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Bayer
Acquires Noria and
PSMA
Therapeutics to Expand Pipeline in
Prostate Cancer
2021-06-03
·
BioSpace
抗体
小分子药物
并购
合作
WHIPPANY, N.J.--(BUSINESS WIRE)--
Bayer
today announced that it has entered into an agreement to acquire Noria Therapeutics Inc. (Noria) and
PSMA
Therapeutics Inc. Through this acquisition,
Bayer
will obtain exclusive rights to a differentiated alpha radionuclide investigational compound based on
actinium-225
and a small molecule directed towards
prostate-specific membrane antigen (PSMA)
. The acquisition broadens
Bayer
’s existing oncology portfolio of targeted alpha therapies (TATs), which currently includes
Xofigo
® (
radium Ra 223 dichloride
), which is approved for
metastatic castration resistant prostate cancer (mCRPC)
with symptomatic
bone metastases
and no known visceral metastases, and the proprietary platform of investigational TATs based on
thorium-227
. The pre-IND program focuses on the treatment of
prostate cancer
, the second most commonly diagnosed
cancer
in men.1 “
Bayer
is focused on addressing the various medical needs of
cancer
patients, providing treatments that have the potential to improve patient outcomes throughout the different stages of the disease,” said Robert LaCaze, Member of the Executive Committee of the Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at
Bayer
. “This acquisition is another important milestone in enhancing
Bayer
’s oncology portfolio through both in-house expertise and strategic collaborations and agreements.” The companies acquired by
Bayer
, Noria and
PSMA
Therapeutics, have exclusive world-wide rights to technology licensed from
Weill
Cornell Medicine (New York, NY, USA) and
Johns Hopkins University
(Baltimore, MD, USA). Noria was founded by Dr. John Babich, Chief, Radiopharmaceutical Sciences in Radiology at Weill Cornell Medicine. “Weill Cornell Medicine is committed to bringing our faculty’s innovations to market so that patients can benefit from the latest therapeutics,” said Dr. Lisa Placanica, Senior Managing Director Center for Technology Licensing at Weill Cornell Medicine. “
Bayer
’s acquisition of Noria and
PSMA
Therapeutics which have nurtured Dr. Babich’s radiopharmaceutical and diagnostic technology, is an important milestone in drug development, and we look forward to the advances this collaboration can make to enhance
prostate cancer
therapies.” With the first and only approved targeted alpha therapy
Xofigo
,
Bayer
has successfully established
Xofigo
as a TAT for men with mCRPC, symptomatic
bone metastases
and no known
visceral metastases
. Adding
actinium-225-labeled
small molecule to the company’s platform of investigational targeted thorium conjugates, supports our commitment to researching differentiated treatment options for
cancer
patients. “Despite increased
cancer
survivorship overall, there continues to be a significant unmet need in
oncology
,” said Marianne De Backer, MBA, PhD, Member of the Executive Committee of the Pharmaceuticals Division and Head Strategy and Business Development & Licensing at Bayer. “We remain committed to exploring collaborations for innovative and pioneering scientific research for patients with unmet needs.” Financial terms of the agreement were not disclosed. About Targeted Alpha Therapies (TAT) at
Bayer
Targeted Alpha Therapies (TAT) are a class of radionuclide compounds being studied in various difficult to treat
tumors
. They deliver alpha radiation to
tumors
inside the body either via their bone-seeking property (
radium-223
) or by combining alpha radionuclides, such as,
actinium-225
or
thorium-227
, with specific moieties.
Bayer
’s
Xofigo
® (
radium Ra 223 dichloride
) is the first and only approved TAT.
Xofigo
is indicated for the treatment of patients with mCRPC,
symptomatic bone metastases
and no known
visceral metastatic disease
. More than 76,000 patients have been treated worldwide since launch.
Xofigo
is currently under further evaluation in a broad clinical development program. With its proprietary platform of investigational targeted thorium conjugates (TTC),
Bayer
is advancing a series of drug candidates with potential across multiple
cancers
.
PSMA-TTC
, which is combining a
prostate-specific membrane antigen (PSMA)-targeting antibody
prostate-specific membrane antigen (PSMA)-targeting
antibody with
thorium-227
, is a leading TTC project at
Bayer
. It is currently in Phase I clinical evaluation in patients with
metastatic castration-resistant prostate cancer
.
PSMA
is highly expressed on the surface of
prostate cancer
cells. With this acquisition,
Bayer
broadens its existing
TAT
development portfolio by adding an actinium-labeled
PSMA
-targeted alpha therapy. It is planned to be investigated as a treatment option across multiple stages of
prostate cancer
. About
Prostate Cancer
at
Bayer
Bayer
is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines for people living with
cancer
.
Prostate cancer
is the second most commonly diagnosed
cancer
in men1 and a key area of focus for
Bayer
. The company’s franchise includes two products on the market (
Nubeqa
® and
Xofigo
®) and several compounds in development, including advancing targeted alpha therapies.
Bayer
is focused on addressing the medical needs of
prostate cancer
patients. About
Xofigo
® (
radium Ra 223 dichloride
) Injection2
Xofigo
is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic
bone metastases
and no known
visceral metastatic disease
. Important Safety Information for
Xofigo
® (radium Ra 223 dichloride) Injection Warnings and Precautions: Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the
Xofigo
arm experienced
bone marrow failure
or ongoing
pancytopenia
, compared to no patients treated with placebo. There were two deaths due to
bone marrow failure
. For 7 of 13 patients treated with
Xofigo
bone marrow failure
was ongoing at the time of death. Among the 13 patients who experienced
bone marrow failure
, 54% required blood transfusions. Four percent (4%) of patients in the
Xofigo
arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to
vascular hemorrhage
in association with
myelosuppression
were observed in 1% of
Xofigo
-treated patients compared to 0.3% of patients treated with placebo. The incidence of
infection
-related deaths (2%), serious
infections
(10%), and
febrile neutropenia
(<1%) was similar for patients treated with
Xofigo
and placebo. Myelosuppression–notably
thrombocytopenia
,
neutropenia
,
pancytopenia
, and
leukopenia
–has been reported in patients treated with
Xofigo
. Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue
Xofigo
in patients who experience life-threatening complications despite supportive care for
bone marrow failure
In the phase 3 ALSYMPCA trial, 2% of patients in the
Xofigo
arm experienced
bone marrow failure
or ongoing
pancytopenia
, compared to no patients treated with placebo. There were two deaths due to
bone marrow failure
. For 7 of 13 patients treated with
Xofigo
bone marrow failure
was ongoing at the time of death. Among the 13 patients who experienced
bone marrow failure
, 54% required blood transfusions. Four percent (4%) of patients in the
Xofigo
arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to
vascular hemorrhage
in association with
myelosuppression
were observed in 1% of
Xofigo
-treated patients compared to 0.3% of patients treated with placebo. The incidence of
infection
-related deaths (2%), serious
infections
(10%), and
febrile neutropenia
(<1%) was similar for patients treated with
Xofigo
and placebo. Myelosuppression–notably
thrombocytopenia
,
neutropenia
,
pancytopenia
, and
leukopenia
–has been reported in patients treated with
Xofigo
. Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue
Xofigo
in patients who experience life-threatening complications despite supportive care for
bone marrow failure
Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of
Xofigo
. Prior to first administering
Xofigo
, the absolute neutrophil count (ANC) should be ≥1.5 × 10 9 /L, the platelet count ≥100 × 10 9 /L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 10 9 /L and the platelet count ≥50 × 10 9 /L. Discontinue
Xofigo
if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care Monitor blood counts at baseline and prior to every dose of
Xofigo
. Prior to first administering
Xofigo
, the absolute neutrophil count (ANC) should be ≥1.5 × 10 /L, the platelet count ≥100 × 10 /L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 10 /L and the platelet count ≥50 × 10 /L. Discontinue
Xofigo
if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with
Xofigo
have not been established. Outside of a clinical trial, concomitant use of
Xofigo
in patients on chemotherapy is not recommended due to the potential for additive
myelosuppression
. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period,
Xofigo
should be discontinued Safety and efficacy of concomitant chemotherapy with
Xofigo
have not been established. Outside of a clinical trial, concomitant use of
Xofigo
in patients on chemotherapy is not recommended due to the potential for additive
myelosuppression
. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period,
Xofigo
should be discontinued Increased
Fractures
and Mortality in Combination With
Abiraterone
Plus
Prednisone
/
Prednisolone
:
Xofigo
is not recommended for use in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of
Xofigo
in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of
fractures
(28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received
Xofigo
in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
compared to patients who received placebo in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
. Safety and efficacy with the combination of
Xofigo
and agents other than
gonadotropin-releasing hormone analogues
have not been established
Xofigo
is not recommended for use in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of
Xofigo
in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of
fractures
(28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received
Xofigo
in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
compared to patients who received placebo in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
. Safety and efficacy with the combination of
Xofigo
and agents other than
gonadotropin-releasing hormone analogues
have not been established Embryo-Fetal Toxicity: The safety and efficacy of
Xofigo
have not been established in females.
Xofigo
can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with
Xofigo
Administration and Radiation Protection:
Xofigo
should be received, used, and administered only by authorized persons in designated clinical settings. The administration of
Xofigo
is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations Fluid Status:
Dehydration
occurred in 3% of patients on
Xofigo
and 1% of patients on placebo.
Xofigo
increases adverse reactions such as
diarrhea
,
nausea
, and
vomiting
, which may result in
dehydration
. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of
dehydration
or
hypovolemia
Injection Site Reactions:
Erythema
,
pain
, and
edema
at the injection site were reported in 1% of patients on Xofigo
Secondary Malignant Neoplasms
:
Xofigo
contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of
cancer
and hereditary defects. Due to its mechanism of action and neoplastic changes, including
osteosarcomas
, in rats following administration of
radium-223 dichloride
,
Xofigo
may increase the risk of
osteosarcoma
or other
secondary malignant neoplasms
. However, the overall incidence of new
malignancies
in the randomized trial was lower on the
Xofigo
arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of
secondary malignancies
exceeds the duration of follow-up for patients on the trial Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the
Xofigo
group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with
Xofigo
will tolerate subsequent cytotoxic chemotherapy Adverse Reactions: The most common adverse reactions (≥10%) in the
Xofigo
arm vs the placebo arm, respectively, were
nausea
(36% vs 35%),
diarrhea
(25% vs 15%),
vomiting
(19% vs 14%), and
peripheral edema
(13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of
Xofigo
-treated patients and 63% of placebo-treated patients. The most common
hematologic laboratory abnormalities
in the
Xofigo
arm (≥10%) vs the placebo arm, respectively, were
anemia
(93% vs 88%),
lymphocytopenia
(72% vs 53%),
leukopenia
(35% vs 10%),
thrombocytopenia
(31% vs 22%), and
neutropenia
(18% vs 5%) Please see the full Prescribing Information for
Xofigo
(
radium Ra 223 dichloride
). About
NUBEQA
®
(darolutamide)3
NUBEQA
is an
androgen receptor inhibitor (ARi)
with a distinct chemical structure that competitively inhibits androgen binding,
AR
nuclear translocation, and
AR
-mediated transcription.3 A Phase III study in
metastatic hormone-sensitive prostate cancer
(ARASENS) is ongoing. Information about this trial can be found at . INDICATION
NUBEQA
® (
darolutamide
) is an
androgen receptor
inhibitor indicated for the treatment of patients with
non-metastatic castration-resistant prostate cancer
. IMPORTANT SAFETY INFORMATION Embryo-Fetal Toxicity: Safety and efficacy of
NUBEQA
have not been established in females.
NUBEQA
can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with
NUBEQA
and for 1 week after the last dose. Adverse Reactions Serious adverse reactions occurred in 25% of patients receiving
NUBEQA
and in 20% of patients receiving placebo. Serious adverse reactions in ≥1 % of patients who received
NUBEQA
were
urinary retention
,
pneumonia
, and
hematuria
. Overall, 3.9% of patients receiving
NUBEQA
and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%),
cardiac failure
(0.3%),
cardiac arrest
(0.2%), general physical health deterioration (0.2%), and
pulmonary embolism
(0.2%) for
NUBEQA
. Adverse reactions occurring more frequently in the
NUBEQA
arm (≥2% over placebo) were
fatigue
(16% vs 11%),
pain
in extremity (6% vs 3%) and
rash
(3% vs 1%). Clinically significant adverse reactions occurring in ≥2% of patients treated with
NUBEQA
included
ischemic heart disease
(4.0% vs 3.4% on placebo) and heart failure (2.1% vs 0.9% on placebo). Drug Interactions Effect of Other Drugs on
NUBEQA
– Combined
P-gp
and strong or moderate
CYP3A4
inducers decrease
NUBEQA
exposure, which may decrease
NUBEQA
activity. Avoid concomitant use. Combined
P-gp
and strong
CYP3A4
inhibitors increase
NUBEQA
exposure, which may increase the risk of
NUBEQA
adverse reactions. Monitor more frequently and modify
NUBEQA
dose as needed. Effects of
NUBEQA
on Other Drugs –
NUBEQA
inhibits
breast cancer resistance protein (BCRP)
transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of
BCRP
substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.
NUBEQA
inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of
OATP1B1
or
OATP1B3
substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates. Review the prescribing information of drugs that are
BCRP
,
OATP1B1
, and
OATP1B3
substrates when used concomitantly with
NUBEQA
. For important risk and use information about
NUBEQA
, please see the accompanying full Prescribing Information. About
Bayer
Bayer
is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.
Bayer
is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The
Bayer
brand stands for trust, reliability, and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to . About Noria Therapeutics (Noria) /
PSMA
Therapeutics Inc. Noria is a research and development company managed by experienced radiopharmaceutical development leaders and focused on the development of novel targeted alpha therapeutics and theranostic agents.
PSMA
Therapeutics Inc. is a subsidiary of Noria to advance the platform of
prostate-specific membrane antigen (PSMA)
targeting radiotherapeutics. These companies have exclusive world-wide rights to technology licensed from
Weill Cornell Medical College
and
Johns Hopkins University
. It is headquartered in New York City. © 2021
Bayer
BAYER
, the
Bayer Cross
, Xofigo and
Nubeqa
are registered trademarks of
Bayer
. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by
Bayer
management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in
Bayer
’s public reports which are available on the
Bayer
website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 1. GLOBOCAN 2018: Estimated
Cancer
Incidence, Mortality and Prevalence Worldwide in 2018. CA: A
Cancer
Journal for Clinicians. . 2.
XOFIGO
® (
radium-223
dichloride) Injection [Prescribing Information]. Whippany, NJ:
Bayer HealthCare Pharmaceuticals
, December 2019. 3.
NUBEQA
® (
darolutamide
) tablets [Prescribing Information]. Whippany, NJ:
Bayer HealthCare Pharmaceuticals
, January 2021. COR-PFM-ONC-US-0003-1 06/21 View source version on businesswire.com:
机构
The Johns Hopkins University
Bayer AG
Bayer HealthCare Pharmaceuticals, Inc.
[+3]
适应症
出血
疼痛
第二原发肿瘤
[+35]
靶点
PSMA
TAT
AR
[+5]
药物
MTI-201
二氯化镭[223Ra]
Pelgifatamab corixetan
[+7]
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