HOOKIPA advances HB-200 program to Phase 2 and prioritizes oncology portfolio based on clinical data updates across its novel arenaviral platform

• Based mostly on optimistic interim Section 1 information, HOOKIPA initiates Section 2 research to evaluate HB-201 together with pembrolizumab in 1^st and a pair of^nd line head and neck most cancers
  
   
• Interim Section 1 HB-200 information proceed to indicate excessive ranges of tumor-specific CD8+ T cells, promising early anti-tumor exercise (together with 75 p.c illness management fee, three partial responses and one close to partial response), and a good tolerability profile in superior head and neck most cancers
  
   
• HOOKIPA advancing immuno-oncology pipeline throughout quite a few cancers, together with HB-300 for prostate most cancers and HB-700 for KRAS-mutated cancers, and evaluating combos of HB-200 with different oncology remedy modalities
  
   
• Interim Section 2 HB-101 information present constant immunogenicity, tolerability, and discount in CMV viremia in kidney transplant sufferers; HOOKIPA pursuing partnership alternatives for continued improvement of HB-101

NEW YORK and VIENNA, Austria, Nov. 09, 2021 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc.  (NASDAQ: HOOK, ‘HOOKIPA’), an organization creating a brand new class of immunotherapeutics based mostly on its proprietary arenavirus platform, introduced it’s advancing HB-201 to Section 2, to be evaluated together with pembrolizumab as 1^st– or 2^nd-line remedy for Human Papillomavirus Optimistic 16 (HPV16+) squamous cell head and neck cancers (HNSCC). Interim Section 1 information in closely pre-treated sufferers proceed to indicate HB-200 monotherapy (each HB-201 alone and HB-202/HB-201) is very efficient at increasing T cells, has a good tolerability profile and promising, early anti-tumor exercise. As of November 1, 2021, amongst 28 sufferers dosed intravenously, HB-200 resulted in a 75 p.c illness management fee and shrinkage of goal lesions in 53 p.c of sufferers. In these sufferers, HOOKIPA has noticed three partial responses (together with one confirmed and one unconfirmed in an ongoing affected person) and one ongoing affected person with a close to partial response (29 p.c tumor shrinkage). Based mostly on the energy of the HB-200 information, HOOKIPA has prioritized its oncology portfolio and plans additional improvement of its infectious illness packages to be carried out in partnership with different corporations. HOOKIPA will host an investor convention name to evaluation the information at 4:30 p.m. ET.

“We’re extremely enthusiastic about our Section 1 HB-200 information, particularly the demonstrated tumor-specific T cell responses and tumor shrinkage in closely pre-treated HNSCC sufferers, which we consider are extremely differentiated from different lively immunization applied sciences,” stated Joern Aldag, Chief Government Officer at HOOKIPA. “Based mostly on these information, we’re excited to advance our promising HB-200 program into Section 2, initially with the HB-201 and pembrolizumab mixture for head and neck most cancers sufferers, whereas accelerating the event of our earlier stage immuno-oncology candidates HB-300 and HB-700 in prostate and KRAS-mutated cancers, respectively, and focusing our efforts on exploring the potential of our novel arenaviral expertise to deal with unmet wants in most cancers.”

HB-200 information replace

Interim information from the continued Section 1 dose escalation research (NCT04180215) present that

HB-200 (both as HB-201 or as alternating two-vector HB-202/HB-201) quickly induces excessive ranges of tumor-specific CD8+ T cells thought of to be predictive of response, with a good tolerability profile and promising, early anti-tumor exercise in closely pre-treated HPV16+ HNSCC most cancers sufferers.

As of the November 1, 2021 information cut-off, 62 sufferers (representing 24 new sufferers for the reason that information introduced on the American Society of Scientific Oncology in June 2021) with superior HPV16+ tumors had been enrolled and obtained HB-200 remedy. Forty sufferers with HNSCC tumors had been handled intravenously each three weeks, together with 20 sufferers who obtained single vector HB-201 and 20 sufferers who obtained alternating two-vector HB-202/HB-201. The opposite 22 sufferers had both different HPV16+ tumor sorts (not HNSCC) and/or obtained completely different HB-200 regimens. Individuals obtained a median of three prior therapies (starting from zero to 11), and 87 p.c had beforehand obtained a checkpoint inhibitor routine. The next security and interim efficacy information mirror the November 1 closing date.

Security outcomes

HB-200 continued to display a good tolerability profile in closely pre-treated sufferers with HPV16+ cancers, highlighting its potential in attainable mixture with checkpoint inhibitors and different brokers. Therapy-related hostile occasions had been reported in 66 p.c of 62 evaluable sufferers, with solely eight p.c experiencing treatment-related hostile occasions rated grade Three or larger.  

Interim efficacy outcomes

HB-200 demonstrated promising, early anti-tumor exercise within the 28 evaluable sufferers with superior HNSCC. Particularly:

• HB-201 confirmed a 71 p.c illness management fee (10/14 evaluable sufferers, together with one confirmed partial response and one unconfirmed partial response, beforehand reported in December 2020);
• Alternating two-vector HB-202/HB-201 demonstrated a 79 p.c illness management fee (11/14 evaluable sufferers, together with one ongoing unconfirmed partial response and one ongoing close to partial response with 29 p.c tumor shrinkage); and,
• HB-200 confirmed tumor shrinkage in 53 p.c of sufferers (15/28 evaluable sufferers) and an ongoing median progression-free survival (mPFS) of three.45 months.

These outcomes evaluate favorably to the usual of care remedies nivolumab and pembrolizumab utilized in a 2nd plus-line setting in PD1-inhibitor naïve HNSCC sufferers. Based mostly on peer-reviewed revealed information, nivolumab confirmed a mPFS of two months¹ whereas pembrolizumab had illness management charges of 35 p.c general and 40 p.c within the HPV+ subset within the 2nd plus-line setting.²  

T cell information

Interim information continued to indicate that HB-200 quickly induces excessive ranges of activated, tumor-specific CD8+ T cells. As of the September 1, 2021 information cut-off, 20 sufferers had been evaluable, together with 10 sufferers who obtained HB-201 and 10 who obtained alternating two-vector HB-202/HB-201. The evaluation confirmed:

• Greater than 90 p.c of sufferers confirmed a rise in tumor-specific CD8+ T cells inside 2 weeks of preliminary HB-200 dose (both HB-201 or HB-202/HB-201),
• Greater than 50 p.c of sufferers had tumor-specific CD8+ T cell ranges that exceeded the single-digit share threshold of the circulating T cell pool, which is usually thought of a robust indicator of response; and,
• 50 p.c of sufferers with paired biopsies (3/6 sufferers) confirmed elevated tumor infiltrating lymphocytes (“TILs”), or a rise in CD8+ T cells of their tumors.

Based mostly on a evaluation of revealed literature, we consider that no different lively immunization strategy has demonstrated these kind of outcomes, which spotlight the magnitude of tumor-specific CD8+ T cells induced by HB-200 remedy in addition to the potential for HOOKIPA’s versatile arenaviral platform to reinforce anti-tumor exercise throughout tumor killing mechanisms.

“Whereas these T cell information are preliminary, it’s clear that HB-200 induces a speedy and strong vaccine-specific T cell response at magnitudes that we as a discipline have theorized would end in efficacy, if such ranges had been ever achieved,” stated Dmitriy Zamarin, MD, PhD, Translational Analysis Director in Gynecologic Medical Oncology at Memorial Sloan Kettering Most cancers Middle (MSK) and co-investigator on this research. “Hookipa’s arenavirus vectors are, for the primary time, producing these ranges and, with that, we’re seeing monotherapy efficacy in sufferers with superior heavily-pretreated cancers.”

Oncology pipeline enlargement

There may be appreciable unmet want in head and neck cancers, and the HB-200 program represents broad potential for additive advantages together with present customary of care and novel brokers to enhance anti-tumor immune response in these sufferers. HOOKIPA has initiated the Section 2 enlargement portion of its ongoing HB-200 research to guage HB-201 together with pembrolizumab in 1^st– and a pair of^nd-line HNSCC sufferers.

The corporate additionally plans to provoke a separate, randomized Section 2 research of HB-200 together with pembrolizumab as a part of its medical collaboration with Merck & Co., Inc., Kenilworth, NJ, USA.

Based mostly on the optimistic HB-200 information to-date, HOOKIPA is focusing future analysis and improvement in oncology, advancing efforts in head and neck most cancers with HB-200 and prostate cancers with HB-300, in addition to increasing its pipeline to incorporate HB-700, a brand new program focusing on KRAS-mutated colorectal, pancreatic and lung cancers.

Infectious illness portfolio replace

Up to date interim information from the continued Section 2 medical trial (NCT03629080) of HB-101, a prophylactic Cytomegalovirus (CMV) vaccine candidate, present robust immunogenicity and lowered incidence of CMV viremia in individuals who obtained three doses of HB-101, in step with outcomes beforehand reported in November 2020. In comparison with placebo, individuals vaccinated with three HB-101 doses previous to kidney transplant had:

• Robust immunogenicity with 86 p.c seroconversion and 100 p.c CD8+ T cell responses;
• a 41 p.c discount in CMV viremia (presence of CMV DNA within the blood);
• a 41 p.c discount in the usage of antiviral remedy; and,
• No change in CMV illness.

Whereas there have been two instances of CMV illness reported within the placebo group in November 2020, these instances have since been re-classified as not CMV illness.

Security and tolerability had been evaluated in 80 individuals who had been enrolled within the trial by the closing date of July 30, 2021. HB-101 was usually effectively tolerated with 21 p.c of HB-101 recipients experiencing uncomfortable side effects associated to vaccine administration. A complete of 5 instances of human leukocyte antigen (HLA)-sensitization have been reported, 4 characterised as critical hostile occasions.

Enrollment closed in June 2021 with 80 sufferers enrolled, and individuals will proceed to be monitored for the 12-month remark interval following kidney transplantation. Last outcomes are anticipated in 2023. With no accepted CMV vaccine, there stays appreciable unmet want for folks with strong organ transplants. HOOKIPA will discover partnership alternatives for additional improvement of HB-101 as a way to give attention to advancing its promising oncology portfolio.

HOOKIPA is progressing its analysis collaboration with Gilead to develop a possible practical remedy for Hepatitis B virus (HBV). The HBV program efficiently handed Gilead’s Request for Improvement milestone, and Gilead plans to progress this system into IND-enabling stage in 2022 to help IND submitting for the arenavirus vector mixture. For the HIV program, after HOOKIPA efficiently accomplished all pre-clinical analysis obligations in accordance with the mutual Collaboration Settlement, Gilead knowledgeable HOOKIPA of their intention to not transfer ahead with this program in accordance with present phrases. HOOKIPA is in ongoing discussions with Gilead concerning a revised Collaboration Settlement.  

Investor name

HOOKIPA will host an investor convention name to evaluation the information at 4:30 p.m. ET.

A stay webcast of the decision will be accessed on HOOKIPA’s web site at https://ir.hookipapharma.com/events. An archived webcast will probably be accessible for 30 days on the Occasions webpage.

About HB-202/HB-201

HB-201 and HB-202 are HOOKIPA’s lead oncology candidates engineered with the corporate’s proprietary replicating arenaviral vector platform. Every single-vector compound makes use of a special arenavirus spine (Lymphocytic Choriomeningitis Virus for HB-201 and Pichinde Virus for HB-202), whereas expressing the identical antigen, an E7E6 fusion protein derived from HPV16. In pre-clinical research, alternating administration of HB-201 and HB-202 resulted in a ten-fold improve in immune response and higher illness management than both compound alone. HB-201 is being examined clinically as a single vector remedy and in addition in an alternating vector mixture with HB-202.

Concerning the HB-200 trial (NCT04180215)

This Section 1/2 medical trial is an open-label trial exploring completely different dose ranges and dosing schedules in people with treatment-refractory HPV16+ head and neck cancers who progressed on customary of care, together with examine level inhibitors. The trial is evaluating HB-201 as a monotherapy, as an alternating 2-vector remedy with HB-202, and together with a PD-1 inhibitor. The first endpoint of Section 1 is a really useful Section 2 dose. Secondary endpoints embody security and tolerability, in addition to preliminary efficacy outlined by RECIST 1.1. The research additionally consists of exploratory aims on immunogenicity and pharmacodynamic biomarkers.

About HOOKIPA

HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical firm targeted on creating novel immunotherapies that mobilize and amplify focused T cells to deal with unmet wants in most cancers.

The corporate is leveraging its proprietary, versatile platform to engineer a broad pipeline of differentiated arenaviral therapeutics. These novel immunotherapies induce strong antigen-specific killer T cells to a broad vary of self and non-self antigens, together with viral antigens, tumor-associated antigens and neoantigens. HOOKIPA’s platform expertise makes use of replicating viral vectors based mostly on the goal most cancers, with the potential to induce killer T cell response ranges beforehand not achieved by different immunotherapy approaches.

HOOKIPA’s pipeline consists of wholly-owned investigational arenaviral immunotherapeutics focusing on Human Papillomavirus Optimistic 16, prostate most cancers, KRAS-mutated cancers (together with colorectal, pancreatic and lung), and different undisclosed initiatives. As well as, the corporate goals to develop practical cures of HBV and HIV in collaboration with Gilead.

Discover out extra about HOOKIPA on-line at www.hookipapharma.com.

Disclosure: Dr. Zamarin offers consulting providers to HOOKIPA Pharma.

Ahead Trying Statements

This press launch might include a variety of “forward-looking statements” throughout the that means of the Personal Securities Litigation Reform Act of 1995, as amended, together with statements concerning HOOKIPA’s expectation about any or the entire following: (i) the success, value and timing of HOOKIPA’s product improvement actions and medical trials; (ii) the timing, scope or probability of regulatory filings and approvals, together with timing of Investigational New Drug Utility and Organic Licensing Utility filings for HOOKIPA’s present and future product candidates, and closing U.S. Meals and Drug Administration, European Medicines Company or different international regulatory authority approval of HOOKIPA’s present and future product candidates; (iii) HOOKIPA’s capacity to develop and advance its present product candidates and packages into, and efficiently full, medical research; (iv) the potential advantages of and HOOKIPA’s capacity to keep up its collaboration with Gilead Sciences, Inc., and set up or preserve future collaborations or strategic relationships or acquire extra funding; (v) dangers referring to enterprise interruptions ensuing from the coronavirus (COVID-19) illness outbreak or related public well being crises and different issues that would have an effect on the sufficiency of current money to fund operations and HOOKIPA’s capacity to realize the milestones beneath the settlement with Gilead. Ahead-looking statements will be recognized by phrases equivalent to “believes,” “expects,” “plans,” “potential,” “would” or related expressions and the detrimental of these phrases. HOOKIPA has based mostly these forward-looking statements largely on its present expectations and projections about future occasions and monetary tendencies that it believes might have an effect on its enterprise, monetary situation and outcomes of operations. Though HOOKIPA believes that such statements are based mostly on affordable assumptions, forward-looking statements are neither guarantees nor ensures and they’re essentially topic to a excessive diploma of uncertainty and danger. As a result of forward-looking statements are inherently topic to dangers and uncertainties, a few of which can’t be predicted or quantified and a few of that are past HOOKIPA’s management, you shouldn’t depend on these forward-looking statements as predictions of future occasions. These dangers and uncertainties embody, amongst others: outcomes of HOOKIPA’s deliberate medical trials and research might not be favorable; that a number of of HOOKIPA’s product candidate packages won’t proceed as deliberate for technical, scientific or business causes; availability and timing of outcomes from preclinical research and medical trials; uncertainty about regulatory approval to conduct medical trials or to market a merchandise; uncertainties concerning mental property safety; and people danger and uncertainties described beneath the heading “Danger Elements” in HOOKIPA’s Kind 10-Q for the quarter ended June 30, 2021 filed with the U.S. Securities and Change Fee, and in another subsequent filings made by HOOKIPA with the U.S. Securities and Change Fee, which can be found at www.sec.gov and HOOKIPA’s web site at www.hookipapharma.com.

Present and prospectus buyers are cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date they’re made. HOOKIPA disclaims any obligation or endeavor to replace or revise any forward-looking statements contained on this presentation, apart from to the extent required by regulation.

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¹ Ferris R et al. Nivolumab for recurrent squamous-cell carcinoma of the pinnacle and neck. N Engl J Med. 2016; 375:1856-1867.

² Mehra R et al. Efficacy and security of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled evaluation after long-term observe up in KEYNOTE-012. British J of Most cancers. 2018; 119:153-159.