Full Press Release Details
HOOKIPA Pharma Provides Update on Business Priorities
and Oncology Partnership Programs
NEW YORK and VIENNA,
January 29, 2024 - HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA'), a company developing a new class of immunotherapeutics
based on its proprietary arenavirus platform, today announced that the Company will focus
its resources in two strategic areas: (1) prioritize the clinical development of a randomized
trial for its HB-200 program in human papillomavirus 16 positive (HPV16+) head and neck squamous cell carcinoma (HNSCC) and (2) its
two Gilead-partnered infectious disease cure programs for hepatitis B and human immunodeficiency virus.
In the first-line setting
HB-200, in combination with pembrolizumab, has demonstrated best-in-class antigen specific T cell activation and has doubled the historic
objective response rates of standard of care treatment alone. The totality of the HB-200 data presents a clear opportunity for HOOKIPA
to advance this program in a randomized trial starting in mid-2024.
has a tremendous opportunity to transform treatment of multiple disease areas using an entirely new class of medicines,"
said Joern Aldag, Chief Executive Officer at HOOKIPA. "As we move forward with our randomized trial for HB-200 in combination with
pembrolizumab, we have made an important decision to focus our resources and pursue this opportunity in earnest. We will focus on clinical
delivery and execution so that we can help address a significant unmet need for patients with advanced HPV16+ head and neck cancer."
Company also announced that it has received notification from Roche of their decision to terminate the collaboration and licensing agreement
for HOOKIPA's HB-700 program in KRAS mutated cancers. To date, HOOKIPA has met all go-forward criteria under the agreement and remains
eligible for a final milestone payment associated with IND submission. Effective April 25, 2024,
HOOKIPA will regain full control of the associated intellectual property portfolio and have full collaboration and licensing rights for
this program. As part of its strategic refocus, HOOKIPA will pause development activities related to HB-300 and most of its preclinical
research activities.
HOOKIPA will reduce its
workforce by approximately 30 percent and rebalance its cost structure in alignment with the new prioritization of the Company's
programs. HOOKIPA maintains a strong cash position of $117.5 million1 as of December 31, 2023, and believes that the planned
reductions will help to conserve resources and better align its organization in direct support of late stage clinical development efforts.
Update and Upcoming Catalysts
strategic priorities for HOOKIPA are to advance its clinical programs including HB-200 and its two Gilead-partnered infectious disease
programs. The Company is planning to submit an IND for HB-700 in the first quarter of 2024 and will begin searching for a collaboration
partner. At this time, the company will not pursue further preclinical programs into development and pause further development of its
HB-300 to conserve capital and ensure pipeline success and operational efficiency.
| Program | Indication | Upcoming Catalysts |
| Oncology Programs | ||
| HB-200 | HPV16+ HNSCC | Additional first-line data for HB-200 in combination with pembrolizumab (1H 2024) Initiation of randomized trial (mid-2024) |
| HB-700 | KRAS | IND submission (1Q 2024) Publication of preclinical research (1H 2024) Search for new collaboration partner |
| Infectious Disease Programs: Gilead-Partnered | ||
| HB-400 | HBV | Gilead-led: Phase 1b actively enrolling Next milestone: Phase 2 initiation (Timing TBD) |
| HB-500 | HIV | Initiation of Phase 1 trial First patient dosed, milestone payment (1H 2024) |
| Paused Programs | ||
| HB-300 | Prostate Cancer | Paused and utilize capital to support HB-200 development |
| Preclinical | Multiple targets |
1 Cash position as of December 31,
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage
biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed
to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA's replicating and non-replicating
technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies.
HOOKIPA's pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive
cancers, KRAS-mutated cancers, and other unnamed indications. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in
collaboration with Gilead.
Find out more about HOOKIPA online at www.hookipapharma.com.
Forward Looking Statements
release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including,
without limitation, implied and express statements by HOOKIPA regarding: timing and consequences regarding the termination of the Roche
Collaboration Agreement, the extent, timing and plan of and the costs and estimated cash expenditures from, the reduction of workforce,
and expected cash and cash equivalents as of December 31, 2023. Forward-looking statements can be identified by terms such as "will,"
"believes," "expects," "plans," "potential," "would" or similar expressions
and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause HOOKIPA's
research and clinical development programs, future results, performance or achievements to differ significantly from those expressed
or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug
development process, including HOOKIPA's programs' early stage of development, the process of designing and conducting preclinical
and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing
drug products, HOOKIPA's ability to successfully establish, protect and defend its intellectual property, risks relating
to business interruptions resulting from public health crises, the impact of public health crises on the enrollment of patients and timing
of clinical results, and other matters that could affect the sufficiency of existing cash to fund operations. HOOKIPA undertakes
no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could
cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of
the company in general, see HOOKIPA's annual report on Form 10-K for the period ended December 31, 2022, quarterly report
on Form 10-Q for the quarter ended September 30, 2023 and other important factors in HOOKIPA's subsequent filings
with the Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov and HOOKIPA's
website at http://hookipapharma.com/. In addition, any forward-looking statements represent HOOKIPA's views
only as of today and should not be relied upon as representing its views as of any subsequent date. HOOKIPA explicitly disclaims any
obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy
of any such forward-looking statements.
of Other Information About HOOKIPA
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