Toxic leukoencephalopathy

DGAP-News: Abivax presents first-half 2022 financial results and operations update

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Thursday, September 15, 2022
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2022 Research Tax Credit revenue amounts to EUR +2.2M as of June 30, 2022, compared with EUR+1.6M as of June 30, 2021.

Key Points: 
  • 2022 Research Tax Credit revenue amounts to EUR +2.2M as of June 30, 2022, compared with EUR+1.6M as of June 30, 2021.
  • Net loss is amounting at EUR -29.6M as of June 30, 2022 (EUR -13.0M compared to EUR -16.5M as of June30, 2021).
  • Cash at the end of June 2022 was EUR +26.6M, compared to EUR +60.7M at the end of 2021.
  • Following the induction study results, in March 2022, Abivax reported its phase 2a maintenance results in RA after the first year of treatment.

Celsion Completes Enrollment of the Phase I/II OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer

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Thursday, September 15, 2022
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LAWRENCEVILLE, N.J., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer has completed enrollment with 110 patients. GEN-1 is the Company’s IL-12 gene-mediated immunotherapy. Topline results are expected in the second half of 2023.

Key Points: 
  • LAWRENCEVILLE, N.J., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Celsion Corporation(NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer has completed enrollment with 110 patients.
  • The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer.
  • IL-12 is a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer.
  • There are approximately 22,000 new cases of ovarian cancer every year and the majority (approximately 70%) are diagnosed in advanced stages III and IV.

Aptose’s New “G3” Formulation of Luxeptinib Boosts Bioavailability

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Monday, September 12, 2022
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SAN DIEGO and TORONTO, Sept. 12, 2022 (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 the G3 formulation of luxeptinib, designed for rapid and efficient absorption, demonstrates approximately an 18-fold improvement in oral bioavailability relative to the original G1 formulation, and that Aptose plans to move forward with the development of the G3 formulation of luxeptinib to determine if it can achieve desired exposures and deliver clinical responses while continuing to demonstrate a favorable safety profile.

Key Points: 
  • The new G3 formulation, designed for more efficient absorption that could lead to greater accumulation and higher steady-state exposure levels, now has been tested as a single dose in 15 patients in the ongoing clinical trials.
  • Initial computational modeling of the pharmacokinetic (PK) properties of G3 predicts that plasma steady-state exposure achieved with continuous dosing of 50 mg of G3 (every 12 hours, Q12h) is equivalent to that of 900 mg of G1 Q12h, representing up to an 18-fold improvement in bioavailability with G3.
  • The G3 formulation of luxeptinib has shown a significant improvement in bioavailability and the potential for greater absorption, and we are eager to move forward with continuous dosing in our AML trial, said William G. Rice, Ph.D., Chairman, President, and Chief Executive Officer of Aptose.
  • The original G1 formulation of luxeptinib delivered a complete remission (CR) in one AML patient that safely achieved a particularly high plasma steady-state exposure, and we are hopeful the new G3 formulation will enable patients to receive greater exposures and benefit from treatment with Lux.

NuCana Presents Favorable Data on NUC-3373 at the European Society of Medical Oncology (ESMO) Annual Meeting 2022

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Monday, September 12, 2022
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PARIS, Sept. 12, 2022 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced data from the ongoing NuTide:302 study of NUC-3373 in combination with other agents at the European Society for Medical Oncology (ESMO) Annual Meeting being held from September 9 to 13, 2022.

Key Points: 
  • Data presented at ESMO describe NUC-3373 plus leucovorin in combination with either oxaliplatin (NUFOX) or irinotecan (NUFIRI) in the dose-finding part of the study.
  • The disease control rates for the NUFOX and NUFIRI regimens were 80% and 55%, respectively.
  • With these data, NuCana has established the recommended Phase 2 dose for NUC-3373 as part of NUFOX and NUFIRI regimens.
  • TS is required to convert uridine (specifically dUMP) to thymidine (specifically dTMP), one of the four nucleotides that comprise DNA.

Transgene Confirms the Potential of the Intravenous Route of its Invir.IO™ Oncolytic Viruses against Solid Tumors with TG6002 Phase I Data Presented at ESMO Congress 2022

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Monday, September 12, 2022
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No major toxicities limiting the dose escalation process or the intensification of the schedule of administration were observed.

Key Points: 
  • No major toxicities limiting the dose escalation process or the intensification of the schedule of administration were observed.
  • These data further confirm the mechanism of action of the Invir.IO-based oncolytic viruses in humans.
  • These findings support the potential of IV administration of Invir.IO-based oncolytic viruses, extending the use of these therapies to a broad range of solid tumors.
  • Additional data will be produced from the Phase I program and will be presented at a scientific congress in H1 2023.

Anaveon presents updated data from the Phase I/II study of ANV419 during the ESMO Congress 2022

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Saturday, September 10, 2022
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BASEL, Switzerland, Sept. 10, 2022 (GLOBE NEWSWIRE) -- Anaveon, a clinical-stage immuno-oncology company, today announces updated clinical data from the ongoing Phase I/II study of ANV419 in patients with solid tumors, as well as new pre-clinical data further elucidating the mode of action of this powerful and selective interleukin-2 (IL-2) agonist, in poster presentations at the European Society for Medical Oncology (ESMO) Congress 2022, taking place in Paris, September 9 – 13, 2022.

Key Points: 
  • ANV419 is well tolerated, and all drug related events were reversible and responsive to supportive care therapy.
  • No patients have withdrawn from the study due to AEs and no dose limiting toxicities have been observed up to and including 243 g/kg.
  • Preclinical data for ANV419 in combination with checkpoint inhibitors were also presented at ESMO.
  • The Company is pursuing multiple parallel Phase II programs in order to explore the full therapeutic potential of ANV419.

Rhizen Pharmaceuticals AG Announces Upcoming Data Presentations at ESMO 2022 for Its Clinical Stage Assets; Tenalisib in Locally Advanced/ Metastatic Breast Cancer and RP12146 in Multiple Solid Tumors

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Friday, September 9, 2022
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Treatment with orally dosed Tenalisib was found to be effective in a difficult to treat population where majority of patients had visceral disease and multiple metastatic lesions.

Key Points: 
  • Treatment with orally dosed Tenalisib was found to be effective in a difficult to treat population where majority of patients had visceral disease and multiple metastatic lesions.
  • In addition, a lone TNBC patient in the trial showed stable disease for more than 6 months and is continuing on the study.
  • RP12146 showed dose related exposures with robust target engagement and notable absence of haematological toxicities viz anaemia and cytopenia.
  • The expansion phase at 400mg BID is currently in progress in genomically qualified ovarian, breast and prostate cancer patients with HRR mutations.

TFF Pharmaceuticals Announces Presentation of Patient Data with Voriconazole Inhalation Powder (TFF VORI) at the 15th International Congress on Lung Transplantation

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Thursday, September 8, 2022
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FORT WORTH, Texas, Sept. 08, 2022 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that Dr. Bradley Gardiner of the Royal Alfred Hospital in Melbourne, Australia shared a podium presentation on the compassionate use of TFF’s Voriconazole Inhalation Powder (TFF VORI) as part of the 15th International Congress on Lung Transplantation, which is being held in Paris on September 8-9, 2022.

Key Points: 
  • TFFs proprietary Thin Film Freezing technology platform allows the reformulation of voriconazole into a dry powder with properties ideally suited for inhalation.
  • This patient was not able to continue with oral voriconazole or other azole antifungals due to preexisting melanoma and significant toxicities when previously administered oral voriconazole.
  • The patient had also been experiencing a meaningful loss of pulmonary function prior to initiation of the TFF VORI treatment.
  • The patient was able to tolerate inhaled voriconazole due to the limited systemic absorption compared to the oral administration route.

European Patent Office Awards CytRx Key Patent

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Wednesday, September 7, 2022
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CytRx Corporation (OTCQB: CYTR) (CytRx or the Company), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, today announced it has been awarded a key patent by the European Patent Office, and that the period for parties to oppose the patent has lapsed without opposition.

Key Points: 
  • CytRx Corporation (OTCQB: CYTR) (CytRx or the Company), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, today announced it has been awarded a key patent by the European Patent Office, and that the period for parties to oppose the patent has lapsed without opposition.
  • CytRx notes that a US patent US Patent No.
  • 11,384,104 covering the LADR platform has also recently been issued, which when combined with the European patent results in broad international protection of this important new technology.
  • In addition to intellectual property to protect the LADR platform, CytRx has also pursued patent protection covering certain specific drugs that incorporate the LADR backbone.

GenFleet Therapeutics to Present Data from Phase I Trial of GFH018 Monotherapy at the 2022 European Society for Medical Oncology Annual Meeting

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Wednesday, September 7, 2022
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Two phase II combination studies of GFH018 with PD-1 inhibitor are ongoing with additional data to be presented at medical meetings in the future.

Key Points: 
  • Two phase II combination studies of GFH018 with PD-1 inhibitor are ongoing with additional data to be presented at medical meetings in the future.
  • We are pleased to report the preliminary efficacy signal and good safety/tolerability profile of GFH018 monotherapy and look forward to the further trials in combination studies."
  • Developed by GenFleet Therapeutics, GFH018 is an orally administered TGF- R1 inhibitor and entered into phase I clinical trial in 2019.
  • GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies, is dedicated to serving significant global unmet medical needs in oncology and immunology.