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Details:
SP-102 (semdexatm) is expected to be administered in up to 3 injections during a 6-month observation period. Completion of enrollment for Lumbosacral Radicular Pain (Sciatica) in the trial is projected to occur in 2025.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Musculoskeletal Product Name: SP-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2023
Details:
Through the acquisition, Quince gains right for EryDel's Phase 3 lead asset, EryDex (dexamethasone sodium phosphate), targeting a rare fatal pediatric neurological disease, Ataxia-Telangiectasia (A-T), which currently has no approved treatments.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Genetic Disease Product Name: EryDex
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Quince Therapeutics
Deal Size: $485.0 million Upfront Cash: $485.0 million
Deal Type: Acquisition October 23, 2023
Details:
EryDex (dexamethasone sodium phosphate) utilizes a unique drug/device combination that enables a fully automated process at the point of patient care for the autologous intracellular drug encapsulation for the Treatment of Ataxia-Telangiectasia.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Genetic Disease Product Name: EryDex
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2023
Details:
AVM0703 is small molecule immunomodulatory drug enrolling Phase 2 trials in US in relapsed/refractory Non-Hodgkin's Lymphoma (NHL) which began enrollment Q3 2023 (partially funded by NCI Ph II FastTrak grant 1R44CA272096).
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Oncology Product Name: AVM0703
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2023
Details:
Through the acquisition, Quince gains right for EryDel's Phase 3 lead asset, EryDex (dexamethasone sodium phosphate), targeting a rare fatal pediatric neurological disease, Ataxia-Telangiectasia (A-T), which currently has no approved treatments.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Genetic Disease Product Name: EryDex
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Quince Therapeutics
Deal Size: $485.0 million Upfront Cash: $485.0 million
Deal Type: Acquisition July 24, 2023
Details:
AVM0703 (Dexamethasone sodium phosphate) is a small molecule which triggers the production and release of endogenous bispecific gamma delta TCR+ invariant TCR+ Natural Killer T-like cells (AVM-NKT).
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Oncology Product Name: AVM0703
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Cancer Institute
Deal Size: $2.0 million Upfront Cash: Undisclosed
Deal Type: Funding June 14, 2022
Details:
Under the terms of the agreement, TLC will primarily be responsible for the development of the product TLC599 (Dexamethasone Sodium Phosphate) and EVL will primarily be responsible for obtaining regulatory approval and commercialization of the product in the United States.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Rheumatology Product Name: TLC599
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Endo International
Deal Size: $140.0 million Upfront Cash: $30.0 million
Deal Type: Agreement June 13, 2022
Details:
AVM0703 (dexamethasone) led to, complete response in 27% of immune-resistant mouse A20 tumors as monotherapy and complete response in 60% when combined with 2 doses of cyclophosphamide/fludarabine (CyFlu).
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Oncology Product Name: AVM0703
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
Data demonstrated the utility of SEMDEXA (dexamethasone sodium phosphate) in rapidly reducing sciatica pain with an extended effect for up to 99 days following a single epidural injection of SP-102 (SEMDEXA).
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Neurology Product Name: Semdexa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Neurology Product Name: Semdexa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
SP-102 (dexamethasone sodium phosphate) with 401 patients enrolled in C.L.E.A.R. trial experienced a rapid onset of pain relief, measured by Numeric Pain Rating Scale of average daily pain in the affected leg, with highly statistically significant improvement against placebo.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Musculoskeletal Product Name: Semdexa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sorrento Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2022
Details:
Funds will be used for the potential registration and commercialization of SP-102 (SEMDEXA) in 2023 and further development of the other existing non-opioid clinical programs for high unmet need acute and chronic pain conditions.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Musculoskeletal Product Name: Semdexa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Vickers Vantage Corp
Deal Size: $1,640.0 million Upfront Cash: Undisclosed
Deal Type: Merger March 17, 2022
Details:
Results showed that TLC599 (Dexamethasone Sodium Phosphate), a proprietary BioSeizer, demonstrated statistically significantly greater reduction in WOMAC pain and function as well as VAS scores compared to placebo through 24 weeks.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Rheumatology Product Name: TLC599
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2022
Details:
TLC599 is a non-opioid, proprietary BioSeizer® sustained release formulation of dexamethasone sodium phosphate (DSP) intended to manage OA pain for up to six months.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Musculoskeletal Product Name: TLC599
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 28, 2020
Details:
Fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4) has begun to enroll hospitalized adults with coronavirus disease 2019 (COVID-19) who require supplemental oxygen. The trial is blinded for the dexamethasone and baricitinib components.
Lead Product(s): Dexamethasone Sodium Phosphate,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 26, 2020
Details:
This second study will evaluate AVM0703 in two different ARDS patient populations: one with COVID-19-mediated moderate to severe ARDS and the other with Influenza-mediated severe ARDS.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Infections and Infectious Diseases Product Name: AVM0703
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2020
Details:
AVM Biotechnology has been awarded a National Cancer Institute Small Business Innovation Research Grant from the NIH to study the use of AVM0703 as a preconditioning agent to allow safe and efficient delivery of therapeutic immune cells for cancer treatment.
Lead Product(s): Dexamethasone Sodium Phosphate,Hydrocortisone,Undisclosed
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
Subgroup analyses of Phase II data confirm robustness of TLC599’s efficacy response of greater pain reductions than placebo through 24 weeks.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
AVM Biotechnology received clinical trial approval for AVM0703. Unlike chemotherapy and radiation, AVM0703 spares platelets and red blood cells, limiting the need for transfusions.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2020
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