DARPA and JPEO Award Contract to SmartPharm, a Subsidiary of Sorrento, for Development of Rapid Countermeasure Against COVID-19 Using Gene-Encoded Neutralizing Antibodies
Fri, November 27, 2020, 8:00 AM EST
Initial funding of up to $34 million for the project “Gene Mabs: A Scalable, Economic, Gene-Encoded Protective Antibody Platform Against Coronavirus” (HR0011-21-9-0015) to support the development of an STI-2020-encoded Gene MAbTM through Phase 2 clinical studies.
STI-2020-encoded Gene MAb is in development for intramuscular injection against the SARS-CoV-2 virus and its variant strains to produce potent STI- 2020 nAbs in the body.
STI-2020-encoded Gene MAb products can potentially be stored at refrigerator temperatures, avoiding some of the cold chain management challenges associated with the deployment of COVID-19 vaccines currently in development.
Sorrento has a cGMP facility in place to meet initial production demand and Sorrento expects that STI-2020-encoded Gene MAb can be produced in large quantity to meet potentially high demand.
SAN DIEGO, Nov. 27, 2020 (GLOBE NEWSWIRE) -- SmartPharm Therapeutics, Inc. (“SmartPharm”), a wholly-owned subsidiary of Sorrento Therapeutics, Inc. ( Nasdaq: SRNE, “Sorrento”), and developer of next-generation, non-viral gene therapy technologies, announced today that it has been awarded a contract from the Defense Advanced Research Projects Agency (DARPA) co- funded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to develop a rapid countermeasure to COVID-19. The contract would provide SmartPharm up to USD $34 million for development through Phase 2 clinical studies of a gene- encoded antibody (“Gene MAb”) that could enable rapid protection from and/or treatment of SARS-CoV-2 infection and COVID-19. Sorrento will seek further funding in support of the COVID Gene MAb program toward EUA ( emergency use authorization) approval and large-scale manufacturing pending successful clinical studies.
For this Gene MAb approach, the SmartPharm/Sorrento team will produce plasmid DNA encoding the SARS-CoV-2 neutralizing antibody STI-2020 (COVI-AMG™). The FDA is currently reviewing IND filings for STI-2020 as an IV- delivered neutralizing antibody and STI-2099 as an intranasal-delivered neutralizing antibody for the treatment of COVID-19. The expected higher potency of the STI-2020 antibody makes it an ideal candidate for Gene MAb delivery against COVID-19.
The DARPA/JPEO contract supports the accelerated development of a Gene MAbs neutralizing antibody that can be delivered by a simple intramuscular injection, enabling the recipient to produce the protective antibody, potentially within days of the injection. Such an approach would permit the rapid translation of fully characterized potent neutralizing antibodies into clinical use, which Sorrento believes will be important for responding to potential mutations of SARS-CoV-2 that may emerge. It would also enable broader deployment of the Gene MAb approach as a prophylactic solution, as it can be conveniently administered into the muscle like an annual flu vaccine. If successful, it could provide an alternative method of protecting populations where vaccines do not work as well, such as the elderly or immunocompromised.
Dr. Henry Ji, CEO of Sorrento, commented, “We are excited that DARPA and JPEO have recognized our Gene MAbs platform as a potential rapid countermeasure for COVID-19 and the potential value for other applications to combat future viral diseases of pandemic potential. We acquired SmartPharm with the vision of combining the power of our antibody and biologic therapies for cancer and infectious diseases with next-generation gene-encoded technologies. We look forward to working with our Department of Defense partners to potentially add a novel approach to the arsenal of solutions for combating this devastating disease.”
DARPA, founded in 1958, is an agency of the U.S. Department of Defense. Through collaborations with academic, industry, and government partners, DARPA makes investments across multiple sectors to drive breakthrough technologies for U.S. national security. Through the collaboration with JPEO-CBRND, this work is supported by the Office of the Assistant Secretary of Defense for Health Affairs with funding from the Defense Health Agency.
About SmartPharm Therapeutics
SmartPharm Therapeutics, Inc., a wholly owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE), is a development stage biopharmaceutical company focused on developing next-generation, non-viral gene therapies for the treatment of serious or rare diseases with the vision of creating “ biologics from within.” SmartPharm is currently developing a novel pipeline of non-viral, gene-encoded proteins for the treatment of conditions that require biologic therapy such as enzyme replacement and tissue restoration. SmartPharm commenced operations in 2018 and is headquartered in Cambridge, MA, USA. For more information, please visit www.smartpharmtx.com.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies ("G-MAB™ library"), clinical stage immuno-cellular therapies ("CAR-T", "DAR-T™"), antibody-drug conjugates ("ADCs"), and clinical stage oncolytic virus ("Seprehvir®"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVI-GUARD™, COVI-AMG™, COVI-SHIELD™, Gene MAb™ and COVI-DROPS™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non- opioid pain management small molecule, resiniferatoxin ("RTX"), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.
For more information, visit www.sorrentotherapeutics.com
Forward-Looking Statements
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the aggregate amount of funding available pursuant to the DARPA contract; the development of a Gene MAb against SARS-CoV-2 infection and COVID-19; the expectation of the commencement of any clinical trials for a Gene MAb, including phase 2 clinical studies; the potential for a Gene Mab to provide rapid protection and/or treatment of SARS-CoV-2 infection and COVID-19; the potential potency and potential neutralizing profile of STI-2020 and its impact on COVID-19; the potential potency and potential neutralizing profile of STI-2099 and its impact on COVID-19; the expected administration of STI-2020 and STI-2099; the potential for STI-2020 to be an ideal candidate for gene-mediated delivery; the potential administration method of a Gene MAb neutralizing antibody; the potential ability of a recipient of a Gene MAb neutralizing antibody to produce protective antibodies; the expected timing for a recipient of a Gene MAb neutralizing antibody to begin producing protective antibodies; the ability of a Gene MAbs platform to translate recognized neutralizing antibodies into clinical use; the potential for a Gene MAb neutralizing antibody approach to COVID-19 to be used as a prophylactic solution; the potential for a Gene MAb neutralizing antibody to provide an alternative method of protection against SARS-CoV-2 and COVID-19; the potential for a Gene MAbs platform to be used with future viral diseases; the potential for Gene MAb products to be stored at room temperature and/or in refrigeration to avoid cold chain management concerns; the potential for Sorrento’s cGMP facility to meet initial production demand; the potential for Sorrento to mass produce sufficient quantities of STI-2020-encoded Gene MAb to meet demand; the ability of Sorrento to combine its antibody and biologic therapies with SmartPharm’s gene-encoded technologies; and Sorrento’s potential position in the antiviral industry. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's technologies and prospects with newly acquired technologies, including the acquisition of SmartPharm and the utilization of SmartPharm’s Gene-Encoded Therapeutics (GET) platforms for the treatment and prevention of coronavirus infections and other pathogens and cancer cells; risks related to seeking regulatory approvals and conducting clinical trials; the clinical and commercial success of the treatment and prevention of coronavirus infections using gene-encoded antibodies; the viability and success of using gene- encoded antibodies for treatments in anti-viral therapeutic areas, including coronaviruses; clinical development risks, including risks in the progress, timing, cost and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that prior study and trial results may not be replicated in future studies and trials; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks related to seeking regulatory approvals and conducting clinical trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its COVID-19 therapeutic product candidate strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2019, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
【 在 lubbock12 (非老非小将) 的大作中提到: 】 : 直接从DARPA和JPEO生化武器研究项目拿到合同了，生产基因编码抗新冠抗体。 : DARPA and JPEO Award Contract to SmartPharm, a Subsidiary of Sorrento, for : Development of Rapid Countermeasure Against COVID-19 Using Gene-Encoded : Neutralizing Antibodies : Fri, November 27, 2020, 8:00 AM EST : Initial funding of up to $34 million for the project “Gene Mabs: A Scalable : , Economic, Gene-Encoded Protective Antibody Platform Against Coronavirus ” : (HR0011-21-9-0015) to support the development of an STI-2020-encoded Gene : MAbTM through Phase 2 clinical studies. : STI-2020-encoded Gene MAb is in development for intramuscular injection : ...................
直接从DARPA和JPEO生化武器研究项目拿到合同了，生产基因编码抗新冠抗体。
DARPA and JPEO Award Contract to SmartPharm, a Subsidiary of Sorrento, for
Development of Rapid Countermeasure Against COVID-19 Using Gene-Encoded
Neutralizing Antibodies
Fri, November 27, 2020, 8:00 AM EST
Initial funding of up to $34 million for the project “Gene Mabs: A Scalable, Economic, Gene-Encoded Protective Antibody Platform Against Coronavirus” (HR0011-21-9-0015) to support the development of an STI-2020-encoded Gene
MAbTM through Phase 2 clinical studies.
STI-2020-encoded Gene MAb is in development for intramuscular injection
against the SARS-CoV-2 virus and its variant strains to produce potent STI-
2020 nAbs in the body.
STI-2020-encoded Gene MAb products can potentially be stored at refrigerator temperatures, avoiding some of the cold chain management challenges
associated with the deployment of COVID-19 vaccines currently in development.
Sorrento has a cGMP facility in place to meet initial production demand and Sorrento expects that STI-2020-encoded Gene MAb can be produced in large
quantity to meet potentially high demand.
SAN DIEGO, Nov. 27, 2020 (GLOBE NEWSWIRE) -- SmartPharm Therapeutics, Inc. (“SmartPharm”), a wholly-owned subsidiary of Sorrento Therapeutics, Inc. (
Nasdaq: SRNE, “Sorrento”), and developer of next-generation, non-viral
gene therapy technologies, announced today that it has been awarded a
contract from the Defense Advanced Research Projects Agency (DARPA) co-
funded by the Joint Program Executive Office for Chemical, Biological,
Radiological and Nuclear Defense (JPEO-CBRND) to develop a rapid
countermeasure to COVID-19. The contract would provide SmartPharm up to USD $34 million for development through Phase 2 clinical studies of a gene-
encoded antibody (“Gene MAb”) that could enable rapid protection from and/or treatment of SARS-CoV-2 infection and COVID-19. Sorrento will seek
further funding in support of the COVID Gene MAb program toward EUA (
emergency use authorization) approval and large-scale manufacturing pending successful clinical studies.
For this Gene MAb approach, the SmartPharm/Sorrento team will produce
plasmid DNA encoding the SARS-CoV-2 neutralizing antibody STI-2020 (COVI-AMG™). The FDA is currently reviewing IND filings for STI-2020 as an IV-
delivered neutralizing antibody and STI-2099 as an intranasal-delivered
neutralizing antibody for the treatment of COVID-19. The expected higher
potency of the STI-2020 antibody makes it an ideal candidate for Gene MAb
delivery against COVID-19.
The DARPA/JPEO contract supports the accelerated development of a Gene MAbs neutralizing antibody that can be delivered by a simple intramuscular
injection, enabling the recipient to produce the protective antibody,
potentially within days of the injection. Such an approach would permit the rapid translation of fully characterized potent neutralizing antibodies into clinical use, which Sorrento believes will be important for responding to
potential mutations of SARS-CoV-2 that may emerge. It would also enable
broader deployment of the Gene MAb approach as a prophylactic solution, as
it can be conveniently administered into the muscle like an annual flu
vaccine. If successful, it could provide an alternative method of protecting populations where vaccines do not work as well, such as the elderly or
immunocompromised.
Dr. Henry Ji, CEO of Sorrento, commented, “We are excited that DARPA and
JPEO have recognized our Gene MAbs platform as a potential rapid
countermeasure for COVID-19 and the potential value for other applications
to combat future viral diseases of pandemic potential. We acquired
SmartPharm with the vision of combining the power of our antibody and
biologic therapies for cancer and infectious diseases with next-generation
gene-encoded technologies. We look forward to working with our Department of Defense partners to potentially add a novel approach to the arsenal of
solutions for combating this devastating disease.”
DARPA, founded in 1958, is an agency of the U.S. Department of Defense.
Through collaborations with academic, industry, and government partners,
DARPA makes investments across multiple sectors to drive breakthrough
technologies for U.S. national security. Through the collaboration with JPEO-CBRND, this work is supported by the Office of the Assistant Secretary of
Defense for Health Affairs with funding from the Defense Health Agency.
About SmartPharm Therapeutics
SmartPharm Therapeutics, Inc., a wholly owned subsidiary of Sorrento
Therapeutics, Inc. (Nasdaq: SRNE), is a development stage biopharmaceutical company focused on developing next-generation, non-viral gene therapies for the treatment of serious or rare diseases with the vision of creating “
biologics from within.” SmartPharm is currently developing a novel pipeline of non-viral, gene-encoded proteins for the treatment of conditions that
require biologic therapy such as enzyme replacement and tissue restoration. SmartPharm commenced operations in 2018 and is headquartered in Cambridge,
MA, USA. For more information, please visit www.smartpharmtx.com.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company
developing new therapies to treat cancers. Sorrento's multimodal,
multipronged approach to fighting cancer is made possible by its extensive
immuno-oncology platforms, including key assets such as fully human
antibodies ("G-MAB™ library"), clinical stage immuno-cellular
therapies ("CAR-T", "DAR-T™"), antibody-drug conjugates ("ADCs"), and clinical stage oncolytic virus ("Seprehvir®"). Sorrento is also
developing potential antiviral therapies and vaccines against coronaviruses, including COVI-GUARD™, COVI-AMG™, COVI-SHIELD™, Gene MAb™ and COVI-DROPS™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.
Sorrento's commitment to life-enhancing therapies for patients is also
demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-
opioid pain management small molecule, resiniferatoxin ("RTX"), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural
injections to treat lumbosacral radicular pain, or sciatica, and to
commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase IB trial for
intractable pain associated with cancer and a phase 1B trial in
osteoarthritis patients. SEMDEXA is in a pivotal phase 3 trial for the
treatment of lumbosacral radicular pain, or sciatica. ZTlido® was
approved by the FDA on February 28, 2018.
For more information, visit www.sorrentotherapeutics.com
Forward-Looking Statements
This press release and any statements made for and during any presentation
or meeting contain forward-looking statements related to Sorrento
Therapeutics, Inc., under the safe harbor provisions of Section 21E of the
Private Securities Litigation Reform Act of 1995 and subject to risks and
uncertainties that could cause actual results to differ materially from
those projected. Forward-looking statements include statements regarding the aggregate amount of funding available pursuant to the DARPA contract; the
development of a Gene MAb against SARS-CoV-2 infection and COVID-19; the
expectation of the commencement of any clinical trials for a Gene MAb,
including phase 2 clinical studies; the potential for a Gene Mab to provide rapid protection and/or treatment of SARS-CoV-2 infection and COVID-19; the potential potency and potential neutralizing profile of STI-2020 and its
impact on COVID-19; the potential potency and potential neutralizing profile of STI-2099 and its impact on COVID-19; the expected administration of STI-2020 and STI-2099; the potential for STI-2020 to be an ideal candidate for
gene-mediated delivery; the potential administration method of a Gene MAb
neutralizing antibody; the potential ability of a recipient of a Gene MAb
neutralizing antibody to produce protective antibodies; the expected timing for a recipient of a Gene MAb neutralizing antibody to begin producing
protective antibodies; the ability of a Gene MAbs platform to translate
recognized neutralizing antibodies into clinical use; the potential for a
Gene MAb neutralizing antibody approach to COVID-19 to be used as a
prophylactic solution; the potential for a Gene MAb neutralizing antibody to provide an alternative method of protection against SARS-CoV-2 and COVID-19; the potential for a Gene MAbs platform to be used with future viral
diseases; the potential for Gene MAb products to be stored at room
temperature and/or in refrigeration to avoid cold chain management concerns; the potential for Sorrento’s cGMP facility to meet initial production
demand; the potential for Sorrento to mass produce sufficient quantities of STI-2020-encoded Gene MAb to meet demand; the ability of Sorrento to combine its antibody and biologic therapies with SmartPharm’s gene-encoded
technologies; and Sorrento’s potential position in the antiviral industry. Risks and uncertainties that could cause our actual results to differ
materially and adversely from those expressed in our forward-looking
statements, include, but are not limited to: risks related to Sorrento's
technologies and prospects with newly acquired technologies, including the
acquisition of SmartPharm and the utilization of SmartPharm’s Gene-Encoded Therapeutics (GET) platforms for the treatment and prevention of coronavirus infections and other pathogens and cancer cells; risks related to seeking
regulatory approvals and conducting clinical trials; the clinical and
commercial success of the treatment and prevention of coronavirus infections using gene-encoded antibodies; the viability and success of using gene-
encoded antibodies for treatments in anti-viral therapeutic areas, including coronaviruses; clinical development risks, including risks in the progress, timing, cost and results of clinical trials and product development
programs; risk of difficulties or delays in obtaining regulatory approvals; risks that prior study and trial results may not be replicated in future
studies and trials; risks that clinical study results may not meet any or
all endpoints of a clinical study and that any data generated from such
studies may not support a regulatory submission or approval; risks related
to seeking regulatory approvals and conducting clinical trials; risks of
manufacturing and supplying drug product; risks related to leveraging the
expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its COVID-19 therapeutic product candidate
strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on
Form 10-K for the year ended December 31, 2019, and subsequent Quarterly
Reports on Form 10-Q filed with the Securities and Exchange Commission,
including the risk factors set forth in those filings. Investors are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of this release and we undertake no
obligation to update any forward-looking statement in this press release
except as required by law.
首批国防部合同3400万美元，季博士已经比张锋牛逼了
过节不忘视察韭菜
赞寄博士
【 在 lubbock12 (非老非小将) 的大作中提到: 】
: 直接从DARPA和JPEO生化武器研究项目拿到合同了，生产基因编码抗新冠抗体。
: DARPA and JPEO Award Contract to SmartPharm, a Subsidiary of Sorrento, for
: Development of Rapid Countermeasure Against COVID-19 Using Gene-Encoded
: Neutralizing Antibodies
: Fri, November 27, 2020, 8:00 AM EST
: Initial funding of up to $34 million for the project “Gene Mabs: A
Scalable
: , Economic, Gene-Encoded Protective Antibody Platform Against Coronavirus
”
: (HR0011-21-9-0015) to support the development of an STI-2020-encoded Gene : MAbTM through Phase 2 clinical studies.
: STI-2020-encoded Gene MAb is in development for intramuscular injection
: ...................
确实牛逼
以后季博士就要割五角大楼的韭菜了。
【 在 pia (屁吖) 的大作中提到: 】
: 过节不忘视察韭菜
: 赞寄博士
: Scalable
: ”
Chinese virus 得到认可了
是China Virus
【 在 beijingren4 () 的大作中提到: 】
: Chinese virus 得到认可了
Chinese virus首先把五角大楼制服了。MAGA了
牛逼！梅花和铅人机会大不相同
2020年度最牛逼美华非季博士莫属。
【 在 boblan (hotdog) 的大作中提到: 】
: Chinese virus首先把五角大楼制服了。MAGA了
准备在Buffalo Springs买房了？ 我觉得那很不错呀。
【 在 lubbock12(非老非小将) 的大作中提到: 】
: 首批国防部合同3400万美元，季博士已经比张锋牛逼了
恭喜lubbock网友，给华人争光了
争不争光不要紧，干快去买股票啊
【 在 FoodGod (饭中淹) 的大作中提到: 】
: 恭喜lubbock网友，给华人争光了
你能不能给众将军们搞到点股票折扣啊？
【 在 lubbock12 (非老非小将) 的大作中提到: 】
: 争不争光不要紧，干快去买股票啊
这是坏消息。
只能拿军队的人当小白鼠。
正好说明没市场。
今天不过又是拉高出货。
下周就跌回原形。
小黄人搞DOD的钱不是什么好兆头
季博士能忽悠，算是彻底溶入了主流社会。大家说是不是？我鉴定含白量已达80%
这不是DOD，这是DARPA,比DOD厉害多来了啊
【 在 LGKT (龙哥酷塔) 的大作中提到: 】
: 小黄人搞DOD的钱不是什么好兆头
那就更危险了，任何行为都会被放在显微镜下审查
【 在 lubbock12 (非老非小将) 的大作中提到: 】
: 这不是DOD，这是DARPA,比DOD厉害多来了啊
灯下黑，越是这种钱越安全。
【 在 LGKT (龙哥酷塔) 的大作中提到: 】
: 那就更危险了，任何行为都会被放在显微镜下审查
军队给支持才说明厉害啊。
【 在 dragonfly (小蜻蜓-一新冠崩三峡崩粮食崩合称三崩子) 的大作中提到: 】
: 这是坏消息。
: 只能拿军队的人当小白鼠。
: 正好说明没市场。
: 今天不过又是拉高出货。
: 下周就跌回原形。
季博士是谁？媒体说过。
【在 lubbock12(非老非小将)的大作中提到：】
：2020年度最牛逼美华非季博士莫属。
：【 在 boblan (hotdog) 的大作中提到: 】