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[Clinical Trials] 09/19 Aligos Therapeutics Reports Significant Reduction in Liver Fat in phase 2a Study of ALG-055009 on Metabolic-Dysfunction Associated Steatohepatitis Patients same day : ( ↓ NASDAQ: ALGS | -20.54% ) 09/19 Laekna Therapeutics Shares End of Study Results for phase Ib Clinical Trial of LAE002 in Advanced Breast Cancer, Begins Phase III Trial AFFIRM-205 09/18 Transcenta Holding's Cancer Treatment TranStar102 Reports Median Progression-Free Survival of 14.2 Months in CLDN18.2 Expressing Patients, Presented at ESMO Congress 2024 09/18 Genentech's phase III trial of Xofluza shows significant reduction in influenza transmission in households [Deals] 09/19 Basilea Pharmaceutica bags initial $29M from BARDA under multi-year agreement for antifungal and antibacterial development 09/19 Tiziana Life Sciences Secures $4M NIH Grant for Alzheimer's Research, Prepares for First-in-Human Clinical Trials for Nasal Anti-CD3 Treatment [Regulatory] 09/19 FDA grants Rare Pediatric Disease and Orphan Drug designations to Longboard Pharmaceuticals' bexicaserin for Dravet syndrome treatment same day : ( ↑ NASDAQ: LBPH | +2.2% ) 09/19 FDA rejects Vanda Pharmaceuticals' application for gastroparesis medication, asks for further studies same day : ( ↓ NASDAQ: VNDA | -8.28% ) View the full newsletter contents for free via the link in the comments.

📢 FDA approves amivantamab in first-line EGFR exon 20 insertion-mutated non-small cell lung cancer indications; converts to traditional approval (The Janssen Pharmaceutical Companies of Johnson & Johnson) ➤ Amivantamab + carboplatin +pemetrexed showed a statistically significant improvement in PFS vs. carboplatin + pemetrexed with a HR of 0.40 (95% CI: 0.30, 0.53; p-value<0.0001). Median PFS was 11.4 months (95% CI: 9.8, 13.7) and 6.7 months (95% CI: 5.6, 7.3) in the respective arms ➤ FDA action converts the May 2021 2nd line accelerated approval to a full approval based on the confirmatory Phase 3 PAPILLON study #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent #nsclc https://lnkd.in/estqwicD

🧬 Pharma News From The Last Week 🧬 💊US FDA grants full approval for AbbVie ADC for the treatment of ovarian cancer. Elahere is approved for for adult patients with a type of cancer that affects the ovaries, fallopian tube, or walls of the abdomen (See link). 💵 Capstan Therapeutics announced the successful closing of an oversubscribed Series B financing of $175 million, which will support the advancement of the lead program, CPTX230. (https://lnkd.in/demG7KFS) 🔬AbbVie to acquire Landos Biopharma, Inc. Landos’ lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist. Bolstering their portfolio in inflammatory and autoimmune diseases. (https://lnkd.in/dEj4xZWx) 💉 Molecure first patient in the UK is dosed in the OATD-01 Phase 2 KITE study in pulmonary sarcoidosis. The Phase II clinical trial for OATD-01 is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of the oral CHIT1 inhibitor in approximately 100 patients. (https://lnkd.in/dnABPtw5). 💲 Angelini Ventures' investment of €7 million brings the total raised by Nouscom, in its oversubscribed Series C round to €75.8 million. (https://lnkd.in/d24_SVr7) #pharmanews #pharma #biotech 🧬

Are we to expect completely new mechanism of action compound added to the standard of care in the 1st line treatment of patients with unresectable or metastatic hepatocellular carcinoma (#HCC)? Tempest Therapeutics just announced very good results from ongoing global randomized Phase 1b/2 clinical study (NCT04524871) in which #Amezalpat, a Peroxisome Proliferator-Activated Receptor alpha (#PPARα) antagonist, delivered a six-month improvement in median overall survival (OS) advantage when combined with standard #Atezolizumab and #Bevacizumab in a comparison to #Atezolizumab and #Bevacizumab alone in the first-line treatment of patients with unresectable or metastatic HCC of 21 months vs. 15 months. Besides impressive efficacy across HCC patient subpopulations (including PDL-1 positive and negative population), safety profile of the triplet seems encouraging with no significant additional safety signals observable as added from Amezalpat or Amelzapat disrupting dosing of standard of care. This early data obtained in 70 patient trial is great news for HCC patients if pivotal trial ultimately supports these findings. #HCC #1st line treatment #OS #PD(L)-1 defined population #HCC Etiology #Biotech #clinical oncology https://lnkd.in/gy9nAgMV

FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications On March 1, 2024, the Food and Drug Administration approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. The FDA also granted traditional approval to amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. FDA previously granted accelerated approval for this indication. #fda #drugapproval #immunooncology #lungcancer https://lnkd.in/dWC3ydAk

Exciting progress in multiple myeloma treatment! 🌟 The GMMG-HD7 phase 3 study has shown that adding isatuximab (Sarclisa; Sanofi) to the standard-of-care regimen of lenalidomide (Revlimid; Bristol Myers Squibb), bortezomib (Velcade; Millennium Pharmaceuticals), and dexamethasone (Decadron; Pfizer) (RVd) significantly improves progression-free survival (PFS) for patients with newly diagnosed multiple myeloma (MM). This promising combination not only enhances the effectiveness of treatment but also marks a significant advancement in the evolving landscape of MM therapies. With MM being the second most common hematological malignancy, these results highlight the need for continuous innovation in treatment approaches. The integration of isatuximab could provide a new standard in frontline care, offering hope for better outcomes and extended survival for patients. #MultipleMyeloma #Isatuximab #CancerResearch #ClinicalTrials #Oncology #MedicalAdvances https://lnkd.in/ecRNwJPV

FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer FDA has cleared a new first-line therapy for certain types of locally advanced or metastatic non-small cell lung cancer (NSCLC). The treatment pairs lazertinib (Lazcluze—Janssen Biotech) and amivantamab-vmjw (Rybrevant—Janssen Biotech), a combination that was assessed during the MARIPOSA clinical study. In the study, 1,074 participants were randomly assigned to the candidate intervention, to monotherapy with osimertinib or to off-label monotherapy with lazertinib. Progression-free survival, the primary efficacy endpoint, was measured at 23.7 months for lazertinib plus amivantamab vs. 16.6 months for osimertinib. Common adverse reactions include rash, paresthesia, gastrointestinal events, COVID-19 infection, and ocular toxicity, among others. Due to a risk of venous thromboembolic events, anticoagulation prophylaxis is recommended for the initial 4 months of treatment. Lazertinib plus amivantamab is indicated for patients whose NSCLC is characterized by epidermal growth factor receptor exon 19 deletions or exon 21 L8585R substitution mutations and who have not undergone previous systemic therapy for advanced disease. https://lnkd.in/gJVntiwr

Bristol Myers Squibb Gets USFDA Accelerated Approval For Krazati, Cetuximab Combo For Colorectal Cancer Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C -mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) results. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial. #bristolmyerssquibb #bristolmyerssquibbnews #USFDA #krazati #adagrasib #colorectalcancer #fluoropyrimidine#oxaliplatin

Asciminib recently received FDA approval for newly diagnosed chronic myeloid leukemia (CML). This was based off the ASC4FIRST trial, which was presented at ASCO 2024 and simultaneously published in the NEJM.  The main question from this approval is how it compares to the other Bcr-Abl tyrosine kinase inhibitors (TKIs). The main driver of benefit in the ASC4FIRST trial was the difference between the asciminib and imatinib patients. The MMR rate at 48 weeks was numerically higher for asciminib compared to 2nd generation Bcr-Abl TKIs, but was not statistically significant. Safety wise, asciminib is probably better, looking at the ASC4FIRST trial. It has a different mechanism of action (binding to the myristoyl pocket) which explains this difference. It has fewer major drug interactions. It's not necessarily free of adverse events or drug interactions, but it is better, and there is a biological rationale for why that is. There is still a need for a little more data. I think we still want to see MMR at 96 weeks. Also, can patients stop asciminib for treatment free remission (TFR), and at what time points? The data currently shows that the longer a patient has a deep molecular response, the longer their TFR is, but that data lacking for asciminib. In addition, what happens on relapse, do they still respond to other Bcr-Abl TKIs? If this is used more first line, these are questions we will need to answer. Based on its safety profile, asciminib is likely to see use in the newly diagnosed CML setting. Overall, patients with CML are living longer due to all these Bcr-Abl TKIs. This FDA approval provides us another first-line option for CML patients, but I wouldn't definitively call it the best option just yet. #scemblix #cml https://lnkd.in/eGX6CsjM

#Astellas has achieved #approval in #Japan for its #gastriccancer drug #Vyloy (zolbetuximab), targeting #Claudin18.2 (#CLDN18.2) on the surface of gastric cancer cells, despite facing rejection from the FDA due to manufacturing issues. This marks the first worldwide approval for a therapy targeting CLDN18.2-positive gastric cancer, presenting a novel treatment option for this patient group. The drug had previously been granted #priorityreview in the US for CLDN18.2-positive patients with specific types of gastric cancer, but faced delays due to concerns from the FDA regarding a third-party manufacturing facility. Astellas is actively working with the FDA and the involved manufacturer to resolve these issues, although no specific timeline for resolution or reapplication for approval in the US has been provided. Key Highlights: Innovative Treatment Option: Vyloy is the first drug worldwide to offer a targeted therapy for CLDN18.2-positive gastric cancer, representing a significant advancement in the treatment landscape for this disease Regulatory Hurdles: Despite its innovative approach, Vyloy faced regulatory challenges in the US due to manufacturing issues, highlighting the importance of quality control and regulatory compliance in drug development Global Regulatory Dynamics: The approval in Japan demonstrates the variability in regulatory outcomes across different geographies, underlining the strategic importance of navigating global regulatory landscapes Commitment to Resolution: Astellas's engagement with the FDA and its commitment to addressing the manufacturing concerns signify the company's dedication to making this treatment available to a broader patient population https://lnkd.in/gphbNMTn