-fits-all approach to personalized care based on each patient’s unique cancer and molecular makeup. In this episode, we’ll explore how precision oncology is transforming the landscape of cancer care and improving outcomes at leading hospitals like St. Jude Children’s Research Hospital. We’ll discuss the latest precision diagnostic technologies enabling doctors to analyze a tumor’s molecular profile and match targeted therapies to save lives."

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💡 The BBC article below is worth a read for anyone interested in experimental treatment options for #PTSD, and highlights the challenges facing new treatment modalities. While the current FDA advisory committee's decision regarding MDMA treatment for PTSD may disappoint some, this does NOT indicate a final decision by the FDA. "Despite the meeting's outcome, the experts who the BBC spoke to believe there is still a chance that the FDA will grant approval in August. Emerson also remains hopeful." Global SOF Foundation remains committed to advocating for the responsible research of "new" treatment options, to include psychedelic therapy for #servicemembers and #veterans. This remains one of the three #SOFforLife priorities we shared with policy makers and is included in our 2024 SOF Imperatives document (found at https://lnkd.in/djquFVfj). #sof USSOCOM U.S. Department of Veterans Affairs Military Special Operations Family Collaborative

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Important oncology news of the week: ✖ BMS $BMY pulling out of its collaboration with Agenus $AGEN to develop the AGEN1777 bispecific is another hit for the troubled TIGIT class. https://lnkd.in/ejdvSmbK 💊 Some good data from Boehringer in CRC and NSCLC G12C-mutant xenografts showing that combining the KRASi adagrasib with the SOSi BI-3406 results in much better anti-tumor activity. https://lnkd.in/eJmi64iy 💰 Merck $MRK and Daiichi Sankyo join forces to co-develop the DLL-3 targeting tri-specific antibody MK-6070 going mostly after small-cell lung cancer. Daiichi paid $170 million upfront for the Phase I/II asset https://lnkd.in/eVugSzUp ↘ Another failure for Ultimovacs results in stock price drop and forces the company to downsize. The combination of its cancer vaccines UV1 for head & neck cancer in combination with Keytruda failed to show additional synergy in the Phase II FOCUS study. https://lnkd.in/edCBRfQq ☑ Servier's Voranigo (vorasidenib) becomes the first FDA approved medicine for IDH-mutant Grade 2 astrocytoma or oligodendroglioma in over 20 years. The approval was based on the Phase III INDIGO study where Voranigo led to 27.7 mos mPFS vs 11.1 for placebo. https://lnkd.in/eym3n9FY ↘ Exelixis' $EXEL Cabometyx (cabozantinib) + Roche's Tecentriq (atezolizumab) failed to provide an OS benefit in mCRPC compared to 2nd novel hormonal therapy in the final analysis of the CONTACT-02 Phase III trial. Despite this, Exelixis plans to submit an sNDA regardless in a risky move where rejection is more likely. https://lnkd.in/emK4Sw9m ↖ Sanofi's $SAN PFS wing for the quadruplet Sarclisa + RVd regimen in transplant-eligible MM make a label expansion in the 1L almost certain, but will only complicate the treatment selection further without a head-to-head comparison with Darzalex. https://lnkd.in/eaVVavMG

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Tempus now offers HER2 testing by IHC as an add-on to any of our solid tumor tests. The FDA recently approved a drug for the treatment of certain adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors* underscoring the potential impact of HER2 on patient care and the importance of comprehensive HER2 testing in guiding targeted therapy decisions. Looking forward to diving deeper into our IHC portfolio expansion at #ASCO24 in a couple of weeks. *FDA approval of trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

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The flip side of this is also interesting. What are autologous therapy developers looking to improve to avoid beng outcompeted? We are hearing a lot of interest in understanding what is possible in terms of compressed or "fast" autologous manufacturing. There seems to be particular interest in the cell activation and expansion phases although there are many areas that can be optimised to improve vein-to-vein time. There's a nice summary of some these trends in this GEN news article https://lnkd.in/eqjnMzGG

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One of the hottest targets in oncology right now is MAT2A. About 15% of all cancers are MTAP-depleted. This number may double after the first round of therapy. And MAT2A inhibitors selectively eliminate these cells. Please check out our paper on MAT2A inhibition that just got published. See link in comments. And we have a MAT2A inhibitor with IND clearance and suddenly, every pharma company wants it. Especially those with PRMT5 inhibitors - combo with MAT2A is a must to stay competitive. Thanks to the team for taking the time to write this important paper - it is a lot of work. Highlights: • MAT2A sustains the survival of MTAP-deficient tumors, a genetic aberration present in ∼15% of all cancers. • Multiple new MAT2A inhibitors have reached the clinical testing stage as both a monotherapy or in combination. • Understanding which cancer subtypes may benefit from MAT2A + PRMT5 inhibition is critical to advancing MAT2A inhibitors in the clinic. • Recent Phase 1 and 2 findings improve our understanding of the potential safety limitations of these inhibitors, particularly as a new generation of inhibitors is being developed.

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💵 Funding News: 🗓️ News Month: October, 2024 Seaport Therapeutics Raises $225M in Series B to Transform Neuropsychiatric Medicine Boston-based Seaport Therapeutics is breaking barriers in neuropsychiatric care with its proprietary Glyph™ technology platform. Backed by a total of $325M in funding, this Series B round was led by General Atlantic, with support from T. Rowe Price, Goldman Sachs Alternatives, and more. 🌍 The Mission: 🔬 Address high unmet patient needs in neuropsychiatry. ⚙️ Overcome clinical challenges with proprietary Glyph™ technology, enabling: 🔹Oral bioavailability. 🔹Reduced side effects like hepatotoxicity. What’s Next? 💊 SPT-300: A potential breakthrough for major depressive disorder (MDD): 🔸Phase 2b trials underway. 🔸First oral form of allopregnanolone with rapid antidepressant effects. 💊 SPT-320: A novel treatment for generalized anxiety disorder (GAD): 🔸Utilizing Glyph to lower liver exposure and improve systemic efficacy. Why It Matters: Seaport Therapeutics is rewriting the future of neuropsychiatric care with innovative medicines powered by science, addressing critical gaps in treatment. Led by visionary founder Daphne Zohar, this isn’t just progress—it’s a revolution. 🚀 📢 Stay tuned to Future Techly for the latest updates on this groundbreaking initiative and the latest in tech and business! 💥 Source: FinSMEs ♻️ Repost if you think this insight is worth sharing!

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FDA adverse event study shows JAKi in #RA assoc w/ signif more VTE, ischemic heart Dz, & tachyarrhythmias. 75,407 on JAKi vs 303,278 on biologics (TNFi, RTX, TCZ); JAK had more VTE (ROR=2.11), CVA (ROR=1.25), IHD (1.23), arrhythmias (1.15 ), esp in 1st yr. https://buff.ly/3xS9dV9

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➡️ Gene therapies possess unique characteristics that differ from traditional small molecule or biologic treatments, including the need for innovative, sustainable coverage and reimbursement models. ➡️ When it comes to payment and a myriad of other variables, a holistic view is essential to ensuring reliable patient access — now and in the future. ➡️ Learn more in our new paper: https://lnkd.in/e8eNi2Rc National Pharmaceutical Council Becaris Publishing Limited

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FDA released an important guidance about minimal residual disease testing via ctDNA as a biomarker in cancer clinical trails. It's my opinion that MRD and MCED testing will revolutionize how cancer is diagnosed and monitored. https://lnkd.in/g9H7nZTR. #cancerdiagnostics #minimalresidualdisease #multicancerearlydetection

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As part of the Inflation Reduction Act’s (#IRA) first round of #Medicare negotiations, the Biden administration has announced significant price reductions on 10 high-cost #prescriptiondrugs. Set to go into effect in 2026, these cuts will range from 38% to 79%, impacting major treatments for #diabetes, #heartfailure, and #autoimmunediseases in an effort to lower healthcare costs for #Medicarepatients. While the administration celebrates the potential savings for Americans, the #pharmaceuticalindustry argues that the changes may do more harm to patients by limiting access to treatments and stifling innovation. The ongoing debate highlights the complex balance between affordability with the availability of new treatments. 

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Technology enabled, remote, clinical trial services can significantly improve clinical trial access. Such, decententralised, trial procedures are an important way to improve representation on trials and enhance the quality of data obtained while reducing participant burden. Oncology studies are no different. It's great to see sponsors and sites look to apply learnings and enable these tools to redifine who can participate in cancer clinical trials. Fantastic work published in JAMA Oncology by Bloomberg New Economy, Memorial Sloan Kettering Cancer Center, Bayer | Pharmaceuticals, Amgen Oncology , AstraZeneca FDA Science 37

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A team of doctors and researchers at Memorial Sloan Kettering Cancer Center (MSK) have identified a new, rare type of #smallcelllungcancer that primarily affects younger people who have NEVER smoked. https://lnkd.in/es-PGcTc Their findings, which include a detailed analysis of the clinical and genetic features of the disease, also highlight vulnerabilities that could help doctors make better treatment decisions for people diagnosed with it. "It's not every day you identify a new subtype of cancer," says Natasha Rekhtman, MD, Ph.D., an MSK pathologist specializing in lung cancer and the first author of a paper published in Cancer Discovery presenting the team's analysis. "This new disease type has distinct clinical and pathological features, and a distinct molecular mechanism." https://lnkd.in/es-PGcTc The study brought together the expertise of 42 physicians and researchers across MSK—from the doctors who treat #lungcancer and the pathologists who evaluate cells and tissues to make a diagnosis, to specialists in #tumor #genetics and #computationalanalysis. "Understanding this new type of lung cancer required a broad spectrum of expertise from the laboratory to the clinic," says Charles Rudin, MD, Ph.D., a lung cancer specialist and the study's senior author. https://lnkd.in/es-PGcTc Small cell lung cancer (SCLC) is relatively rare to begin with, accounting for 10% to 15% of all lung cancers, according to the American Cancer Society. And the newly discovered subtype accounts for just a fraction of those. Out of 600 patients with #SCLC whose cancers were analyzed for the study, only 20 people (or 3%) were found to have the rare subtype. SCLC is normally characterized by the deactivation of two genes that protect against the development of #cancer—RB1 and TP53—but patients with the new subtype have intact copies of those genes. Instead, most carried a signature "shattering" of one or more of the chromosomes in their cancer cells, an event known as chromothripsis. The new subtype appears to arise through a transformation of lower-grade neuroendocrine tumors (pulmonary carcinoids) into more aggressive carcinomas. The research team has dubbed the new type "atypical small cell lung carcinoma." https://lnkd.in/es-PGcTc More information: Natasha Rekhtman et al, Chromothripsis-mediated small cell lung carcinoma, Cancer Discovery (2024). https://lnkd.in/egpANCPC

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🧠 Transforming Glioblastoma: AI's Role in Revolutionizing Cancer Treatment 🚀 Imagine a world where a deadly brain tumor doesn’t just fight to survive but actively works to destroy itself. That’s the astonishing promise of artificial intelligence in glioblastoma treatment—taking the seemingly impossible and turning it into a potential breakthrough. Recent advancements reveal that AI can reprogram glioblastoma cells into immune-like cells, effectively transforming the tumor's own structure into a weapon against itself. This isn’t just theoretical; it’s happening in cutting-edge research today. Why This Matters: 1️⃣ Reprogramming Cancer Cells: AI uncovers genetic "switches" that convert cancer cells into immune allies. 2️⃣ Personalized Tumor Vaccines: Every treatment is tailored to the patient’s unique tumor profile, potentially revolutionizing immunotherapy. 3️⃣ Overcoming Traditional Limitations: Current methods often fail to deliver long-term survival. AI is changing the game. The Results Speak Volumes: Traditional Treatments: Median survival remains at 14 months, with only 18% of patients surviving beyond two years. AI-Driven Therapies: Early research shows potential recovery rates soaring to 85%—a transformative leap that could save countless lives. At DrugsIntel we believe in the power of innovation and are inspired by these breakthroughs. By integrating AI-driven approaches, we're committed to making personalized medicine not just a vision but a reality. From cutting-edge cancer research to everyday patient care, the future of healthcare is smarter, faster, and more precise. #SKcure #Glioblastoma #PrecisionMedicine #FutureOfMedicine

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In the latest edition of CMO Confidential I discuss the notable regulatory milestones in oncology and rare disease treatments from October. The FDA's approval of Zolbetuximab (Vyloy) for gastric and gastroesophageal junction adenocarcinoma marked a step forward in targeted therapies, particularly for patients with CLDN18.2 expression. This approval offers a new therapeutic option for patients with advanced gastric or GEJ cancer, highlighting the importance of biomarker-driven treatments in oncology. In hematology, Asciminib (Scemblix) received accelerated approval for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia, backed by compelling trial data showing substantial improvements in major molecular response rates compared to the investigator-selected tyrosine kinase inhibitors (IS-TKIs). The FDA also released an update on the Rare Disease Innovation Hub aimed at streamlining the development of treatments for rare diseases. By centralizing resources and accelerating the review process this initiative is a promising move to bring more therapies to patients with significant unmet need. The momentum we’re seeing in biomarker-driven treatments and rare disease innovation reflect the transformative changes the industry is making in how we treat complex conditions. As we look to the future, I’m optimistic that these trends of regulatory and patient centered innovation will continue to drive progress and improve outcomes for patients globally.

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