Multiple myeloma

EQS-News: Heidelberg Pharma granted orphan drug designation by FDA for its proprietary ATAC candidate HDP-101

Retrieved on: 
Wednesday, April 10, 2024
ODD, Diagnosis, RRMM, BCMA, Patient, Multiple myeloma, Spacecraft, Amanitin, AACR, Antibody, Safety, HPHA, FDA, B-cell maturation antigen, ATAC, Food, Pharmaceutical industry

Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.

Key Points: 
  • Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.
  • Heidelberg Pharma is investigating the candidate in a clinical Phase I/IIa study for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “We are delighted that our proprietary ATAC candidate HDP-101 has been granted Orphan Drug Designation by the FDA, providing further validation of its potential benefit as a therapeutic for patients with multiple myeloma.
  • The designation provides significant incentives to promote the development of the drug including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.

EQS-News: Heidelberg Pharma announces financial figures and reports on successful business performance in 2023

Retrieved on: 
Wednesday, April 10, 2024
Malignancy, Spanish mythology, State university system, Patient, Sale, Renal cell carcinoma, Clinical trial, Neoplasm, Therapy, Depreciation, HPHA, USD, Marketing, GLP, Health, Research, ATACS, EPO, Immune system, ADC, BLA, ATAC, Food, Biologics license application, Disease, Magenta, Multiple myeloma, AACR, GCC, Annual report, FDA, Diagnosis, EUR, Supervisory board, Accounting, PET, EDT, Spacecraft, Amanitin, European Patent Convention, Patent, Eli Lilly and Company, Binghamton University, Pharmaceutical industry

Minority interest in Emergence sold: In summer 2023, Heidelberg Pharma sold its minority interest in Emergence Therapeutics AG, Duisburg, Germany, (Emergence).

Key Points: 
  • Minority interest in Emergence sold: In summer 2023, Heidelberg Pharma sold its minority interest in Emergence Therapeutics AG, Duisburg, Germany, (Emergence).
  • As a result, Heidelberg Pharma lost sales revenue in the low single-digit millions for the 2023 financial year.
  • In April 2023, Heidelberg Pharma signed a termination agreement with Magenta under which all licensed ATAC rights and some Magenta patents were assumed by Heidelberg Pharma.
  • The Heidelberg Pharma Group includes two entities, Heidelberg Pharma AG and Heidelberg Pharma Research GmbH.

EQS-News: Heidelberg Pharma announces progress into Cohort 6 with its proprietary ATAC candidate HDP-101 in Phase I/IIa multiple myeloma study

Retrieved on: 
Wednesday, April 10, 2024
Multiple myeloma, Bone marrow, Cohort, Infection, Incidence, BCMA, Patient, Plasma cell, Mortality, B cell, Spacecraft, AACR, Annual report, Antibody, The Annual Report, Safety, Pharmacokinetics, HPHA, FDA, ATAC, Food, Pharmaceutical industry

Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow and can affect more than one part of the body.

Key Points: 
  • Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow and can affect more than one part of the body.
  • Plasma cells are a type of blood cell that makes antibodies to fight infection, created by bone marrow.
  • Heidelberg Pharma’s Phase I/IIa clinical study is an ongoing, non-randomised, open label study which is actively enrolling patients with relapsed or refractory multiple myeloma or other plasma cell disorders expressing BCMA.
  • Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, said: “Our proprietary ATAC candidate HDP-101 is showing exciting potential for treating multiple myeloma.

EQS-News: Heidelberg Pharma announces receipt of non-refundable upfront cash payment following the successful closing of its royalty purchase agreement with HealthCare Royalty

Retrieved on: 
Wednesday, April 10, 2024
Diagnosis, Telix, Biologics license application, PET, Research, Sale, Multiple myeloma, Spacecraft, HPHA, ADC, USD, Positron emission tomography, Pharmaceutical industry

Ladenburg, Germany, 19 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the formal closing of the royalty purchase agreement with HealthCare Royalty (HCRx) for Zircaix®, signed earlier this month.

Key Points: 
  • Ladenburg, Germany, 19 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the formal closing of the royalty purchase agreement with HealthCare Royalty (HCRx) for Zircaix®, signed earlier this month.
  • Dr. George Badescu, Chief Business Officer at Heidelberg Pharma, said: “The funding from the royalty purchase agreement with HealthCare Royalty is enabling us to further advance Heidelberg Pharma’s leading expertise in the field of ADC research and development.
  • The upfront payment strengthens the Company’s liquidity, and along with future anticipated payments, should extend our cash runway.
  • The funds will be used to advance the expansion of our ADC pipeline including our preclinical projects HDP-102, HDP-103 and HDP-201.”

Linvoseltamab Pivotal Data Presented at AACR Reinforce High Response Rate that Deepens Over Time in Patients with Heavily Pre-Treated Multiple Myeloma

Retrieved on: 
Sunday, April 7, 2024
Regeneron Pharmaceuticals, Multiple myeloma, BCMA, Patient, AACR, FDA, B-cell maturation antigen, Pharmaceutical industry

Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

Key Points: 
  • Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
  • “In clinical trials, linvoseltamab treatment led to responses that occurred early, were durable and deepened over time – all critical efficacy measures for this heavily pre-treated patient population.
  • Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
  • The Phase 3 confirmatory trial for linvoseltamab in patients with R/R MM (LINKER-MM3) is underway.

Molecular Templates, Inc. Reports Fourth Quarter 2023 Financial Results and Business Update

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Friday, March 29, 2024
Multiple myeloma, Private placement, Symantec Endpoint Protection, EGFR, CD8, Exercise, Disease, AML, HNSCC, CMV, Patient, Common, Tom Clancy's Ghost Recon, Neoplasm, Immunoglobulin A, Tumor microenvironment, Sale, Bristol Myers Squibb, Form 10-K, Cancer, MHC, PD-L1, Antibody, Interim, Therapy, MTD, Poster, Total, ETB, UPR, Pharmaceutical industry

The net loss attributable to common shareholders for the fourth quarter of 2023 was $3.9 million, or $0.73 per basic and diluted share.

Key Points: 
  • The net loss attributable to common shareholders for the fourth quarter of 2023 was $3.9 million, or $0.73 per basic and diluted share.
  • Revenues for the fourth quarter of 2023 were $7.0 million, compared to $2.6 million for the same period in 2022.
  • Revenues for the fourth quarter of 2023 were comprised of revenues from collaborative research and development agreements with Bristol-Myers Squibb and grant revenue.
  • For more details on MTEM’s financial results for 2023, refer to Form 10-K filed with the SEC.

Oncopeptides and Vector Pharma FZCO Announce Collaboration to Provide Pepaxti to Patients in the Middle East and North Africa 

Retrieved on: 
Wednesday, March 27, 2024
Vector, Dexamethasone, Disease, Bone marrow, Partnership, Patient, Multiple myeloma, Cancer, WODA, Health professional, PDC, Medicine, Pharmaceutical industry

Under the terms of this exclusive agreement, Vector will distribute Pepaxti to patients in the MENA region for the treatment of patients with multiple myeloma.

Key Points: 
  • Under the terms of this exclusive agreement, Vector will distribute Pepaxti to patients in the MENA region for the treatment of patients with multiple myeloma.
  • The two parties have agreed on a revenue split on all Pepaxti sales in the region, with Vector carrying all costs through their existing structure in the region.
  • “I am excited to announce this regional agreement with Oncopeptides,” says Vector Pharma FZCO Managing Partner Patrick Jordan.
  • “We are happy for our partnership with Vector and look forward to working together as we enter this promising region together.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
Saturday, April 6, 2024
Guillain–Barré syndrome, Bone marrow, Medical College of Wisconsin, Encephalopathy, Survival, Immunotherapy, BCMA, Patient, Hypotension, Mortality, B-cell maturation antigen, Edema, Periodic breathing, Associate professor, Dexamethasone, Certification, Neutropenia, Dizziness, Risk, Headache, Chills, Myelodysplastic syndrome, Coagulopathy, DPD, Johnson & Johnson, Immune system, Effect, Fatigue, Thrombocytopenia, Food, Disease, Drive, Appetite, Lymphocytopenia, JNJ, Constipation, Multiple myeloma, Acute myeloid leukemia, CRS, Death, Hypersensitivity, Cytopenia, Cytokine release syndrome, ASCO, Use, Hematology, FDA, PVD, Annual general meeting, T cell, DSM-IV codes, Incidence, Tachycardia, Bortezomib, Diarrhea, Viral, Hope, United, Cough, Daratumumab, Nausea, Society, Division, Physician, Pharmaceutical industry

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

Kronos Bio Reports Recent Business Progress and Fourth-Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Thursday, March 21, 2024
Research, Ovarian cancer, Conference, Survival, AML, Carcinoma, RECIST, Patient, SAN, Multiple myeloma, KRON, Cancer, IRF4, Lung cancer, IND, AACR, Investment, KAT, CDK9, Pharmaceutical industry

SAN MATEO, Calif. and CAMBRIDGE, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today reported recent business progress and fourth-quarter and full-year 2023 financial results.

Key Points: 
  • “In 2023, we made great progress across our portfolio and business.
  • Kronos Bio extended its expected cash runway by a year, into the second half of 2026, through restructurings and resource optimization.
  • Net Loss: Net loss for the fourth quarter of 2023 was $25.3 million, or $0.43 per share, including non-cash stock-based compensation expense of $5.2 million.
  • Net loss for the full-year 2023 was $112.7 million, or $1.95 per share, including non-cash stock-based compensation expense of $25.0 million.

BrightSpring Health Services’ Specialty Pharmacy Onco360® Celebrates Excellent Patient Care and Preferred Pharmacy Status

Retrieved on: 
Thursday, March 14, 2024
Diagnosis, Health care, Disease, Selinexor, Partnership, Patient, Pharmacy, Multiple myeloma, Pharmacist, Cancer, B cell, NPS, Insurance, Patient satisfaction, DLBCL, Health, Hospital

“At BrightSpring Health Services, we are proud of our leading service lines like Onco360® as we continue to innovate in the health care industry and provide patients with life-improving and life-sustaining treatments,” said BrightSpring President and CEO Jon Rousseau.

Key Points: 
  • “At BrightSpring Health Services, we are proud of our leading service lines like Onco360® as we continue to innovate in the health care industry and provide patients with life-improving and life-sustaining treatments,” said BrightSpring President and CEO Jon Rousseau.
  • “It is an honor for Onco360® to be selected as the preferred pharmacy for XPOVIO® (selinexor) and shows the Company’s dedication to innovation, quality patient care and improving health outcomes.
  • Onco360® and its dedicated employees do a fantastic job of keeping BrightSpring’s important mission at the core of everything they do.”
    As another demonstration of BrightSpring and Onco360®’s commitment to patient care, this year, Onco360® celebrates excellent service and care that resulted in unmatched patient satisfaction scores.
  • “It’s incredibly important to us to provide patient care that prioritizes expertise, reliability, consistency, and overall satisfaction,” said Benito Fernandez, Chief Commercial Officer at Onco360®.