Phase 2 study, led by Dr. Antonio Jimeno at the University of Colorado Anschutz Medical Campus will evaluate NT219 in combination with either pembrolizumab or cetuximab as a strategy to overcome tumor resistance REHOVOT, Israel, June 17, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, today announced the initiation of a Phase 2 cli ...

SHELTON, Conn., June 11, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or the "Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced the pricing of its underwritten public offering of 6,675,000 shares of its common stock at a public offering price of $0.30 per share, for gross proc ...

SHELTON, Conn., June 11, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or the "Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced that it intends to offer to sell shares of its common stock in an underwritten public offering. All of the shares of common stock are to be sold by t ...

WALTHAM, Mass., June 10, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced the appointment of Akintunde (Tunde) Bello, Ph.D., to the company’s board of directors. “Tunde is an accomplished leader with a strong track record of successfully developing novel therapies across a broad range of therapeutic areas, including several important cance ...

Core Insights - Innovent Biologics has received a second Breakthrough Therapy Designation (BTD) from China's NMPA for IBI363, a bispecific antibody fusion protein targeting squamous non-small cell lung cancer (sqNSCLC) [1][3] - IBI363 has also received Fast Track Designations (FTDs) from the U.S. FDA for sqNSCLC and melanoma, highlighting its potential in treating immunotherapy-resistant cancers [1][8] - The drug aims to address unmet clinical needs in patients who have progressed after anti-PD-(L)1 immunotherapy and platinum-based chemotherapy [1][4] Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focusing on developing high-quality medicines for various diseases, including oncology and autoimmune disorders [9] - The company has launched 15 products and has multiple assets in various stages of clinical trials, including 3 new drug applications under regulatory review [9] - Innovent collaborates with over 30 global healthcare companies, enhancing its research and development capabilities [9] Clinical Development - IBI363 has shown promising results in Phase 1 clinical studies, demonstrating manageable safety and encouraging efficacy in immunotherapy-resistant patients [2][6] - The drug's dual mechanism of action combines PD-1 blockade and IL-2-driven T-cell expansion, potentially reshaping the tumor microenvironment [3][5] - Innovent is accelerating global development for IBI363, with ongoing clinical studies in China, the U.S., and Australia targeting various tumor types [7]

Whitehawk Therapeutics (AADI) 2025 Conference June 04, 2025 02:00 PM ET Speaker0 Alright. Alright. Welcome everyone to Jefferies twenty twenty five global health care conference. My name is Roger Song, one of the senior analysts covers MiCA Biotech in The US. It's my pleasure to have to introduce our next printing company, Whitehawk Therapeutics, and then CEO, Dave. And then it will be a presentation. And then if we have some time to do a q and a, we'll save that toward the end. Dave? Speaker1 Well, thank y ...

REHOVOT, Israel, June 04, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, today announced a poster presentation on its novel CAPTN-3 tri-specific antibody platform, will be featured at the Annual Congress of the European Association for Cancer Research (EACR) 2025, being held in Lisbon, Portugal from June 16 – 19, 2025. Company Con ...

Core Insights - 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 Annual Meeting, demonstrating its potential to convert "cold tumors" into "hot tumors" in advanced colorectal cancer [1][2][10] Clinical Data Summary - IBI363 monotherapy showed a median overall survival (OS) of 16.1 months in patients with advanced colorectal cancer, significantly better than standard treatments which range from 6.4 to 9.3 months [6][10] - In Phase 1 studies, IBI363 combined with bevacizumab resulted in a confirmed objective response rate (cORR) of 15.1% and a disease control rate (DCR) of 61.6% among 73 participants [9] - The combination therapy showed a median progression-free survival (PFS) of 4.7 months, with a notable increase in efficacy for patients without liver metastases, achieving a cORR of 31.3% and a DCR of 81.3% [9] Mechanism of Action - IBI363 operates by blocking the PD-1/PD-L1 pathway while activating the IL-2 pathway, specifically targeting tumor-specific T cells, which enhances its therapeutic efficacy in treating colorectal cancer [11][12] - Tumor immune cell infiltration analysis indicated that higher levels of CD8+ T cells were associated with improved clinical responses to IBI363, supporting its mechanism of action [8] Future Development - Innovent is conducting further clinical studies in multiple countries to explore IBI363's efficacy across various tumor indications, including immune-resistant and cold tumors [12] - The company has initiated a pivotal trial for IBI363 targeting unresectable locally advanced or metastatic mucosal or acral melanoma [12][13] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer, and has launched 15 products to date [14][15] - The company has received fast track and breakthrough designations from regulatory authorities for IBI363, indicating its potential in treating specific cancer types [13]

Summary of Bicara Therapeutics (BCAX) Update / Briefing June 01, 2025 Company and Industry Overview - **Company**: Bicara Therapeutics - **Industry**: Oncology, specifically focusing on head and neck cancer treatment Key Points and Arguments 1. **Treatment Efficacy**: Updated data shows deep and durable responses with Fiserafusp alfa (Fysera) plus pembrolizumab in patients with HPV negative head and neck cancer, addressing a significant unmet medical need in this patient population [1][3][79] 2. **Current Standard of Care**: The current standard of care, pembrolizumab, has a low response rate of only 19% in HPV negative head and neck cancer patients, highlighting the need for more effective therapies [3][11] 3. **Mechanism of Action**: Fysera is designed to inhibit TGF beta directly at the tumor site, which helps to remodel the tumor microenvironment (TME) and allows immune cells to penetrate the tumor, leading to improved treatment outcomes [4][5][85] 4. **Clinical Data**: In a phase 1b study, the combination of Fysera and pembrolizumab demonstrated a 54% confirmed response rate and an 89% disease control rate among HPV negative patients, with 80% of responders achieving at least 80% tumor shrinkage [19][21] 5. **Survival Metrics**: The median overall survival for HPV negative patients treated with Fysera plus pembrolizumab is reported at 21.3 months, significantly better than the typical 9-12 months seen with standard treatments [21][94] 6. **Durability of Response**: The median duration of response (DOR) is 21.7 months, indicating that the treatment not only provides a response but also maintains it over time [20][23] 7. **Patient Demographics**: The study population included patients with a high burden of disease, with 47% presenting with bulky tumors and a significant proportion having low CPS scores, which are typically associated with poorer outcomes [16][17][90] 8. **Safety Profile**: The combination therapy has a manageable safety profile, with adverse events primarily related to EGFR and TGF beta, which are generally mild and resolve quickly [18][19] 9. **Future Trials**: Bicara is advancing to a pivotal phase 2/3 trial (FORTIFY HN01) focusing on HPV negative patients, designed to demonstrate improved overall survival compared to pembrolizumab alone [28][30] 10. **Commercial Opportunity**: The company views the potential approval of Fysera as a significant commercial opportunity in a market with high unmet needs for effective treatments in HPV negative head and neck cancer [33][34] Additional Important Insights - **Unmet Medical Need**: There is a critical need for therapies that not only extend survival but also improve the quality of life for patients suffering from head and neck cancer [11][90] - **Distinct Disease Biology**: HPV negative and HPV positive head and neck cancers are recognized as distinct diseases, each requiring tailored treatment approaches [12][92] - **Regulatory Strategy**: The trial design and patient selection are informed by historical data and FDA feedback, aiming to ensure a robust demonstration of efficacy and safety [30][39] This summary encapsulates the critical findings and strategic direction of Bicara Therapeutics as presented in the June 2025 briefing, emphasizing the innovative approach to treating HPV negative head and neck cancer.

Core Insights - Xilio Therapeutics announced a preliminary objective response rate (ORR) of 26% in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer (MSS CRC) without liver metastases, demonstrating deep and durable responses lasting up to 37 weeks [1][4][10] - The combination therapy of vilastobart and atezolizumab showed a differentiated safety profile with a low incidence of immune-related adverse events, particularly colitis [2][7][11] - The ongoing Phase 2 trial is evaluating vilastobart in combination with atezolizumab, with plans to expand the study to include a higher dose level [9][13] Patient Data - As of May 12, 2025, 44 patients with metastatic MSS CRC were treated with vilastobart at 100 mg every six weeks and atezolizumab at 1200 mg every three weeks, with a median age of 55 years [3][5] - 80% of patients had previously received three or more lines of anti-cancer therapy, indicating a heavily pre-treated population [3] Anti-Tumor Activity - The preliminary ORR of 26% included seven partial responses, with six confirmed responses, and substantial decreases in tumor biomarkers such as circulating tumor DNA [4][10] - In patients without liver metastases, responses were deep and durable, with reductions in target lesions of up to 71% from baseline [10] Safety Profile - The combination therapy exhibited a low incidence of immune-mediated adverse events, with only 7% of patients experiencing colitis [7][11] - Common treatment-related adverse events included fatigue (30%), infusion-related reactions (23%), and diarrhea (18%) [11] Future Development Plans - Xilio is enrolling a cohort of patients at a higher dose level of 150 mg Q6W for vilastobart in the ongoing Phase 2 trial, with additional data expected in the first half of 2026 [9][12] - The company is seeking partnership opportunities to accelerate the development of the vilastobart program [12]