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I think the offering is a non issue. They obviously had it Pre sold, it closes Monday. Probably Gilead or ROCHE took it, we should know by Wednesday, because whoever took it is going to own about 40% of the company. I am not sure why they said it was a public offering.
SUB DOLLAR WAS RED FIRE
SMH
No they announced an offering at 930 pm. Unbelievable
The news is excellent. Will it catch fire tomorrow? Thats the 99k question.
HOPE ONE OF THESE CATCH AND RUN BETTER
WE NEED ANOTHER BIG RUNNER TO BOOST THE MARKET AGAIN
INSTEAD OF THE USUALY GAP, TRAP & GRIND
HOOKIPA Pharma Announces Positive Preliminary Phase 2 Data on HB-200 in Combination with Pembrolizumab in Patients with HPV16+ Head and Neck Cancers
May 31 2023 - 04:45PM
GlobeNewswire Inc.
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HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive preliminary data from its ongoing Phase 2 study of HB-200 in combination with pembrolizumab in patients with recurrent/metastatic Human Papillomavirus 16-positive (HPV16+) head and neck cancer. New data show a 43 percent objective response rate (ORR) with HB-200 in combination with pembrolizumab in checkpoint inhibitor (CPI)-naïve patients, doubling the 19 percent response rate for pembrolizumab alone. HOOKIPA plans to share the full data at a medical conference later this year and is preparing to start a pivotal trial of HB-200 in combination with pembrolizumab in the 1st-line setting in 2024. The company will host a webcast call June 1st at 8:00 a.m. EDT.
“Given the unmet medical need for patients with recurrent/metastatic HPV16+ head and neck cancers, we are thrilled to share the preliminary data on HB-200 in combination with pembrolizumab as they show a robust improvement in objective response rate and prolonged tumor control compared to pembrolizumab alone,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “Efficacy, immunogenicity and safety data observed in our HB-200 program to-date support our decision to progress to a pivotal trial of HB-200 in combination with pembrolizumab as 1st-line treatment for these patients. The data also underscore the scalability of our arenaviral platform across a range of cancers.”
HB-200 results (NCT04180215)
As of March 31, 2023, 35 patients with HPV16+ recurrent/metastatic head and neck cancers received HB-200 in combination with pembrolizumab as part of the Phase 2 study: 20 patients were treated with HB-200 and pembrolizumab in the 1st-line setting and 15 in the 2nd-line setting. All received HB-200 intravenously every three weeks for the first five doses and every six weeks thereafter. HB-200 means 2-vector therapy with alternating application of HB-201 (LCMV), HB-202 (PICV) vectors, encoding HPV16 E6/E7 antigens.
1st-line combination data
HB-200 in combination with pembrolizumab demonstrated promising anti-tumor activity with a 43 percent objective response rate (6 of 14 patients with confirmed responses by investigator assessment under RECIST 1.1) among CPI-naïve patients with recurrent/metastatic HPV16+ PD-L1+ head and neck cancer. These data represent a doubling of the 19 percent objective response rate reported with pembrolizumab alone.1 As of March 31, 2023, 14 patients with at least two imaging assessments were included in the interim efficacy analysis. Six patients responded (one with confirmed complete response and five with confirmed partial responses), with a 71 percent disease control rate (10 of 14 patients), meaning stable disease or a complete or partial response. While recruitment is ongoing, based on these data, HOOKIPA is preparing to start a pivotal trial of HB-200 in combination with pembrolizumab as 1st-line treatment of recurrent/metastatic HPV16+ PD-L1+ head and neck cancers in 2024.
2nd-line plus combination data
Data on HB-200 in combination with pembrolizumab in the 2nd-line plus setting are trending positively in this small initial cohort, but they are preliminary and need further maturation. As of March 31, 2023, five patients with at least two imaging assessments were included in the interim efficacy analysis based on RECIST 1.1. Preliminary results show one confirmed partial response and three patients with stable disease. Preliminary median progression-free survival in this small cohort was 5.3 months. Enrollment is ongoing, and a decision on a potential path forward in the 2nd-line plus setting will be made in 2024.
Monotherapy data
Given the limited options for heavily pre-treated patients with recurrent/metastatic HPV16+ head and neck cancers, HOOKIPA continues to evaluate HB-200 as monotherapy among these patients in the ongoing Phase 1/2 trial. Follow-up data show HB-200 monotherapy demonstrated a preliminary median overall survival of 14.2 months in the intent-to-treat population, indicating potential for prolonged clinical benefit in this heavily pre-treated population. These data are based on 11 patients who received HB-200 as monotherapy at the same dose being evaluated in combination with pembrolizumab, with a median follow-up period of 12.8 months. Additional patients are also being followed to continue to assess median overall survival in a larger cohort.
Immunogenicity
Importantly, new follow-up data from heavily pre-treated patients show an association between the induction of unprecedented levels of functional T cells after treatment with HB-200 monotherapy and clinical benefit. T cell increases were rapid and sustained for at least 8 months, as of data cut-off. Patients who achieved disease control after treatment with HB-200 monotherapy generally had greater CD8+ T cell infiltration in tumors compared to patients whose disease progressed, suggesting an association of HB-200-induced T cells and clinical benefit.
Safety and tolerability profile
Results from the Phase 1/2 study showed that HB-200 was generally well tolerated among 132 patients treated. The safety profile was similar for patients who received HB-200 monotherapy or HB-200 in combination with pembrolizumab. This favorable tolerability profile highlights the potential of HB-200 – and arenaviral immunotherapies in general – to be combined with other immunotherapies where tumor antigen-specific T cells are needed. Only seven percent of patients showed serious adverse events related to the treatment with HB-200. Only two percent of patients discontinued due to such events.
Webcast: HOOKIPA will host a live webcast on June 1, 2023 at 8:00 a.m. EDT. Joern Aldag, Chief Executive Officer, Katia Schlienger M.D., Ph.D., Chief Medical Officer, and Klaus Orlinger, Ph.D., Chief Scientific Officer will provide an overview of the HB-200 data and future plans for HOOKIPA’s oncology program. Alan Ho, M.D., Ph.D., a study investigator, will also offer commentary on the unmet medical need for patients with head and neck cancer.
Dial In: +1 646 876 9923
UK Dial In: +44 208 080 6591
Austria Dial In: +43 72 011 5988
Webinar ID: 899 3030 4628
Webcast: Link
The webcast and the presentation will be available within the Investors & Media section of HOOKIPA’s website at https://ir.hookipapharma.com/events. An archived replay will be accessible for 30 days following the event.
About HB-200
HB-200 is HOOKIPA’s lead oncology candidate engineered with the company’s proprietary replicating arenaviral vector platform. It comprises two single-vector compounds with arenaviral backbones based on lymphocytic choriomeningitis virus and pichinde virus. Both express the same transgene encoding an E7E6 fusion protein derived from HPV16. HB-200 is an alternating 2-vector immunotherapy designed to further focus the immune response against the encoded antigen. HB-200 in combination with pembrolizumab received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of 1st-line recurrent/metastatic HPV16+ head and neck cancers.
About the HB-200 trial (NCT04180215)
This Phase 1/2 clinical trial is an open-label trial evaluating HB-200 for the treatment of advanced HPV16+ cancers. Phase 1 assessed various dose levels, regimen, and modes of administration in a post-standard of care setting. Based on safety and tolerability, initial anti-tumor activity and T cell response data, HB-200 advanced for further development in Phase 2.
The Phase 2 part of the trial is open-label with primary endpoints of efficacy based on objective response and disease control rate as defined by RECIST 1.1 and iRECIST.
needs to build base
going lower
https://stockcharts.com/h-sc/ui?s=hook&p=D&yr=0&mn=6&dy=0&id=p38090673899
https://www.barchart.com/stocks/quotes/hook/technical-chart?plot=CANDLE&volume=total&data=DO&density=ML&pricesOn=1&asPctChange=0&logscale=0&indicators=ACCUM;SMA(20);SMA(50);SMA(100);SMA(200);CHKMF(20)&sym=SYSX&grid=1&height=210&studyheight=100
https://www.barchart.com/stocks/quotes/hook/opinion
Weedssssdsdddddddddx$)$$!$!!$$
Another KALA weeeee Merry Christmas $$$$$$$$$$$$$$$$$$$$$$Buy Buy tell your friends $$$$$$$$$$$$
Why would Morgan Stanley increase their shares in HOOK on 10/27? Take a guess!!!
Not much going on here. Lot of chatter on Twitter and Stocktwits with strong support for a move up. Could be a major reversal starting after bottoming out!!!
Well. These low 1.30’s were quite unexpected and a tad bit poopish too
Cool! Your very welcome
Quick flip already thanks
MEGA MONSTER NEWS
HOOKIPA announces strategic collaboration and license agreement with Roche to develop novel arenaviral immunotherapy for KRAS-mutated cancers
October 20 2022 - 07:00AM
GlobeNewswire Inc.
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HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, announced today a strategic collaboration and license agreement with Roche to develop HB-700 for KRAS-mutated cancers and a second undisclosed novel arenaviral immunotherapy. This represents HOOKIPA’s first oncology licensing collaboration.
Through the collaboration, HOOKIPA will conduct research and early clinical development through Phase 1b for HB-700, a novel investigational arenaviral immunotherapy for the treatment of KRAS-mutated cancers. Upon the completion of the Phase 1b trial, Roche has the right to assume development responsibility and to commercialize licensed products across multiple indications upon approval. The agreement also includes an option for Roche to license a second arenaviral cancer immunotherapy.
“Roche is an ideal partner, both in terms of development and reaching patients with novel cancer therapeutics. We look forward to working with them to benefit people with KRAS-mutated cancers,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “This collaboration validates the potential of our arenavirus platform and accelerates the development pathway to bring new treatments to people with cancer.”
“We are excited to collaborate with HOOKIPA in leveraging their arenaviral technology, which has clinically demonstrated the ability to induce potent antigen specific CD8+ T cell responses and represents a promising approach for new cancer immunotherapies,” said James Sabry, Global Head of Pharma Partnering at Roche. “This collaboration further strengthens our leadership in oncology, and we are optimistic about advancing this innovative platform to potentially provide more options for people with KRAS-mutated cancers, as well as other potential cancer types.”
Under the terms of the agreement, HOOKIPA will receive an upfront payment of $25 million. Roche will have the option to expand the initial collaboration by adding an additional product candidate, whereafter HOOKIPA will receive an additional $15 million payment at option exercise. Including this option payment, HOOKIPA is eligible for research, development and commercialization milestone-based payments for HB-700 and the additional product candidate totaling up to approximately $930 million. Upon commercialization, HOOKIPA is eligible to receive tiered royalties of a high single-digit to mid-teens percentage on the worldwide net sales of HB-700 and the additional product candidate.
About KRAS-mutated cancers
KRAS is a gene that acts as an on/off switch for cell growth. When there is a mutation, or error, in the gene, cells can grow out of control. KRAS mutations are among the most common mutations that cause cancer. While KRAS-mutated, tumor-specific treatments exist, there remains an opportunity to target a broader range of KRAS-mutations simultaneously to potentially help more people impacted by these cancers.
About HOOKIPA’s Arenaviral Technology
HOOKIPA’s novel, replicating arenaviral technology has demonstrated the ability to induce potent antigen-specific T cell responses and promising anti-tumor activity in a Phase 1 clinical trial which treated patients with advanced Human Papillomavirus 16-positive head and neck cancers. Preclinical studies have also demonstrated the ability of arenaviral immunotherapies to break self-tolerance and induce potent T cell responses to tumor self-antigens and mutated epitopes, or target parts of a mutated, cancer-causing gene. These findings provide scientific rationale for the HB-700 program.
About HB-700
HB-700 is an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700 is a replicating 2-vector therapy that targets the most common KRAS mutations: (G12D, G12V, G12R, G12C and G13D) and thereby benefits more patients than single mutation inhibitors.
About HOOKIPA
This one I liked but as afraid of dilution (now over for now):
https://ir.hookipapharma.com/news-releases/news-release-details/hookipa-announces-first-patient-enrolled-phase-2-trial
Usually that success offers a rise.
Usually that success offers a rise.
I added some HOOK today in the 1.70s on the thesis that it will bounce at least a little bit once the offering closes. Presumably we will see the PR announcing the close of the offering after the close today or on Monday.
I am impressed that they are getting such a good price on the offering ($2.00) when in fact they are selling about as many new shares as there are already outstanding! This tells me that they had a LOT of demand for the shares.
GREEN Babyyy
Back to 2.50+ and green soon
2.30s lets go back to 3.00s soon enough
was just there yesterday
$HOOK
$HOOK Strong move last week..closing near high of day…
— Tommy Boy Trader (@QuabbinR) February 21, 2022
Post Masters Telegram Room adding to their watchlist..check us out…we deliver!https://t.co/qZaQQOjnVV pic.twitter.com/CHGqDtLe1m
Scmbag MM caught short trying to keep it from going over $2.50 the piece of shtt needs to get blown out and squeezed much higher.
10 million volume $2.43 in the first half an hour. I think we're looking good
Nice accumulation. I'm thinking could do like BFRI did a couple months ago. Not to 14 but over 3 imo.
I seriously doubt $3 anytime soon. This news out is short lived and once the dust settles it will be beat back down when the demand becomes less. It will take along time for Trials and submissions. So it will be a good mid-long term hold but the price will fall once dust settles. But you can for sure jump in and out now and then for a short term play with 10% gains. When they are done and FDA approval which will be long term this will be much higher then $3 but that is going to take time. If you play Pharma biotech often you learn this is how these flow.
HOOK
Money to be made flipping but mkt and manipulation tells me we’re headed for 3$
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