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CARVYKTI™ (ciltacabtagene autoleucel), BCMA-Directed CAR-T Therapy, Receives U.S. FDA Approval for the Treatment of Adult Patients With Relapsed or Refractory Multiple Myeloma
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CARVYKTI™ marks the first product approved by a health authority for Legend Biotech
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Approval is primarily based on the pivotal phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate (ORR) of 98 percent in patients with refractory or relapsed multiple myeloma after four or more prior lines of therapy including proteasome inhibitor, immunomodulatory agent and anti-CD38 monoclonal antibody1
FDA Grants Orphan Drug Designation to Celularity’s CYNK-101, an NK Cell Therapy for GI Cancers
CYNK-101 is an investigational genetically modified NK cell therapy designed to synergize with antibody therapeutics for difficult to treat cancers of high unmet medical need
Phase 1/2a clinical trial will evaluate the safety and preliminary efficacy of CYNK-101 in combination with standard chemotherapy, trastuzumab, and pembrolizumab
5th designation received by Celularity within 12 months from the US FDA
StemCyte Reports Successful Phase I Trial Using Cord Blood to Treat Cerebral Stroke
StemCyte Announces Successful Outcome in Phase I Clinical Trial for Treating Acute Cerebral Stroke Using Allogeneic Human Umbilical Cord Blood
StemCyte is a portfolio company of Microbio Group focusing on new drug discovery in cell therapy with operations in the U.S., Taiwan, and India
BALDWIN PARK, Calif., Jan. 26, 2022 — Southern California cord blood therapeutics company StemCyte Inc. is announcing successful preliminary results for Phase I of the company’s clinical trial for treating acute cerebral stroke using monocytes from allogeneic human umbilical cord blood (hUCB). [Read more…]
Excellos Launches as Latest Cell and Gene Therapy CDMO with $15M in Funding
Founded by an Experienced Management Team and Built on the Reach and Infrastructure of the San Diego Blood Bank
SAN DIEGO, January 25, 2022 — Excellos, Incorporated, a cell therapy Contract Development and Manufacturing Organization (CDMO), announces its official corporate launch and closing of $15M in growth funding from Telegraph Hill Partners (THP). Built on the foundation of the San Diego Blood Bank (SDBB), Excellos is focused on supplying cGMP cellular products and services, together with process development and manufacturing expertise to scientists and clinicians working with cell and gene therapies. [Read more…]
Basilard Biotech to Transform the Engineering of Cell-based Therapies Using Their Novel Nanomechanical Gene Delivery Technology
Basilard Biotech is a Southern-California-based company poised to lead a revolution in the engineering of cell based therapies in Cell and Gene Therapy (CGT). In 2019, the company launched a disruptive gene delivery technology platform called SoloPore™. This novel approach to nanomechanical gene delivery has the potential to disrupt the current limitations of current viral and non-viral gene delivery—a breakthrough that could facilitate better scalability and more  cost-effective production of cell and gene therapies.
In this interview with Brynley Lee, CEO of Basilard, we learn about the formation of Basilard Biotech, explore the company’s novel SoloPore™ technology, dive into the company’s funding strategy, and explore its future goals. Enjoy! [Read more…]
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