Kalytera Therapeutics, Inc. (TSX-V:KALY) (“Kalytera”) announced
today that it has successfully completed the previously announced
acquisition (the “Acquisition”) of Talent Biotechs Ltd. (“Talent”),
strengthening Kalytera’s position as an emerging market leader in
cannabidiol (“CBD”) pharmaceuticals. Talent is a privately held,
Israeli-based company evaluating the use of CBD to prevent and
treat Graft versus Host Disease (“GvHD”).
“We feel incredibly fortunate to be continuing Talent’s
groundbreaking work in GvHD,” said Andrew Salzman, M.D., Kalytera’s
Chief Executive Officer. “There are currently few options to
prevent or treat persons with GvHD, a large and critically
underserved market. The results of Talent’s Phase 2 clinical
studies are unprecedented, and mark a major milestone in the
potential prevention and treatment of this severe and
life-threatening disease. We are encouraged by the data and seek to
rapidly advance the GvHD program into FDA Phase 2b clinical
studies.”
“This is a transformational transaction for Kalytera,” said
Robert Farrell, President, COO, and CFO of Kalytera. “Multiple
studies have demonstrated that CBD, a non-psychoactive cannabis
constituent, possesses remarkable therapeutic potential across a
broad range of diseases and disorders. The acquisition of Talent
and its late-stage GvHD program significantly advances Kalytera’s
position as an emerging leader in CBD pharmaceuticals. We expect
our work in GvHD to be the first of many programs that seek to
investigate and commercialize this important compound.”
Summary of Transaction Terms
As consideration for the Acquisition, Kalytera will provide a
combination of cash, securities, and future contingent payments to
Talent. To date, Kalytera has made cash payments to Talent totaling
USD$10,000,000. In addition, Kalytera has issued 17,301,208 common
shares to Talent, which securities will be subject to a contractual
hold period expiring December 30, 2017. Subject to the completion
of certain milestones in relation to the development and
commercialization of the GvHD program, Kalytera will pay up to
USD$20,000,000 in aggregate future contingent payments. Kalytera
shall also issue to Talent an additional 2,883,535 common shares
upon the completion of the first Phase 2b clinical study, and a
further additional 2,883,535 common shares upon the issuance of the
first patent by the USPTO or EU with respect to certain assets of
Talent acquired in connection with the Acquisition. The
shareholders of Talent shall also receive additional earn-out
payments equal to 5% of the aggregate annual net sales of all
products covered by patent rights included in the business of
Talent. The Acquisition has been conditionally approved by
the TSX Venture Exchange, but remains subject to final
approval.
About Graft versus Host
Disease
GvHD is an orphan disease that can arise following hematopoietic
stem cell transplantation (“HCT”), a procedure where the stem cells
of the bone marrow or peripheral blood of a healthy donor are
transplanted into a new host after chemotherapy or radiation. HCT
is a lifesaving procedure for many diseases of the blood and bone
marrow including leukemia, Hodgkin and Non-Hodgkin lymphoma,
multiple myeloma, sickle cell anemia, and thalassemia. There were
over 8,000 HCT procedures in the U.S. in 20141 and the use of
HCT procedures is expected to continue to increase. While HCT
procedures can be lifesaving, they pose many dangerous side
effects, including infection and GvHD.
GvHD is a multisystem disorder that occurs when the transplanted
cells from a donor (“the graft”) recognize the transplant recipient
(“the host”) as foreign. This interaction initiates an immune
reaction that causes disease in the transplant recipient. This
reaction can occur within days after the transplant (acute GvHD) or
months to years after HCT (chronic GvHD).
GvHD can be mild, moderate, severe, and even life threatening.
Patients with acute GvHD may suffer from rashes and blistering of
the skin, nausea, vomiting, abdominal cramps accompanied by
diarrhea, and jaundice. Generally, acute reactions are more severe
and life threatening.
GvHD is a major cause of morbidity and mortality following HCT.
Researchers estimate that even with intensive prophylaxis with
immunosuppressive treatments, 30-50% of patients transplanted from
fully matched sibling donors and 50-70% of patients transplanted
from unrelated donors will develop some level of GvHD2. The GvHD
market was valued at $295M across the six major markets in 2013,
and is expected to grow to $544M by 2023, according to the research
and consulting firm GlobalData3.
Standard of Care: Prevention and Treatment of
GvHD
The first step in prevention of GvHD is the selection of donor
cells that closely match the genetics of the immune system of the
transplant recipient, ideally a sibling donor. From there, the
patient relies on drugs that have been developed to prevent or
treat GvHD. Medicinal prevention of acute GvHD is dependent on
immunosuppression of the donor cells, either pharmacologically or
through T cell depletion. Common drugs include methotrexate,
cyclosporine tacrolimus, sirolimus, mycophenolate mofetil, and ATG.
Preventive measures and clinical practices vary by
institution4.
Treatment of GvHD involves pharmacologic suppression of the
graft’s immune cell activation and reestablishment of donor-host
immune-tolerance. Most patients are prescribed corticosteroids,
which directly suppress the donor’s immune cell attack on host
tissue, but also raise the risk of infection and cancer relapse. As
with prevention, the optimal drug strategy for GvHD is not well
defined. Only 30-50% of patients with moderate to severe GvHD
respond to corticosteroids, putting many at risk for fatal
outcomes5. Better treatment options are needed to improve the
mortality and morbidity outcomes for transplant recipients.
CBD and GvHD
CBD is a major component of Cannabis sativa, commonly known as
marijuana. CBD possesses potent anti-inflammatory and
immunosuppressive properties. Unlike the other major component of
cannabis, tetrahydrocannabinol (“THC”), CBD is non-psychoactive and
is well tolerated by humans when taken over extended periods of
time6. CBD has shown benefit in a number of models of inflammatory
diseases including diabetes7, rheumatoid arthritis8, multiple
sclerosis9, and inflammatory bowel disease10.
GvHD Clinical Research
In May 2015, Moshe Yeshurun, M.D., Chief Medical Officer of
Talent and of the Head of the Bone Marrow Transplantation
Department at the Rabin Medical Center in Israel, published the
results of a Phase 2a study that followed adult recipients of HCT
receiving standard GvHD prophylaxis11. Study participants were
provided with daily doses of CBD for the seven days prior to
transplantation and for 30 days after HCT. Participants were
monitored for an average of 16 months following treatment. Talent
researchers compared the trial results to historical data and
reported that:
- No participants developed Acute GvHD while being treated with
CBD
- The risk of developing Acute GvHD by day 100 was decreased
- Among those that did develop GvHD after HCT, the time to onset
was significantly longer (60 days in the CBD group versus 20 days
in the control group)
- Participants treated with CBD had fewer skin and
gastrointestinal issues compared to the control group
- CBD treatment was found to be safe and well tolerated
Based on these promising results, Talent
commenced a second phase 2a trial to evaluate the efficacy of a
longer administration of CBD following HCT. As disclosed by
Kalytera in its January 18, 2017 press release, in this study,
which enrolled 12 patients, participants were provided daily doses
of CBD 7 days prior to transplantation and for 100 days following
the procedure. With a median follow up of 8.5 months following
transplantation, preliminary results show that 85% of the patients
did not develop significant (Grades 2-4) acute GvHD, although most
of them received bone marrow from unrelated donors, and only 2
patients developed acute GVHD (being 15% of patients), versus the
predicted incidence of 50-70% in the scientific literature.
Talent has completed additional pilot studies exploring the use
of CBD in the treatment of GvHD. Kalytera plans to initiate
placebo-controlled, double blind, randomized studies of CBD for
both the prevention and treatment of GvHD. These clinical studies
may support U.S. Food and Drug Administration (“FDA”) Breakthrough
Therapy and Fast Track Designations, which could accelerate the
regulatory approval process.
About Kalytera TherapeuticsKalytera
(TSX-V:KALY) is pioneering the development of a next generation of
cannabinoid therapeutics. Through its proven leadership, drug
development expertise, and intellectual property portfolio,
Kalytera seeks to establish a leading position in the development
of novel cannabinoid medicines for a range of important unmet
medical needs, with an initial focus on Graft versus Host Disease
(“GvHD”).
Kalytera is focused first on developing a new class of
proprietary cannabidiol (“CBD”) therapeutics. CBD is a remarkable
compound that has shown activity against a number of
pharmacological targets. However, there are limitations associated
with natural CBD, including its poor oral bioavailability and short
half-life. Kalytera is developing innovative CBD formulations and
prodrugs in an effort to overcome these limitations, and to target
specific disease sites within the body. Kalytera intends to file
composition of matter and method of use patents covering its novel
inventions, with the goal of limiting future competition.
- Website Home: https://kalytera.co/
- News and Insights: https://kalytera.co/news/
- Investors: https://kalytera.co/investors/
Cautionary NoteNeither the TSXV nor its
Regulation Services Provider (as that term is defined in the
policies of the TSXV) has in any way passed upon the merits of the
proposed Transaction and associated transactions and neither of the
foregoing entities has in any way approved or disapproved of the
contents of this press release.
Neither the TSXV nor its Regulation Services Provider (as that
term is defined in the policies of the TSXV) accepts responsibility
for the adequacy or accuracy of this press release.
Forward-Looking Statement DisclosureThis news
release contains “forward-looking information” within the meaning
of applicable securities laws relating to the proposed Transaction
including statements regarding the terms and conditions of the
proposed Transaction, as well as information relating to Talent.
The information about Talent contained in the press release has not
been independently verified by Kalytera. Although Kalytera believes
in light of the experience of its officers and directors, current
conditions and expected future developments and other factors that
have been considered appropriate, that the expectations reflected
in this forward-looking information are reasonable, undue reliance
should not be placed on them because Kalytera can give no assurance
that they will prove to be correct. Readers are cautioned to not
place undue reliance on forward-looking information. Actual results
and developments may differ materially from those contemplated by
these statements, depending on, among other things, the risks of
failure to obtain final approval of the TSX Venture Exchange,
failure of the results of the Phase 2a clinical trial to be
consistent with the preliminary results of such trial, that the
Phase 2a clinical trial results are not determinative of or
consistent with the results of the results of future Phase 2 or
other clinical studies, that the small number of patients in the
Phase 2a clinical trial may contribute to the risk that future
studies may be inconsistent with the results of the Phase 2a
clinical trial, and that clinical trials are subject to a number of
other health, safety, efficacy and regulatory risks. The statements
in this press release are made as of the date of this release.
Kalytera undertakes no obligation to comment on analyses,
expectations or statements made by third-parties in respect of
Kalytera, Talent, their securities, or their respective financial
or operating results (as applicable). Kalytera disclaims any intent
or obligation to update publicly any forward-looking information,
whether as a result of new information, future events or results or
otherwise, other than as required by applicable securities
laws.
1 Center for International Blood and Marrow Transplant
Research (CIBMTR) HCT Trends and Survival Data
2 Weisdorf D. GVHD the nuts and bolts. Hematology Am Soc
Hematol Educ Program. 2007;:62-7.
3 GlobalData Report (2015)
4 Ruutu T, Van biezen A, Hertenstein B, et al. Prophylaxis
and treatment of GVHD after allogeneic haematopoietic SCT: a survey
of centre strategies by the European Group for Blood and Marrow
Transplantation. Bone Marrow Transplant. 2012;47(11):1459-64.
5 Weisdorf D. GVHD the nuts and bolts. Hematology Am Soc
Hematol Educ Program. 2007;:62-7.
6 Mechoulam R, Peters M, Murillo-rodriguez E, Hanus LO.
Cannabidiol--recent advances. Chem Biodivers.
2007;4(8):1678-92.
7 Weiss L, Zeira M, Reich S, et al. Cannabidiol lowers
incidence of diabetes in non-obese diabetic mice. Autoimmunity.
2006;39(2):143-51.
8 Malfait AM, Gallily R, Sumariwalla PF, et al. The
nonpsychoactive cannabis constituent cannabidiol is an oral
anti-arthritic therapeutic in murine collagen-induced arthritis.
Proc Natl Acad Sci USA. 2000;97(17):9561-6.
9 Trojano M. Advances in the management of MS symptoms:
real-life evidence. Neurodegener Dis Manag. 2015;5(6
Suppl):19-21.
10 Schicho R, Storr M. Topical and systemic cannabidiol
improves trinitrobenzene sulfonic acid colitis in mice.
Pharmacology. 2012;89(3-4):149-55.
11 Yeshurun M, Shpilberg O, Herscovici C, et al.
Cannabidiol for the Prevention of Graft-versus-Host-Disease after
Allogeneic Hematopoietic Cell Transplantation: Results of a Phase
II Study. Biol Blood Marrow Transplant. 2015;21(10):1770-5.
Company Contact
Robert Farrell
President, COO and CFO
Phone: (888) 861-2008
Email: ir@kalytera.co
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