Toxic leukoencephalopathy

Bicycle Therapeutics Announces BT5528 Phase I Dose Escalation Results in Patients with Advanced Solid Tumors

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Wednesday, September 7, 2022
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Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, today announced Phase I dose escalation top-line results from its Phase I/II trial of BT5528, a BTC targeting EphA2, in patients with advanced solid tumors.

Key Points: 
  • Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, today announced Phase I dose escalation top-line results from its Phase I/II trial of BT5528, a BTC targeting EphA2, in patients with advanced solid tumors.
  • The therapeutic profile from the dose escalation portion of the Phase I/II trial of BT5528 in patients with late-line disease suggests both differentiated safety and promising activity, most notably in ovarian and urothelial cancers, said Dominic Smethurst, Chief Medical Officer of Bicycle Therapeutics.
  • BT5528, a BTC targeting EphA2, a target for which prior antibody-based approaches have been unsuccessful, has demonstrated anti-tumor activity and differentiated tolerability.
  • Bicycle has established an RP2D dose (6.5mg/m2 every other week) and is enrolling ongoing expansion cohorts.

NIH Awards AVM Biotechnology SBIR Grant to Study AVM0703 Combined with Standard of Care in Non-Hodgkin’s Lymphoma (NHL) to Improve Complete Response Rates Without Additional Toxicities

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Thursday, August 25, 2022
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AVM0703 is currently the subject of an adaptive design expansion cohort clinical trial treating imminently terminal no-option NHL patients (NCT04329728) .

Key Points: 
  • AVM0703 is currently the subject of an adaptive design expansion cohort clinical trial treating imminently terminal no-option NHL patients (NCT04329728) .
  • After a single, one-hour outpatient infusion, AVM0703 induces and mobilizes endogenous bispecific gamma delta TCR+ invariant TCR+ Natural Killer T-like cells.
  • While R-CHOP typically administered in six repeat cycles can elicit high response rates in NHL, relapse rates are high and long-term toxicities problematic.
  • An approach that increases complete response rates and lowers relapse rates without significant toxicities continues to be an unmet need for NHL.

Northwest Biotherapeutics Announces Approval of Pediatric Investigation Plan (PIP) by MHRA

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Tuesday, August 23, 2022
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Under applicable UK law, when a new medicine is developed for adult patients, that medicine must also be tested for potential application to pediatric patients. The sponsor must develop an overall Plan to select the specific form or stage of the disease to be treated, to adapt the dosing and administration of the medicine for pediatric physiology, and to evaluate the safety and efficacy of the medicine in pediatric patients. Further, the Plan must include not just general focus areas, aims and approaches -- it must include the full design of the specific clinical trials to be carried out, including all aspects required for clinical trial approvals, such as the patient population, eligibility criteria, stage of disease, treatment regimen, trial design and endpoints. 

Key Points: 
  • BETHESDA, Md., Aug. 23, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, today announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company's Pediatric Investigation Plan (PIP).
  • The Company's approved PIP includes 2 clinical trials: one for newly diagnosed pediatric high grade glioma (HGG), and one for recurrent pediatric HGG.
  • The Plan developed by the sponsor must go through a series of stages of regulatory review and comment to reach a final approval by regulators.
  • Northwest Biotherapeutics worked with expert consultants for months to develop a PIP tailored for application of DCVax-L to pediatric cases of HGG.

Northwest Biotherapeutics Announces Approval of Pediatric Investigation Plan (PIP) by MHRA

Retrieved on: 
Tuesday, August 23, 2022
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BETHESDA, Md., Aug. 23, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company's Pediatric Investigation Plan (PIP).  The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients, such as DCVax®-L. 

Key Points: 
  • BETHESDA, Md., Aug. 23, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, today announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company's Pediatric Investigation Plan (PIP).
  • The Company's approved PIP includes 2 clinical trials: one for newly diagnosed pediatric high grade glioma (HGG), and one for recurrent pediatric HGG.
  • The Plan developed by the sponsor must go through a series of stages of regulatory review and comment to reach a final approval by regulators.
  • Northwest Biotherapeutics worked with expert consultants for months to develop a PIP tailored for application of DCVax-L to pediatric cases of HGG.

VA Houston Healthcare System Selects ViewRay to Expand Advanced Radiation Therapy Services

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Tuesday, August 23, 2022
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DENVER, Aug. 23, 2022 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY) announced today that the VA Houston Healthcare System has selected a MRIdian MRI-guided radiation therapy system to expand radiation therapy services at the Michael E. DeBakey VA Medical Center. The MRIdian system will enable the VA Houston Cancer Program to offer advanced MRI-guided radiation therapy technology to Veterans throughout the region who are seeking personalized treatment for pancreas, prostate, lung, liver, breast, and oligometastatic cancers.

Key Points: 
  • DENVER, Aug. 23, 2022 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY) announced today that the VA Houston Healthcare System has selected a MRIdian MRI-guided radiation therapy system to expand radiation therapy services at the Michael E. DeBakey VA Medical Center.
  • The MRIdian system will enable the VA Houston Cancer Program to offer advanced MRI-guided radiation therapy technology to Veterans throughout the region who are seeking personalized treatment for pancreas, prostate, lung, liver, breast, and oligometastaticcancers.
  • VA Houston Healthcare System provides state-of-the-art healthcare services to Veterans at 12 locations of care in southeast Texas and is one of the leading healthcare systems serving Veterans in the South-Central VA Health Care Network.
  • "ViewRay is excited to see another VA Healthcare system join the MRIdian community.

Aileron Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights

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Monday, August 15, 2022
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As recently announced, Aileron anticipates reinitiating enrollment in the breast cancer trial under the amended protocol in the coming weeks.

Key Points: 
  • As recently announced, Aileron anticipates reinitiating enrollment in the breast cancer trial under the amended protocol in the coming weeks.
  • Aileron has submitted these and other results from the healthy volunteer study for presentation at a scientific congress in 2H 2022.
  • Net Loss: Net loss for the quarter ended June 30, 2022, was $8.0 million, compared to $5.7 million for the corresponding quarter in 2021.
  • The basic and diluted net loss per share for the second quarter of 2022 was $0.09 compared to $0.06 for the second quarter of 2021.

AN2 Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Updates

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Thursday, August 11, 2022
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Second Quarter & Recent Business Updates:

Key Points: 
  • Second Quarter & Recent Business Updates:
    Initiated Pivotal Phase 2/3 Trial for Epetraborole in Treatment-Refractory MAC Lung Disease.
  • During the second quarter of 2022, AN2 Therapeutics announced that Maggie FitzPatrick, a corporate affairs, communications and business operations leader, was appointed to its Board of Directors.
  • AN2 Therapeutics has completed enrollment in the Phase 1 safety and pharmacokinetics (PK) study of oral epetraborole in healthy volunteers in Japan.
  • AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs.

Cyclacel Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Update

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Wednesday, August 10, 2022
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- Oral fadraciclib demonstrated good tolerability with continuous dosing;

Key Points: 
  • - Oral fadraciclib demonstrated good tolerability with continuous dosing;
    - Conference call scheduled for August 10, 2022 at 4:30 pm ET -
    BERKELEY HEIGHTS, N.J., Aug. 10, 2022 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced second quarter 2022 financial results and provided a business update.
  • In the second half of 2022 we are optimizing the dosing schedule to maximize target coverage and determine recommended Phase 2 dose (RP2D).
  • Tax credit receipts of $3.3 million in respect of the financial year ended December 31, 2021, were received in April 2022.
  • The Cyclacel logo and Cyclacel are trademarks of Cyclacel Pharmaceuticals, Inc.

Aileron Therapeutics Is Pleased to Outline Strategy to Strengthen Phase 1b Clinical Trial of ALRN-6924 in Patients with p53-Mutated Breast Cancer

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Monday, August 1, 2022
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Our team has worked methodically and expeditiously to modify the Phase 1b breast cancer trial in order to enhance our opportunity to demonstrate a robust chemoprotective effect of ALRN-6924 in patients with p53-mutated breast cancer.

Key Points: 
  • Our team has worked methodically and expeditiously to modify the Phase 1b breast cancer trial in order to enhance our opportunity to demonstrate a robust chemoprotective effect of ALRN-6924 in patients with p53-mutated breast cancer.
  • We expect that this will allow us to get to topline readouts for the breast cancer trial next year and if warranted by the trial results, to initiate preparation for a potential pivotal trial.
  • Five of the Sargon Research network sites, in addition to the Gabrail Cancer Center, will participate in the Aileron breast cancer trial.
  • Thus, the breast cancer trial will also enable the evaluation, across treatment cycles, of ALRN-6924s ability to prevent chemotherapy-induced alopecia.

Aptose to Present at the Canaccord Genuity 42nd Annual Growth Conference

Retrieved on: 
Wednesday, July 27, 2022
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The Aptose management team also will be hosting 1x1 meetings during the events.

Key Points: 
  • The Aptose management team also will be hosting 1x1 meetings during the events.
  • Aptose Biosciences is a clinical-stage biotechnology company committed to developing personalized therapies addressing unmet medical needs in oncology, with an initial focus on hematology.
  • The Company's small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities.
  • For more information, please visit www.aptose.com .