Advaxis Provides 2017 Business Outlook
January 09 2017 - 8:00AM
Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company
developing cancer immunotherapies, today issued its 2017 business
outlook to provide an overview of anticipated events and key
milestones for the coming year, as well as a look back at clinical
and business highlights from 2016.
Advaxis made significant strides in its clinical
development programs and expanded its pipeline with additional
preclinical assets in 2016. The company’s lead product candidate,
axalimogene filolisbac, received Fast Track designation and a
Special Protocol Assessment (SPA) for the global Phase 3 AIM2CERV
study, a randomized study of axalimogene filolisbac following
chemoradiation in patients with high-risk, locally advanced
cervical cancer (HRLACC). Also in 2016, axalimogene filolisbac was
classified as an advanced therapy medicinal product (ATMP) for the
treatment of cervical cancer by the European Medicines Agency's
(EMA) Committee for Advanced Therapies (CAT). Late in 2016, the
company initiated AIM2CERV and announced positive, final data from
the GOG-0265 Phase 2 trial that supports pursuing a second global
Phase 3 study in a metastatic recurrent cervical cancer. Also in
2016, Advaxis entered into a collaboration with Amgen Inc. (Amgen)
for the global development and commercialization of Advaxis’
preclinical neoantigen technology, ADXS-NEO, to create a
personalized approach to cancer treatment.
In 2016, Advaxis expanded its capabilities and
added significant resources to support execution of two global
registrational clinical trials and future commercialization of its
immuno-oncology products. The company added close to $100 million
in capital from proceeds from the Amgen collaboration, a direct
placement and a state grant. Advaxis expanded its management team
in 2016 with the appointment of Chris Duke as Chief Operating
Officer, and added approximately 30 more employees in key areas, as
the company grew its headcount to 80 over the course of the year.
In September, the company completed the buildout of its
clinical manufacturing facility to produce clinical trial supplies
and expanded its research laboratory facility. Also, the company
began construction of its commercial manufacturing facility, all at
its Princeton headquarters.
2017 OPERATIONAL MILESTONES
Advaxis anticipates the following development
milestones in 2017:
Clinical Operations
Axalimogene Filolisbac
- Present a detailed data analysis of the completed Phase 2
GOG-0265 trial, which was conducted by the GOG Foundation, Inc.
(GOG, now part of NRG Oncology), evaluating patients with
persistent or recurrent metastatic (squamous or non-squamous cell)
carcinoma of the cervix (PRmCC), at a medical meeting in the first
half of 2017. Top-line data released in 2016 showed a 12-month
overall survival rate of 38 percent observed in 50 patients in the
trial. This is a 52 percent improvement over the 12-month overall
survival rate that was expected in the trial’s patient population
based on prognostic factors.
- Attend an end-of-Phase-2 meeting with respect
to PRmCC with the U.S. Food and Drug Administration (FDA)
to discuss the results of GOG-0265.
- Submit a marketing authorization application to the EMA for
approval of axalimogene filolisbac to treat patients with
metastatic cervical cancer in the second half of 2017.
- Open approximately 150 clinical sites for the global,
450-patient Phase 3 AIM2CERV trial in patients with HRLACC, with a
trial enrollment update to be issued at a medical meeting in the
first half of 2017. There are 10 active trial sites in the United
States as of this week.
- Initiate a second global, registrational Phase 3 study in
patients with metastatic cervical cancer in the second half of
2017.
- Present updated clinical data from the Phase 1/2 combination
trial with AstraZeneca’s investigational anti-PD-L1 inhibitor,
durvalumab, in patients with recurrent, persistent or metastatic
cervical cancer or HPV+ squamous cell cancer of the head and neck
(HNSCC) at a medical meeting in the second half of 2017.
- Present additional data from the Phase 2 BrUOG trial in
high-risk, locally advanced anal cancer, conducted in collaboration
with Brown University’s Oncology Research Group, at a medical
meeting in the first half of 2017.
- Present additional data from the Phase 2 window of opportunity
trial in HPV-positive head and neck cancers at a medical meeting in
the first half of 2017.
- With full enrollment achieved in Stage 1 of the FAWCETT Phase 2
trial in patients with persistent or recurrent metastatic anal
cancer, the company plans to present a preliminary trial update at
a medical meeting in the second half of 2017.
ADXS-PSA
- Complete initial dosing of Part B of the Phase 1/2 trial
evaluating ADXS-PSA in combination with KEYTRUDA® (pembrolizumab)
in advanced, metastatic castration-resistant prostate cancer
(mCRPC) and present preliminary data at a medical meeting in 2017.
- Initiate and complete enrollment of the expansion cohort by
year-end 2017.
ADXS-HER2
- Initiate a study in pediatric osteosarcoma in collaboration
with the Children’s Oncology Group in 2017.
Expanding Pipeline
ADXS-NEO Collaboration with Amgen
- Submit an Investigational New Drug (IND) application to the FDA
in early 2017.
- Initiate the first-in-human ADXS-NEO clinical trial.
- Accelerate the discovery of personalized cancer immunotherapies
derived from neoantigens as part of the TESLA (Tumor neoantigEn
SeLection Alliance) with the Parker Institute for Cancer
Immunotherapy and the Cancer Research Institute.
ADXS-HOT
- Prepare and file an IND with the FDA for ADXS-HOT constructs
that target tumor driver genes, so-called hotspot mutations or
public mutations, found in various cancer types in the second half
of 2017.
Enhanced
Manufacturing and Research Capabilities
- Increase capacity to include in-house clinical and commercial
manufacturing capabilities, initially to manufacture clinical
supplies for the ADXS-NEO program in 2017.
- Reduce lead times and improve overall supply chain by
operationalizing several technology transfers with its partners and
by installing new innovative technologies.
Corporate Development
- Pursue research, clinical and commercial partnerships to
optimize the cancer immunotherapy portfolio, including to enable
development of lead asset, axalimogene filolisbac, in combination
with other novel cancer therapies and to support its registration
and potential commercialization in the EU.
- Explore the application of detoxified Listeriolysin O (dtLLO)
technology and optimize the research and development as an adjuvant
molecule in the development of vaccines.
2016 REVIEW
Advaxis achieved several regulatory, clinical, business and
operational milestones in 2016:
Clinical Milestones
Axalimogene Filolisbac
- June: Presented preliminary data at American Society of
Clinical Oncology (ASCO) from stage 1 of the Phase 2 GOG-0265
clinical study showing a 6-month survival rate of 38.5 percent in
26 patients, which exceeds prior historical GOG trials in this
patient population. Of particular note, a patient from this stage
experienced a complete response following three doses which remains
ongoing.
- June: Dosed the first patient in the first stage of the Phase 2
FAWCETT trial in patients with persistent or recurrent metastatic
anal cancer.
- July: Reached an agreement with the FDA under the SPA process
for the Phase 3 AIM2CERV trial.
- July: Received classification as an ATMP for the treatment of
cervical cancer by the EMA’s CAT and received Fast Track
Designation from the FDA for high-risk, locally advanced cervical
cancer.
- October: Entered Phase 3 with initiation of AIM2CERV evaluating
axalimogene filolisbac as an adjuvant therapy following
chemotherapy and radiation.
- October: Announced updated data from the Phase 2 GOG-0265
clinical study which showed a patient with recurrent cervical
cancer achieved a durable complete response, as well as a 12-month
overall survival rate of 38 percent across all study subjects
(n=50), surpassing historical 12-month survival rates in GOG
studies which have never exceeded 30 percent.
- November: As presented at the Society for Immunotherapy of
Cancer annual meeting, a patient with cervical cancer participating
in the combination trial with AstraZeneca’s durvalumab achieved a
complete response, and two patients with HNSCC achieved stable
disease.
- April: The window of opportunity trial, as presented as
American Association for Cancer Research annual meeting, showed
increased systemic HPV-reactive T-cell responses in patients with
late-stage HPV-positive oropharyngeal cancer, allowing for the
trial to advance to the second stage, being conducted at the Icahn
School of Medicine at Mount Sinai.
ADXS-PSA
- April: Finalized the part A dose-escalation cohort of the Phase
1/2 KEYNOTE-046 combination trial with Merck, which evaluated
maximum tolerability of ADXS-PSA in patients with previously
treated mCRPC.
- October: Initiated the combination portion evaluating ADXS-PSA
in combination with KEYTRUDA.
ADXS-HER2
- May: As published in Clinical Cancer Research, in a
dose-escalation study of ADXS-HER2 in canine osteosarcoma,
antigen-specific T-cell responses were seen within 6 months of
immunotherapy administration.
- April: FDA granted Fast Track designation for ADXS-HER2 for
patients with newly diagnosed, non-metastatic,
surgically-resectable osteosarcoma.
Expanding Pipeline
ADXS-NEO
- January: Established a five-year exclusive supply agreement
with Synthetic Genomics, Inc. to manufacture the synthetic DNA used
in ADXS-NEO.
- August: Advaxis entered into a global collaboration with Amgen
to develop and commercialize ADXS-NEO. Under the collaboration
agreement, Advaxis will lead the clinical development of ADXS-NEO
through proof-of-concept, retain manufacturing responsibilities,
and receive development, regulatory and sales milestone payments of
up to $475 million. Amgen received worldwide rights to develop and
commercialize ADXS-NEO.
- December: Advaxis joined the TESLA (Tumor neoantigEn SeLection
Alliance) collaboration with the Parker Institute for Cancer
Immunotherapy and the Cancer Research Institute, along with 30
leading academia and industry partners, to further cancer
neoantigen research.
Business & Operations
Advaxis achieved the following operational milestones in
2016:
- Over the course of 2016, Advaxis expanded its leadership team,
deepening its clinical operations, manufacturing and business
development functions:
- Christopher Duke, Senior Vice President and Chief Operating
Officer.
- Ranya Dajani, Vice President, Corporate Development
- January: Established a Scientific Advisory Board, including
Antoni Ribas, M.D., Ph.D., Jedd Wolchok, M.D., Ph.D., Nancy
Freitag, Ph.D., Marc Lecuit, M.D., Ph.D.
- January: Added two more patents to its growing patent
portfolio; European Patent No. 1804831 expands the composition of
matter claims covering HER-2 tumor antigens, and U.S. Patent No.
9,226,958 expands the use of the Company's Lm Technology™ beyond
oncology, specifically to induce an immune response in
parasitically infected patients.
- February: Bradley Monk, co-primary investigator of the GOG-0265
Phase 2 study, joined Advaxis as the company’s Lead Cervical Cancer
Advisor to head the development of Advaxis’ Lm Technology platform
and lead the AIM2CERV program.
- February: Agreement established with Especificos Stendhal SA de
CV (“Stendhal”) to co-develop and commercialize axalimogene
filolisbac in Latin America.
- February: Daniel O’Connor, president and chief executive
officer of Advaxis, was appointed to the Board of Trustees of
BioNJ.
- April: Advaxis became the first biotechnology company to
receive the Vision of Hope Award from the Sarcoma Foundation of
America for its ADXS-HER2 osteosarcoma immunotherapy platform.
- August: Advaxis secured $30 million in direct placement
financing from healthcare institutional specialist investors.
- September: Advaxis unveiled its state-of-the-art laboratory and
manufacturing facility to develop immuno-oncology therapeutics in
Princeton N.J. where Governor Chris Christie led the ribbon-cutting
event.
- October: Advaxis received $2.5M through the New Jersey Economic
Development Authority’s (NJEDA) New Jersey Technology Business Tax
Certificate Transfer (NOL) program.
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a
clinical-stage biotechnology company developing multiple cancer
immunotherapies based on its proprietary Lm Technology.
The Lm Technology, using bioengineered live
attenuated Listeria monocytogenes (Lm) bacteria, is the
only known cancer immunotherapy agent shown in preclinical studies
to both generate cancer fighting T cells directed against cancer
antigens and neutralize Tregs and myeloid-derived suppressor cells
(MDSCs) that protect the tumor microenvironment from immunologic
attack and contribute to tumor growth. Advaxis'
lead Lm Technology immunotherapy, axalimogene filolisbac,
targets HPV-associated cancers and is in clinical trials for three
potential indications: Phase 3 in invasive cervical cancer, Phase 2
in head and neck cancer, and Phase 2 in anal cancer. The FDA has
granted axalimogene filolisbac orphan drug designation for each of
these three clinical settings, as well as Fast Track designation
for adjuvant therapy for HRLACC patients and a Special Protocol
Assessment for the Phase 3 AIM2CERV trial in HRLACC patients.
Axalimogene filolisbac has also been classified as an advanced
therapy medicinal product for the treatment of cervical cancer by
the European Medicines Agency's Committee for Advanced Therapies.
Advaxis has two additional immunotherapy products: ADXS-PSA in
prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in
human clinical development. In addition, Advaxis and Amgen are
developing ADXS-NEO, a preclinical investigational cancer
immunotherapy treatment designed to activate a patient's immune
system to respond against the unique mutations, or neoepitopes,
contained in and identified from each individual patient's tumor,
with plans to enter the clinic in 2017.
For additional information on Advaxis, visit
www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube
and Google+.
Advaxis Forward-Looking Statement
This press release contains forward-looking
statements, including, but not limited to, statements regarding
Advaxis’ ability to develop the next generation of cancer
immunotherapies, and the safety and efficacy of Advaxis’
proprietary immunotherapy, axalimogene filolisbac. These
forward-looking statements are subject to a number of risks
including the risk factors set forth from time to time in Advaxis’
SEC filings including, but not limited to, its report on Form 10-K
for the fiscal year ended October 31, 2016, which is available at
http://www.sec.gov.
Any forward-looking statements set forth in this
presentation speak only as of the date of this presentation. We do
not intend to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof
other than as required by law.
You are cautioned not to place undue reliance on
any forward-looking statements.
KEYTRUDA® is a registered trademark of Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Whitehouse Station, N.J., USA.
CONTACTS:
Company:
Advaxis, Inc. Ranya Dajani, Vice President, Corporate
Development dajani@advaxis.com 609.250.7559
Media Contact:
JPA Health Communications David Connolly dconnolly@jpa.com
617.945.9316
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