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Immutep Announces Update for TACTI-004 (KEYNOTE-F91) Phase III Trial in First Line Non-Small Cell Lung Cancer
Globenewswire· 2025-10-09 12:00
Global Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount needed to conduct the futility analysisOver 100 clinical sites across 24 countries now activated and open for recruitment Futility analysis remains on track for completion in the first quarter of CY2026 SYDNEY, AUSTRALIA, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and ...
Greenwich LifeSciences Announces Addition of Austria to Flamingo-01 Clinical Trial
Globenewswire· 2025-10-09 10:00
STAFFORD, Texas, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Austria. The Company's application to European regulators has been formally approved, adding Austria as an approved country in FLAMINGO-01 in addition to S ...
Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First and Only Immunotherapy for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with a High Risk of Recurrence After Surgery and Radiation
Globenewswire· 2025-10-08 18:31
Approval based on pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001), the primary endpoint of the trial Libtayo is the current standard of care in advanced CSCC; approval has the potential to change the treatment paradigm for patients in an earlier setting TARRYTOWN, N.Y., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today ...
Roche Wins FDA Nod for Label Expansion of Tecentriq in Lung Cancer
ZACKS· 2025-10-06 18:16
Key Takeaways FDA cleared Tecentriq and Tecentriq Hybreza with Zepzelca for ES-SCLC maintenance treatment.The IMforte study showed the combo cut progression or death risk by 46% versus Tecentriq alone.NCCN Guidelines now list the Tecentriq and Zepzelca combo as a preferred ES-SCLC maintenance option.Roche (RHHBY) announced that the FDA approved the label expansion of immunotherapy drug Tecentriq (atezolizumab).The FDA approved Tecentriq and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combinat ...
Corvus Pharmaceuticals Appoints David Moore to Board of Directors
Globenewswire· 2025-10-02 20:01
SOUTH SAN FRANCISCO, Calif., Oct. 02, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, announced today that David Moore, Executive Vice President, US Operations at Novo Nordisk A/S and President at Novo Nordisk Inc., has been appointed to the company’s Board of Directors. Mr. Moore brings a wealth of experience from his 27-year career in the industry, including broad expertise across strategy, commercial, market access, business development an ...
Kazia Therapeutics Announces 86% Reduction in Tumor Burden in Expanded-Access Case of Metastatic TNBC Patient Treated with Paxalisib-Immunotherapy Regimen
Prnewswire· 2025-10-02 12:30
Core Insights - Kazia Therapeutics Limited reported an 86% reduction in tumor burden in a single patient with triple-negative breast cancer (TNBC) after three weeks of treatment with a combination of immunotherapy, chemotherapy, and the investigational drug paxalisib [1][2][3] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, primarily developing paxalisib, a pan-PI3K/mTOR inhibitor [5] - The company has conducted multiple clinical trials involving paxalisib, including a completed Phase 2/3 study in glioblastoma and ongoing trials in advanced breast cancer and other cancers [5] Clinical Trial Information - Kazia is conducting a multi-centered Phase 1b study in Australia to evaluate the safety and preliminary anti-tumor activity of paxalisib in combination with Keytruda® and chemotherapy for advanced breast cancer, including TNBC [4] - The ongoing trial aims to assess the effects on circulating tumor cells and cluster dynamics to understand how paxalisib may enhance immunotherapy responsiveness [4] Patient Case Details - The patient treated under the expanded-access protocol was a 40+ year old female diagnosed with TNBC in April 2023, who had no residual cancer after initial treatments but later developed metastatic disease [2] - The treatment regimen included immunotherapy, chemotherapy, and paxalisib, leading to significant tumor regression [2][3]
Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Belgium
Globenewswire· 2025-10-02 10:00
STAFFORD, Texas, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Belgium. The Company's application to European regulators has been formally approved, adding Belgium as an approved country in FLAMINGO-01 in addition to S ...
ImmunityBio, Inc. (IBRX) Reports Strong Q2 Growth, Eyes Lung Cancer and NMIBC Expansion
Yahoo Finance· 2025-10-01 17:45
We recently compiled a list of the 12 Healthcare Stocks with Insider Buying in 2025. ImmunityBio, Inc. is one of them. ImmunityBio, Inc. (NASDAQ:IBRX) is advancing its position as a leader in immunotherapy, focusing on cancer and immune disorders through its flagship therapy ANKTIVA®, which combines IL-15 superagonist N-803 with Bacillus Calmette-Guérin (BCG) for patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to BCG. The company is also expanding ANKTIVA’s use across new indications ...
BioNTech (NasdaqGS:BNTX) 2025 Investor Day Transcript
2025-10-01 14:02
Summary of BioNTech and InstaDeep AI Day Conference Company and Industry Overview - **Company**: BioNTech - **Industry**: Biotechnology, specifically focusing on oncology and infectious diseases Key Points and Arguments 1. **Integration of AI in BioNTech**: AI is fully integrated into BioNTech's business model and development processes, enhancing research and development capabilities across multiple continents [3][4][5] 2. **Focus on Oncology**: BioNTech is a late-stage clinical company with a core focus on oncology, utilizing advanced therapies such as immunotherapy and messenger RNA therapeutics [4][5] 3. **Partnerships for Development**: BioNTech has partnered with Bristol-Myers Squibb to develop bispecific antibodies, particularly BNT327 (pumitamic), targeting multiple cancer indications [8][9] 4. **AI-Driven Personalized Vaccines**: The company is developing personalized vaccines based on individual mutations identified through sequencing, aiming to induce immune responses against various cancer types [10][11][12] 5. **AI in Drug Discovery**: InstaDeep, BioNTech's AI unit, is leveraging AI to optimize drug discovery processes, including the development of a supercomputer (KyberCluster) to enhance computational capabilities [30][34][35] 6. **Nucleotide Transformer v3**: InstaDeep introduced Nucleotide Transformer v3, a state-of-the-art genomics model capable of processing sequences of up to 1 million nucleotides, demonstrating superior performance in genome annotation and experimental data prediction [42][44][58] 7. **Generative Capabilities**: Nucleotide Transformer v3 can generate DNA sequences with specific properties, validated through lab experiments, showcasing its potential in gene therapy applications [55][56][58] 8. **AI's Exponential Growth**: The conference highlighted the exponential growth in data, compute power, and model efficiency in AI, emphasizing the transformative potential of AI in biotechnology [23][25][26] Additional Important Content 1. **Historical Context**: The conference took place at the Science Museum, a location significant for the history of vaccines, linking BioNTech's current innovations to past breakthroughs in medicine [3] 2. **AI's Role in Cancer Treatment**: The discussion included the complexity of cancer treatment and the need for personalized approaches due to the heterogeneity of tumors [9][10][19] 3. **Collaborative Research**: The collaboration between BioNTech and InstaDeep has led to significant advancements in AI applications in biology, evidenced by multiple publications in prestigious journals [31] 4. **Future Vision**: BioNTech envisions a future where AI-driven personalized medicine becomes standard, integrating clinical samples with advanced AI tools to optimize treatment strategies [20][21] This summary encapsulates the core discussions and innovations presented during the AI Day conference, highlighting the strategic direction of BioNTech and its AI unit, InstaDeep, in revolutionizing biotechnology and personalized medicine.
Medicenna Therapeutics to Participate in the ROTH 4th Annual Healthcare Opportunities Conference
Globenewswire· 2025-10-01 11:00
TORONTO and HOUSTON, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines for the treatment of cancer as well as autoimmune and inflammatory diseases, announced today that Dr. Fahar Merchant, President and CEO of Medicenna, will participate in the ROTH 4th Annual Healthcare Opportunities Conference, taking place at the Metropolitan Club in New York City on Octob ...