Designation Supported by CLOVER WaM Phase 2 Study DataWhich Reported an 83.6% Overall Response Rate (ORR) Seeking Guidance from EMA to Determine if CLOVER WaM Phase 2 Data Meets Criteria to Apply for Fast-Track, Conditional Marketing Authorization, Answer Expected Late July FLORHAM PARK, N.J., June 04, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announ ...

Core Viewpoint - Elicio Therapeutics has secured a $10 million senior secured promissory note to extend its operational runway into Q1 2026, supporting its clinical development initiatives, particularly the AMPLIFY-7P Phase 2 interim analysis expected in Q3 2025 [2][4]. Financial Summary - The company received gross proceeds of $10 million from the Note Financing, which bears an interest rate of up to 12.5% and matures on June 3, 2028 [3]. - The financing includes a 24-month interest-only period, with interest accrued during the first 12 months payable in a lump sum starting from the thirteenth month [3]. Product Development - Elicio's lead product candidate, ELI-002, targets mKRAS-driven tumors, which account for approximately 25% of all solid tumors [4][5]. - ELI-002 is currently being studied in a randomized clinical trial for mKRAS-positive pancreatic cancer and has shown promising Phase 1 data, including a 16.3-month median recurrence-free survival and a 28.9-month median overall survival [4][6]. Technology Platform - Elicio's proprietary Amphiphile (AMP) platform is designed to enhance the education and activation of cancer-specific T cells, aiming for durable cancer immunosurveillance [4][7]. - The AMP technology allows for targeted delivery of immunotherapeutics to lymph nodes, potentially leading to superior clinical outcomes compared to conventional therapies [7][8]. Future Plans - The company plans to explore combination regimens for ELI-002 in treating pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer, leveraging robust interest from clinical investigators [4]. - Elicio intends to expand ELI-002 to other indications, including mKRAS-positive lung cancer, and is developing additional off-the-shelf therapeutic cancer vaccine candidates [4][6].

Core Viewpoint - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2025 ASCO conference, demonstrating its potential efficacy in treating advanced non-small cell lung cancer (NSCLC) and other tumor types [1][2][11]. Group 1: Clinical Data and Efficacy - IBI363 has shown a manageable safety profile and encouraging efficacy in patients with immunotherapy-resistant squamous NSCLC and wild-type lung adenocarcinoma, with trends indicating long-term survival benefits [1][4][11]. - In a Phase 1 study, IBI363 monotherapy was administered to 136 NSCLC patients, with a focus on those with squamous cell carcinoma and EGFR wild-type adenocarcinoma [3][6]. - The confirmed overall response rate (ORR) for squamous NSCLC patients receiving IBI363 at different dosages was reported as 25.9% and 36.7%, with disease control rates (DCR) of 66.7% and 90.0% respectively [5][6]. Group 2: Long-term Survival Benefits - IBI363 demonstrated potential long-term survival benefits, with median overall survival (OS) of 15.3 months for the 1/1.5 mg/kg dose group and not reached for the 3 mg/kg group, alongside a 12-month OS rate of 70.9% [5][6][10]. - Among patients with PD-L1 TPS<1%, the ORR was 30.0% for the lower dose and 46.2% for the higher dose, indicating IBI363's effectiveness in low PD-L1 expression populations [7]. Group 3: Future Development Plans - Innovent plans to initiate a Phase 3 registration clinical study for IBI363 in locally advanced or metastatic squamous NSCLC patients who have failed prior treatments [11]. - The company has received Breakthrough Therapy Designation (BTD) from China CDE and Fast Track Designation (FTD) from the US FDA for IBI363 in treating squamous NSCLC [11][17]. Group 4: Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, with 15 products launched and multiple assets in clinical trials [18]. - The company collaborates with over 30 global healthcare companies to advance its innovative therapies [18].

Recently disclosed clinical cohort data from high (1x1015 total vg) and low dose (5.7x1014 total vg) TSHA-102 from REVEAL adolescent/adult and pediatric Phase 1/2 trials Caregiver research regarding gain/regain of developmental milestones supporting alignment with FDA on primary endpoint in the pivotal Part B trial of TSHA-102 Previously disclosed preclinical data supporting broad biodistribution across brain and spinal cord regions following lumbar intrathecal delivery of AAV9 gene therapy vectors in non-h ...

Châtillon, France, June 03, 2025 DBV Technologies announces the filing of an addendum to the 2024 Universal Registration Document DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company (the “Company”), today announced today the filing of an addendum to the 2024 Universal Registration Document (the “Addendum”) with the French market authority, “Autorité des Marchés Financiers” (“AMF”). This Addendum provides an update to the Board of Dir ...

Core Insights - Immix Biopharma's NXC-201 achieved a complete response (CR) rate of 70% in the NEXICART-2 Phase 1/2 clinical trial for relapsed/refractory AL Amyloidosis, meeting its primary endpoint [1][4][3] - The trial reported no relapses or safety signals to date, indicating a favorable safety profile for NXC-201 [1][4] - Immix plans to submit a Biologics License Application (BLA) to the FDA for NXC-201 following these promising results [1][3] Clinical Trial Details - The NEXICART-2 trial is a U.S. multi-site, single-arm study evaluating NXC-201 in patients with relapsed/refractory AL Amyloidosis, with a data cutoff of April 11, 2025 [1][3][7] - Prior to treatment, patients had a median of 4 lines of therapy, and all had organ involvement from the disease [4] - After treatment, all patients normalized pathological disease markers, with 70% achieving complete responses [4] Safety and Efficacy - No neurotoxicity was observed, and only low-grade cytokine release syndrome was reported [4][9] - The remaining 3 patients who did not achieve CR are minimum residual disease (MRD) negative, suggesting potential future CRs [4] Market Context - Current treatments for relapsed/refractory AL Amyloidosis have a CR rate of less than 10%, highlighting a significant unmet medical need [5] - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients by 2024 [11] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [11] Company Overview - Immix Biopharma is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [12] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation from both the FDA and EMA [9][12]

Core Points - Biofrontera Inc. announced the inclusion of its propylene glycol-free formulation of Ameluz nanoemulsion gel in the FDA's Orange Book, confirming its FDA-approved status and intellectual property protection [1][2][7] - The revised formulation eliminates propylene glycol, a known allergen, enhancing patient safety while maintaining treatment efficacy [3][4] - The patent for the new formulation was issued on April 22, 2025, and is valid until December 8, 2043, preventing generic competition during this period [2][3][7] Company Overview - Biofrontera Inc. specializes in biopharmaceuticals, focusing on dermatological treatments using photodynamic therapy (PDT) [5] - The company commercializes Ameluz in combination with the RhodoLED lamp series for treating actinic keratosis and is conducting clinical trials for additional applications [5]

Summary of CRISPR Therapeutics (CRSP) FY Conference Call - June 03, 2025 Company Overview - CRISPR Therapeutics is focused on creating transformative gene-based medicines for serious diseases, leveraging its Nobel Prize-winning CRISPR technology [3][4][32]. Key Products and Pipeline - **KASJEVY**: The flagship product for treating sickle cell disease, with a global addressable market of approximately 60,000 patients and a price point of $2 million, creating a multibillion-dollar market opportunity [10][11]. - **Clinical Trials**: Several ongoing clinical trials with readouts expected in the next 6 to 12 months, which will shape the company's strategic direction [4][8]. - **Franchises**: The company has four key franchises: 1. **Hematology**: KASJEVY as the anchor product. 2. **CAR T Platform**: Targeting oncology and autoimmune diseases using CRISPR technology [5][14]. 3. **In Vivo Platform**: Developing therapies for cardiovascular diseases, including a one-time infusion to reduce triglycerides and LDL cholesterol [6][17]. 4. **Type 1 Diabetes**: Aiming to provide insulin-producing pancreatic islet cells [6][28]. Financial Highlights - Strong balance sheet with $1.86 billion in cash, allowing for purposeful spending and investment in growth opportunities [8][31][50]. - Anticipation of significant revenue generation from KASJEVY and other pipeline products, with a focus on achieving profitability in the future [49][50]. Recent Developments - **Partnership with Vertex**: Vertex is leading the commercialization of KASJEVY, with CRISPR receiving 40% of the net income from the program [31][45]. - **Business Development Deal**: Acquisition of siRNA technology from Sirius Therapeutics targeting Factor XI, which presents a multibillion-dollar opportunity in the anticoagulation space [8][31][33]. Clinical Data and Efficacy - **CTX-310**: Early data shows a 56% average reduction in triglycerides and a 28% reduction in LDL cholesterol, with some patients experiencing reductions of up to 82% and 65%, respectively [19][20][21]. - **CTX-112**: In oncology trials, a 67% overall response rate and a 50% complete response rate were reported, indicating promising efficacy [15][16]. Market Opportunities - Expansion into untapped markets, particularly in the Middle East, with significant patient populations for KASJEVY [12][48]. - Potential for addressing underserved populations in Africa and other regions with innovative therapies [13][45]. Strategic Vision - CRISPR aims to become a sector-leading biotech company with a sustainable business model, focusing on innovation and the development of a diverse pipeline [8][32][40]. - The company is committed to maintaining a high hurdle rate for new assets and partnerships, ensuring that any new initiatives align with its long-term goals [39][40]. Conclusion - 2025 is viewed as a pivotal year for CRISPR Therapeutics, with multiple clinical data readouts and the ongoing launch of KASJEVY expected to drive growth and establish the company as a leader in the biotech sector [31][32].

Core Insights - Amgen's Imdelltra (tarlatamab-dlle) shows promising results in treating small cell lung cancer (SCLC), demonstrating a 40% reduction in the risk of death and extending median overall survival by more than five months compared to standard chemotherapy [1][2][5] Clinical Data - The global phase III DeLLphi-304 study reported a median overall survival of 13.6 months for patients treated with Imdelltra, compared to 8.3 months for the control group [3][5] - Imdelltra also exhibited a statistically significant improvement in median progression-free survival compared to standard-of-care chemotherapy [3][5] - The drug was well-tolerated, with most adverse events being mild to moderate in severity [4][5] Market Context - SCLC accounts for approximately 15% of over 2.4 million global lung cancer cases annually, with a low five-year survival rate of 5-10% across all stages [8] - Amgen's stock has increased by 10.7% year-to-date, contrasting with a 3.9% decline in the industry [4] Regulatory Approval - Imdelltra received FDA approval in 2024 for pre-treated extensive-stage SCLC patients under the accelerated approval pathway, marking it as the first DLL3-targeting BiTE therapy [9] - The drug generated sales of $81 million in Q1 2025, reflecting a 21% sequential increase driven by volume growth [10] Future Outlook - Continued approval of Imdelltra is contingent on the success of the ongoing phase III DeLLphi-304 study, which serves as the confirmatory study for the extensive-stage SCLC indication [10]

Oral presentation of CARTITUDE-1 study data showcases long-term outcomes after a single infusion of CARVYKTI® with one-third of patients with relapsed/refractory multiple myeloma progression-free for ≥5 years CARTITUDE-4 subgroup analyses featured in a poster presentation highlight consistent, durable progression-free and overall survival benefit vs. standard therapies across cytogenetic risk groups as early as second-line therapyPromising early results from ongoing Phase 1 dose-escalation studies of LB1908 ...