Pipeline 2

Sorrento’s R&D is focused on driving innovation in COVID-19, cancer treatment, full pain control and autoimmune diseases

Portfolio Key Programs Indication Preclinical Phase I Phase II Phase III/Pivotal FDA Approval
COVID-19 Programs
COVI-TRACE™ (diagnostic) Diagnostic Test

0%*

FDA Emergency Use Authorization (EUA) Application Expected

COVI-TRACE (Diagnostic Test for the Detection of SARS-CoV-2 Virus in Nasal Swab and Saliva)

Sorrento Therapeutics has entered into a licensing agreement with Columbia University for the rights to a rapid, one-step diagnostic test that detects SARS-CoV-2 virus in as little as 30 minutes from a sample of saliva. 

Unlike other commercially available diagnostic products, the COVI-TRACE test:

  • Gives simple positive or negative color change results in 30 minutes or less
  • Requires no special laboratory equipment and is practical for on-site deployment
  • Uses saliva, eliminating the need for painful nasal swabbing
  • Demonstrated sensitivity and specificity of 97% and 100%, respectively, in a preliminary study

The COVI-TRACE approach eliminates the extraction step and simplifies overall sample processing. 

A small sample of saliva is collected in a cup and then placed into a tube containing enzymes and reagents that can detect the SARS-CoV-2 virus’s RNA. The tube is then placed into a simple heat block or water bath to keep the sample warm throughout the chemical reaction, which takes 30 minutes or less to provide a colorimetric reading based on detection of the presence of the virus.

COVI-TRACE

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COVI-STIX™ (diagnostic) Antigen Test

0%*

FDA Emergency Use Authorization (EUA) Application Submitted

COVI-STIX™ (Antigen Test for the Detection of SARS-CoV-2 Virus in Nasal Swab)

COVI-STIX™ has been developed by Sorrento as a highly sensitive and accurate lateral flow immunoassay for rapid SARS-CoV-2 antigen detection. COVI-STIX is a highly sensitive assay that detects single SARS-CoV-2 virus antigens directly from a shallow nasal swab (nasal, not nasopharyngeal) sample in 15 – 20 minutes. COVI-STIX uses a simple one-step protocol that only requires mixing the sample with a buffer and applying the sample to the COVI-STIX test well. Simple capillary action will drive the sample through the cassette and displays an obvious black line if the viral antigen is detected. This technology is ideally suited (when cleared for use) for rapid laboratory, point-of-care testing or at-home use.

covi-stick-img

The test uses a proprietary platinum nano-catalyst core (PtNC) which yields up to 100-fold increases in sensitivity over conventional lateral flow colloidal gold assays. As viral antigen passes over the labeled antibody, the sample encounters the PtNC particles targeted specifically to the virus nucleocapsid(N) or matrix (M) antigens. The antigen is then captured in a strong biotin-avidin complex, producing a conspicuous black line on the membrane stick, indicating a positive result. 

Initial validation of COVI-STIX has demonstrated a sensitivity of 98%, a specificity of 100%, and an LOD of 6.25 TCID50/swab (exact values to be confirmed by the FDA). COVI-STIX has been tested for cross-reactivity and is specific for detection of SARS-CoV-2 and viruses in the same family. As a platform technology, the PtNC lateral flow also has the potential to be developed as a multiplex system to detect other respiratory pathogens leveraging the same assay, processes, and training. A request for EUA of this technology is expected to be submitted in December. We are also evaluating the potential for COVI-STIX using a saliva sample as well. Development plans include multiplexing this platform to enable a patient to tell if they have COVID-19 or Flu A/Flu B.

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COVI-TRACK™ Platinum (diagnostic) Antibody Test

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In final manufacturing and clinical testing

COVI-TRACKTM – Platinum (Antibody Test for the Detection of Antibodies to SARS-CoV-2)

Sorrento is developing the COVI-TRACKTM  in vitro diagnostic test kit for the detection of IgG and IgM antibodies in blood samples from patients who may have been exposed to the SARS-CoV-2 virus.

The rapid antibody test kit is easy to use and allows for results to be available in about eight minutes. The test develops two clear lines on independent tracks confirm the detection and differentiation of IgM and IgG antibodies associated with the SARS-CoV-2 virus.

covi-track-indicators-opti

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COVI-GUARD™ (treatment) Neutralizing Antibody (IV) in Inpatients

30%*


COVID-19 Treatment: COVI-GUARD (Neutralizing Antibody – STI 1499)

Sorrento is developing a Neutralizing Antibody which binds to S1 subunit of SARS-CoV-2 Spike protein. COVI-GUARD Fc region is engineered to eliminate interactions with host Fc receptors, thereby potentially decreasing risk of Antibody Dependent Enhancement of SARS-CoV-2 infection.

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COVI-AMG™ (treatment) Neutralizing Antibody (IV) in Outpatients

30%*


COVI-AMG (Affinity Matured COVI-GUARD Neutralizing Antibody – STI 2020)

Sorrento is developing COVI-AMG™ (STI-2020; Affinity Matured COVI-Guard) neutralizing antibodies (nAbs) against SARS-CoV-2 infection.  STI-2020 has demonstrated greater than 50-fold increase in potency in in vitro experiments.

In preclinical cell-based assay, STI-2020 has shown 100% in vitro neutralization of SARS-CoV-2 at concentrations of 78 ng/ml. The neutralization activity at this concentration protected against both the original SARS-CoV-2 virus isolate and the highly contagious Spike D614G isolate. 

A few highlights of the data from the most recent STI-2020 study include:

  • Hamsters infected with SARS-CoV-2 and then treated with a single dose of 500 µg STI-2020 started gaining weight within 48 hours of STI-2020 administration, as compared to control animals that steadily lost weight for 5 days before recovery.
  • At day 5, STI-2020-treated (500 µg) hamsters had gained 5% weight, versus a weight loss of about 10% for the control animals (15% difference).
  • At day 5, all STI-2020-treated (500 µg) hamsters (5 out of 5 analyzed animals) had undetectable virus load in lungs as compared to the lungs of animals in the control group, where more than 1,000 infectious viral particles per gram of tissue were readily detected.

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COVI-DROPS™ (treatment) Neutralizing Antibody (Intranasal) in Outpatients

10%*


COVI-DROPS™ (Intranasal COVI-AMG Neutralizing Antibody – STI 2099)

In addition to the intravenous formulation of COVI-AMG™ neutralizing antibody,  Sorrento is developing COVI-DROPS which will be the intranasal formulation of COVI-AMG™. 

A few highlights of the preclinical animal data from the most recent STI-2099 study include:

  • Intravenously-dosed animals recovered from the infection with noticeable differences in weight loss between the Control IgG and COVI-AMG-treatment groups reaching a maximum at Day-5 after infection.
  • Intranasally-COVI-DROPS-treated animals remarkable showed evidence, as early as Day-2 into the experiment, of prevention of disease progression with limited weight loss in the very early stages of infection and reduced duration of disease symptoms as compared to COVI-AMG IV-treated animals.
covi-drops-graphic
  • Current neutralization antibodies in development are administered in large amounts that require infusions over hours in a hospital setting (Figure 1A). 
  • Sorrento’s intravenous COVI-AMG nAb (STI-2020) may require only an intravenous slow push due to the high potency demonstrated in animal models to date (Figure 1B). 
  • Intranasal COVID-DROPS (STI-2099) may be able to be administered as simple intranasal drops (Figure 1C), which would avoid the need for IV infusion or injection and a hospital visit for treatment.

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COVI-SHIELD™ (treatment) Neutralizing Abs (IV) in Inpatients

10%*


COVID-19 Treatment: COVI-SHIELD (Neutralizing Antibody Cocktail)

Sorrento is developing a Neutralizing Antibody Cocktail to bind to distinct epitopes on SARS-CoV-2 Spike protein. The antibody cocktail potentially creates a high barrier to emergence of resistant variants in treated individuals. COVI-SHIELD mAbs Fc regions are engineered to eliminate interactions with host Fc receptors, thereby decreasing risk of Antibody Dependent Enhancement of SARS-CoV-2 infection.

covi-shield

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COVIDTRAP™ (treatment) ACE2 Receptor Decoy (IV) in Inpatients

10%*


COVI-TRACE (Diagnostic Test for the Detection of SARS-CoV-2 Virus in Nasal Swab and Saliva)

Sorrento Therapeutics has entered into a licensing agreement with Columbia University for the rights to a rapid, one-step diagnostic test that detects SARS-CoV-2 virus in as little as 30 minutes from a sample of saliva. 

Unlike other commercially available diagnostic products, the COVI-TRACE test:

  • Gives simple positive or negative color change results in 30 minutes or less
  • Requires no special laboratory equipment and is practical for on-site deployment
  • Uses saliva, eliminating the need for painful nasal swabbing
  • Demonstrated sensitivity and specificity of 97% and 100%, respectively, in a preliminary study

The COVI-TRACE approach eliminates the extraction step and simplifies overall sample processing. 

A small sample of saliva is collected in a cup and then placed into a tube containing enzymes and reagents that can detect the SARS-CoV-2 virus’s RNA. The tube is then placed into a simple heat block or water bath to keep the sample warm throughout the chemical reaction, which takes 30 minutes or less to provide a colorimetric reading based on detection of the presence of the virus.

COVI-TRACE

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ABIVERTINIB (treatment) Severe or Critical COVID-19 in ICU Patients

55%*


ABIVERTINIB (Cytokine Storm – STI 5656)

Abivertinib is a novel small molecule tyrosine kinase inhibitor (TKI) that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) and Bruton’s tyrosine kinase (BTK).  On May 21, 2020, Sorrento announced that it had entered into a binding term sheet for an exclusive license to ACEA Therapeutics’ Abivertinib across all indications for all territories outside of China.  The parties have since entered into an exclusive license agreement.

Abivertinib irreversibly binds to the BTK receptor, preventing the phosphorylation of the receptor.  Due to this effect, it has shown potent immunomodulatory activities in vitro by inhibiting key pro-inflammatory cytokine production, including IL-1beta, IL-6 and TNF-alpha. These cytokines are associated with cytokine release syndrome (CRS) or cytokine storm and COVID-19 disease progression with poor outcomes in patients with acute respiratory distress syndrome (ARDS).

Since Abivertinib targets multiple cytokines simultaneously, Sorrento anticipates that the effects of Abivertinib will potentially superior to the initial published findings by others for IL-6 inhibitors targeted for COVID-19 trials, and the clinical benefits will be more pronounced given the broader range of anti-cytokine activity.

The trial, titled A Phase 2, Double Blinded, Randomized Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With Standard of Care Versus Standard of Care in Subjects Hospitalized With COVID-19 (NCT04440007), will be initially conducted in centers in the USA.

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SALICYN - 30 (treatment) Anti-viral

10%*


Salicyn-30 (Anti-viral – STI 2030)

Since the beginning of the COVID-19 pandemic, Sorrento has developed a program targeting the entire continuum of care (for prevention, early treatment and rescue therapies) to manage COVID-19 disease. It is Sorrento’s belief that multi-modal therapies will naturally follow the approval of effective single therapies, regardless of individual drug potential. 

Our latest discovery in the Sorrento COVID-19 Program includes Salicyn-30 anti-viral that strongly inhibits SARS-CoV-2 infection in preclinical studies and highlights its place in a potential multi-modal therapy in combination with neutralizing antibodies against COVID.

Salicyn-30 will be developed initially as a stand-alone oral therapy to potentially reduce viral load in severely affected patients.  In parallel, its potential in combination with Sorrento’s potent STI-1499 and affinity matured STI-2020 neutralizing antibodies currently in development will be validated, both for synergistic efficacy but also to ensure that the safety of the combination therapy is established prior to human trials.

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COVI-MSC (treatment) ARDS due to COVID-19 in ICU Pts

30%*


COVI-MSC (Acute Respiratory Distress Syndrome – STI 8282)

Sorrento is entering Phase I Trial of COVI-MSC for patients suffering from Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19, which have been cleared by the FDA.

The primary objective of the Phase 1 study  is to evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 and in respiratory distress. The secondary objective is to evaluate a set of safety and efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress.

Stem cells have been demonstrated to support resolution of symptoms in multiple disease settings and have the potential to reduce the long-term effects associated with pulmonary tissue damage for these patients. MSC represent a treatment modality with high potential to help in the fight against COVID-19 as a stand-alone therapy or in synergy with other product candidates in Sorrento’s pipeline, including small molecules (abivertinib or salicyn-30) and neutralizing antibodies (STI-1499 or STI 2020).

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Immunotherapy
CD38 CAR-T Multiple Myeloma

30%*


CAR T (Chimeric Antigen Receptor-T Cell) 

Sorrento’s cellular therapy programs focus on Chimeric Antigen Receptor-T Cell (CAR T) for adoptive cellular immunotherapy to treat both solid and liquid tumors. 

The CAR T program includes CD38, CEA and CD123.

Sorrento’s CD38 CAR T targets high-expressing CD38 positive cells, which may limit on-target/off-tumor toxicity.

The company’s CD38 CAR T candidate is currently being evaluated in multiple myeloma (MM). The program has successfully demonstrated strong preclinical anti-tumor activity in animal models and is currently in phase 1 trial in RRMM. Additionally, Sorrento has reported data from Phase I trials of carcinoembryonic antigen (CEA) directed CAR T program.

The company is assessing CD123 CAR T in acute myeloid leukemia (AML).

DAR T (Dimeric Antigen Receptor-T Cell)

Sorrento utilizes a proprietary knock-out knock-in (KOKI) technology to modify normal healthy donor derived T cells to genetically engineer them to express the dimeric antigen receptor into T-cell receptor (TCR) alpha chain constant region (TRAC). In this manner, TRAC is knocked out and antigen is knocked into its locus. 

The Dimeric Antigen Receptor (DAR) utilizes a Fab instead of the scFv used by traditional Chimeric Antigen Receptor (CAR) T cells. We believe this DAR has been demonstrated in preclinical studies greater specificity, stability and potency.

Chimeric Antigen Receptors (CARs)

Current CAR T Cell Technology

Next-Gen Dimeric Antigen Receptor (DAR) Technology

Sorrento-Graphics-DART

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CD38 DAR-T Multiple Myeloma

10%*


CAR T (Chimeric Antigen Receptor-T Cell) 

Sorrento’s cellular therapy programs focus on Chimeric Antigen Receptor-T Cell (CAR T) for adoptive cellular immunotherapy to treat both solid and liquid tumors. 

The CAR T program includes CD38, CEA and CD123.

Sorrento’s CD38 CAR T targets high-expressing CD38 positive cells, which may limit on-target/off-tumor toxicity.

The company’s CD38 CAR T candidate is currently being evaluated in multiple myeloma (MM). The program has successfully demonstrated strong preclinical anti-tumor activity in animal models and is currently in phase 1 trial in RRMM. Additionally, Sorrento has reported data from Phase I trials of carcinoembryonic antigen (CEA) directed CAR T program.

The company is assessing CD123 CAR T in acute myeloid leukemia (AML).

DAR T (Dimeric Antigen Receptor-T Cell)

Sorrento utilizes a proprietary knock-out knock-in (KOKI) technology to modify normal healthy donor derived T cells to genetically engineer them to express the dimeric antigen receptor into T-cell receptor (TCR) alpha chain constant region (TRAC). In this manner, TRAC is knocked out and antigen is knocked into its locus. 

The Dimeric Antigen Receptor (DAR) utilizes a Fab instead of the scFv used by traditional Chimeric Antigen Receptor (CAR) T cells. We believe this DAR has been demonstrated in preclinical studies greater specificity, stability and potency.

Chimeric Antigen Receptors (CARs)

Current CAR T Cell Technology

Next-Gen Dimeric Antigen Receptor (DAR) Technology

Sorrento-Graphics-DART

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CD38 ADC Amyloidosis

30%*


ADC (Antibody Drug Conjugates)

Antibody Drug Conjugates (ADC)

Antibody-drug conjugates (ADCs) are targeted immunotherapies that utilize potent cytotoxic drugs conjugated to antibodies via chemical linkers. This increases the efficacy of chemotherapeutic agents by effectively targeting the drug directly to cancer cells. Thus, ADCs also have reduced side effects because targeting the cancer cells means less of the cytotoxic drug will enter healthy cells.

Sorrento’s next generation ADC technology platform utilizes innovative conjugation methods to produce stable ADCs by linking the toxin to only specific, preselected sites of an antibody; the resulting ADCs have shown high anti-tumor efficacy in preclinical studies.

ADC technology uses proprietary conjugation chemistries (C-Lock™ and K-Lock™), initially developed by Concortis Biosystems, Corp.

The combination of C-Lock and K-Lock conjugation methods enables multifunctional ADCs, such as dual drug ADCs and Bispecific ADCs. We are also actively studying the combination of ADCs with immuno-oncology therapy as a new anti-cancer strategy.

We are developing ADCs targeting CD38 and BCMA. 

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Seprehvir™ Solid Tumors

30%*


Oncolytic Viruses (Seprehvir™, Seprehvec™)

Oncolytic Immunotherapies

Sorrento’s oncolytic viral vector assets are a modified version of the common human herpes simplex virus (HSV-1). Seprehvir has been designed with the ability to specifically destroy tumor cells while also stimulating anti-tumor patient immune responses. As part of its global clinical development program, Seprehvir has been administered to over 100 adult and pediatric patients in a variety of solid tumors including glioblastoma, mesothelioma, melanoma, head and neck cancer, pediatric sarcomas and pediatric neuroblastomas.

A key advantage of Seprehvir, as compared to other HSV-based oncolytic therapies, is that it has been safely administered intravenously, intratumorally and by loco-regional infusion to specifically tailor the therapy to a patient’s cancer.

The Seprehvec asset is a future generation project which aims to provide additional therapeutic options and can rapidly generate novel oncolytic immunotherapies:

  • “Targeted” specifically to certain types of tumor cells
  • “Armed” with additional genes to enhance the destruction of tumor cells
  • Multi-functional “targeted” and “armed” variants with enhanced cell killing and immuno-stimulatory activities

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Seprehvec™ Solid Tumors

30%*


Oncolytic Viruses (Seprehvir™, Seprehvec™)

Oncolytic Immunotherapies

Sorrento’s oncolytic viral vector assets are a modified version of the common human herpes simplex virus (HSV-1). Seprehvir has been designed with the ability to specifically destroy tumor cells while also stimulating anti-tumor patient immune responses. As part of its global clinical development program, Seprehvir has been administered to over 100 adult and pediatric patients in a variety of solid tumors including glioblastoma, mesothelioma, melanoma, head and neck cancer, pediatric sarcomas and pediatric neuroblastomas.

A key advantage of Seprehvir, as compared to other HSV-based oncolytic therapies, is that it has been safely administered intravenously, intratumorally and by loco-regional infusion to specifically tailor the therapy to a patient’s cancer.

The Seprehvec asset is a future generation project which aims to provide additional therapeutic options and can rapidly generate novel oncolytic immunotherapies:

  • “Targeted” specifically to certain types of tumor cells
  • “Armed” with additional genes to enhance the destruction of tumor cells
  • Multi-functional “targeted” and “armed” variants with enhanced cell killing and immuno-stimulatory activities

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ABIVERTINIB NSCLC

80%*


ABIVERTINIB

Abivertinib is a novel small molecule tyrosine kinase inhibitor (TKI) that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) and Bruton’s tyrosine kinase (BTK) to treat Non-Small Cell Lung Cancer.   

More than 600 patients have been treated with Abivertinib at different oral doses up to 300 mg bid in multiple trials through registration trial (NCT03856697) in patients with non-small cell lung cancer (NSCLC) and B cell malignancies (Phase 1) conducted in China.  Favorable safety, tolerability and efficacy in patients with NSCLC or relapsed/refractory B-cell malignancies were demonstrated in the studies.

Abivertinib is also being tested as a potential treatment for cytokine storm associated with COVID-19 and as a potential treatment for cytokine release syndrome associated with CAR-T.

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ADNIC Solid and Liquid Tumors

55%*


ADNIC

The primary mechanism of action of ADNICs involves targeted delivery of paclitaxel to the tumor microenvironment.  The effectiveness of delivery is influenced by particle size and the kinetics of release of its various components including mAb-HSA-paclitaxel complex or HSA-paclitaxel in the tumor microenvironment.

mAb Binding to HSA

adnic

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Pain
RTX (resiniferatoxin)
Epidural route
Intractable Pain in Advanced Cancer

55%*

Orphan designation

RTX

Pain associated with Arthritis of the Knee

Pain associated with terminal cancer

RTX (resiniferatoxin) is a unique neural intervention molecule that is highly selective and may be applied peripherally (e.g., nerve block, intra-articular) or centrally (e.g., epidural), to control chronic pain across multiple conditions including arthritis and cancer.

RTX has the potential to be a first-in-class drug addressing currently intractable pain in a novel and unique way, by targeting the nerves responsible for the chronic debilitating pain signal transmission.

RTX strongly binds to TRPV1 receptors and forces open calcium channels located in the end-terminal of the nerve or the soma of the neuron (depending upon the route of administration). This in turn generates a slow and sustained  cation influx that rapidly leads to the deletion of TRPV1-positive cells.

RTX directly interacts with afferent nerve cells without affecting sensations such as touch, pressure, acute prickling pain, vibration sense or muscle coordination function.

Administration at the peripheral nerve ending results in a sustained temporal effect to treat pain associated with arthritis of the knee.

RTX can potentially help patients with terminal cancer pain, after a single epidural injection, by permanently blocking the pain signal transmission from the tumor tissue to the dorsal root ganglion (DRG) in the spinal cord, without the undesirable side effects associated with high and repeated doses of opioids.  If opioids remain part of the therapeutic arsenal for these patients, RTX has the potential to significantly reduce the amount and frequency of opioid use.

RTX has been granted Orphan Drug Status by the US Food and Drug Administration for the treatment of end-stage diseases, including intractable cancer pain.

Sorrento has successfully completed a positive Phase Ib clinical proof of concept trial with the National Institutes of Health under a Cooperative Research and Development Agreement (CRADA) which showed improved pain and reduced opioid consumption after intrathecal administration (directly into the spinal cord space).

The company will be initiating pivotal studies in 2020 and is aiming for an NDA filing in 2022.

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RTX (resiniferatoxin)
Intra-articular route
Moderate to Severe OA

55%*


RTX

Pain associated with Arthritis of the Knee

Pain associated with terminal cancer

RTX (resiniferatoxin) is a unique neural intervention molecule that is highly selective and may be applied peripherally (e.g., nerve block, intra-articular) or centrally (e.g., epidural), to control chronic pain across multiple conditions including arthritis and cancer.

RTX has the potential to be a first-in-class drug addressing currently intractable pain in a novel and unique way, by targeting the nerves responsible for the chronic debilitating pain signal transmission.

RTX strongly binds to TRPV1 receptors and forces open calcium channels located in the end-terminal of the nerve or the soma of the neuron (depending upon the route of administration). This in turn generates a slow and sustained  cation influx that rapidly leads to the deletion of TRPV1-positive cells.

RTX directly interacts with afferent nerve cells without affecting sensations such as touch, pressure, acute prickling pain, vibration sense or muscle coordination function.

Administration at the peripheral nerve ending results in a sustained temporal effect to treat pain associated with arthritis of the knee.

RTX can potentially help patients with terminal cancer pain, after a single epidural injection, by permanently blocking the pain signal transmission from the tumor tissue to the dorsal root ganglion (DRG) in the spinal cord, without the undesirable side effects associated with high and repeated doses of opioids.  If opioids remain part of the therapeutic arsenal for these patients, RTX has the potential to significantly reduce the amount and frequency of opioid use.

RTX has been granted Orphan Drug Status by the US Food and Drug Administration for the treatment of end-stage diseases, including intractable cancer pain.

Sorrento has successfully completed a positive Phase Ib clinical proof of concept trial with the National Institutes of Health under a Cooperative Research and Development Agreement (CRADA) which showed improved pain and reduced opioid consumption after intrathecal administration (directly into the spinal cord space).

The company will be initiating pivotal studies in 2020 and is aiming for an NDA filing in 2022.

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Lymphatic Delivery
Sofusa® anti-TNF Autoimmune

30%*


The Sofusa® Lymphatic Delivery System (S-LDS) is a new method of treatment designed to deliver injectable medicines directly into lymphatic and systemic capillaries just beneath the epidermis via a proprietary microneedle and microfluidics system.

Sofusa Lymphatic Delivery System Overview. Visit www.sofusa.com »

sofusa-graphic01
enhanced-absorption
 
Enhanced Absorption

Unlike traditional injections, the Sofusa (“soft transdermal infusion) system enables controlled absorption into tiny lymphatic and systemic capillaries just beneath the epidermis.

nano-structured-microneedles
 
Nanotopography (highly magnified)

Proprietary thin film nanotopography applied to microneedles results in a dramatic increase in absorption of large molecules vs undraped microneedles


Intra-Lymphatic Targeting

In pre-clinical models compared to traditional injection, Sofusa has demonstrated improved clinical response with increased in lymphatic concentrations and reduced systemic exposure1.

(1) Data on file – Multiple pre-clinical studies involving etanercept, trastuzumab, CTLA-4, PD-1, and PD-L1

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Sofusa® anti-PD-1 CTCL

30%*


The Sofusa® Lymphatic Delivery System (S-LDS) is a new method of treatment designed to deliver injectable medicines directly into lymphatic and systemic capillaries just beneath the epidermis via a proprietary microneedle and microfluidics system.

Sofusa Lymphatic Delivery System Overview. Visit www.sofusa.com »

sofusa-graphic01
enhanced-absorption
 
Enhanced Absorption

Unlike traditional injections, the Sofusa (“soft transdermal infusion) system enables controlled absorption into tiny lymphatic and systemic capillaries just beneath the epidermis.

nano-structured-microneedles
 
Nanotopography (highly magnified)

Proprietary thin film nanotopography applied to microneedles results in a dramatic increase in absorption of large molecules vs undraped microneedles


Intra-Lymphatic Targeting

In pre-clinical models compared to traditional injection, Sofusa has demonstrated improved clinical response with increased in lymphatic concentrations and reduced systemic exposure1.

(1) Data on file – Multiple pre-clinical studies involving etanercept, trastuzumab, CTLA-4, PD-1, and PD-L1

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