Glioma

XOMA Reports Third Quarter 2023 Financial Results and Highlights Upcoming Events Expected to Drive Shareholder Value

Retrieved on: 
Tuesday, November 7, 2023
FDA, Janssen, Organon, G&A, Inflammation, Place of birth, NDA, License, End-user license agreement, Glioma, Video game, Cryptocurrency, Pharmaceutical industry

EMERYVILLE, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq: XOMA), the biotech royalty aggregator, reported its third quarter 2023 financial results and highlighted recent portfolio activities expected to drive long-term shareholder value.

Key Points: 
  • XOMA recorded total revenues of $0.8 million for the third quarter of 2023 and $0.5 million for the third quarter of 2022.
  • General and administrative (“G&A”) expenses were $6.4 million for the third quarter of 2023, compared to $4.8 million for the third quarter of 2022.
  • In the third quarter of 2023, G&A expenses included $2.7 million in non-cash stock-based compensation expense, compared with $0.8 million in the third quarter of 2022.
  • Other income, net was $0.3 million for the third quarter of 2023 and $0.2 million in the corresponding quarter of 2022.

Janux Therapeutics Reports Third Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Tuesday, November 7, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Other Health, Colon, PD-L1, FUTURE, FINANCIAL, CD28, Renal cell carcinoma, Colorectal cancer, Head, Lung, Therapy, Investment, PSMA, Breast, Prostate, Neck, Glioma, EGFR, Pharmaceutical industry, Vaccine, Cryptocurrency

Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today reported financial results for the third quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today reported financial results for the third quarter ended September 30, 2023, and provided a business update.
  • Research and development expenses: For the quarter ended September 30, 2023, Janux reported research and development expenses of $11.9 million compared to $13.7 million for the comparable period in 2022.
  • Net loss: For the quarter ended September 30, 2023, Janux reported a net loss of $11.6 million compared to $16.7 million for the comparable period in 2022.
  • In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

MAIA Biotechnology Reports Third Quarter 2023 Financial Results and Highlights Recent Development Progress for Anticancer Asset THIO

Retrieved on: 
Tuesday, November 7, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Survival, Research, Research and development, Trial of the century, IND, NYSE, Food, DCR, Enrollment, Form, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, R, CPI, Investigational New Drug, DCR Workforce, Diffuse intrinsic pontine glioma, Cancer, Central nervous system, Lung cancer, TMZ, Patient, Drug discovery, Potential, Administration, DIPG, Pharmaceutical industry, Mobile phone, Medical imaging, Cryptocurrency, NSCLC, Glioma

MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, today reported financial results for the third quarter ended September 30, 2023 and key operational updates.

Key Points: 
  • MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, today reported financial results for the third quarter ended September 30, 2023 and key operational updates.
  • Research and Development (R&D) Expenses: R&D expenses were approximately $2.6 million for the quarter ended September 30, 2023, compared to approximately $2.3 million for quarter ended September 30, 2022.
  • Weighted average shares outstanding were 13,675,802 in the third quarter of 2023, compared to 10,165,622 in the third quarter of 2022.
  • For additional information on the Company’s financial results for the quarter ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.

Ivy Center Announces First Patient Treated in Targeted Phase 0/1 Clinical Trial for High-Grade Glioma

Retrieved on: 
Monday, November 6, 2023
Diamond, Patient, MD, Barrow Neurological Institute, Drug development, Traffic barrier, Clinical trial, Lung cancer, Glioblastoma, Glioma, EGFR, Pharmaceutical industry, Medical imaging

BDTX-1535 is a targeted agent designed to enhance brain penetration relative to other drugs in its class.

Key Points: 
  • BDTX-1535 is a targeted agent designed to enhance brain penetration relative to other drugs in its class.
  • This Phase 0/1 clinical trial will assess the drug’s ability to cross the blood-brain barrier in patients with EGFR-altered gliomas, and measure tumor response to the drug.
  • It is one of more than a dozen Phase 0 clinical trials the Ivy Center has initiated for patients with glioblastoma and other aggressive brain tumors.
  • BDTX-1535 is intended to expand the addressable patient population by targeting families of EGFR mutations with a single oral drug.

Lisata Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 2, 2023
Neoplasm, Research, Colon, Standard of care, GBM, Temozolomide, Peritoneum, Ovarian cancer, Therapy, RNA, IDMC, Cohort study, Head, Cholangiocarcinoma, National Health, Cytoreductive surgery, Pancreatic cancer, University, Safety, Cancer, PDAC, Patient, Gemcitabine, Glioblastoma, FOLFIRINOX, HIPEC, ASCEND, SOC, CRS, Chemistry, FDA, Glioma, Tumor microenvironment, Randomized controlled trial, Neck, Intramuscular injection, Pharmaceutical industry, Cryptocurrency

BASKING RIDGE, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced its financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Lisata and its development collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies, and RNA-based therapeutics.
  • The trial continues to make steady progress with enrollment completion expected by the fourth quarter of 2023 and data readouts expected in 2024.
  • We anticipate the first patient treated to be in the fourth quarter of 2023.
  • Lisata will hold a live conference call on Thursday, November 2, 2023, at 4:30 p.m. Eastern time to discuss financial results, provide a business update and answer questions.

XOMA Earns $5 Million Milestone Upon FDA Acceptance of Day One’s Tovorafenib NDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

Retrieved on: 
Tuesday, October 31, 2023
FDA, PDUFA, Food, Economics, Prescription Drug User Fee Act, Glioma, Priority review, New Drug Application, NDA, Therapy, BRAF, Pharmaceutical industry

EMERYVILLE, Calif., Oct. 31, 2023 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $5 million milestone related to the U.S. Food and Drug Administration’s (FDA) acceptance of Day One Biopharmaceuticals’ New Drug Application (NDA) for tovorafenib as a monotherapy for relapsed or progressive pediatric low-grade glioma (pLGG).

Key Points: 
  • EMERYVILLE, Calif., Oct. 31, 2023 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $5 million milestone related to the U.S. Food and Drug Administration’s (FDA) acceptance of Day One Biopharmaceuticals’ New Drug Application (NDA) for tovorafenib as a monotherapy for relapsed or progressive pediatric low-grade glioma (pLGG).
  • The FDA has granted tovorafenib Priority Review and established a Prescription Drug User Fee Act (PDUFA) date of April 30, 2024.
  • “Tovorafenib has the potential to address a key unmet need in children whose low-grade gliomas with BRAF alterations have relapsed or progressed,” stated Owen Hughes, Executive Chairman of XOMA.
  • “A novel, targeted, orally available option has the opportunity to set a new standard-of-care in this patient population.”
    In March 2021, XOMA paid $13.5 million upfront plus a share of a future event-based milestone, to acquire the $54 million in potential milestones and mid-single digit royalties associated with tovorafenib, in addition to the economics associated with vosaroxin, from Viracta Therapeutics.

Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

Retrieved on: 
Monday, October 30, 2023
FDA, Ageing, PDUFA, Food, Glioma, Regulation of tobacco by the U.S. Food and Drug Administration, Caregiver, Neoplasm, New Drug Application, NDA, Day One, Patient, BRAF, Pharmaceutical industry

The FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.

Key Points: 
  • The FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.
  • The FDA is not currently planning to hold an advisory committee meeting to discuss the application.
  • For the vast majority of patients in the relapsed setting, there is no standard of care and no approved therapy.
  • Updated data was recently disclosed when the Company announced the completion of its rolling NDA submission on September 11, 2023.

Study Fueled by Xenium Analysis Sheds Light on Resistance Mechanisms in Model of Lethal Pediatric Brain Tumors

Retrieved on: 
Thursday, October 26, 2023
Rosenbergia xenium, Neoplasm, Radiation therapy, Genomics, Pathology, Duke University, Health, Assistant, Custom, DMG, Glioma, BioRxiv, Professor, Brain, Radiation, Panel, Semaphorin, Patient, DMG Mori Seiki Co., DNA, Pharmaceutical industry, Medical imaging, ATM, Neurosurgery

PLEASANTON, Calif., Oct. 26, 2023 /PRNewswire/ -- 10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, announced today that the 10x Xenium Analyzer was used in a study recently published on bioRxiv characterizing radiation-resistance mechanisms of diffuse midline gliomas (DMGs). Led by researchers at Duke University, the study also provides a lens by which to understand clinical response in patients for current and future clinical trials using a novel kinase inhibitor as part of DMG therapeutic strategies.

Key Points: 
  • Researchers conducting the study analyzed formalin-fixed paraffin-embedded tissue sections of a mouse brain tumor model that mimics the common human DMG genetic drivers and to examine the molecular and cellular mechanisms driving radiation efficacy or resistance in these tumors.
  • The study put particular focus on the role that loss of Atm, which encodes a protein responsible for cellular response to double-stranded DNA damage, plays in treatment response.
  • Dr. Zach Reitman, lead author and Assistant Professor of Radiation Oncology, Pathology and Neurosurgery, said, "These are diffuse tumors that infiltrate the normal brain.
  • It is awesome to see our customers using Xenium in their own labs with such an incredible and immediate impact.

Flashpoint Therapeutics Announces $10M Seed Financing Led by Beta Lab to Pioneer Nanotechnology-Enabled Medicines

Retrieved on: 
Wednesday, October 25, 2023
Research, General Health, Pharmaceutical, Data Management, Oncology, Technology, Genetics, Clinical Trials, Science, Nanotechnology, Biotechnology, Health, Other Science, Trial of the century, Cervical cancer, Therapy, RNA, Hope, Northwestern University, CRISPR, Architecture, Liver, Nokia phones beta labs, General partnership, Flashpoint, Prostate cancer, Cell, Cancer, International Institute for Nanotechnology, Immune system, Breast cancer, Nanostructure, Kinetics, Brain, Melanoma, Glioma, Lymphoma, Pharmaceutical industry, Vaccine

Flashpoint will also use the funds to expand its team and enhance the platform to develop best-in-class multi-targeted RNA, CRISPR and peptide therapeutics with unique characteristics.

Key Points: 
  • Flashpoint will also use the funds to expand its team and enhance the platform to develop best-in-class multi-targeted RNA, CRISPR and peptide therapeutics with unique characteristics.
  • This approach overcomes limitations of current technologies that rely on mixing therapeutic components with little control over their co-delivery or structural presentation.
  • “We are thrilled to announce a $10 million seed financing round led by Beta Lab, a leading deep tech venture capital firm,” said Adam Margolin, Ph.D., CEO & Founder, Flashpoint Therapeutics.
  • Flashpoint plans to partner with leading companies in nucleic acid and peptide therapeutics to develop best-in-class therapeutic candidates in these areas.

HighField Biopharmaceuticals Announces Positive Phase 1a Data of HF1K16, a new Immuno-Oncology Drug, For Patients with Recurrent and Refractory Glioma

Retrieved on: 
Monday, October 23, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, ATRA, Survival, MDSC, Myeloid-derived suppressor cell, B cell, Partnering, Tumor microenvironment, Safety, Cancer, Patient, Myelocyte, Glioma, Pharmaceutical industry

“These encouraging results show HF1K16 is well tolerated and patients have experienced significant disease control,” said Yuhong Xu, CEO of HighField.

Key Points: 
  • “These encouraging results show HF1K16 is well tolerated and patients have experienced significant disease control,” said Yuhong Xu, CEO of HighField.
  • One of the other two patients, with grade IV glioblastoma, maintained stable disease for more than 4 months.
  • The third patient had stable disease for nearly 3 months and survival to date for more than 9 months.
  • The Phase 1b/2 trial, underway in China, and will assess safety and efficacy as well as evaluate changes in MDSC numbers and phenotypes.