Immunotherapies

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Xilio Therapeutics (XLO) Earnings Call Presentation
2025-07-03 06:50
Unleashing the Potential of Immuno-Oncology Therapies June 5, 2025 © 2025 Xilio Therapeutics, Inc. 1 Forward-Looking Statements and Disclaimers This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, timing and expectations related to: development timelines and anticipated milestones for Xilio's programs; the receipt of future contingent payments under Xilio's coll ...
Calidi Biotherapeutics Announces Shareholder Letter from CEO
Globenewswire· 2025-06-27 12:00
Core Viewpoint - Calidi Biotherapeutics is undergoing significant transformation in leadership, focus, and financial management, aiming to advance its innovative oncology therapies, particularly the RedTail platform, which shows promise in delivering genetic medicines to metastatic cancer sites [1][3][7]. Company Developments - The appointment of Eric Poma as CEO in April 2025 marks a new leadership direction, with a focus on advancing therapeutic approaches in oncology [2]. - Dr. Guy Travis Clifton has been appointed as Chief Medical Officer, enhancing the company's expertise in clinical program advancement and regulatory strategy [2]. R&D Pipeline Progress - The RedTail platform is highlighted as a key focus, utilizing an engineered enveloped virus for systemic delivery of genetic medicines to metastatic cancer sites, representing over a decade of research [3][9]. - Recent preclinical data indicates that RedTail demonstrates potent tumor-selective targeting and improved anti-tumor immune modulation, differentiating it in the oncology market [4]. Strategic Partnerships - The company is actively seeking partnerships with leading biopharmaceutical firms to accelerate the development and commercialization of therapies, which could enhance market reach and shareholder value [4]. Future Milestones - The roadmap for the next 18 months includes completing IND-enabling studies for the lead candidate CLD-401, with an IND filing anticipated by the end of 2026 [5]. - An IND for the SuperNova virotherapy (CLD-201) was opened in April 2025, with Phase I trials expected to start by the end of 2025 [6]. Financial Management - As of Q1 2025, the company reported approximately $10.6 million in cash, with efforts to reduce costs and lower the burn rate while retiring most of its debt [7].
HCW Biologics Regains Compliance with Nasdaq Capital Market Requirements
Globenewswire· 2025-06-26 11:55
Core Viewpoint - HCW Biologics Inc. has regained compliance with Nasdaq's listing requirements, ensuring its continued presence on the Nasdaq Capital Market [1][2]. Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases [3]. - The company aims to improve healthspan and quality of life by addressing age-related and senescence-associated diseases through its proprietary drug platforms [3]. Compliance Details - On June 24, 2025, HCW Biologics received formal notice from Nasdaq confirming compliance with the minimum stockholders' equity requirement [2]. - The company had previously regained compliance with other Nasdaq requirements, including bid price, public float, and market value of publicly held shares [2]. Product Development - The lead product candidate, HCW9302, was developed using the TOBI™ platform, while the TRBC platform allows for the creation of various immunotherapeutic compounds [3]. - The TRBC platform has produced over 50 molecules, with ongoing preclinical evaluations for selected candidates based on early promising data [3].
CureVac Soars 41% in a Month on a $1.25B Buyout Offer From BioNTech
ZACKS· 2025-06-20 16:56
Key Takeaways CVAC surged 40.8% in a month after a $1.25 billion acquisition agreement with BioNTech was announced. Each CVAC share is to convert to $5.46 in BNTX ADS, a 55% premium to its 3-month average price. Deal boosts BNTX's mRNA cancer pipeline and expands its infrastructure for global development efforts.Shares of CureVac N.V. (CVAC) have skyrocketed 40.8% in a month after the company signed a definitive agreement to be acquired by BioNTech SE (BNTX) in an all-stock transaction last week. Per the ...
IMUNON Announces PlaCCine® DNA Vaccine Technology Abstract Selected for Oral Presentation at 10th International Conference on Vaccines Research & Development™
Globenewswire· 2025-06-17 12:05
Core Insights - IMUNON, Inc. announced positive results from a Phase 1 clinical trial of its investigational DNA plasmid vaccine, IMNN-101, which demonstrated better durability of protection compared to mRNA vaccines after a single dose targeting the SARS-CoV-2 Omicron XBB1.5 variant [3][4] - The company is seeking strategic partnerships to advance its PlaCCine technology platform and fund its core pipeline with non-dilutive capital [1][4] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing non-viral DNA-mediated immunotherapies and next-generation vaccines [1][8] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, which has completed multiple clinical trials [9] Clinical Trial Details - The Phase 1 trial enrolled 24 participants and evaluated three escalating doses of IMNN-101, with a focus on safety, tolerability, and immunogenicity [6] - Results indicated a median increase of up to 3-fold in serum neutralizing antibody titers at six months, with no serious adverse effects reported [3][6] Technology Advantages - The PlaCCine technology platform offers several competitive advantages, including better durability of protection, temperature stability, and ease of manufacturing compared to current mRNA vaccines [4][5] - IMNN-101 utilizes a proprietary DNA plasmid that regulates the expression of key pathogen antigens, providing flexibility in manufacturing and delivery [5]
Marker Therapeutics and Cellipont Bioservices Announce Collaboration to Advance cGMP Manufacturing of MT-601, a Multi-Antigen Recognizing T Cell Therapy for Patients with Lymphoma
Globenewswire· 2025-06-17 12:00
HOUSTON, June 17, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical- stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced a collaboration with Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), for current good manufacturing practice (cGMP) manufacturing of MT-601, Marker's lead Multi-Antig ...
Fate Therapeutics Announces Updated Clinical Data for FT819 Off-the-shelf CAR T-cell Product Candidate Demonstrating Durability of Drug-free Remission for Severe Lupus Nephritis at EULAR 2025 Congress
Globenewswire· 2025-06-11 13:00
All three patients treated with FT819 following fludarabine-free conditioning regimen for severe lupus nephritis achieve Primary Efficacy Renal Response (PERR); first patient to reach 1-year follow-up continues in drug-free Definition of Remission in SLE (DORIS) First extrarenal SLE patient on maintenance therapy treated with FT819 in the absence of conditioning achieves Low Lupus Disease Activity State (LLDAS) at 3-month follow-up and maintained at 6 months Cumulative clinical experience in nearly 60 patie ...
Candel Therapeutics Appoints Maha Radhakrishnan, M.D., to its Board of Directors
Globenewswire· 2025-06-06 12:05
Core Insights - Candel Therapeutics has appointed Dr. Maha Radhakrishnan to its Board of Directors, effective June 4, 2025, to enhance its strategic capabilities as it moves towards Biologics License Application (BLA) submission and commercial development [1][2][4] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies aimed at treating cancer [5] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [5] Product Development - Candel's lead product candidate, CAN-2409, is being developed for intermediate-to-high-risk prostate cancer, with BLA submission anticipated in Q4 2026 [2][4] - Recent successful phase 2a clinical trials of CAN-2409 were completed in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [6] - CAN-2409 has received Fast Track Designation from the FDA for treating PDAC and stage III/IV NSCLC in specific patient populations [6] Leadership Experience - Dr. Radhakrishnan brings over 20 years of experience in product development and commercialization from major biotechnology and pharmaceutical companies [3] - Her previous roles include Senior Vice President and Chief Medical Officer at Biogen and Global Head of Medical at Sanofi [3] Future Outlook - The company aims to leverage Dr. Radhakrishnan's expertise as it prepares for the BLA submission and advances its innovative immunotherapy candidates [2][4]
Calidi Biotherapeutics Presents systemic oncolytic platform with CD55-Enhanced expression and IL-15 Superagonist Payload at ASCO Annual Meeting
Globenewswire· 2025-06-02 12:00
Core Insights - Calidi Biotherapeutics Inc. is a clinical-stage biotechnology company focused on developing systemic oncolytic targeted immunotherapies, with its lead candidate CLD-401 presented at the ASCO Annual Meeting [1][2] Group 1: Technology and Innovation - Calidi has developed an enveloped form of its proprietary oncolytic virus that shows greater resistance to immune clearance, enhancing systemic delivery and efficacy in pre-clinical models [2] - The novel genetic modification in CLD-401 incorporates a chimeric CD55 receptor into the virus envelope, which inhibits complement-mediated clearance, improving the virus's stability in circulation [2][4] - The RedTail platform allows for the delivery of genetic payloads directly into the tumor microenvironment, with CLD-401 expressing an IL-15 superagonist to activate and expand natural killer (NK) cells and CD8+ T cells [3][4] Group 2: Strategic Development - Calidi is conducting IND-enabling studies for CLD-401 and plans to submit an Investigational New Drug (IND) application in the second half of 2026 [4] - The company is actively seeking strategic partnerships to accelerate clinical development and enhance the impact of its RedTail platform [4][6] - The lead candidate targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical needs [7]
Immunocore to present at the 2025 Jefferies Global Healthcare Conference
Globenewswire· 2025-06-02 11:00
Core Insights - Immunocore Holdings plc is a commercial-stage biotechnology company focused on developing immunomodulating medicines for cancer, infectious diseases, and autoimmune diseases [1][3] - The company will participate in the 2025 Jefferies Global Healthcare Conference, indicating its ongoing engagement with investors and the healthcare community [1][2] Company Overview - Immunocore is pioneering a novel class of TCR bispecific immunotherapies known as ImmTAX, aimed at treating a wide range of diseases [3] - The company has a robust pipeline with multiple active clinical and pre-clinical programs across oncology, infectious diseases, and autoimmune diseases [3] - KIMMTRAK, Immunocore's leading oncology TCR therapeutic, is approved for treating HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in several regions including the US, EU, Canada, Australia, and the UK [3]