TIDMPRTC
PureTech Health PLC
10 December 2018
10 December 2018
PureTech Health plc
Bristol-Myers Squibb and PureTech's Vedanta Biosciences Announce
New Immuno-Oncology Collaboration to Evaluate OPDIVO(R) (nivolumab)
and VE800 in Patients with Advanced
or Metastatic Cancers
PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG) Axis, is pleased to note
that Bristol-Myers Squibb and Vedanta Biosciences today announced a
clinical collaboration to evaluate VE800, Vedanta Biosciences'
microbiome-derived immuno-oncology candidate, in combination with
Bristol Myers-Squibb's programmed death-1 (PD-1) immune checkpoint
inhibitor Opdivo (nivolumab), in patients with advanced or
metastatic cancers. Under the terms of the agreement, Vedanta
Biosciences will maintain control of its VE800 programme, including
global R&D and commercial rights.
In conjunction with this collaboration, and subject to the
completion of due diligence, the negotiation by the parties of
definitive transaction agreements and the receipt by Bristol-Myers
Squibb of all requisite approvals, Bristol-Myers Squibb currently
intends to make an equity investment in Vedanta Biosciences.
Bharatt Chowrira, JD, PhD, President and Chief of Business and
Strategy at PureTech Health, said:
"There is growing evidence to support the role of the microbiome
across a range of immune-mediated diseases, including cancers. We
are pleased to be working with Bristol-Myers Squibb to explore
VE800 in combination with Opdivo as a potential treatment option
for patients with advanced or metastatic cancers."
The full text announcement from Bristol-Myers Squibb and Vedanta
Biosciences is as follows:
Bristol-Myers Squibb and Vedanta Biosciences Announce a New
Clinical
Collaboration to Evaluate OPDIVO(R) (nivolumab) and VE800 in
Patients with Advanced
or Metastatic Cancers
NEW YORK and Cambridge, MA - December 10, 2018 - Bristol-Myers
Squibb Company (NYSE: BMY) and Vedanta Biosciences today announced
a clinical trial collaboration to evaluate Bristol-Myers Squibb's
programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo
(nivolumab) in combination with Vedanta Biosciences' VE800, a
rationally-defined human bacterial consortium, in patients with
advanced or metastatic cancers.
In a range of preclinical models of cancer, including those
sensitive and resistant to checkpoint inhibition, VE800 was shown
to induce CD8+ T cells, potentiate the immune system's attack of
tumor cells, and significantly amplify the effects of anti-PD-1
therapy. These models support clinical research to explore whether
modulating the microbiome with VE800 has the potential to broaden
the efficacy of checkpoint inhibitors.
"Our lead, microbiome-based immuno-oncology candidate, VE800, is
based on work conducted in collaboration with our co-founder, Dr.
Kenya Honda, showing in preclinical models that certain
gut-dwelling bacterial strains potentiate cytotoxic CD8+ T cells
and enhance infiltration into tumors," said Bernat Olle, Ph.D.,
Co-founder and Chief Executive Officer of Vedanta Biosciences.
"Through this collaboration our goal is to determine whether VE800
in combination with Opdivo can improve outcomes for patients with
advanced or metastatic cancers."
"We are continuing to explore the novel mechanisms of new assets
in combination with our oncology portfolio," said Fouad Namouni,
M.D., head of development, oncology, Bristol-Myers Squibb. "Vedanta
Biosciences is a leading company focused on the characterization of
immunomodulatory human gut commensals and the development of live
bacterial products for the potential treatment of human diseases.
Our collaboration with Vedanta Biosciences will allow us to gain a
deeper understanding about the emerging microbiome landscape, its
role in oncology, and the potential to improve outcomes for
patients with advanced or metastatic cancer."
"Checkpoint inhibitors, particularly PD-1 antibodies, have been
a major advance in cancer therapy; however, a large proportion of
patients either do not respond or have response of brief duration
to those new therapies," said Jeffrey Weber, M.D., Ph.D., Deputy
Director, Laura and Isaac Perlmutter Cancer Center and Professor of
Medicine, NYU Langone Health. "Alteration of the gut microbiome
could play a significant role in enhancing the effectiveness of
checkpoint inhibitors, and with increased understanding may also be
used to select for patients who would benefit most from these
immunotherapies."
In conjunction with this collaboration, and subject to the
completion of due diligence, the negotiation by the parties of
definitive transaction agreements and the receipt by Bristol-Myers
Squibb of all requisite approvals, Bristol-Myers Squibb currently
intends to make an equity investment in Vedanta Biosciences.
Vedanta Biosciences will maintain control of its VE800 program,
including global R&D and commercial rights.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint
inhibitor that is designed to uniquely harness the body's own
immune system to help restore anti-tumor immune response. By
harnessing the body's own immune system to fight cancer, Opdivo has
become an important treatment option across multiple cancers.
Opdivo's leading global development program is based on
Bristol-Myers Squibb's scientific expertise in the field of
Immuno-Oncology, and includes a broad range of clinical trials
across all phases, including Phase 3, in a variety of tumor types.
To date, the Opdivo clinical development program has enrolled more
than 25,000 patients. The Opdivo trials have contributed to gaining
a deeper understanding of the potential role of biomarkers in
patient care, particularly regarding how patients may benefit from
Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint
inhibitor to receive regulatory approval anywhere in the world.
Opdivo is currently approved in more than 65 countries, including
the United States, the European Union, Japan and China. In October
2015, the Company's Opdivo and Yervoy combination regimen was the
first Immuno-Oncology combination to receive regulatory approval
for the treatment of metastatic melanoma and is currently approved
in more than 50 countries, including the United States and the
European Union.
U.S. FDA-APPROVED INDICATIONS FOR OPDIVO
OPDIVO(Ò) (nivolumab) as a single agent is indicated for the
treatment of patients with BRAF V600 mutation-positive unresectable
or metastatic melanoma. This indication is approved under
accelerated approval based on progression-free survival. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in the confirmatory trials.
OPDIVO(Ò) (nivolumab) as a single agent is indicated for the
treatment of patients with BRAF V600 wild-type unresectable or
metastatic melanoma.
OPDIVO(R) (nivolumab), in combination with YERVOY(R)
(ipilimumab), is indicated for the treatment of patients with
unresectable or metastatic melanoma. This indication is approved
under accelerated approval based on progression-free survival.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the
confirmatory trials.
OPDIVO(Ò) (nivolumab) is indicated for the treatment of patients
with metastatic non--small cell lung cancer (NSCLC) with
progression on or after platinum-based chemotherapy. Patients with
EGFR or ALK genomic tumor aberrations should have disease
progression on FDA-approved therapy for these aberrations prior to
receiving OPDIVO.
OPDIVO(Ò) (nivolumab) is indicated for the treatment of patients
with advanced renal cell carcinoma (RCC) who have received prior
anti-angiogenic therapy.
OPDIVO(R) (nivolumab), in combination with YERVOY(R)
(ipilimumab), is indicated for the treatment of patients with
intermediate or poor-risk, previously untreated advanced renal cell
carcinoma (RCC).
OPDIVO(Ò) (nivolumab) is indicated for the treatment of adult
patients with classical Hodgkin lymphoma (cHL) that has relapsed or
progressed after autologous hematopoietic stem cell transplantation
(HSCT) and brentuximab vedotin or after 3 or more lines of systemic
therapy that includes autologous HSCT. This indication is approved
under accelerated approval based on overall response rate.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trials.
OPDIVO(Ò) (nivolumab) is indicated for the treatment of patients
with recurrent or metastatic squamous cell carcinoma of the head
and neck (SCCHN) with disease progression on or after
platinum-based therapy.
OPDIVO(Ò) (nivolumab) is indicated for the treatment of patients
with locally advanced or metastatic urothelial carcinoma who have
disease progression during or following platinum-containing
chemotherapy or have disease progression within 12 months of
neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy. This indication is approved under accelerated
approval based on tumor response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trials.
OPDIVO(R) (nivolumab) is indicated for the treatment of adult
and pediatric (12 years and older) patients with microsatellite
instability high (MSI-H) or mismatch repair deficient (dMMR)
metastatic colorectal cancer (CRC) that has progressed following
treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on
overall response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials.
OPDIVO(R) (nivolumab) is indicated for the treatment of patients
with hepatocellular carcinoma (HCC) who have been previously
treated with sorafenib. This indication is approved under
accelerated approval based on tumor response rate and durability of
response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the
confirmatory trials.
OPDIVO(R) (nivolumab) is indicated for the adjuvant treatment of
patients with melanoma with involvement of lymph nodes or
metastatic disease who have undergone complete resection.
IMPORTANT SAFETY INFORMATION
Immune-Mediated Pneumonitis
OPDIVO can cause immune-mediated pneumonitis. Fatal cases have
been reported. Monitor patients for signs with radiographic imaging
and for symptoms of pneumonitis. Administer corticosteroids for
Grade 2 or more severe pneumonitis. Permanently discontinue for
Grade 3 or 4 and withhold until resolution for Grade 2. In patients
receiving OPDIVO monotherapy, fatal cases of immune-mediated
pneumonitis have occurred. Immune-mediated pneumonitis occurred in
3.1% (61/1994) of patients.
In Checkmate 205 and 039, pneumonitis, including interstitial
lung disease, occurred in 6.0% (16/266) of patients receiving
OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of
patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).
Immune-Mediated Colitis
OPDIVO can cause immune-mediated colitis. Monitor patients for
signs and symptoms of colitis. Administer corticosteroids for Grade
2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO
monotherapy for Grade 2 or 3 and permanently discontinue for Grade
4 or recurrent colitis upon re-initiation of OPDIVO. In patients
receiving OPDIVO monotherapy, immune-mediated colitis occurred in
2.9% (58/1994) of patients.
Immune-Mediated Hepatitis
OPDIVO can cause immune-mediated hepatitis. Monitor patients for
abnormal liver tests prior to and periodically during treatment.
Administer corticosteroids for Grade 2 or greater transaminase
elevations. For patients without HCC, withhold OPDIVO for Grade 2
and permanently discontinue OPDIVO for Grade 3 or 4. For patients
with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT
is within normal limits at baseline and increases to >3 and up
to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and
up to 3 times ULN at baseline and increases to >5 and up to 10
times the ULN, and if AST/ALT is >3 and up to 5 times ULN at
baseline and increases to >8 and up to 10 times the ULN.
Permanently discontinue OPDIVO and administer corticosteroids if
AST or ALT increases to >10 times the ULN or total bilirubin
increases >3 times the ULN. In patients receiving OPDIVO
monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994)
of patients.
In Checkmate 040, immune-mediated hepatitis requiring systemic
corticosteroids occurred in 5% (8/154) of patients receiving
OPDIVO.
Immune-Mediated Endocrinopathies
OPDIVO can cause immune-mediated hypophysitis, immune-mediated
adrenal insufficiency, autoimmune thyroid disorders, and Type 1
diabetes mellitus. Monitor patients for signs and symptoms of
hypophysitis, signs and symptoms of adrenal insufficiency, thyroid
function prior to and periodically during treatment, and
hyperglycemia. Administer hormone replacement as clinically
indicated and corticosteroids for Grade 2 or greater hypophysitis.
Withhold for Grade 2 or 3 and permanently discontinue for Grade 4
hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal
insufficiency. Withhold for Grade 2 and permanently discontinue for
Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement
therapy for hypothyroidism. Initiate medical management for control
of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently
discontinue for Grade 4 hyperglycemia.
In patients receiving OPDIVO monotherapy, hypophysitis occurred
in 0.6% (12/1994) of patients. In patients receiving OPDIVO
monotherapy, adrenal insufficiency occurred in 1% (20/1994) of
patients. In patients receiving OPDIVO monotherapy, hypothyroidism
or thyroiditis resulting in hypothyroidism occurred in 9%
(171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994)
of patients receiving OPDIVO monotherapy. In patients receiving
OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of
patients.
Immune-Mediated Nephritis and Renal Dysfunction
OPDIVO can cause immune-mediated nephritis. Monitor patients for
elevated serum creatinine prior to and periodically during
treatment. Administer corticosteroids for Grades 2-4 increased
serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently
discontinue for Grade 4 increased serum creatinine. In patients
receiving OPDIVO monotherapy, immune-mediated nephritis and renal
dysfunction occurred in 1.2% (23/1994) of patients.
Immune-Mediated Skin Adverse Reactions
OPDIVO can cause immune-mediated rash, including Stevens-Johnson
syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases
with fatal outcome. Administer corticosteroids for Grade 3 or 4
rash. Withhold for Grade 3 and permanently discontinue for Grade 4
rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and
refer the patient for specialized care for assessment and
treatment; if confirmed, permanently discontinue. In patients
receiving OPDIVO monotherapy, immune-mediated rash occurred in 9%
(171/1994) of patients.
Immune-Mediated Encephalitis
OPDIVO can cause immune-mediated encephalitis. Evaluation of
patients with neurologic symptoms may include, but not be limited
to, consultation with a neurologist, brain MRI, and lumbar
puncture. Withhold OPDIVO in patients with new-onset moderate to
severe neurologic signs or symptoms and evaluate to rule out other
causes. If other etiologies are ruled out, administer
corticosteroids and permanently discontinue OPDIVO for
immune-mediated encephalitis. In patients receiving OPDIVO
monotherapy, encephalitis occurred in 0.2% (3/1994) of patients.
Fatal limbic encephalitis occurred in one patient after 7.2 months
of exposure despite discontinuation of OPDIVO and administration of
corticosteroids.
Other Immune-Mediated Adverse Reactions
Based on the severity of the adverse reaction, permanently
discontinue or withhold OPDIVO, administer high-dose
corticosteroids, and, if appropriate, initiate hormone-replacement
therapy. Across clinical trials of OPDIVO, the following clinically
significant immune-mediated adverse reactions, some with fatal
outcome, occurred in <1.0% of patients receiving OPDIVO:
myocarditis, rhabdomyolysis, myositis, uveitis, iritis,
pancreatitis, facial and abducens nerve paresis, demyelination,
polymyalgia rheumatica, autoimmune neuropathy, GuillainBarré
syndrome, hypopituitarism, systemic inflammatory response syndrome,
gastritis, duodenitis, sarcoidosis, histiocytic necrotizing
lymphadenitis (Kikuchi lymphadenitis), motor dysfunction,
vasculitis, aplastic anemia, pericarditis, and myasthenic
syndrome.
If uveitis occurs in combination with other immune-mediated
adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome,
which has been observed in patients receiving OPDIVO and may
require treatment with systemic steroids to reduce the risk of
permanent vision loss.
Infusion Reactions
OPDIVO can cause severe infusion reactions, which have been
reported in <1.0% of patients in clinical trials. Discontinue
OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt
or slow the rate of infusion in patients with Grade 1 or 2. In
patients receiving OPDIVO monotherapy as a 60-minute infusion,
infusion-related reactions occurred in 6.4% (127/1994) of patients.
In a separate study in which patients received OPDIVO monotherapy
as a 60-minute infusion or a 30-minute infusion, infusion-related
reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients,
respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of
patients, respectively, experienced adverse reactions within 48
hours of infusion that led to dose delay, permanent discontinuation
or withholding of OPDIVO.
Complications of Allogeneic HSCT after OPDIVO
Complications, including fatal events, occurred in patients who
received allogeneic HSCT after OPDIVO. Outcomes were evaluated in
17 patients from Checkmate 205 and 039, who underwent allogeneic
HSCT after discontinuing OPDIVO (15 with reduced-intensity
conditioning, 2 with myeloablative conditioning). Thirty-five
percent (6/17) of patients died from complications of allogeneic
HSCT after OPDIVO. Five deaths occurred in the setting of severe or
refractory GVHD. Grade 3 or higher acute GVHD was reported in 29%
(5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of
patients. A steroid-requiring febrile syndrome, without an
identified infectious cause, was reported in 35% (n=6) of patients.
Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic
encephalitis without an identified infectious cause, and Grade 3
(n=1) suspected viral encephalitis. Hepatic veno-occlusive disease
(VOD) occurred in one patient, who received reduced-intensity
conditioned allogeneic HSCT and died of GVHD and multi-organ
failure. Other cases of hepatic VOD after reduced-intensity
conditioned allogeneic HSCT have also been reported in patients
with lymphoma who received a PD-1 receptor blocking antibody before
transplantation. Cases of fatal hyperacute GVHD have also been
reported. These complications may occur despite intervening therapy
between PD-1 blockade and allogeneic HSCT.
Follow patients closely for early evidence of transplant-related
complications such as hyperacute GVHD, severe (Grade 3 to 4) acute
GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other
immune-mediated adverse reactions, and intervene promptly.
Embryo-Fetal Toxicity
Based on its mechanism of action, OPDIVO can cause fetal harm
when administered to a pregnant woman. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential
to use effective contraception during treatment with an
OPDIVO-containing regimen and for at least 5 months after the last
dose of OPDIVO.
Lactation
It is not known whether OPDIVO is present in human milk. Because
many drugs, including antibodies, are excreted in human milk and
because of the potential for serious adverse reactions in nursing
infants from an OPDIVO-containing regimen, advise women to
discontinue breastfeeding during treatment.
Serious Adverse Reactions
In Checkmate 037, serious adverse reactions occurred in 41% of
patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions
occurred in 42% of patients receiving OPDIVO. The most frequent
Grade 3 and 4 adverse drug reactions reported in 2% to <5% of
patients receiving OPDIVO were abdominal pain, hyponatremia,
increased aspartate aminotransferase, and increased lipase. In
Checkmate 066, serious adverse reactions occurred in 36% of
patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions
occurred in 41% of patients receiving OPDIVO. The most frequent
Grade 3 and 4 adverse reactions reported in >=2% of patients
receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and
diarrhea (3.4%). In Checkmate 017 and 057, serious adverse
reactions occurred in 46% of patients receiving OPDIVO (n=418). The
most frequent serious adverse reactions reported in >=2% of
patients receiving OPDIVO were pneumonia, pulmonary embolism,
dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory
failure. In Checkmate 032, serious adverse reactions occurred in
45% of patients receiving OPDIVO (n=245). The most frequent serious
adverse reactions reported in at least 2% of patients receiving
OPDIVO were pneumonia, dyspnea, pneumonitis, pleural effusion, and
dehydration. In Checkmate 025, serious adverse reactions occurred
in 47% of patients receiving OPDIVO (n=406). The most frequent
serious adverse reactions reported in >=2% of patients were
acute kidney injury, pleural effusion, pneumonia, diarrhea, and
hypercalcemia. In Checkmate 205 and 039, adverse reactions leading
to discontinuation occurred in 7% and dose delays due to adverse
reactions occurred in 34% of patients (n=266). Serious adverse
reactions occurred in 26% of patients. The most frequent serious
adverse reactions reported in >=1% of patients were pneumonia,
infusion-related reaction, pyrexia, colitis or diarrhea, pleural
effusion, pneumonitis, and rash. Eleven patients died from causes
other than disease progression: 3 from adverse reactions within 30
days of the last OPDIVO dose, 2 from infection 8 to 9 months after
completing OPDIVO, and 6 from complications of allogeneic HSCT. In
Checkmate 141, serious adverse reactions occurred in 49% of
patients receiving OPDIVO (n=236). The most frequent serious
adverse reactions reported in >=2% of patients receiving OPDIVO
were pneumonia, dyspnea, respiratory failure, respiratory tract
infection, and sepsis. In Checkmate 275, serious adverse reactions
occurred in 54% of patients receiving OPDIVO (n=270). The most
frequent serious adverse reactions reported in >=2% of patients
receiving OPDIVO were urinary tract infection, sepsis, diarrhea,
small intestine obstruction, and general physical health
deterioration. In Checkmate 040, serious adverse reactions occurred
in 49% of patients (n=154). The most frequent serious adverse
reactions reported in >=2% of patients were pyrexia, ascites,
back pain, general physical health deterioration, abdominal pain,
and pneumonia. In Checkmate 238, Grade 3 or 4 adverse reactions
occurred in 25% of OPDIVO-treated patients (n=452). The most
frequent Grade 3 and 4 adverse reactions reported in >=2% of
OPDIVO-treated patients were diarrhea and increased lipase and
amylase. Serious adverse reactions occurred in 18% of
OPDIVO-treated patients.
Common Adverse Reactions
In Checkmate 037, the most common adverse reaction (>=20%)
reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the
most common adverse reactions (>=20%) reported with OPDIVO
(n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%),
musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus
(23% vs 12%). In Checkmate 017 and 057, the most common adverse
reactions (>=20%) in patients receiving OPDIVO (n=418) were
fatigue, musculoskeletal pain, cough, dyspnea, and decreased
appetite. In Checkmate 032, the most common adverse reactions
(>=20%) in patients receiving OPDIVO (n=245) were fatigue (45%),
decreased appetite (27%), musculoskeletal pain (25%), dyspnea
(22%), nausea (22%), diarrhea (21%), constipation (20%), and cough
(20%). In Checkmate 025, the most common adverse reactions
(>=20%) reported in patients receiving OPDIVO (n=406) vs
everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%),
nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%),
diarrhea (25% vs 32%), constipation (23% vs 18%), decreased
appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20%
vs 14%). In Checkmate 205 and 039, the most common adverse
reactions (>=20%) reported in patients receiving OPDIVO (n=266)
were upper respiratory tract infection (44%), fatigue (39%), cough
(36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%),
rash (24%), nausea (20%), and pruritus (20%). In Checkmate 141, the
most common adverse reactions (>=10%) in patients receiving
OPDIVO (n=236) were cough and dyspnea at a higher incidence than
investigator's choice. In Checkmate 275, the most common adverse
reactions (>=20%) reported in patients receiving OPDIVO (n=270)
were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and
decreased appetite (22%). In Checkmate 142 in MSI-H/dMMR mCRC
patients receiving OPDIVO as a single agent, the most common
adverse reactions (>=20%) were fatigue (54%), diarrhea (43%),
abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal
pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation
(20%), and upper respiratory tract infection (20%). In Checkmate
040, the most common adverse reactions (>=20%) in patients
receiving OPDIVO (n=154) were fatigue (38%), musculoskeletal pain
(36%), abdominal pain (34%), pruritus (27%), diarrhea (27%), rash
(26%), cough (23%), and decreased appetite (22%). In Checkmate 238,
the most common adverse reactions (>=20%) reported in
OPDIVO-treated patients (n=452) vs ipilimumab-treated patients
(n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35%
vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%),
headache (23% vs 31%), nausea (23% vs 28%), upper respiratory
infection (22% vs 15%), and abdominal pain (21% vs 23%). The most
common immune-mediated adverse reactions were rash (16%),
diarrhea/colitis (6%), and hepatitis (3%).
Please see U.S. Full Prescribing Information for OPDIVO.
About VE800
VE800 is Vedanta Biosciences' oral immuno-oncology product
candidate. It consists of a rationally-defined bacterial consortium
that activates cytotoxic CD8+ T cells, a type of white blood cell
that is the predominant effector in cancer immunotherapy. In
preclinical studies, VE800 has been shown to enhance the ability of
these T cells to infiltrate tumors, thereby promoting suppression
of tumor growth and enhancing survival. Data also suggest that
VE800 may enhance the effects of checkpoint inhibitors. Vedanta
Biosciences is evaluating VE800 alone and in combination with
checkpoint inhibitors as a potential treatment for patients with
advanced or metastatic cancers.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook.
About Vedanta Biosciences
Vedanta Biosciences is a clinical-stage company developing a new
category of therapies for immune-mediated diseases based on
rationally-defined consortia of human microbiome-derived bacteria.
Vedanta Biosciences is a leader in the microbiome field with
capabilities and deep expertise to discover, develop, and
manufacture live bacteria drugs. These include what is believed to
be the largest collection of human microbiome-associated bacterial
strains, a suite of proprietary assays to select pharmacologically
potent strains, vast proprietary datasets from human interventional
studies, and facilities for cGMP-compliant manufacturing of
rationally-defined bacterial consortia in powder form. Vedanta
Biosciences' pioneering work, in collaboration with its scientific
co-founders, has led to the identification of human commensal
bacteria that induce a range of immune responses - including
induction of regulatory T cells, CD8+ T cells, and Th17 cells,
among others. These advances have been published in leading
peer-reviewed journals, including Science (multiple), Nature
(multiple), Cell, and Nature Immunology. Vedanta Biosciences has
harnessed these biological insights and its capabilities to
generate a pipeline of programs in infectious disease, autoimmune
disease, allergy, and immuno-oncology.
Vedanta Biosciences was founded by PureTech Health (PRTC.L). Its
scientific co-founders are world-renowned experts in immunology and
microbiology who have pioneered the fields of innate immunity, Th17
and regulatory T cell biology, and include Ruslan Medzhitov, Ph.D.,
(Yale and Howard Hughes Medical Institute (HHMI)), Brett Finlay,
Ph.D., (University of British Columbia and HHMI), Kenya Honda,
Ph.D., (inventor of Vedanta Biosciences' lead product candidate;
Keio University and RIKEN), Dan Littman, Ph.D., (New York
University and HHMI), Alexander Rudensky, Ph.D., (Sloan Kettering
and HHMI), and Jeremiah Faith, Ph.D., (Mount Sinai School of
Medicine).
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that the Opdivo plus VE800 combination will receive regulatory
approval in the US for any of the indications described in this
release. Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect
Bristol-Myers Squibb's business, particularly those identified in
the cautionary factors discussion in Bristol-Myers Squibb's Annual
Report on Form 10-K for the year ended December 31, 2017 in our
Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K.
Bristol-Myers Squibb undertakes no obligation to publicly update
any forward-looking statement, whether as a result of new
information, future events or otherwise.
Vedanta Biosciences Forward-Looking Statement
This press release contains statements that are or may be
forward-looking statements, including statements that relate to
Vedanta Biosciences' future prospects, developments and strategies.
The forward-looking statements are based on current expectations
and are subject to known and unknown risks and uncertainties that
could cause actual results, performance and achievements to differ
materially from current expectations. These forward-looking
statements are based on assumptions regarding the present and
future business strategies of the company and the environment in
which it will operate in the future. Each forward-looking statement
speaks only as at the date of this press release. Except as
required by law and regulatory requirements, neither Vedanta
Biosciences nor any other party intends to update or revise these
forward-looking statements, whether as a result of new information,
future events or otherwise.
About PureTech Health
PureTech Health (LSE: PRTC) is an advanced biopharmaceutical
company developing novel medicines for dysfunctions of the
Brain-Immune-Gut (BIG) Axis. The Company has developed deep
insights into the connection between the individual components of
these systems and the resulting role in many chronic diseases,
which have proven resistant to established therapeutic approaches.
By harnessing this emerging field of human biology, PureTech Health
is developing new categories of medicines with the potential to
have great impact on people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies across two divisions: the Affiliates division and the
Internal division. Its Affiliates division includes two product
candidates that have been filed with the US Food and Drug
Administration (FDA) for review and several other novel clinical
and pre-clinical programmes. These affiliates are developing
ground-breaking platforms and therapeutic candidates in
collaboration with some of the world's leading experts.
PureTech's Internal division is advancing a pipeline fuelled by
recent discoveries in lymphatics and immune cell trafficking to
modulate disease in a tissue-specific manner. These programmes
leverage the transport and biodistribution of various immune system
components for the targeted treatment of diseases with major unmet
needs, including cancers, autoimmune diseases, and neuroimmune
disorders.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Forward Looking Statement
This press release contains statements that are or may be
forward-looking statements, including statements that relate to the
company's future prospects, developments and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks and uncertainties that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, those risks and uncertainties described in the risk factors
included in the regulatory filings for PureTech Health plc. These
forward-looking statements are based on assumptions regarding the
present and future business strategies of the company and the
environment in which it will operate in the future. Each
forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements,
neither the company nor any other party intends to update or revise
these forward-looking statements, whether as a result of new
information, future events or otherwise.
Contact:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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