Toxic leukoencephalopathy

IGM Biosciences Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

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Thursday, March 30, 2023
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MOUNTAIN VIEW, Calif., March 30, 2023 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2022 and provided an update on recent developments.

Key Points: 
  • “Also, and perhaps most significantly, the initial clinical results from IGM-8444, our anti-death receptor 5 IgM antibody, highlight the exciting potential of IgM antibodies as agonist antibody medicines.
  • The study is designed to assess the benefit of IGM-8444 when combined with the current standard of care regimen of FOLFIRI and bevacizumab.
  • In November 2022, the Company presented preclinical results at the Society for Immunotherapy of Cancer Annual Meeting.
  • IGM will host a live conference call and webcast at 4:30 p.m. EDT today, March 30, 2023, to discuss the Company’s financial results and provide a corporate update.

Plus Therapeutics Successfully Treats First Patient in Cohort 8 of ReSPECT-GBM Phase 1/2a Trial

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Tuesday, March 28, 2023
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AUSTIN, Texas, March 28, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced the first patient in Cohort eight of the ReSPECT-GBM Phase 1/2a dose escalation clinical trial evaluating the Company’s lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, in recurrent glioblastoma (GBM) has been successfully treated.

Key Points: 
  • The dose escalation phase of the trial has now treated 25 patients with no dose-limiting toxicities observed through 7 completed dosing cohorts.
  • Cohort 8 is now enrolling using 41.5 millicuries (mCi) administered dose rhenium (186Re) obisbemeda with an infused volume of 16.34 milliliters (mL) which allows the treatment of large and morphologically complex tumors.
  • “Taken together, the safety and efficacy signals observed thus far in 30 treated recurrent GBM patients are very promising,” said Norman La France, M.D., President and Chief Medical Officer of Plus Therapeutics.
  • More information about the ReSPECT-GBM trial may be found at ReSPECT-Trials.com and ClinicalTrials.gov ( NCT01906385 ).

Aptose Reports Results for the Fourth Quarter and Full Year 2022

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Thursday, March 23, 2023
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SAN DIEGO and TORONTO, March 23, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today announced financial results for the fourth quarter and year ended December 31, 2022, and provided a corporate update.

Key Points: 
  • The net loss for the quarter ended December 31, 2022, was $10.0 million ($0.11 per share) compared with $24.3 million ($0.27 per share) for the quarter ended December 31, 2021.
  • Total cash and cash equivalents and investments as of December 31, 2022, were $47.0 million.
  • Aptose Appoints VP, Controller – During the fourth quarter, Aptose appointed Brooks Ensign, Vice President and Controller.
  • A summary of the results of operations for the years ended December 31, 2022 and 2021 is presented below:

Plus Therapeutics Initiates Cohort 3 in Phase 1/Part A of the ReSPECT-LM Trial for Leptomeningeal Metastases

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Wednesday, March 22, 2023
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Thus far, no dose-limiting toxicities have been observed with administered radiation doses of up to 26.4 millicuries.

Key Points: 
  • Thus far, no dose-limiting toxicities have been observed with administered radiation doses of up to 26.4 millicuries.
  • This dose represents a theoretical maximum absorbed radiation dose to the cerebral spinal fluid of approximately 200 gray.
  • The ReSPECT-LM trial is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1/2a study using a modified Fibonacci 3+3 study design.
  • ReSPECT-LM is funded by a 3-year, $17.6 million grant by the Cancer Prevention & Research Institute of Texas (CPRIT).

Agendia Announces First Patient Enrolled in PROOFS Registry Trial to Determine Optimal Treatment and Ability to Forgo Chemotherapy for Premenopausal Women with Early HR+ Breast Cancer

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Thursday, March 16, 2023
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Agendia, Inc. , a leader in gene expression profiling for early-stage breast cancer, today announced the first patient has been enrolled in the PROOFS Registry trial.

Key Points: 
  • Agendia, Inc. , a leader in gene expression profiling for early-stage breast cancer, today announced the first patient has been enrolled in the PROOFS Registry trial.
  • Breast cancer uses estrogen to grow, and chemotherapy suppresses the ovaries’ production of estrogen to cut off the cancer’s fuel source.
  • Every young woman with early-stage breast cancer deserves the right to make truly informed treatment decisions tailored to her unique biology.
  • These insights could allow some young women with breast cancer to forgo chemotherapy and avoid unnecessary toxicity,” said William Audeh, MD, Chief Medical Officer at Agendia.

Viracta Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides a Corporate Update

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Monday, March 13, 2023
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Our pivotal NAVAL-1 trial site footprint continues to grow as we seek to advance multiple EBV-positive lymphoma subtypes into Stage 2 of this global study.

Key Points: 
  • Our pivotal NAVAL-1 trial site footprint continues to grow as we seek to advance multiple EBV-positive lymphoma subtypes into Stage 2 of this global study.
  • An update on NAVAL-1’s first lymphoma subtype that may advance from Stage 1 to Stage 2 is anticipated in the first half of 2023.
  • Research and development expenses increased to $26.3 million compared to $23.9 million for the years ended December 31, 2022 and 2021, respectively.
  • There was not a comparative adjustment to loss from operations for the three and twelve months ended December 31, 2022.

AB Science reports a first complete bone marrow response in a relapsed refractory acute myeloid leukemia patient from the very low dose arm of its AB8939 Phase I/II clinical trial (AB18001)

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Monday, March 13, 2023
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Remarkably, this response was achieved at a very low dose of AB8939, corresponding to the second step of dose increment (out of 13 potential steps) in phase I.

Key Points: 
  • Remarkably, this response was achieved at a very low dose of AB8939, corresponding to the second step of dose increment (out of 13 potential steps) in phase I.
  • At the request of the investigator, AB Science has authorized further treatment cycles of AB8939 to this patient.
  • AB8939 treatment of this AML subpopulation is the subject matter of a provisional patent application filed by AB Science.
  • Study AB18001 is titled ‘A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in patients with Relapsed/Refractory Acute Myeloid Leukemia’.

Werewolf Therapeutics Announces Initiation of Patient Dosing in Phase 1 Study of WTX-330

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Friday, February 24, 2023
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WATERTOWN, Mass., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, today announced that the first patient has been dosed in a Phase 1 clinical trial evaluating WTX-330, the Company’s lead INDUKINETM molecule targeting Interleukin-12 (IL-12). The Phase 1 clinical trial is a first-in-human, multi-center, open-label trial that will evaluate WTX-330 in patients with advanced or metastatic solid tumors or lymphoma resistant to checkpoint inhibitors or for which checkpoint inhibitors are not approved.

Key Points: 
  • “Dosing the first patient in our Phase 1 trial of WTX-330 marks the second INDUKINE molecule arising from our PREDATORTM protein engineering platform to enter the clinic.
  • Our continued transition into a clinical stage company comes at an exciting time for Werewolf following the initiation of a Phase 1/1b clinical study of WTX-124 last year,” said Daniel J. Hicklin, Ph.D., Werewolf’s Founder and Chief Executive Officer.
  • In preclinical studies, WTX-330 exhibited excellent anti-tumor activity and a favorable pharmacokinetic and tolerability profile.
  • For additional information about the trial, please visit www.clinicaltrials.gov using the Identifier: NCT05678998

Aravive to Present Positive Updated Data from Phase 1b Trial of Batiraxcept in Combination with Cabozantinib for Treatment of Clear Cell Renal Cell Carcinoma at the 2023 ASCO Genitourinary (GU) Cancers Symposium

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Monday, February 13, 2023
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No dose limiting toxicities were observed at either dose of batiraxcept.

Key Points: 
  • No dose limiting toxicities were observed at either dose of batiraxcept.
  • 58% (15/26) of total population achieved a better response on batiraxcept plus cabozantinib than they did on prior therapy.
  • Safety, PK/PD, and clinical activity results support a recommended Phase 2 dose of 15 mg/kg.
  • In addition, data demonstrated clinical activity of batiraxcept plus cabozantinib in patients with metastatic ccRCC, with an objective response rate (ORR) of 57% and median PFS of 11.4 months in this population (n=14/26).

Aptose Initiates Dosing of Tuspetinib in APTIVATE Expansion Trial in Patients with Acute Myeloid Leukemia

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Monday, January 30, 2023
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SAN DIEGO and TORONTO, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose”) (NASDAQ: APTO, TSX: APS) today announced the 120 mg monotherapy dosing of patients in the APTIVATE Phase 1/2 clinical trial of tuspetinib (formerly HM43239), an oral, mutation agnostic tyrosine kinase inhibitor (TKI) being developed for the treatment of patients with relapsed or refractory acute myeloid leukemia (R/R AML). In parallel, another clinical response has been achieved by a R/R AML patient receiving 40 mg tuspetinib once daily orally in the original dose exploration trial, the second response at the recently launched low-dose 40 mg cohort.

Key Points: 
  • SAN DIEGO and TORONTO, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose”) (NASDAQ: APTO, TSX: APS) today announced the 120 mg monotherapy dosing of patients in the APTIVATE Phase 1/2 clinical trial of tuspetinib (formerly HM43239), an oral, mutation agnostic tyrosine kinase inhibitor (TKI) being developed for the treatment of patients with relapsed or refractory acute myeloid leukemia (R/R AML).
  • Importantly, Aptose has elucidated a rationale for the superior safety profile of tuspetinib.
  • In the APTIVATE expansion trial, tuspetinib also will be tested in combination with venetoclax.
  • “We are pleased to have dosing underway in our APTIVATE clinical trial of tuspetinib in a very ill R/R AML population,” said William G. Rice, Ph.D., Chairman, President, and Chief Executive Officer.