CD19

InnoCare Announces Approval of Clinical Trial of BCL2 Inhibitor ICP-248 in Combination with Orelabrutinib as First-Line Therapy for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China

Retrieved on: 
Wednesday, March 13, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, SLL, CLL, Hematology, E-3, Incidence, Patient, Malignancy, BCL2, Cancer, Leukemia, Death, IND, Clinical trial, Investigational New Drug, HKEX, BTK, Safety, Marketing, NRDL, Lymphoma, CD19, Pharmaceutical industry

This multicenter, randomized-controlled, open-label clinical study is designed to evaluate the efficacy and safety of ICP-248 combined with orelabrutinib versus immunochemotherapy in treatment-naive patients with CLL/SLL.

Key Points: 
  • This multicenter, randomized-controlled, open-label clinical study is designed to evaluate the efficacy and safety of ICP-248 combined with orelabrutinib versus immunochemotherapy in treatment-naive patients with CLL/SLL.
  • ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies.
  • BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies.
  • ICP-248 has an anti-tumor effect by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death.

Navrogen Presents Its Anti-CD20 Antibody NAV-006 and ICAM-1 Refractory Antibody-Drug Conjugate Platform at the 2024 American Association for Cancer Research Annual Meeting

Retrieved on: 
Thursday, April 4, 2024
Conference, Rituximab, B-cell lymphoma, Serum, HIO, Patient, CD20, Humoral immunity, Cancer, BRITE, NHL, AACR, CA125, ADC, Lymphoma, CD19, Vaccine

Recent clinical evidence suggests that high serum levels of the tumor-produced MUC16/CA125 protein has a negative impact on the efficacy of rituximab.

Key Points: 
  • Recent clinical evidence suggests that high serum levels of the tumor-produced MUC16/CA125 protein has a negative impact on the efficacy of rituximab.
  • Navrogen will present data showing NAV-006's superior efficacy over rituximab in animal models of human NHL.
  • "We have engineered a trastuzumab-drug conjugate variant with superior cytotoxicity against ICAM-1 positive cancer cells.
  • We are now building a portfolio of enhanced ADCs using this platform to advance internal as well as partnered ADC programs".

Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR™-310 in Relapsed/Refractory B-cell NHL

Retrieved on: 
Wednesday, April 3, 2024
Malignancy, MCL, Patient, B-cell lymphoma, Standard of care, Follicular lymphoma, Trial of the century, NHL, IND, Verismo, Clinical trial, Investigational New Drug, Therapy, Mantle cell lymphoma, FDA, NK, DLBCL, B cell, CD19, Food, Bone marrow, Pharmaceutical industry

PHILADELPHIA, April 3, 2024 /PRNewswire/ -- Verismo Therapeutics, a clinical-stage CAR T company developing the novel KIR-CAR platform technology, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its Phase 1 clinical trial of SynKIR™-310, for the treatment of relapsed/refractory (r/r) B-cell Non-Hodgkin Lymphomas (B-cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL).

Key Points: 
  • Commercially approved CAR T cell therapies have shown impressively high initial response rates in blood cancers.
  • Over time, however, these therapies result in relapse in an estimated 40-50% of patients1.
  • There are currently very limited treatment options for patients with r/r DLBCL who relapse following treatment with commercial CAR T cell therapies.
  • Initiation of the clinical trial is the culmination of years of focused research and diligent work by the Verismo team."

CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2023 BUSINESS AND FINANCIAL RESULTS

Retrieved on: 
Thursday, March 28, 2024
Agreement, Transplant, CASI Pharmaceuticals, CASI, Patient, Travel, PTCL, Immunoglobulin G, CMC, Depreciation, Bone marrow, Therapy, VCP, Marketing, Research, Cleave, Pralatrexate, MCL, Rituximab, AML, Pembrolizumab, Trial of the century, Myelodysplastic syndrome, Melphalan, MDS, Clinical trial, Follicular lymphoma, Republic, Multiple myeloma, Acute myeloid leukemia, Annual report, National Medical Products Administration, Haematopoietic system, FDA, Cayman, CD19, NMPA, COVID-19, CTA, HKIAC, NHL, Non-Hodgkin lymphoma, MICL, Pharmaceutical industry

BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.

Key Points: 
  • BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.
  • CASI reported fourth quarter 2023 revenue of $6.9 million for EVOMELA®, 33% lower than the same period in 2022.
  • 2023 marks a major milestone for CASI and our partner Juventas; Inaticabtagene Autoleucel (CNCT-19 CAR-T cell therapy) was approved by National Medical Products Administration (NMPA) in November 2023.
  • As of December 31, 2023, CASI had cash, cash equivalents and short term investment of $29.1 million compared to $48.6 million as of December 31, 2022.

Phase 1 onCARlytics solid tumour trial advances to combination arm treatment

Retrieved on: 
Monday, March 11, 2024
Therapy, Amgen, Safety, CD19, Breast, ASX, Ovary, Patient, OASIS, IMU, Blinatumomab, Melanoma, Vaccine

Known as OASIS, the first-in-class clinical trial is targeting adult patients with advanced or metastatic solid tumours, and aims to evaluate the safety and efficacy of two routes of administration, intratumoral (IT) injection and intravenous (IV) infusion, either alone, or in combination with blinatumomab.

Key Points: 
  • Known as OASIS, the first-in-class clinical trial is targeting adult patients with advanced or metastatic solid tumours, and aims to evaluate the safety and efficacy of two routes of administration, intratumoral (IT) injection and intravenous (IV) infusion, either alone, or in combination with blinatumomab.
  • The trial is titled: “A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors.” See https://clinicaltrials.gov/study/NCT06063317
    The combination arm of the study will see onCARlytics combined with CD19 targeting bispecific monoclonal antibody blinatumomab (marketed as Blincyto® by Amgen which currently is specifically approved only for liquid blood cancers).
  • onCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto® therapy alone and will represent a paradigm shift in solid tumour treatment.
  • OASIS is a dose escalation trial that will be conducted across multiple sites across the United States, with 52 patients proposed to take part in the trial.

Oncternal Therapeutics Provides Business Update and Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 7, 2024
FDG, SAN, Research, Prostate cancer, Investment, Food, Pneumonia, CD19, Lymphoma, Therapy, CMR, Patient, Patient safety, Cytokine release syndrome, CRS, Pharmaceutical industry

Our grant revenue was $0.3 million for the fourth quarter ended December 31, 2023 and was $0.8 million for the full year 2023.

Key Points: 
  • Our grant revenue was $0.3 million for the fourth quarter ended December 31, 2023 and was $0.8 million for the full year 2023.
  • Our total operating expenses for the fourth quarter ended December 31, 2023 were $9.9 million, including $2.2 million in non-cash stock-based compensation expense.
  • Research and development expenses for the quarter totaled $6.7 million, and general and administrative expenses for the quarter totaled $3.3 million.
  • We believe these funds will be sufficient to fund our operations into the first quarter of 2025.

Sana Biotechnology Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates

Retrieved on: 
Thursday, February 29, 2024
Neoplasm, CD47, VIVID, CD19, Exercise, Science Translational Medicine, Bone marrow, Lymphoid leukemia, Lupus nephritis, CTA, Biotechnology, Escape Room, Research and development, GLEAM, ANCA, GAAP, Sana, Insulin, Development, Immune system, Regeneration, ASH, CD22, AACR, B cell, Safety, Immunosuppression, Diabetes, Patent, IND, Insurance, Nature Biotechnology, NHL, Cancer, CLL, Contingency, Cell, NHP, Organoid, Autoimmunity, Administration, Cell Stem Cell, Patient, HIP, Nature Communications, ISSCR, C-peptide, Vaccine

The Investigational New Drug Application (IND) cleared in 4Q 2023, and Sana expects to share initial data in 2024.

Key Points: 
  • The Investigational New Drug Application (IND) cleared in 4Q 2023, and Sana expects to share initial data in 2024.
  • The Clinical Trial Application (CTA) cleared in 4Q 2023, and Sana expects initial data to be shared in the first half of 2024.
  • Non-GAAP research and development expense in 2023 excludes an expense related to the impairment of certain lab equipment and leasehold improvements, primarily due to the portfolio prioritization in the fourth quarter of 2023.
  • A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.”

TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2023 Financial Results

Retrieved on: 
Wednesday, February 28, 2024
CD20, Conference call, European Commission, Patent, CD19, Precision, Precision BioSciences, Conference, Multiple sclerosis, Consultant, Therapy, Patient, Autoimmunity, Clinical trial, Finance, RMS, Prescription, Pharmaceutical industry

NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) --  TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the fourth quarter and year ended December 31, 2023, along with recent company developments.Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, “2023 was an exciting year of execution for TG, which we believe has set the stage for a successful 2024. The BRIUMVI launch exceeded our expectations, and we ended the year with approximately $89 million in U.S. net revenue and provided a BRIUMVI U.S. net revenue target of $220 - $260 million for 2024. Further executing on our corporate objectives in 2023, we presented the first data from our ENHANCE Phase 3 b trial evaluating patients who switch from prior CD20 therapy to BRIUMVI, and recently broadened our BRIUMVI clinical efforts to include subcutaneous development and potential expansion beyond MS. We look forward to sharing additional developments from these efforts throughout the year, as well as advancing our recent pipeline addition, azer-cel, an allogeneic CAR T into clinical development in autoimmune disease.” Mr. Weiss continued, “We were also pleased to see our ex-US partner, Neuraxpharm, commence the launch of BRIUMVI in Europe this week. As the year progresses, we look forward to providing continued updates on our launch of BRIUMVI in the U.S. and sharing data updates throughout the year at major medical meetings.”

Key Points: 
  • Fourth quarter and full year 2023 BRIUMVI U.S. net revenue of approximately $40 million and $89 million, respectively
    Conference call to be held today, February 28, 2024, at 8:30 AM ET
    NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) --  TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the fourth quarter and year ended December 31, 2023, along with recent company developments.
  • Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $217.5 million as of December 31, 2023.
  • The Company will host a conference call today, February 28, 2024, at 8:30 AM ET, to discuss the Company’s financial results from the fourth quarter and full year ended December 31, 2023.
  • To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics.

Fate Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates

Retrieved on: 
Monday, February 26, 2024
Neoplasm, Regenerative medicine, CIRM, B-cell lymphoma, Graft-versus-host disease, Investment, TRAC, ADR, CD19, Cytokine release syndrome, Cell, Destiny, HER2, BCMA, Lupus, IPSC, Safety, GAAP, Therapy, Trastuzumab, Pharmacokinetics, Lymphoid leukemia, Patient, NK, Multiple myeloma, SLE, Immunotherapy, Research, CRS, Vaccine

SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Total Operating Expenses: For the fourth quarter of 2023, GAAP operating expenses were $49.8 million, including research and development expenses of $31.8 million and general and administrative expenses of $17.9 million.
  • Shares Outstanding: Common shares outstanding were 98.6 million, and preferred shares outstanding were 2.8 million, as of December 31, 2023.
  • ET to review financial and operating results for the quarter and full year ended December 31, 2023.
  • The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com.

Imugene Highlights Recent Achievements and Looks Ahead to Key Upcoming Immuno-oncology Catalysts

Retrieved on: 
Thursday, February 22, 2024
Allotransplantation, Skin cancer, Cholangiocarcinoma, Fast track (FDA), NHL, Melanoma, FDA, Pembrolizumab, CD19, Rupture, Lung, Epidemiology, Breast, Safety, Neoplasm, ASX, Bone marrow, Patient, RECIST, MAST, National library, IMU, Blinatumomab, DLBCL, Cancer, BTC, Vaccine

Imugene Managing Director & CEO Leslie Chong said: “We are encouraged by the initial safety and efficacy signals seen to date.

Key Points: 
  • Imugene Managing Director & CEO Leslie Chong said: “We are encouraged by the initial safety and efficacy signals seen to date.
  • Notably, in our Phase 1 MAST CF33 oncolytic virus trial, we’ve seen encouraging response rates during dose escalation, including one complete response in a patient with cholangiocarcinoma, and two partial responses in melanoma as we continue to dose escalate with no safety issues.
  • Importantly, two out of three of these responses were achieved with CF33 monotherapy.
  • onCARlytics uses an antigen/target-armed CF33, followed by treatment with a CD19 targeting therapy directed against that antigen or target.