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Correction: Evaxion to announce business update and third quarter 2025 financial results on November 6, 2025
Globenewswire· 2025-10-31 13:05
Core Points - Evaxion A/S, a clinical-stage TechBio company, will provide a business update and report its Q3 2025 financial results on November 6, 2025 [1] - The company's Executive Management will host a conference call and webcast on the same day at 14:30 CET/08:30 EST, which is open to the public [2] - Evaxion specializes in developing AI-Immunology™ powered vaccines, focusing on immunotherapies for cancer, bacterial diseases, and viral infections [4] Company Overview - Evaxion A/S utilizes its proprietary AI platform, AI-Immunology™, to decode the human immune system and develop novel immunotherapies [4] - The company has a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline targeting bacterial and viral diseases with high unmet medical needs [4] - Evaxion aims to transform patients' lives by providing innovative and targeted treatment options [4]
Corvus Pharmaceuticals to Present at the Guggenheim 2nd Annual Healthcare Innovation Conference
Globenewswire· 2025-10-31 11:30
Core Insights - Corvus Pharmaceuticals, Inc. will engage with investors through one-on-one meetings and a fireside chat at the Guggenheim 2 Annual Healthcare Innovation Conference in Boston, MA on November 10, 2025 at 8:30 am ET [1] Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing ITK inhibition as a novel immunotherapy approach for various cancers and immune diseases [3] - The company's lead product candidate is soquelitinib, an investigational oral small molecule drug that selectively inhibits ITK [3] - Corvus has additional clinical-stage candidates targeting a range of cancer indications [3] Event Details - A live webcast of the fireside chat will be available, along with access for 90 days post-event, through the investor relations section of the Corvus website [2]
The Cure Wasn’t The End, It Was The Beginning | Emily Whitehead & Tom Whitehead | TEDxFargo
TEDx Talks· 2025-10-30 16:09
[Music] Hi everyone. Uh, I'm Tom Whitehead. I'm still a journeyman line for the journeyman lineman for the power company, but also the president and co-founder of the Emily Whitehead Foundation and most proudly Emily's father. And Emily is the first child in the world to have her immune system trained to beat her cancer. So Emily was born May 2nd, 2005, was completely healthy and stayed that way until just after her fifth birthday. So we were going into Memorial Day weekend of 2010 and on Thursday she was h ...
New Clinical and Translational Data on PDS Biotechnology’s Novel Investigational Cancer Therapies PDS0101 and PDS01ADC to be Presented at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting
Globenewswire· 2025-10-30 12:00
Core Insights - PDS Biotechnology Corporation announced that the National Cancer Institute (NCI) will present new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, focusing on its investigational immunotherapy platforms [1][4] - The presentations will include three abstracts that highlight clinical and translational findings related to PDS Biotech's immunotherapy candidates, including PDS0101 and PDS01ADC [1][4] Company Overview - PDS Biotechnology is a late-stage immunotherapy company dedicated to transforming immune system responses to cancer [4] - The company is advancing its lead program, PDS0101, in pivotal clinical trials for treating advanced HPV16-positive head and neck squamous cell cancers [5] Clinical Data Presentation - The NCI will present three abstracts at SITC, including: 1. Early changes in serum proteomic profiles predicting anti-tumor activity in patients with advanced HPV-associated malignancies [3] 2. A tumor-targeting IL-12 immunocytokine therapy that increases peripheral natural killer (NK) cells associated with enhanced tumor cell lysis [3] 3. Increases in peripheral memory T cells with self-renewing properties in patients treated with IL-12 immunocytokine therapy [3] Leadership Commentary - The CEO of PDS Biotechnology expressed optimism about the collaboration with NCI and the potential of their platforms to enhance immune system recognition and elimination of cancer [2]
Vaxil Announces Non-Brokered Private Placement
Globenewswire· 2025-10-29 21:05
Core Viewpoint - Vaxil Bio Ltd. is planning a non-brokered private placement to raise up to $350,000 through the issuance of units priced at $0.1425 each, which will include common shares and warrants [1][2]. Group 1: Offering Details - The offering will consist of up to 2,456,140 units, with each unit comprising one common share and one common share purchase warrant [1]. - Each warrant will allow the holder to purchase one share at a price of $0.19 for five years post-closing [1]. - The expected closing date for the offering is around November 14, 2025, pending approval from the TSX Venture Exchange [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to support general corporate purposes [2]. Group 3: Finder's Fees - The company will pay finders a cash commission of up to 8% of the gross proceeds and non-transferrable warrants equal to up to 8% of the total units issued [3]. - The units, shares, and warrants will be subject to a hold period of four months and one day from the issuance date [3]. Group 4: Company Background - Vaxil is an immunotherapy biotech company focused on targeting cancer markers and infectious diseases, with its lead product being ImMucin™, which has received orphan drug status from the FDA and EMA [4]. - The company is exploring other business opportunities that may or may not be within the biotechnology sector to enhance shareholder value [4].
PDS Biotech to Seek Expedited Approval Pathway for PDS0101 in HPV16-Positive Head and Neck Cancer
Globenewswire· 2025-10-29 12:37
Core Insights - PDS Biotechnology Corporation is seeking an expedited approval pathway from the FDA for its immunotherapy PDS0101 targeting HPV16-positive head and neck cancer, projected to be the most prevalent type of head and neck cancer in the US by the mid-2030s [1][2] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on innovative cancer treatments, particularly through its lead program PDS0101, which is being developed in combination with standard immune checkpoint inhibitors [4] Clinical Trials - The VERSATILE-002 trial has shown promising results, reporting a median overall survival (mOS) of 39.3 months and a median progression-free survival (PFS) of 6.3 months, leading to a proposed amendment in the ongoing VERSATILE-003 trial to include PFS as an earlier primary endpoint [1][2][3] - The VERSATILE-002 trial is an open-label, multi-center Phase 2 study evaluating the safety and efficacy of PDS0101 in combination with pembrolizumab for patients with unresectable, recurrent, or metastatic HPV16-positive head and neck cancer [3] Regulatory Strategy - The company plans to meet with the FDA to discuss changes to the current trial protocol, aiming to shorten the trial duration by making PFS an earlier primary endpoint, which could facilitate an accelerated approval submission [1][2]
Immutep Quarterly Activities Report Q1 FY26
Globenewswire· 2025-10-29 12:00
Core Insights - Immutep Limited is advancing its clinical trials for eftilagimod alfa (efti) in oncology and autoimmune diseases, with significant progress reported in multiple trials [2][3][31] Oncology Development Programs - The TACTI-004 (KEYNOTE-F91) Phase III trial for advanced non-small cell lung cancer (NSCLC) is ongoing, with over 100 clinical sites activated across 24 countries, aiming to enroll approximately 756 patients [3][4] - The trial has successfully enrolled and randomized over 170 patients, surpassing the number required for a futility analysis, which is expected to be completed in Q1 CY2026 [6] - Positive feedback from the FDA has been received regarding the late-stage clinical development of efti for head and neck cancer patients with low PD-L1 expression [9][11] - The INSIGHT-003 Phase I trial is also evaluating efti in combination with KEYTRUDA® and chemotherapy for non-squamous NSCLC, with data presented at ESMO 2025 [7][8] Soft Tissue Sarcoma and Breast Cancer Trials - The EFTISARC-NEO Phase II trial for soft tissue sarcoma has met its primary endpoint, showing significant tumor hyalinization compared to historical data [16] - The AIPAC-003 trial for metastatic breast cancer has enrolled 71 patients, with ongoing follow-up and data analysis expected to be reported at the San Antonio Breast Cancer Symposium in December 2025 [17][19] Financial Position - As of September 30, 2025, Immutep reported a strong cash position of approximately A$109.85 million, consisting of A$83.41 million in cash and cash equivalents and A$26.44 million in term deposits [27] - The net cash used in R&D activities during Q1 FY26 was A$15.83 million, reflecting increased clinical trial activities [28] Intellectual Property Developments - Immutep was granted four new patents during the quarter, enhancing its intellectual property portfolio related to LAG-3 and its therapeutic applications [24]
X @The Wall Street Journal
From @WSJopinion: If Marty Makary and Vinay Prasad really want to prove they’re not impeding life-saving treatments, they’ll approve Replimune’s RP1 immunotherapy for metastatic melanoma, which the agency rejected this summer https://t.co/cDT7st0w6w ...
Corvus Pharmaceuticals to Provide Business Update and Third Quarter 2025 Financial Results on November 4, 2025
Globenewswire· 2025-10-28 20:01
Core Points - Corvus Pharmaceuticals, Inc. will host a conference call and webcast on November 4, 2025, at 4:30 pm ET to provide a business update and report third quarter 2025 financial results [1] - The conference call can be accessed via a toll-free number or through a link for instant access, with a replay available for 90 days on the company's website [2] - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition for immunotherapy targeting various cancers and immune diseases, with its lead product candidate being soquelitinib [3]
Regeneron(REGN) - 2025 Q3 - Earnings Call Presentation
2025-10-28 12:30
Financial Performance - Regeneron reported total revenues of $3.75 billion for Q3 2025[8] - The company's Non-GAAP EPS for Q3 2025 was $11.83[8] - Dupixent global net sales reached $4.9 billion in Q3 2025, representing a 26% year-over-year increase[12] - EYLEA HD and EYLEA together held approximately 60% of the U S branded anti-VEGF category share in Q3 2025[26] - Libtayo global net sales for Q3 2025 were $365 million, a 24% increase year-over-year[34] Pipeline Developments and Regulatory Milestones - A positive CHMP opinion was received for CSU, with an EC decision expected soon[8, 12] - FDA approved Libtayo for adjuvant treatment of CSCC with high risk of recurrence[11, 32] - Positive Phase 3 data was announced for cemdisiran in generalized myasthenia gravis, with FDA submission expected in 1Q26[11] - Positive Phase 3 data was announced for garetosmab in FOP, with FDA submission expected by year-end 2025[11] Strategic Initiatives - Regeneron Genetics Center has created a large DNA sequence-linked healthcare database to improve drug discovery and healthcare analytics[6] - The company anticipates reimbursing approximately $1 billion in 2025 towards Sanofi's antibody development balance[18] - The company is investing >$5 billion into R&D in 2025[112]