For Investors and Analysts Autolus Therapeutics is excited to be attending the European Hematology Association (EHA) meeting in IFEMA MADRID and presenting three clinical data updates:
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Atossa Therapeutics, Inc. (NASDAQ:ATOS) unveiled its second quarter financial results highlighted by a strong balance sheet to support the company in completing its Phase 2 trials for (Z)-endoxifen. The Seattle-based #biotech finished the three-month period ending June 30, 2023, with $99.4 million of cash and cash equivalents, according to its results statement. #Atossa is creating an innovative oral formulation of (Z)-endoxifen that sidesteps the need for liver metabolism to achieve #therapeutic levels and designed to bypass stomach acidity, a factor that can convert a significant portion of (Z)-endoxifen to the inactive (E)-endoxifen. The company is conducting three Phase 2 trials involving (Z)-endoxifen. One study is focused on healthy women with measurable breast density, while the other two are part of the EVANGELINE trial for women with ER+/HER2- breast #cancer. More at #Proactive #ProactiveInvestors http://ow.ly/RrNc104R7k9 #NASDAQ #ATOS
Atossa Therapeutics rides strong momentum in 2Q to clinical advancements and corporate expansion
proactiveinvestors.com
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BioLineRx Ltd (NASDAQ:BLRX) shares jumped at the market open on Monday after the US Food and Drug Administration approved the use of Aphexda (motixafortide) in combination with filgrastim for patients with multiple myeloma, a type of bone marrow cancer. The company’s Nasdaq-listed shares rose as much as 23% in pre-market trading before opening 10% higher at $2.33. Multiple #myeloma is the second most common hematologic malignancy, the Israel-based commercial-stage biopharmaceutical company explained in a statement. With #Aphexda administered by injection for subcutaneous use, it said the combination therapy is aimed at mobilizing hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. More at #Proactive #ProactiveInvestors #NASDAQ #BLRX #BiolineRX #USfoodanddrug #FDA http://ow.ly/Nk11104TTVR
BioLineRx rallies on FDA approval of Aphexda with Filgrastim
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#CandelTherapeutics shares gained more than 37% after the biopharmaceutical firm announced that its pancreatic cancer therapeutic has received U.S. Food and Drug Administration (FDA) Fast Track Designation. Candel’s lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir) is targeting the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) to improve overall survival. The Fast Track Designation comes after the company reported interim data from a Phase 2 study which showed the drug led to prolonged and sustained survival in patients with borderline resectable PDAC compared to real-world data on patients receiving radiotherapy. More at #Proactive #ProactiveInvestors http://ow.ly/WRK41055qT7
Candel Therapeutics pancreatic cancer therapy awarded FDA Fast Track Designation
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Challenges within early phase oncology trials can happen quickly and high attention to patient safety is absolutely critical with events on one trial informing whole program. This situation just happened as FDA placed partial clinical holds on trials evaluating #Azenosertib (ZN-c3, a #WEE1 inhibitor) (by Zentalis Pharmaceuticals, https://lnkd.in/eHXUBMXJ) . Clinical hold includes the phase 1 ZN-c3-001 trial (NCT04158336) for patients with advanced solid tumors, the phase 2 DENALI trial (NCT05128825) for patients with platinum-resistant #ovarian cancer, and the phase 2 TETON trial (NCT04814108) for patients with #uterine serous carcinoma. The clinical holds were initiated following 2 deaths due to presumed sepsis reported in patients being treated in the DENALI trial. Arena of #WEE1 inhibitors so far showed that WEE1 inhibitor can be safely combined with different chemotherapy agents as well as radiotherapy with concurrent chemotherapy, but clinical development has been hampered by the higher rate of grade 3 toxicities. With this development on Azenosertib and further evaluation implications for the class of these inhibitors remains to be seen. #FDA #Phase II #clinical hold #solid tumors #oncology program
Zentalis Pharmaceuticals Provides Update on Azenosertib Clinical Development Program | Zentalis Pharmaceuticals
ir.zentalis.com
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https://lnkd.in/eUEh_TNU 𝐍𝐨𝐯𝐚𝐫𝐭𝐢𝐬' 𝐒𝐜𝐞𝐦𝐛𝐥𝐢𝐱 𝐏𝐨𝐢𝐬𝐞𝐝 𝐭𝐨 𝐑𝐞𝐬𝐡𝐚𝐩𝐞 𝐂𝐌𝐋 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐋𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞 𝐰𝐢𝐭𝐡 𝐈𝐦𝐩𝐫𝐞𝐬𝐬𝐢𝐯𝐞 𝐏𝐡𝐚𝐬𝐞 𝐈𝐈𝐈 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 👏 👨⚕️ The Phase III ASC4FIRST trial results for Novartis' Scemblix, presented at ASCO 2024, offer a promising new direction for first-line chronic myeloid leukemia (CML) treatment. The data reveals that Scemblix, a kinase inhibitor currently used as a third-line therapy, demonstrated superior efficacy compared to standard tyrosine kinase inhibitors (TKIs) in achieving major molecular response (MMR) and deep molecular response (DMR). ✅ Beyond its efficacy, Scemblix also showed a favorable safety and tolerability profile, with fewer adverse events and lower discontinuation rates compared to TKIs. This is a significant advancement, as the drug's unique mechanism of action, targeting the ABL myristoyl pocket, offers a new level of precision and effectiveness in CML management. 🌟 The potential for Scemblix to enable treatment-free remission is particularly noteworthy, offering new hope for patients and clinicians alike. With FDA review underway and a breakthrough therapy designation granted, the drug is on an expedited path toward potential approval as a first-line treatment, which could reshape the standard of care for CML. #CML #oncology #hematology #ASCO2024 #clinicaltrials #innovation #healthcare #biotech #pharmaceutical #lifescience
ASCO 2024: Novartis’ Scemblix outperforms standard of care in CML
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We are pleased to see the publication of "A call to adapt the regulation of HLA testing for T cell receptor-based therapeutics" in Nature Reviews today. This collaborative call to change the regulatory thinking around HLA testing was led by the team at Immatics and brought together expertise from Adaptimmune, Affini-T Therapeutics, BioNTech SE, Bristol Myers Squibb, Enara Bio, Immunocore, Medigene AG, Miltenyi Biotec, TKnife USA, TScan Therapeutics, Zelluna Immunotherapy and academia. “This commentary advocates for an update to regulatory frameworks that currently mandate repeat testing of germline invariant HLA alleles each time a patient is being considered for an HLA-restricted therapy. Robust clinical HLA testing is the corner stone of bone marrow transplantation and as such is fit for purpose to establish a person’s HLA alleles, and for that information to be sufficient for therapy selection. We propose removing the unnecessary burden on patients of repeat testing to bring novel T cell receptor based therapies, with real potential of benefit to patients, to the clinic safely and efficiently”, Sophie Papa, CMO and Head of Translational Science at Enara Bio.
A call to adapt the regulation of HLA testing for T cell receptor-based therapeutics
nature.com
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Oricell Therapeutics announced that the U.S. FDA has granted Fast Track Designation for OriCAR-017, a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). This designation is expected to accelerate the progress of clinical trials and the New Drug Application (NDA/BLA) review process. Prior to this, the FDA has granted Orphan Drug Designation (ODD) and has cleared an Investigational New Drug Application (IND) for OriCAR-017. As a groundbreaking innovation leveraging Oricell Therapeutics' cutting-edge proprietary technology platforms, OriCAR-017 exhibits clearly differentiated binding avidity, persistence, anti-tumor efficacy, and safety profile. #OriCAR017 #FastTrackDesignation #FDAApproval #CAR_TCellTherapy #GPRC5D #MultipleMyeloma #InnovativeTherapies #ClinicalTrials #NewDrugApplication #OrphanDrugDesignation #BiotechInnovation #CancerResearch #QimingPortfolio #QimingHealthcare Read More: https://lnkd.in/gvsPdeVM
Oricell Therapeutics’ GPRC5D-Targeted CAR-T Therapy, OriCAR-017, Receives FDA Fast Track Designation for Relapsed/Refractory Multiple Myeloma
oricell.com
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Trishula Therapeutics, Inc., has initiated a randomized Phase 2 trial to evaluate the efficacy and safety of TTX-030. The trial will evaluate TTX-030 in combination with chemotherapy, with or without budigalimab (an investigational anti-PD-1 antibody), compared to chemotherapy alone, as first-line treatment for metastatic pancreatic ductal adenocarcinoma patients. TTX-030 is a first-in-class inhibitory anti-CD39 antibody that prevents ATP processing and increases T-cell activation. At the conclusion of this Phase 2 study, AbbVie will have an exclusive option to license TTX-030 for further development. https://lnkd.in/gSFKaxVZ
– Trishula will continue its collaboration with AbbVie Inc. for the development of TTX-030
trishulatx.com
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Our proprietary algorithms analyzed over 1540 press releases between July 21-July 26 to identify the top 10 news stories impacting the market this week. Calliditas Therapeutics announces positive TRANSFORM Phase 2b topline data in primary biliary cholangitis https://lnkd.in/e-5eQnyQ Telix Pharmaceuticals Limited FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent https://lnkd.in/e54fUZkH A.forall A.forall Announces the Launch of Their Fifth Abbreviated New Drug Application (ANDA) and Second “First Cycle” FDA Approval https://lnkd.in/epnnVsM7 “First-Cycle”-FDA-Approval Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as First-Line Treatment for Patients With Unresectable or Metastatic Urothelial Carcinoma https://lnkd.in/esAiCPqA Tonix Pharmaceuticals Granted Fast Track Designation by FDA for Tonmya™ for Fibromyalgia https://lnkd.in/eWJ8tWV5 Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases https://lnkd.in/eugi6nTw Chemomab Therapeutics Announces Positive Phase 2 Trial Results: CM-101 Achieves Primary and Secondary Endpoints Demonstrating Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Effects in Patients with Primary Sclerosing Cholangitis https://lnkd.in/eYhhkFbT Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over https://lnkd.in/eafPFR_m SpyBiotech SpyBiotech Announces the Completion of Enrollment in Phase I Trial of SPYVLP01 Targeting Human Cytomegalovirus (HCMV) https://lnkd.in/e8xAvnvN Inimmune INIMMUNE ANNOUNCES FIRST CANCER PATIENT DOSED IN PHASE 1 CLINICAL STUDY USING THE IMMUNOTHERAPEUTIC INI-4001, A NOVEL TLR7/8 AGONIST https://lnkd.in/eWkma72Z
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Senior Vice President, Chief Medical Officer, Oncology/Hematology
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