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HOOKIPA Pharma Inc. (symbol: HOOK) is a clinical-stage biopharmaceutical company dedicated to the development of immunotherapeutics aimed at preventing and treating infectious diseases and cancer. Leveraging its proprietary arenavirus platform, HOOKIPA has created VaxWave® and TheraT®, groundbreaking technologies that reprogram and stimulate the immune system.
VaxWave® is a replication-deficient viral vector, while TheraT® is an attenuated replicating vector. Both technologies are designed to induce strong pathogen-neutralizing antibodies and CD8+ T cells. Remarkably, these vectors can be administered repeatedly without losing efficacy. TheraT® has shown the ability to stimulate CD8+ T cell responses to tumor antigens, achieving frequencies and potencies comparable to or surpassing those seen in adoptive T cell therapy.
HOOKIPA's viral vectors are administered systemically and target dendritic cells in vivo, effectively activating the immune system. This capability is particularly beneficial in the field of immuno-oncology, where it allows for the systemic combating of both primary and metastatic solid tumors.
In recent achievements, HOOKIPA has successfully completed a Phase 1 clinical trial, demonstrating the potential and safety of its innovative approaches. The company continues to focus on advancing its pipeline, which includes the development of an arenavirus-based immunotherapy for KRAS mutant cancer and a neoadjuvant HPV16-specific immunotherapy combined with chemotherapy for HPV16-positive oropharyngeal cancer.
As of December 31, 2023, the company maintains a robust financial position. HOOKIPA remains committed to pioneering immune-based treatments that offer hope for patients with infectious diseases and cancer, positioning itself at the forefront of biopharmaceutical innovation.
HOOKIPA Pharma (NASDAQ: HOOK) reported Q3 2024 financial results and business updates. Key highlights include completion of Phase 2 study enrollment for eseba-vec + pembrolizumab in HPV+ HNSCC with 68 patients, and first patients dosed in Phase 2 adjuvant therapy study with MSKCC. The company reported Q3 revenue of $4.7 million, down from $6.9 million in Q3 2023. Net loss was $13.8 million compared to $19.1 million in the same period last year. Cash position stood at $60.0 million as of September 30, 2024. The company received a $5.0 million milestone payment from Gilead for HB-500 HIV-1 treatment trial initiation.
HOOKIPA Pharma presented updated Phase 2 data for eseba-vec combined with pembrolizumab as front-line therapy for HPV16+ relapsed/metastatic head and neck cancer. The study showed a 52% overall response rate and 80% disease control rate in PD-L1 CPS>20 patients (n=27). Preliminary data indicated median progression-free survival exceeding 16 months and a 12-month overall survival rate of 83%. At the selected Phase 3 dose level, the 55% response rate represents approximately double the historical pembrolizumab monotherapy results. The treatment demonstrated manageable toxicity with only 7.6% serious treatment-related adverse events.
HOOKIPA Pharma (NASDAQ: HOOK) announced that updated Phase 2 data for eseba-vec (HB200) plus pembrolizumab in first-line recurrent/metastatic HPV16-positive head and neck cancer will be presented at SITC 2024. The presentation will be delivered as a late-breaking poster by Dr. Alan Ho, Chief of Head and Neck Oncology Service at Memorial Sloan Cancer Center, on November 9, 2024, in Houston, Texas.
The presentation will focus on updated results in PD-L1 CPS ≥20 patients receiving the combination treatment. The poster will be accessible on HOOKIPA's website under the Scientific Publications section.
HOOKIPA Pharma (NASDAQ: HOOK) has initiated dosing in a Phase 2 investigator-led trial evaluating eseba-vec as adjuvant therapy for HPV16+ head and neck cancer patients. The study, conducted in collaboration with Memorial Sloan Kettering Cancer Center, will assess the treatment in patients with minimal residual disease positive (MRD+) HPV-driven head and neck cancer. The randomized, double-blind, placebo-controlled study aims to enroll approximately 50 patients, with initial safety and efficacy data expected in 2026. The primary endpoint is disease-free survival. This trial expands on positive Phase 2 data in recurrent/metastatic HNSCC, with the company also planning to initiate the pivotal AVALON-1 Phase 2/3 study in Q4 2024.
HOOKIPA Pharma (NASDAQ: HOOK) is set to present preclinical data for its HB-700 program, targeting KRAS mutated cancers, at the 6th Annual RAS-Targeted Drug Development Summit in Boston from September 24-26, 2024. The company's Chief Research & Development Officer, Mark Winderlich, PhD, highlighted that HB-700 is uniquely positioned to target multiple prevalent KRAS mutations in pancreatic, colorectal, and lung cancers within a single therapy.
Key points:
- HB-700 is designed as a potential multi-KRAS therapy
- Preclinical data shows safety, induction of target-specific CD8+ T-cells, and target cell killing
- FDA granted IND clearance in Q2 2024, making HB-700 Phase 1 ready
The virtual oral presentation, titled 'Development of an Arenavirus-Based Immunotherapy for Treatment of KRAS Mutant Cancer,' is scheduled for September 25, 12:45 to 1:15 PM ET, during the Drug Discovery & Preclinical Development session.
HOOKIPA Pharma Inc. (NASDAQ: HOOK), a company developing immunotherapeutics based on its arenavirus platform, has announced significant changes to its Board of Directors. Julie O'Neill has been appointed as Non-Executive Chair, succeeding Jan van de Winkel, who is stepping down due to increasing commitments as CEO of Genmab A/S. Additionally, Tim Reilly is also leaving the Board to focus on other professional responsibilities. Both departures are effective August 30, 2024. The Board will now comprise five members, with the vacated seats remaining unfilled. O'Neill expressed gratitude for van de Winkel's seven years of service and Reilly's contributions, emphasizing her commitment to working with the management team for the benefit of shareholders and stakeholders.
HOOKIPA Pharma (NASDAQ: HOOK) announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York. Key highlights include:
1. Management team will host one-on-one meetings with investors.
2. CEO Dr. Malte Peters will participate in a Fireside Chat on September 9, 2024, at 1:30 p.m. ET.
3. The Fireside Chat will be available via webcast with a replay accessible for 90 days.
4. HOOKIPA is developing a new class of immunotherapeutics based on its proprietary arenavirus platform.
This event provides an opportunity for investors to gain insights into HOOKIPA's innovative approach to immunotherapy and its potential impact on the biotechnology sector.
HOOKIPA Pharma (NASDAQ: HOOK) reported Q2 2024 financial results and business highlights. Key points include:
1. On track to initiate Phase 2/3 'AVALON-1' study for eseba-vec in Q4 2024
2. Reported best-in-class Phase 2 data for eseba-vec at ASCO 2024
3. Received FDA clearance for HB-700 IND in KRAS-mutated cancers
4. Dosed first person in Phase 1b trial of HB-500 for HIV treatment
5. Q2 2024 revenue: $1.3 million; net loss: $19.1 million
6. Cash position as of June 30, 2024: $77.4 million
7. New CEO and CFO appointed; implemented 1:10 reverse stock split
HOOKIPA Pharma Inc. (NASDAQ: HOOK) announced significant leadership changes on July 22, 2024. Dr. Malte Peters was appointed as CEO and Terry Coelho as EVP and CFO, replacing Jörn Aldag and Reinhard Kandera respectively. Both new executives will retain their Board positions. The company is initiating a review of its business strategy and operations to maximize the potential of HB-200 and create shareholder value.
HOOKIPA has recently received PRIME designation from the EMA for HB-200 and aligned with the FDA on a clinical development strategy with potential for accelerated approval. The company is also advancing other programs, including a collaboration with Gilead for HB-500 in HIV treatment. Sean Cassidy, former CFO of Arvinas, has been appointed to HOOKIPA's Board of Directors and will chair the Audit Committee.
HOOKIPA Pharma has announced a 1-for-10 reverse stock split effective July 9, 2024, to comply with Nasdaq's minimum bid price requirement. The stock will trade on a split-adjusted basis from July 10, 2024, under the symbol 'HOOK' with the new CUSIP number 43906K209. The reverse split will combine every 10 outstanding shares into one, reducing the total number of issued and outstanding shares from 96.6 million to 9.7 million, and proportionately adjusting authorized shares from 400 million to 40 million. Stockholders will receive cash for fractional shares, and adjustments will be made for stock options and convertible preferred stock.
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