Histology

Promising Data for Investigational Innovative Bispecific Ivonescimab Featured at ASCO 2023

Retrieved on: 
Sunday, June 4, 2023

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is being presented today from 8:00 to 11:00am at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is being presented today from 8:00 to 11:00am at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
  • AK112-201 (NCT04736823) is an open-label Phase II study evaluating ivonescimab plus chemotherapy for 174 patents across three cohorts of patients.
  • After a median follow-up time of 13.3 months, median overall survival (OS) was not reached; although, estimated 9-month OS was 93.2%.
  • Over 750 patients have been treated with ivonescimab across multiple clinical studies in different indications in China and Australia.

OncoNano Medicine Presents Positive Final Results from Phase 2 Trial of Pegsitacianine in Podium Presentation at 2023 ASCO Annual Meeting

Retrieved on: 
Wednesday, May 31, 2023

OncoNano Medicine, Inc. will present positive final results from its Phase 2 study of pegsitacianine, a pH-sensitive fluorescent nanoprobe for enhanced intra-operative visualization of cancer, in a podium presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023.

Key Points: 
  • OncoNano Medicine, Inc. will present positive final results from its Phase 2 study of pegsitacianine, a pH-sensitive fluorescent nanoprobe for enhanced intra-operative visualization of cancer, in a podium presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023.
  • Results of the study show that acidic pH is a viable marker and can be used for tumor targeting by the company’s ON-BOARD™ micelle platform.
  • Pegsitacianine has been studied in more than 135 patients across multiple tumor types, including peritoneal metastatic, breast, head and neck, colorectal, esophageal, ovarian and prostate cancers.
  • Results show that pegsitacianine is able to localize different tumor types regardless of their histology or anatomic location.

Castle Biosciences Opens New State-of-the-Art Laboratory in Pittsburgh

Retrieved on: 
Monday, May 22, 2023

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has opened a new state-of-the-art laboratory facility in Pittsburgh.

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has opened a new state-of-the-art laboratory facility in Pittsburgh.
  • “Castle is proud to be a member of the Pittsburgh community and grow our footprint in this great city,” said Derek Maetzold, president and chief executive officer of Castle Biosciences.
  • Castle expects to have the capacity and ability to process each of its proprietary tests out of the new laboratory.
  • The new laboratory in Pittsburgh brings Castle’s total laboratory operations space to more than 52,000 square feet combined.

Candel Therapeutics Announces New Data from Ongoing Phase 1 Clinical Trial of CAN-3110 in Recurrent High-Grade Glioma at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting

Retrieved on: 
Friday, May 19, 2023

The data were presented today in an Oral Presentation Session at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT).

Key Points: 
  • The data were presented today in an Oral Presentation Session at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT).
  • “We are encouraged by the increased survival of treated patients in two independent cohorts observed to date.
  • mOS in arm B is ongoing at 12.0 months and supports the encouraging clinical activity of CAN-3110 observed in in arm A.
  • Additional extensive biomarker studies including histology, transcriptomics, and single cell sequencing are ongoing.

Aziyo Biologics Presents Positive Clinical Data on CanGaroo® Biologic Envelope

Retrieved on: 
Friday, May 19, 2023

SILVER SPRING, Md., May 19, 2023 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, today announced that positive data from the HEAL Study will be presented at Heart Rhythm Society (HRS 2023) on May 21, 2023, at 12:30 PM CT at the Morial Convention Center in New Orleans, LA.

Key Points: 
  • HEAL is a national multi-center study evaluating patients who previously underwent implantation of a cardiac implantable electronic device (CIED) with either an Aziyo CanGaroo® Envelope, Medtronic’s Tyrx™ non-biologic envelope, or no envelope, and are returning for a revision procedure at least four months after initial placement.
  • The CanGaroo Envelope is made of an acellular biologic matrix that is designed to promote a natural healing response, resulting in a healthy, vascularized tissue capsule.
  • This interim analysis includes the evaluation of medical and clinical profiles, procedural notes and physician subjective scoring of the pocket, and histology.
  • During the event, Aziyo Biologics will be exhibiting at Booth 319.

Inventiva reports 2023 First Quarter Financial Information¹ and provides a corporate update

Retrieved on: 
Tuesday, May 16, 2023

R&D expenses for the first quarter were up 38% compared to the first quarter of 2022.

Key Points: 
  • R&D expenses for the first quarter were up 38% compared to the first quarter of 2022.
  • Net cash used in investing activities for the first quarter of 2023 amounted to (€8.4) million, compared to (€0.1) million in the first quarter of 2022.
  • The Company did not recognize revenues for the first quarter of 2023, in line with the first quarter of 2022.
  • The topline results are expected to be published in the middle of the second quarter of 2023.

COMPASSIONATE CERVIX BRUSH BIOPSY DEVICES PIVOTAL FOR NCI GLOBAL "MOONSHOT" CANCER SCREENING INITIATIVE

Retrieved on: 
Tuesday, May 16, 2023

ANAHEIM, Calif., May 16, 2023 /PRNewswire/ -- Histologics LLC manufactures Kylon® medical fabric sterile brush devices which use gentle friction to biopsy the outer cervix and endocervical canal.

Key Points: 
  • ANAHEIM, Calif., May 16, 2023 /PRNewswire/ -- Histologics LLC manufactures Kylon® medical fabric sterile brush devices which use gentle friction to biopsy the outer cervix and endocervical canal.
  • Over 1 million of such cervical biopsies have been performed with this technology in the USA.
  • "Clinicians want to find true cervical cancer precursors at an early treatable stage, known to be caused by infection with the Human Papilloma Virus".
  • "The histology results obtained with the Histologics' biopsy devices have been diagnostic from samples thus far in Cambodia and a cervical cancer has been already diagnosed" said Dr. Goldstein.

Akero Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, May 15, 2023

SOUTH SAN FRANCISCO, Calif., May 15, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported first quarter financial results for the period ending March 31, 2023. In addition, after close of the first quarter, the company raised $124.2 million in net proceeds through an At-the-Market (ATM) facility, which strengthens the company’s cash position as it prepares to initiate the Phase 3 SYNCHRONY Histology and SYNCHRONY Real-World studies of Efruxifermin (EFX) in NASH.

Key Points: 
  • Akero remains on track to report Week 36 results of the Phase 2b SYMMETRY main study in adult patients with cirrhotic NASH (F4, compensated) in the fourth quarter of 2023.
  • Akero remains on track to report results of Cohort D in the second quarter of 2023.
  • Akero's cash, cash equivalents and short-term marketable securities for the period ended March 31, 2023 were $343.2 million.
  • Akero believes that its current cash, cash equivalents and short-term marketable securities will be sufficient to fund its current operating plan into 2025.

Tango Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Highlights

Retrieved on: 
Tuesday, May 9, 2023

BOSTON, May 09, 2023 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported its financial results for the first quarter ended March 31, 2023, and provided business highlights.

Key Points: 
  • We look forward to providing additional data from the trial in 2024,” said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics.
  • TNG908 proof-of-mechanism as an MTA-cooperative PRMT5 inhibitor demonstrated by marked SDMA reduction in MTAP-deleted cancer cells versus normal tissue.
  • The TNG462 Investigational New Drug (IND) application cleared in January 2023, and the first patient is expected to be dosed in mid-2023.
  • General and administrative expenses were $8.0 million for the three months ended March 31, 2023, compared to $6.8 million for the same period in 2022.

AltruBio Announces Poster Presentation at Digestive Disease Week Conference 2023

Retrieved on: 
Monday, May 8, 2023

“Histological remission is an important and evolving goal in the treatment of ulcerative colitis.

Key Points: 
  • “Histological remission is an important and evolving goal in the treatment of ulcerative colitis.
  • However, application of this treatment target is limited by a number of challenges, including the time and inter-observer variability of interpretation of the mucosa,” said Dr. Rubin.
  • 12 subjects with UC received 10 doses of ALTB-168, administered over a 12-week period, with biopsies taken at weeks 0 and 12.
  • Presentation Title: A Novel AI Tool is Accurate at Interpreting Histology and Detects Response to ALTB-168 Therapy in Patients with Moderate to Severe Ulcerative Colitis: Proof of Concept