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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or Section 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): December 6, 2023
ANIXA
BIOSCIENCES, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-37492 |
|
11-2622630 |
(State
or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS
Employer
Identification
No.) |
3150
Almaden Expressway, Suite 250
San
Jose, CA |
|
95118 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (408) 708-9808
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation to the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.01 per share |
|
ANIX |
|
The
NASDAQ Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01. Regulation FD Disclosure.
On
December 6, 2023, Anixa Biosciences, Inc. (“we,” “us,” “our,” or the “Company”) issued
a press release announcing that the Company and Cleveland Clinic Foundation (“Cleveland Clinic”) presented new and updated
positive data from the Phase 1 study of its breast cancer vaccine. The press release, which is furnished as Exhibit 99.1 hereto, was
issued following a presentation made by G. Thomas Budd, M.D. of Cleveland Clinic Cancer Institute. Furnished hereto as Exhibit 99.2 is
the poster utilized by Dr. Budd for the presentation.
Statements
that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform
Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect our current expectations concerning
future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,”
“anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such
forward-looking statements, including those concerning our clinical trials, involve risks, uncertainties and other factors, some of which
are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different
from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties
and factors include, but are not limited to, those factors set forth in “Item 1A - Risk Factors” and other sections of our
most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake
no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise,
except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented
in this Current Report.
Item 9.01. Financial Statements and Exhibits
(d)
Exhibits
The
following exhibits are filed with this Current Report on Form 8-K:
Exhibit
No. |
|
Description |
|
|
|
99.1 |
|
Press Release |
99.2 |
|
Presentation
|
104 |
|
Cover Page Interactive Data File (embedded within the
Inline XBRL document). |
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 hereunto duly authorized.
Dated:
December 7, 2023 |
|
|
|
|
|
|
ANIXA
BIOSCIENCES, INC. |
|
|
|
|
By: |
/s/
Michael J. Catelani |
|
Name: |
Michael
J. Catelani |
|
Title: |
President,
Chief Operating Officer and Chief Financial Officer |
Exhibit
99.1
|
Anixa
Biosciences, Inc. 3150
Almaden
Expressway
Suite
250
San
Jose, CA 95118
408.708.9808
NASDAQ:
ANIX |
Anixa
Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine
–
Antigen-specific T cell responses were observed at all dose levels –
–
IFNγ and IL-17, immune-mediated biomarkers of T cell activation, increased over time from baseline –
–
Vaccine was safe and well tolerated –
–
Conference call to commence today at 6:30 p.m. ET –
SAN
JOSE, Calif., December 6, 2023 /PRNewswire/ — Anixa Biosciences, Inc. (“Anixa” or the “Company”)
(NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced new and updated positive results
from the Phase 1 clinical trial of its breast cancer vaccine. The trial is being conducted in collaboration with Cleveland Clinic with
funding by a grant from the U.S. Department of Defense.
The
data were presented at the 2023 San Antonio Breast Cancer Symposium by G. Thomas Budd, M.D., staff physician at Cleveland Clinic Cancer
Institute and principal investigator of the study, in a poster entitled “Phase I Trial of alpha-lactalbumin vaccine in high-risk
operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC.”
Patients
who had been curatively treated for TNBC received three vaccinations given once every two weeks. IFNγ and IL-17, which are T cell
immune response indicators (cellular immunity), and antibody production (B cell humoral immunity) were measured to evaluate the vaccination
effect. Data from the 16 patients treated to date showed that:
● |
The
majority of patients developed ELISpot (T-cell) responses that met the rigorous protocol-specified definition of an immune response,
with a measurable but lesser magnitude of response noted in the remaining patients. |
|
|
● |
12
(75%) of the women had antigen-specific IFNγ and/or IL-17 ELISpot responses that were observed at all dose levels, while ELISA
antibody responses were observed at Dose Level 2 and higher. |
|
|
● |
A
statistically significant (P = 0.03) increase in IFNγ over baseline (Day 0) was observed by Day 56; while a significant (P
= 0.0001) increase in IL-17 over baseline was observed by Day 14. |
|
|
● |
Among
the doses studied, Dose Level 1 (10 mcg α-lactalbumin/10 mcg zymosan) was determined to be a usable immunologic dose as well
as the maximum tolerated dose (MTD). |
|
|
● |
No
significant side effects were observed, at the MTD, besides irritation at the sites of injection. No myalgias, flu-like symptoms,
or aberrant laboratory values were noted. |
Anixa
and Cleveland Clinic plan to investigate additional intermediate dose levels and continue studying the vaccine’s safety and immunologic
effects in two additional patient cohorts.
● |
The
first cohort, which opened for enrollment in August 2023, is evaluating the combination of the Company’s breast cancer vaccine
with Keytruda® (pembrolizumab) in post-operative patients found to have residual disease following neoadjuvant chemo-immunotherapy.
|
|
|
● |
The
second cohort will investigate the safety and immunologic effects of the vaccine in patients who are BRCA1, BRCA2, or PALB2 mutation
positive and are planning prophylactic risk-reducing mastectomies. |
“The
data from our Phase 1 trial to date has exceeded our expectations, and we are pleased with our progress. This vaccine is designed to
direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine
development,” stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. “We look forward to reviewing additional data
as the trial continues to completion, and we are in the planning stages of the Phase 2/3 studies of this vaccine. Our goal is to initially
evaluate the vaccine’s ability to prevent recurrence of cancer in survivors, and continue with extension studies to eventually
determine its effectiveness in preventing the initial onset of TNBC.”
“There
is a large unmet need for preventing TNBC, an aggressive form of breast cancer with few targeted treatment options available,”
said Dr. Budd, Cleveland Clinic. “We are encouraged by the data gathered to date and look forward to determining the optimal vaccine
dose in additional patient cohorts. Our hope is that future studies will demonstrate that the antigen-specific T cell responses we observed
translate to the prevention of breast cancer recurrence.”
Anixa
is the exclusive worldwide licensee to the novel breast cancer vaccine technology invented at Cleveland Clinic, the site of the Phase
1 trial. The grant from the U.S. Department of Defense was made directly to Cleveland Clinic.
Conference
Call Information
Anixa
is pleased to invite all interested parties to participate in a conference call, during which this new data will be discussed.
Conference
Call Details:
Presentation
host: |
Anixa
management, with special guest speakers |
Date
and time: |
Today,
December 6, 2023, at 6:30 p.m. ET |
Phone
access: |
Registration
Link to receive your dial-in number and unique PIN |
Webcast: |
Available
at www.anixa.com under “Events & Presentations” |
About
Triple-Negative Breast Cancer
One
in eight women in the U.S. will be diagnosed with an invasive breast cancer at some point in their lives. Approximately 10-15% of those
diagnoses are TNBC, however TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of
recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast
tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.
About
Anixa Bioscience’s Breast Cancer Vaccine
Anixa’s
breast cancer vaccine takes advantage of endogenously produced proteins that have a function at certain times in life, but then become
“retired” and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which
is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers. Activating
the immune system against this “retired” protein provides preemptive immune protection against emerging breast tumors that
express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune
system to mount a response against emerging tumors to prevent them from growing. This vaccine technology was invented by the late Dr.
Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation
and Immunity at Cleveland Clinic’s Lerner Research Institute. Dr. Tuohy was inventor of the technology, which Cleveland Clinic
exclusively licensed to Anixa Biosciences. He was entitled to a portion of the commercialization revenues received by Cleveland Clinic
and also held equity in Anixa.
About
Anixa Biosciences, Inc.
Anixa
is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa’s therapeutic portfolio consists
of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-
T, known as chimeric endocrine receptor T-cell (CER-T) technology. The Company’s vaccine portfolio includes a novel vaccine being
developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC),
the most lethal form of the disease – as well as a vaccine to prevent ovarian cancer. These vaccine technologies focus on immunizing
against “retired” proteins that have been found to be expressed in certain forms of cancer. Anixa’s unique business
model of partnering with world-renowned research institutions on clinical development allows the Company to continually examine emerging
technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow
Anixa on Twitter, LinkedIn, Facebook and YouTube.
Forward-Looking
Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa’s
current expectations concerning future events and results. We generally use the words “believes,” “expects,”
“intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions
to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks,
uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements,
or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking
statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A - Risk
Factors” and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10- Q and
Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result
of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward- looking
statements when evaluating the information presented in this press release.
Contacts:
Stephen
Kilmer
Investor
Relations
skilmer@anixa.com
646-274-3580
Mike
Catelani
President,
COO & CFO
mcatelani@anixa.com
408-708-9808
Exhibit 99.2
v3.23.3
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