Lantern Pharma Reports Strong Clinical Results and AI Platform Advancements in 2024 Year-End Update
• Lantern Pharma's HARMONIC trial for LP-300 demonstrated an impressive 86% clinical benefit rate and 43% objective response rate in never-smoker NSCLC patients, with enrollment expanding in Japan and Taiwan where never-smokers represent up to 40% of NSCLC cases.
• LP-184 received FDA Fast Track Designations for both Glioblastoma and Triple Negative Breast Cancer in 2024, plus three additional Rare Pediatric Disease Designations, advancing through Phase 1a trials with early signs of clinical activity at higher dose levels.
• The company's proprietary RADR® AI platform surpassed 100 billion oncology-specific data points in 2024, powering precision medicine initiatives and reducing development timelines by 30-50% compared to traditional approaches.
Verastem Oncology to Present New LGSOC Treatment Data at SGO 2025 Annual Meeting
• Verastem Oncology will present additional analyses from the Phase 2 RAMP 201 trial evaluating avutometinib plus defactinib in recurrent low-grade serous ovarian cancer at SGO 2025, building on their FDA Priority Review submission.
• The presentations include new subgroup analyses by KRAS mutational status, supporting the company's ongoing efforts to advance treatment options for RAS/MAPK pathway-driven cancers.
• The company's NDA for the avutometinib-defactinib combination therapy has received Priority Review from the FDA with a PDUFA date of June 30, 2025, for KRAS mutant LGSOC patients.
Yaqrit Advances L-ornithine Phenylacetate to Phase 3 for Acute Hepatic Encephalopathy Treatment
• Yaqrit's subsidiary Amalive is preparing to launch Phase 3 trials in 2025 for L-ornithine phenylacetate (OPA), an ammonia scavenger acquired from Mallinckrodt Pharmaceuticals, targeting acute hepatic encephalopathy.
• The company plans parallel development of oral formulations for hepatic encephalopathy prevention and urea cycle disorders, building on previous clinical data showing faster ammonia reduction compared to standard care.
• With 200,000 annual US hospitalizations for acute hepatic encephalopathy and a 40-50% recurrence rate within one year, OPA addresses a significant unmet medical need in advanced liver disease.
Novartis to Acquire Anthos Therapeutics for $925M, Advancing Novel Stroke Prevention Drug Abelacimab
• Novartis has entered into an agreement to acquire Anthos Therapeutics for $925 million upfront, with potential additional payments of up to $2.15 billion based on milestone achievements.
• Abelacimab, a first-in-class Factor XI inhibitor antibody, demonstrated significant reduction in bleeding events compared to standard anticoagulants in Phase 2 trials for atrial fibrillation patients.
• The acquisition strengthens Novartis's cardiovascular portfolio with a late-stage asset that has received FDA Fast Track Designation for both cancer-associated thrombosis and stroke prevention in atrial fibrillation.
ITM-11 Demonstrates Superior Progression-Free Survival Compared to Everolimus in GEP-NETs
• ITM-11, a targeted radiopharmaceutical, significantly improved progression-free survival (PFS) in patients with Grade 1/2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
• The Phase 3 COMPETE trial marks the first time a radiopharmaceutical has shown superior PFS compared to everolimus in this patient population.
• ITM plans to present the COMPETE data at an upcoming medical conference and discuss a potential New Drug Application (NDA) submission with the FDA in 2025.
• The trial results support ITM-11's potential as a more effective treatment option for GEP-NETs, addressing a significant unmet need.
Ariceum's 225Ac-Satoreotide Receives FDA Orphan Drug Designation and IND Clearance for SCLC and Merkel Cell Carcinoma
• The FDA granted Orphan Drug Designation to Ariceum Therapeutics' 225Ac-satoreotide for small cell lung cancer (SCLC), offering development incentives and potential market exclusivity.
• Ariceum's IND application for 225Ac-SSO110 was cleared by the FDA, enabling a Phase I/II trial for SCLC and Merkel Cell Carcinoma (MCC) patients.
• The SANTANA-225 trial, set to begin in Q1 2025, will assess the safety, tolerability, and preliminary efficacy of 225Ac-SSO110 in patients with advanced SCLC or MCC.
• Preclinical data showed 225Ac-satoreotide's potential to outperform SSTR2 targeting agonists, demonstrating complete responses and 100% survival in models of aggressive cancers.
Immuneering's IMM-1-104 Shows Promise in Phase 2a Pancreatic Cancer Trial
• Immuneering's IMM-1-104, combined with modified gemcitabine/nab-paclitaxel, shows a 43% overall response rate and 86% disease control rate in first-line pancreatic cancer.
• The combination of IMM-1-104 with modified FOLFIRINOX demonstrates target tumor shrinkage in all evaluable patients, including a complete 100% reduction in one patient.
• IMM-1-104 monotherapy in second-line pancreatic cancer shows a 67% reduction in target lesions, supporting its potential in first-line combination therapies.
• The company plans to expand the Phase 2a trial in 2025 to include additional combination arms, exploring IMM-1-104's potential in melanoma and non-small cell lung cancer.
Biogen and Stoke Therapeutics Collaborate to Advance Zorevunersen for Dravet Syndrome
• Biogen and Stoke Therapeutics will collaborate to develop and commercialize zorevunersen for Dravet syndrome outside the U.S., Canada, and Mexico.
• Stoke's Phase 3 EMPEROR study of zorevunersen, expected to begin in mid-2025, aims to reduce seizure frequency and improve cognition and behavior in children with Dravet syndrome.
• Zorevunersen, an antisense oligonucleotide targeting the SCN1A gene, has shown promising results in earlier trials, including an 87% median reduction in convulsive seizure frequency.
• Biogen will provide Stoke with an upfront payment of $165 million, potential milestone payments up to $385 million, and tiered royalties on net sales in Biogen's territory.
FDA Approves Subcutaneous Opdivo Qvantig for Multiple Solid Tumors
• The FDA approved Opdivo Qvantig, a subcutaneous injection of nivolumab, for adult solid tumors previously approved for intravenous Opdivo.
• CheckMate-67T trial data showed non-inferior pharmacokinetic exposures, similar efficacy, and comparable safety to intravenous Opdivo.
• Opdivo Qvantig offers a faster 3-5 minute administration time, providing convenience and flexibility for patients.
• The approval helps Bristol Myers Squibb maintain market share amid patent expirations and increasing biosimilar competition.
Alphamab Oncology Advances JSKN003 and JSKN033 in Clinical Trials for Multiple Cancers
• Alphamab Oncology's JSKN003, an anti-HER2 bispecific ADC, enters Phase III trial for platinum-resistant recurrent ovarian cancer, comparing its efficacy against chemotherapy.
• China's NMPA approves Alphamab's IND for JSKN033, a subcutaneous co-formulation of anti-HER2 ADC and PD-L1 inhibitor, to begin Phase I/II trials.
• A Phase III trial of JSKN003 is set to compare its efficacy and safety against trastuzumab emtansine (T-DM1) in HER2-positive advanced breast cancer patients.
• JSKN033 combines immunotherapy with ADC technology, potentially improving efficacy and convenience through subcutaneous administration in advanced metastatic tumors.
Humacyte's Bioengineered Vessel SYMVESS Receives FDA Approval for Extremity Vascular Trauma
• The FDA has approved SYMVESS, Humacyte's acellular tissue-engineered vessel, for treating extremity arterial injuries in adults when urgent revascularization is needed.
• SYMVESS offers a readily available alternative to autologous vein grafts, reducing surgical time and avoiding additional incisions in already-injured patients.
• Clinical trials showed high patency rates and low rates of amputation and infection, positioning SYMVESS as a promising option for vascular trauma care.
• SYMVESS has received Regenerative Medicine Advanced Therapy designation and priority review, highlighting its potential to address a significant unmet medical need.
FDA Approves Tevimbra Plus Chemotherapy for First-Line Treatment of Gastric and GEJ Adenocarcinoma
• The FDA has approved Tevimbra (tislelizumab-jsgr) in combination with chemotherapy for first-line treatment of HER2-negative gastric or gastroesophageal junction adenocarcinoma with PD-L1 expression.
• The approval was based on the RATIONALE-305 trial, which showed a median overall survival of 15.0 months with Tevimbra plus chemotherapy compared to 12.9 months with chemotherapy alone.
• Common side effects of Tevimbra in combination with chemotherapy include decreased blood cell counts, fatigue, and gastrointestinal issues, but the combination offers a manageable safety profile.
• This approval marks the second for Tevimbra in 2024, highlighting its potential to address critical needs in oncology and providing a valuable new treatment option.
Ascendis Pharma's Yorvipath Commercially Available in the US, Offering New Hope for Hypoparathyroidism
• Ascendis Pharma has launched Yorvipath (palopegteriparatide) in the US, the first FDA-approved treatment for hypoparathyroidism in adults.
• Yorvipath is a once-daily prodrug of parathyroid hormone, designed to provide continuous exposure to active PTH over 24 hours.
• Ascendis has established a dedicated support program to assist patients with clinical education, access, and injection training.
• Clinical trials demonstrated that 93% of YORVIPATH-treated patients achieved independence from both active vitamin D and therapeutic doses of elemental calcium.
GE HealthCare's SIGNA MAGNUS Head-Only MRI System Receives FDA Clearance
• GE HealthCare's SIGNA MAGNUS, a 3.0T head-only MRI, has received FDA clearance, offering advanced neuroimaging capabilities for clinical and research use.
• The SIGNA MAGNUS features an innovative asymmetric gradient coil design, enhancing gradient performance and enabling high-resolution imaging with shorter scan times.
• This new MRI technology aims to improve the detection of neurological, oncological, and psychiatric conditions through advanced imaging and biomarker research.
• The system's HyperG gradient technology achieves high performance levels, improving spatial resolution and image clarity for more accurate diagnoses.
Cretostimogene Shows Durable Responses in High-Risk Bladder Cancer
• Cretostimogene monotherapy demonstrated a 74.5% complete response rate at any time in patients with high-risk BCG-unresponsive NMIBC.
• The median duration of response has not been reached but exceeds 27 months, indicating a sustained treatment effect.
• The BOND-003 trial showed a favorable safety profile with no Grade 3 or higher treatment-related adverse events reported.
• 97.3% of patients were free from progression to muscle-invasive bladder cancer at 12 months, highlighting the therapy's potential to prevent disease advancement.
MAIA Biotechnology's THIO Shows Promising Survival Benefit in Advanced NSCLC
• MAIA Biotechnology's THIO, combined with cemiplimab, demonstrated a median overall survival of 16.9 months in advanced NSCLC patients who failed prior therapies.
• The Phase 2 THIO-101 trial data suggests a significant improvement compared to standard-of-care chemotherapy, which typically shows overall survival of 5-6 months.
• The trial's findings support MAIA's regulatory strategy, potentially paving the way for accelerated FDA approval of THIO for third-line NSCLC treatment.
• THIO's dual mechanism targets telomeric DNA damage and boosts cancer-specific immune responses, offering a novel approach to treating resistant NSCLC.
Puma Biotechnology Reports Positive Third Quarter 2024 Financial Results and Clinical Development Updates
• Puma Biotechnology announced a net income of $20.3 million for Q3 2024, compared to $5.8 million in Q3 2023, driven by increased product and royalty revenue.
• The company's total revenue for Q3 2024 reached $80.5 million, including $56.1 million from NERLYNX sales and $24.4 million from royalty revenue.
• Puma is advancing the clinical development of alisertib, with a Phase II trial in small cell lung cancer and plans to initiate a trial in metastatic breast cancer.
• Key milestones anticipated include interim data presentations from alisertib trials in small cell lung cancer and metastatic breast cancer in 2025.
MAIA Biotechnology and Regeneron Expand Clinical Trial Collaboration for NSCLC Treatment
• MAIA Biotechnology and Regeneron have expanded their clinical supply agreement to further evaluate THIO in third-line NSCLC patients.
• The Phase 2 trial, THIO-101, will assess THIO sequenced with cemiplimab (Libtayo®) in patients resistant to prior checkpoint inhibitors and chemotherapy.
• MAIA expects to begin enrolling new patients soon and is exploring potential accelerated approval opportunities based on trial outcomes.
• Preliminary results from THIO-101 have demonstrated favorable disease control, progression-free survival, and overall response rates.
MAIA Biotechnology's THIO-101 Shows Promise in Advanced NSCLC
• MAIA Biotechnology's THIO-101, in combination with cemiplimab, demonstrates potential long-term benefits in advanced NSCLC patients resistant to prior treatments.
• The Phase 2 trial data suggests THIO-101 can induce cancer cell-specific immune memory, remaining active even after treatment cessation.
• Interim data shows THIO-101 surpasses current standard-of-care overall survival in third-line NSCLC, offering a potential new treatment option.
• The late-breaking abstract of THIO-101 updates will be presented at the SITC 2024 Annual Meeting, highlighting efficacy and safety data.
Bavarian Nordic Initiates Phase II Trial of Mpox Vaccine in Toddlers
• Bavarian Nordic has commenced a Phase II clinical trial to assess the safety and immunogenicity of its MVA-BN mpox vaccine in children aged 2-11 years.
• The trial, partly funded by CEPI, aims to expand the vaccine's approval label to include younger children, addressing a critical gap in mpox prevention.
• MVA-BN, known as Jynneos in the US and Imvanex in Europe, has already been approved for adults and adolescents, demonstrating its potential against mpox.
• The study will enroll participants in the Democratic Republic of Congo and potentially Uganda, regions affected by recent mpox outbreaks.
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