CD20 | Jotup

ImmPACT Bio Announces Opening of California-Based GMP Facility for Clinical Production of IMPT-314, a CD19/CD20 CAR T Therapy for B-Cell Malignancies and Autoimmune Diseases

Retrieved on:

Monday, May 8, 2023

GMP, University, CD19, QC, WEST, CD20, Cancer, Foot, DRS, University of California, Research, B-cell lymphoma, Malignancy, CAR, Patient, Quality control, Knowledge, UCLA, Safety, Vaccine

WEST HILLS, Calif., May 8, 2023 /PRNewswire/ -- ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, today announced the opening of the Company's 21,500 square foot Good Manufacturing Practices (GMP) facility in Los Angeles, California. The integrated, state-of-the-art development and manufacturing facility will support clinical production of the Company's lead candidate IMPT-314, a potential first-in-class CD19/CD20 bispecific CAR T therapy for B-cell mediated malignancies and autoimmune diseases. IMPT-341 was based on research and work conducted by Yvonne Chen, Ph.D., associate professor, and Sarah Larson, M.D., principal investigator, both of University of California, Los Angeles (UCLA). Drs. Chen and Larson initiated an ongoing investigator Phase 1 study at UCLA in patients with relapsed or refractory non-Hodgkin lymphoma. ImmPACT Bio licensed the logic-gate-based CAR T-cell platforms from UCLA Technology Development Group.

Key Points:

The integrated, state-of-the-art development and manufacturing facility will support clinical production of the Company's lead candidate IMPT-314, a potential first-in-class CD19/CD20 bispecific CAR T therapy for B-cell mediated malignancies and autoimmune diseases.
"We are pleased to celebrate the grand opening of ImmPACT Bio's first U.S.-based GMP manufacturing facility, an instrumental milestone marking the clinical readiness of our lead program IMPT-314.
ImmPACT Bio's GMP manufacturing facility will initially focus on clinical manufacturing of IMPT-314, a bispecific autologous CAR T-cell therapy targeting prevalent B-cell antigens CD19 and CD20.
ImmPACT Bio will evaluate IMPT-314 in a Phase 1/2 clinical trial for aggressive B-cell lymphoma, including diffuse large B-cell lymphoma.

Cellular Biomedicine Group Announces Exclusive Collaboration and License Agreement with Janssen to Develop and Commercialize anti CD19 & CD20 Bi-Specific and anti CD20 CAR-Ts for Non-Hodgkin Lymphoma

Retrieved on:

Tuesday, May 2, 2023

Biologics license application, CD20, DLBCL, NHL, Cancer, Hope, Janssen, Follicular lymphoma, Orphan drug, Non-Hodgkin lymphoma, Patient, FDA, BLA, IND, Technology transfer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Disease, Pharmaceutical industry

The U.S. Food and Drug Administration (FDA) has granted C-CAR039 Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed/refractory Diffuse Large B-cell Lymphoma (r/r DLBCL).

Key Points:

The U.S. Food and Drug Administration (FDA) has granted C-CAR039 Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed/refractory Diffuse Large B-cell Lymphoma (r/r DLBCL).
Furthermore, C-CAR039 has also received Orphan Drug designation from the FDA for the treatment of Follicular lymphoma (FL).
"We are very excited to announce the C-CAR039 and C-CAR066 CAR-T collaboration and license agreement with Janssen to develop and commercialize our novel CAR-T therapies," said Tony (Bizuo) Liu, Chairman and CEO of CBMG.
We feel privileged to work with Janssen to advance the promise of our innovative medicines."

Janssen Enters Worldwide Collaboration and License Agreement with Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies

Retrieved on:

Tuesday, May 2, 2023

HORSHAM, Pa., May 2, 2023 /PRNewswire/ -- Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that it has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. These investigational CD20-directed autologous CAR-Ts have demonstrated promising overall and complete response rates in Phase 1 studies in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) in China, with the majority of study participants having diffuse large B-cell lymphoma (DLBCL), the most common type of aggressive lymphoma accounting for approximately one-third of B-cell lymphomas globally.1,2

Key Points:

A Phase 1b study in the U.S. evaluating C-CAR039 in the treatment of patients with R/R DLBCL is underway.
Under terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China.
Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the China territory.
"The Cellular Biomedicine Group team has discovered differentiated cell therapies with clinically validated CD20 CAR constructs, and we look forward to harnessing our expertise, capabilities and scale to lead the global development of these innovative CAR-T products."

EvolveImmune Therapeutics Presents New Preclinical Data Demonstrating Improved Anti-Tumor Potential of Novel Costimulatory T Cell Engager Platform at Festival of Biologics Immunotherapy World Congress

Retrieved on:

Wednesday, March 22, 2023

Monoclonal antibody, Lymphoid leukemia, CD2, Immunology, Therapy, CD3, CD28, CD20, Neoplasm, Cancer, Research, Immunotherapy, Acute myeloid leukemia, CD8, Festival, Lymphocyte, EVOLVE, Pharmaceutical industry, Vaccine

BRANFORD, Conn., March 22, 2023 (GLOBE NEWSWIRE) -- EvolveImmune Therapeutics, an immuno-oncology company developing first-in-category, multifunctional biotherapeutics to overcome cancer-driven immunodeficiency, today announced that new preclinical data on EVOLVE™, the company’s novel costimulatory T cell engager platform, were featured in an oral presentation at the Festival of Biologics Immunotherapy World Congress. The presentation highlighted the potential of the company’s innovative integrated CD2 costimulatory strategy to overcome treatment limitations of current immunotherapies. Additionally, the company disclosed the first data for EVOLVE-105, its best-in-class CD20xCD3 multispecific T cell engager that also selectively mediates CD2 costimulation.

Key Points:

The presentation highlighted the potential of the company’s innovative integrated CD2 costimulatory strategy to overcome treatment limitations of current immunotherapies.
Additionally, the company disclosed the first data for EVOLVE-105, its best-in-class CD20xCD3 multispecific T cell engager that also selectively mediates CD2 costimulation.
Moreover, they do not provide coordinated costimulatory receptor activation to overcome T cell dysfunction and drive more effective and longer lasting anti-tumor responses.
The Festival of Biologics presentation, entitled, “A novel costimulatory T cell engager platform engineered for the treatment of immune suppressive tumors,” included key new findings for the company’s EVOLVE platform and its growing costimulatory T cell engager portfolio.

Shattuck Labs Presents Preclinical Data at the 2023 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on:

Thursday, March 16, 2023

Poster, Cancer, AACR, FC, CD20, Patient, Autoimmune disease, Fragment crystallizable region, Primate, BTN3A1, Cytokine release syndrome, Toxicity, Vaccine

AUSTIN, TX and DURHAM, NC, March 16, 2023 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced preclinical data at the 2023 American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida, from the company’s GADLEN platform.

Key Points:

“We are pleased to share pre-clinical data demonstrating that the CD20-targeted GADLEN efficiently directs small numbers of human Vγ9Vδ2 T cells to serially kill greater than 99% of human B cells in a humanized mouse model,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck.
“These data led to the first study of a GADLEN compound in non-human primates, where once again treatment with a CD20-targeted GADLEN directed low frequencies of endogenous Vγ9Vδ2 T cells to eliminate CD20 positive B cells with a rapid kinetic.
Additional meeting information can be found on the AACR website, https://www.aacr.org .
The poster will be available under Posters on the Company’s website shortly after the event

Early Launch Metrics for TG Therapeutics' Briumvi in RMS Trail Those of Novartis' In-Class Competitor Kesimpta, According to Spherix Global Insights

Retrieved on:

Wednesday, March 15, 2023

Acquisition, Multiple sclerosis, Therapy, RMS, MS, TG, Patient, CD20, Neurology, DMT, WAC, Pharmaceutical industry, Ublituximab, Novartis, Genentech

EXTON, Pa., March 15, 2023 /PRNewswire/ -- With the U.S. commercial launch of TG Therapeutics' Briumvi (ublituximab-xiiy) on January 26th, 2023 for the treatment of relapsing multiple sclerosis (RMS), patients gained access to the third therapy in the increasingly dominant anti-CD20 drug class. Briumvi joins established blockbusters Ocrevus (ocrelizumab) from Genentech and Kesimpta (ofatumumab) from Novartis in this class.

Key Points:

Briumvi joins established blockbusters Ocrevus (ocrelizumab) from Genentech and Kesimpta (ofatumumab) from Novartis in this class.
With Briumvi's later entrance onto the MS market, TG Therapeutics is positioning its brand for success by highlighting its distinct properties, particularly compared with Ocrevus.
However, when compared with Novartis' subcutaneous anti-CD20 brand, fewer neurologists considered Briumvi to be a substantial advance over other MS agents.
Even with early launch metrics being overshadowed by those for Kesimpta, half of respondents anticipate Briumvi trial for RMS in six months' time.

Adicet Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights Recent Company Progress

Retrieved on:

Wednesday, March 15, 2023

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today reported financial results and operational highlights for the fourth quarter and year ended December 31, 2022.

Key Points:

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today reported financial results and operational highlights for the fourth quarter and year ended December 31, 2022.
Enrollment in the trial is currently ongoing to provide additional durability data and further support the recommended Phase 2 dose.
In November 2022, Adicet announced the appointment of Dr. Nancy Boman, M.D., Ph.D., as Senior Vice President and Chief Regulatory Officer.
In the fourth quarter of 2022, Adicet’s new in-house manufacturing capabilities in its Redwood City facility became operational.

Xencor Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on:

Thursday, February 23, 2023

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2022

Key Points:

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2022
Cash, cash equivalents, receivables and marketable debt securities totaled $613.5 million as of December 31, 2022, compared to $664.1 million on December 31, 2021.
Total revenue for the fourth quarter ended December 31, 2022 was $21.6 million compared to $154.0 million for the same period in 2021.
General and administrative (G&A) expenses for the fourth quarter ended December 31, 2022 were $12.8 million compared to $11.4 million for the same period in 2021.
ET (1:30 p.m. PT) to discuss the full year 2022 financial results and provide a corporate update.

Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Retrieved on:

Friday, January 20, 2023

Reddy’s”), a global pharmaceutical company, announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions.

Key Points:

Reddy’s”), a global pharmaceutical company, announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions.
Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets.
The company undertook further clinical development to meet regulatory requirements of highly regulated markets.
The successful completion and positive outcome of these clinical studies highlights our capability for global clinical development of biosimilar products for highly regulated and global markets.

Shattuck Labs Provides Corporate Update and Highlights Upcoming Key Milestones in 2023

Retrieved on:

Monday, January 9, 2023

DURHAM, Autoimmune disease, AML, CD47, Azacitidine, CD20, Growth, Webcast, Patient, TX, CD40, Cancer, Clinical trial, ImmunoGen, Investment, Shattuck, Pharmaceutical industry

AUSTIN, TX & DURHAM, NC, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK ), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today provided a corporate update and highlighted upcoming key milestones anticipated in 2023.

Key Points:

AUSTIN, TX & DURHAM, NC, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK ), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today provided a corporate update and highlighted upcoming key milestones anticipated in 2023.
“Throughout 2022, we focused on clinical execution to position ourselves for key clinical data readouts for SL-172154 in 2023.
These milestones are now rapidly approaching for both solid tumor and hematologic indications.
A replay of the webcast will be archived for up to 30 days following the presentation date.