UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of October 2023
Commission File Number: 001-37643
PURPLE BIOTECH LTD.
(Translation of registrant’s name into English)
4 Oppenheimer Street, Science Park, Rehovot
7670104, Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F
☐
On October 3, 2023, Purple Biotech Ltd. (the “Company”
or the “Registrant”) issued a press release, “Purple Biotech Reports Positive Interim and Preliminary Results
from NT219 Phase 1/2 Study in R/M Head & Neck Cancer”, which is attached hereto as Exhibit 99.1.
Incorporation by Reference
This Report on Form
6-K, including all exhibits attached hereto, is hereby incorporated by reference into each of the Registrant’s Registration Statement
on Form S-8 filed with the Securities and Exchange Commission on May 20, 2016 (Registration file number 333-211478), the Registrant’s
Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 6, 2017 (Registration file number 333-218538),
the Registrant’s Registration Statement on Form F-3, as amended, originally filed with the Securities and Exchange Commission
on July 16, 2018 (Registration file number 333-226195), the Registrant’s Registration Statement on Form S-8 filed with the Securities
and Exchange Commission on March 28, 2019 (Registration file number 333-230584), the Registrant’s Registration Statement on Form F-3 filed with the Securities and Exchange Commission on September 16, 2019 (Registration file number 333-233795), the Registrant’s
Registration Statement on Form F-1 filed with the Securities and Exchange Commission on December 27, 2019 (Registration file
number 333-235729), the Registrant’s Registration Statement on Form F-3 filed with the Securities and Exchange Commission on May
13, 2020 (Registration file number 333- 238229), the Registrant’s Registration Statement on Form S-8 filed with the Securities
and Exchange Commission on May 18, 2020 (Registration file number 333-238481), each of the Registrant’s Registration Statements
on Form F-3 filed with the Securities and Exchange Commission on July 10, 2020 (Registration file numbers 333-239807 and 333-233793),
the Registrant’s Registration Statement on Form S-8 filed with the Securities and Exchange Commission on April 4, 2022 (Registration
file number 333-264107) and the Registrant’s Registration Statement on Form F-3 filed with the Securities and Exchange Commission
on March 23, 2023 (Registration file number 333-270769) and the Registrant’s Registration Statement on Form F-3, as amended,
originally filed with the Securities and Exchange Commission on December 8, 2022 (Registration file number 333-268710), to be a part
thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
October 3, 2023 |
PURPLE BIOTECH LTD. |
|
|
|
By: |
/s/ Lior Fhima |
|
|
Lior Fhima |
|
|
Chief Financial Officer |
Exhibit
99.1
Purple
Biotech Reports Positive Interim and Preliminary Results from
NT219 Phase 1/2 Study in R/M Head & Neck Cancer
| ● | Anti-tumor
activity noted in the highest dose cohort of NT219 in combination with cetuximab; |
| ● | 2
out of 4 SCCHN patients at the highest dose cohort demonstrated a confirmed partial response |
| ● | NT219
exposure at the highest dose level reaching human equivalent dose for efficacy based on animal
models |
| ● | Target
engagement was confirmed in patients’ tissue biopsies |
| ● | Phase
2 study of NT219 in combination with cetuximab in 2L SCCHN, is being designed |
REHOVOT, Israel, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech” or “the Company”) (NASDAQ/TASE: PPBT), a clinical-stage
company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and
drug resistance, provides clinical updates from its dose escalation portion of the Phase 1/2 study of NT219, a first in class dual inhibitor
of Insulin receptor substrate (IRS) 1/2 and Signal Transducer and Activator of Transcription 3 (STAT3) and provides its outlook for planning
the next clinical development steps with NT219 for second-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma
of the head & Neck (R/M SCCHN).
The
Phase 1/2 study (NCT04474470), an open-label, dose escalation and expansion study is designed to assess the safety, pharmacokinetics
(PK), pharmacodynamics (PD) and efficacy of NT219 as a monotherapy and in combination with Erbitux® (cetuximab), in patients with
R/M SCCHN, or with advanced colorectal cancer. Forty-nine patients were enrolled in five dose levels (3, 6, 12, 24 and 50 mg/kg); 27
in the monotherapy arm, and 22 in the combination therapy with cetuximab. Patients in both cohorts were dosed to the highest NT219 dose
level of 50mg/kg. No dose-limiting toxicities (DLTs) were reported in either cohort and NT219 was well tolerated
as a monotherapy and in combination with cetuximab.
A
dose-dependent increase in drug exposure of NT219 was reported. The exposure achieved at the highest dose level of 50mg/kg was within
the efficacy range of the human equivalent dose level as predicted from preclinical models. Inhibition of intra-tumoral IRS 1/2 and STAT3,
NT219’s targets, was demonstrated in patients’ biopsies.
Among
the four R/M SCCHN patients dosed at 50mg/kg of NT219 in combination with cetuximab, that were evaluable for efficacy, two patients demonstrated
confirmed partial response by response evaluation criteria in solid tumors (RECIST) 1.1. Other results from the Phase 1/2 study will
be provided at one of the upcoming medical conferences.
“We
believe these results are very encouraging given the low response rate to cetuximab as monotherapy in recurrent/metastatic SCCHN patients
in the second/third line,” said Ari Rozenberg, M.D, University of Chicago and study Investigator. “While still early, we
are excited to see responders at the highest NT219 dose level where we expected the appropriate exposure to be attained, along with evidence
of on target treatment effect in patients’ biopsies. I look forward to continuing investigating NT219 and seeing more data in this
disease setting with urgent need for improved therapies.”
Treatment
options for patients who had progressed following treatment with immunotherapy in first line R/M SCCHN are limited, with mostly cetuximab
and chemotherapy currently available. The Company is in the process of designing a Phase 2 study of NT219 in combination with cetuximab
in 2L R/M SCCHN. Such a study may evaluate NT219 in combination with cetuximab with or without standard of care chemotherapy following
progression after immunotherapy in first line treatment.
Gil
Efron, Purple Biotech CEO, added, “I am very satisfied with the observed activity of NT219 in recurrent and/or metastatic SCCHN
patients. Due to the dire unmet need in this difficult to treat population, we believe that extending these early results through a robust
proof of concept study would be meaningful for patients and for Purple Biotech and may lead us to next development steps. We will continue
exploring higher dose optimization while designing our next study. We believe that the good tolerability of NT219 in combination with
cetuximab can position this combination as a strong candidate to combine with other agents in 2L SCCHN and to achieve better survival
for patients. Additionally, as demonstrated by our preclinical data, we believe that this data could potentially pave the way for development
of NT219 in combination with EGFR inhibitors or other agents such as a-PD1 and KRAS inhibitors, potentially unlocking the full potential
of NT219.”
About
Purple Biotech
Purple
Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion
and drug resistance. The Company’s oncology pipeline includes NT219, CM24 and IM1240. NT219 is a dual inhibitor, novel small molecule
that simultaneously targets IRS1/2 and STAT3. In a Phase 1/2 study of NT219, the Company is currently advancing it in a dose escalation
as a monotherapy treatment of solid tumors, and in a dose escalation in combination with cetuximab for the treatment of recurrent and
metastatic squamous cell carcinoma of the head and neck (SCCHN) or colorectal adenocarcinoma (CRC). These studies will be followed by
a proof-of-concept study of NT219 at its recommended Phase 2 level in combination with cetuximab in patients with recurrent and metastatic
SCCHN. CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and
survival through multiple pathways. The Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in a
Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC). The Company has entered into a clinical collaboration agreement
with Bristol Myers Squibb for the Phase 2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab in addition
to chemotherapy. IM1240 is a preclinical, conditionally-activated tri-specific antibody that engages both T cells and NK cells to mount
a strong, localized immune response within the tumor microenvironment. The third arm specifically targets the Tumor Associated Antigen
(TAA) 5T4 that is expressed in a variety of solid tumors and is correlated with advanced disease, increased invasiveness and poor clinical
outcomes. IM1240 has a cleavable capping technology that confines the compound’s therapeutic activity to the local tumor microenvironment,
and thereby potentially increases the anticipated therapeutic window in patients. The Company’s corporate headquarters are located in
Rehovot, Israel. For more information, please visit https://purple-biotech.com/.
Forward-Looking
Statements and Safe Harbor Statement
Certain
statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include,
but are not limited to, statements that are not statements of historical fact, and may be identified by words such as “believe”,
“expect”, “intend”, “plan”, “may”, “should”, “could”, “might”,
“seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate”
or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly
to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance.
Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject
to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other
factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance
or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences
include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development
for NT219, CM24 and IM1240; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product
is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development
and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize
our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation
and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order
to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable
regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which
we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular
market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other
protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference
or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action;
and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual
Report on Form 20-F for the year ended December 31, 2022 and in our other filings with the U.S. Securities and Exchange Commission (“SEC”),
including our cautionary discussion of risks and uncertainties under “Risk Factors” in our Registration Statements and Annual
Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides
those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which
it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained
herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however,
to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC’s website, https://www.sec.gov.
CONTACTS:
Company
Contact:
Lior Fhima
Chief Financial Officer
IR@purple-biotech.com
Purple Biotech (NASDAQ:PPBT)
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Purple Biotech (NASDAQ:PPBT)
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