Standard of care

EQS-News: TVM CAPITAL LIFE SCIENCE TO PARTICIPATE IN LSI USA ’24 EMERGING MEDTECH SUMMIT 2024

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수요일, 4월 10, 2024

Munich, Germany and Montreal, Quebec, Canada (March 13, 2024) – TVM Capital Life Science (“TVM”), a leading international venture capital firm focused on investments in life sciences innovation, today announced that the Company will participate in the sixth annual LSI USA ’24 Emerging Medtech Summit 2024, which brings together leading innovators, active investors and committed strategics from the medtech industry to partner and build next-generation healthcare technologies.

Key Points: 
  • Munich, Germany and Montreal, Quebec, Canada (March 13, 2024) – TVM Capital Life Science (“TVM”), a leading international venture capital firm focused on investments in life sciences innovation, today announced that the Company will participate in the sixth annual LSI USA ’24 Emerging Medtech Summit 2024, which brings together leading innovators, active investors and committed strategics from the medtech industry to partner and build next-generation healthcare technologies.
  • The conference will take place March 18-22, 2024, in Dana Point, California, USA.
  • "Medtech innovation continues to be at the forefront of healthcare advancement, driving transformative changes in patient care, operational efficiency and cost reduction.
  • As part of our commercial-stage medical technologies investment strategy, TVM seeks breakthrough solutions that align with emerging trends and could redefine the standard of care.

EQS-News: MorphoSys AG Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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수요일, 4월 10, 2024

“Now, in 2024, we are pleased that Novartis is committing to the future of our promising pipeline.

Key Points: 
  • “Now, in 2024, we are pleased that Novartis is committing to the future of our promising pipeline.
  • With its ample resources, additional scientific expertise and global footprint, Novartis can help accelerate pelabresib's potential worldwide.
  • Total revenues for the fourth quarter 2023 were € 59.0 million compared to € 81.6 million for the same period in 2022.
  • The decrease resulted first and foremost from prior year revenues stemming from the execution of an out-licensing agreement with Novartis.

Qualigen Therapeutics Announces Poster Featuring Positive Early Clinical Experience with QN-302, a Novel First-in-Class G-Quadruplex Experimental Anti-Cancer Drug, at the American Association of Cancer Research (AACR) 2024 Annual Meeting

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화요일, 4월 9, 2024

CARLSBAD, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (“Qualigen” or the “Company,” Nasdaq: QLGN) today announces that a poster featuring its early clinical experience with a novel first-in-class G-Quadruplex experimental anti-cancer drug, QN-302, was presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 held April 5 – 10 in San Diego, California.

Key Points: 
  • CARLSBAD, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (“Qualigen” or the “Company,” Nasdaq: QLGN) today announces that a poster featuring its early clinical experience with a novel first-in-class G-Quadruplex experimental anti-cancer drug, QN-302, was presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 held April 5 – 10 in San Diego, California.
  • Dose escalation initiated (patient #101-004) after three patients successfully completed cycle 1 of the initial dose.
  • Dose escalation will be continued, with more patients being enrolled in the coming months.
  • One patient was withdrawn from study 3/1/2024 after 4 months of stable disease.

Cue Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results and Updated Business Highlights

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월요일, 4월 8, 2024

BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results.

Key Points: 
  • BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results.
  • The increase was due to revenue earned from our strategic collaboration agreement entered into with Ono Pharmaceutical in the first quarter of 2023.
  • As of December 31, 2023, the Company had approximately $48.5 million in cash, cash equivalents and marketable securities compared with $76.3 million as of December 31, 2022.
  • We expect our current cash, cash equivalents, and marketable securities to fund operations into the first quarter of 2025.

Longeveron Issues Letter to Shareholders Highlighting Corporate Strategy, Clinical Pipeline and 2024 Key Priorities and Goals

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월요일, 4월 8, 2024

MIAMI, April 08, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders.

Key Points: 
  • MIAMI, April 08, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders.
  • Today, I am excited to update you on our overall strategy, business objectives, approach to capital allocation, and 2024 key priorities and goals.
  • Our focus remains steadfast on raising the funds necessary to continue our operations and delivering transformative solutions to patients and creating sustainable value for our shareholders.
  • In 2024, we are focusing our efforts on two of our most promising programs: Hypoplastic Left Heart Syndrome (HLHS); and Alzheimer’s Disease.

Zymeworks Presents New Data from Multiple Preclinical Development Programs at 2024 American Association for Cancer Research Annual Meeting

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월요일, 4월 8, 2024

The compelling preclinical activity profile supports ZW191 development across multiple tumor types, including FRα-high/mid/low ovarian cancers and other FRα-expressing indications, including non-small cell lung cancer, endometrial cancer, and triple-negative breast cancer.

Key Points: 
  • The compelling preclinical activity profile supports ZW191 development across multiple tumor types, including FRα-high/mid/low ovarian cancers and other FRα-expressing indications, including non-small cell lung cancer, endometrial cancer, and triple-negative breast cancer.
  • An investigational new drug (IND) submission or foreign equivalent is planned for 2024.
  • Small cell lung cancer (SCLC) is an aggressive neuroendocrine cancer with a poor prognosis and high unmet medical need2.
  • Displays no cross-linking of T cells and exhibits obligate cis T cell binding of CD28, requiring co-engagement of CD3.

Psyence Biomed Partners with Fluence and iNGENū CRO to Train Research Therapists for Phase IIb Psilocybin Trial

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월요일, 4월 8, 2024

NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (Nasdaq:PBM) (“Psyence Biomed” or the “Company”) today announced that its Australian subsidiary, Psyence Australia Pty Ltd. (“Psyence Australia”), has entered into a partnership with Fluence , a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support an upcoming Phase llb clinical trial.

Key Points: 
  • NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (Nasdaq:PBM) (“Psyence Biomed” or the “Company”) today announced that its Australian subsidiary, Psyence Australia Pty Ltd. (“Psyence Australia”), has entered into a partnership with Fluence , a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support an upcoming Phase llb clinical trial.
  • According to Lancet Oncology, Adjustment Disorder affects as many as 19% of patients following a life-limiting cancer diagnosis.
  • “The success of the clinical trial relies on rigorous, standardized therapist training designed to achieve the highest standard of patient care,” said Elizabeth Nielson, PhD, Fluence co-founder.
  • Psyence Biomed anticipates enrolling the first subject in the second quarter of 2024 and expects the primary endpoint results to be available in 2025.

Corcept Completes Enrollment in Pivotal Phase 3 Rosella Trial of Relacorilant in Patients With Platinum-Resistant Ovarian Cancer

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월요일, 4월 8, 2024

“Fully enrolling ROSELLA takes us a big step closer to addressing the unmet medical need of women with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

Key Points: 
  • “Fully enrolling ROSELLA takes us a big step closer to addressing the unmet medical need of women with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer.
  • “Relacorilant has the potential to become the standard of care for patients with this devastating disease.
  • The ROSELLA trial enrolled 381 women at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia.
  • Patients were randomized 1:1 to receive either relacorilant dosed intermittently with nab-paclitaxel or nab-paclitaxel monotherapy.

Caribou Biosciences Expands Clinical Development of CB-010 with FDA Clearance of IND in Lupus

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목요일, 4월 4, 2024

BERKELEY, Calif., April 04, 2024 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.

Key Points: 
  • The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.
  • CB-010 targets CD19, a protein on the surface of B cells, and has a PD-1 knockout (KO) that reduces CAR-T cell exhaustion.
  • CB-010 holds the potential for deep depletion of disease-causing B cells which could reset the immune system, leading to sustained drug-free remission.
  • Instead, the chRDNA technology allows for precise insertion of the CAR at an intended location within the T cell genome.

Candel Therapeutics Announces Positive Interim Data from Randomized Phase 2 Clinical Trial of CAN-2409 in Non-Metastatic Pancreatic Cancer

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목요일, 4월 4, 2024

At 24 months, survival rate was 71.4% in CAN-2409 treated patients versus only 16.7% in the control group after chemoradiation.

Key Points: 
  • At 24 months, survival rate was 71.4% in CAN-2409 treated patients versus only 16.7% in the control group after chemoradiation.
  • Survival data were updated with eight months of further follow-up since the first analysis presented at the 2023 Society for Immunotherapy (SITC) Annual Meeting.
  • “We are very encouraged by the improved survival associated with CAN-2409, which has been shown to be durable after prolonged follow-up based on the updated data shown in this randomized clinical trial.
  • Only 1 out of 6 patients, randomized to control SoC chemotherapy, remained alive at data cut-off (alive at 50.6 months).