FIH

Xencor Presents Preclinical Data from Multiple XmAb® Research Programs at the SITC Annual Meeting

Retrieved on: 
Friday, November 3, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, CD3, Poster, NKG2D, Ovarian cancer, CD28, MICB, Antigen, Cytokine, PD-1, Dose, CLDN6, SITC, Immunotherapy, IL18BP, FIH, NK, Antibody, Cancer, Tumor microenvironment, Society, Patient, Ghyslaine Nke, MICA, Vaccine, NCR1

We are also developing additional CD3 and CD28 T cell engaging bispecific antibodies against solid tumor targets.”

Key Points: 
  • We are also developing additional CD3 and CD28 T cell engaging bispecific antibodies against solid tumor targets.”
    Posters will be available in the poster hall and virtually to registrants of the SITC Annual Meeting.
  • In the poster hall, odd-numbered posters will be displayed on Friday, November 3, and even-numbered posters will be displayed on Saturday, November 4.
  • Xencor’s posters will be archived under "Events & Presentations" in the Investors section of the Company's website located at www.xencor.com .
  • To enhance the anti-tumor activity, Xencor engineered multi-specific NK cell-engaging antibodies that simultaneously target MICA/B antigens and an orthogonal activating receptor on NK cells, NKp46.

Nectero Medical Granted Breakthrough Therapy Designation for the Nectero EAST® System to Treat Infrarenal AAA

Retrieved on: 
Wednesday, November 1, 2023
FDA, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Food, Acanthosis nigricans, Fast Track, Agency, Medicine, Mortality, AAA, Rupture, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Sudden death, Journal, Aneurysm, Growth, FIH, Breakthrough therapy, PGG, Safety, Patient, Pharmaceutical industry

Nectero Medical , a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System to treat patients with infrarenal AAAs, maximum diameter 3.5 – 5.0cm.

Key Points: 
  • Nectero Medical , a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System to treat patients with infrarenal AAAs, maximum diameter 3.5 – 5.0cm.
  • Breakthrough Therapy designation is an FDA program intended to facilitate design and conduct of an efficient product development program.
  • Nectero Medical’s Breakthrough Therapy designation is supported by results from the first-in-human (FIH) study (NCT05133492) of the Nectero EAST System.
  • “This designation reinforces Nectero Medical’s belief that the Nectero EAST System has the potential to have a significant impact for patients with AAA disease,” said Jack Springer, President and Chief Executive Officer of Nectero Medical.

Florida Cancer Specialists & Research Institute Physicians Contribute to Immunotherapy Treatment Advances at Global Meeting

Retrieved on: 
Friday, November 3, 2023
Drug development, Science, Patient, Trial of the century, Education, PD, Nivolumab, Hope, Pembrolizumab, Physician, CD22, MD, HPK1, Research, INT, Immunotherapy, ADC, FIH, Disease, Immune system, Safety, Society, Cancer, FCS, T cell, Vaccine, Pharmaceutical industry, Pharmacokinetics

FORT MYERS, Fla., Nov. 3, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute (FCS) physicians will present at the Society for Immunotherapy of Cancer Annual Meeting this week in San Diego.

Key Points: 
  • FORT MYERS, Fla., Nov. 3, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute (FCS) physicians will present at the Society for Immunotherapy of Cancer Annual Meeting this week in San Diego.
  • They will join stakeholders across the immune-oncology field worldwide to advance the science, discover breakthroughs and enhance education on cancer immunotherapy, which uses the body's own immune system to find, target and fight many forms of the disease.
  • "Immunotherapy is one of the most promising and successful treatment areas for cancer, even at the most advanced stages, said Lucio N. Gordan, MD , FCS President & Managing Physician.
  • "Through our robust and far-reaching clinical trials research program, FCS continues to contribute to cutting-edge research that is providing hope and improving outcomes for cancer patients worldwide."

Carisma to Present First Results From in vivo CAR-M Collaboration with Moderna at SITC 2023

Retrieved on: 
Wednesday, October 25, 2023
Society for Immunotherapy of Cancer, Cancer, Immunotherapy, Conference, CARM, Journal, SITC, Intrinsic termination, FIH, JITC, Messenger, Annual general meeting, Society, Therapy, Patient, Pharmaceutical industry

PHILADELPHIA, Oct. 25, 2023 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that new pre-clinical data leveraging an mRNA platform to develop in-vivo chimeric antigen receptor macrophage ("CAR-M") will be presented as a late-breaking abstract (#LBA1514) at the upcoming Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting held from Wednesday, November 1, to Sunday, November 5, 2023, in San Diego, California. Two posters highlighting next-generation enhancements to Carisma's CAR-M platform, including a custom intronic shRNA approach and data on Engineered Microenvironment Converters (EM-C), will also be presented. Additionally, Carisma will share a trial-in-progress poster overviewing its Phase 1 first-in-human (FIH) study design of its lead program, CT-0508, sharing objectives and eligibility criteria.

Key Points: 
  • Two posters highlighting next-generation enhancements to Carisma's CAR-M platform, including a custom intronic shRNA approach and data on Engineered Microenvironment Converters (EM-C), will also be presented.
  • Additionally, Carisma will share a trial-in-progress poster overviewing its Phase 1 first-in-human (FIH) study design of its lead program, CT-0508, sharing objectives and eligibility criteria.
  • Carisma will participate in the virtual SITC 2023 Annual Meeting Press Conference on Wednesday, November 1, 2023, from 12:00–1:30 pm PT.
  • "We are excited to present this pre-clinical data from our collaboration with Moderna for the first time," said Steven Kelly, President and Chief Executive Officer of Carisma.

Immunomic Therapeutics Reports Positive Results from Its Phase 1 Clinical Trial of ITI-3000 in Patients Diagnosed with Merkel Cell Carcinoma

Retrieved on: 
Monday, October 23, 2023
Oncology, Health, Other Science, Clinical Trials, Research, Science, Biotechnology, FDA, Standard of care, SOC, Angela Merkel, Food, Fast track (FDA), NEAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MCC, LAMP, ITI, FIH, Clinical trial, Recurrence, Merkel cell polyomavirus, Safety, Plasmid, Therapy, Patient, Skin cancer, FTD, DNA, Merkel-cell carcinoma, Pharmaceutical industry

ITI-3000 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in November 2022.

Key Points: 
  • ITI-3000 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in November 2022.
  • As we are encouraged by the immunological responses in patients, we look forward to continuing the development of ITI-3000.
  • The phase 1 clinical trial was a six-patient, single center, open label, first-in-human (FIH) study, investigating the safety, tolerability and immunogenicity of ITI-3000 in patients with polyomavirus-positive Merkel cell carcinoma (MCC).
  • Additional information regarding the phase 1 trial may be found at clinicaltrials.gov , using identifier: NCT05422781.

Research Conducted by Florida Cancer Specialists & Research Institute Featured at European Society of Medical Oncology 2023 Congress

Retrieved on: 
Friday, October 20, 2023
Research, Annals of Oncology, ESMO, SERD, Physician, MAPK, Congress, European Society for Medical Oncology, Estate (law), Drug development, B7-H4, Adenoid cystic carcinoma, FIH, Abstract, Oncology, Safety, Cancer, FCS, ATR, Patient, Diagnosis, Conjugation, Pharmaceutical industry, MD

FORT MYERS, Fla., Oct. 20, 2023 /PRNewswire/ -- Research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) is featured this week among the latest advancements and findings in cancer care at the European Society of Medical Oncology (ESMO) Congress in Madrid, Spain. Five FCS physicians are the first authors and/or co-authors of 12 cancer research studies that will be shared at the global gathering of oncologists, researchers, patient advocates, pharmaceutical representatives and journalists. With more than 30,000 members from 168 countries worldwide, ESMO is the leading professional organization for medical oncology.

Key Points: 
  • FORT MYERS, Fla., Oct. 20, 2023 /PRNewswire/ -- Research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) is featured this week among the latest advancements and findings in cancer care at the European Society of Medical Oncology (ESMO) Congress in Madrid, Spain.
  • With more than 30,000 members from 168 countries worldwide, ESMO is the leading professional organization for medical oncology.
  • The ESMO Congress 2023 is a global stage for the exchange of potentially practice-changing data and multidisciplinary conversations that will spur transformative therapies against cancer.
  • All of the study abstracts will be published online in the ESMO Congress 2023 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.

FIH Trial Trends: How far we've come and where we're going with PK data, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Thursday, October 19, 2023
Trial of the century, Pharmacist, Data collection, Doctor of Philosophy, Drug development, FIH, Clinical trial, PK, Eye, Pharmacy, Patient, Pharmaceutical industry, Pharmacokinetics

TORONTO, Oct. 19, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar delving into pharmacokinetics (PK) in first-in-human (FIH) studies and how it optimizes the data points in clinical trials. In the ever-evolving landscape of pharmaceutical research, it's crucial to keep a close eye on the changes in PK in FIH trials over the past decade. These changes hold valuable insights that can significantly impact the success of clinical studies.

Key Points: 
  • The featured speakers will discuss how PK data in FIH trials optimize the data points that are collected in long-term patient studies.
  • TORONTO, Oct. 19, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar delving into pharmacokinetics (PK) in first-in-human (FIH) studies and how it optimizes the data points in clinical trials.
  • Furthermore, comprehending how PK data gathered in FIH trials can be leveraged to optimize data collection in long-term patient studies is paramount.
  • Join this webinar to gain insights into PK in FIH trials and how the data is essential for driving innovation and improving patient outcomes.

Myrtelle Announces Presentation of Positive 12-month Post Treatment Data in its First-in-Human Clinical Study of rAAV-Olig001-ASPA Gene Therapy at the 2023 Cell & Gene Meeting on the Mesa held by the Alliance for Regenerative Medicine

Retrieved on: 
Tuesday, October 10, 2023
Research, Neurology, Genetics, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Canavan disease, FIH, ASPA, White matter, Regenerative medicine, CD, Cell, Inc., Gene, Mutation, Tissue engineering, Clinical trial, Preyasi Raave, Gene editing, Natural history, Patient, Medical device

In CD, normal brain development is impaired due to a mutation in the ASPA gene that encodes the enzyme aspartoacylase.

Key Points: 
  • In CD, normal brain development is impaired due to a mutation in the ASPA gene that encodes the enzyme aspartoacylase.
  • Following gene therapy, statistically significant gains in certain target white matter and myelin were observed.
  • In turn, improvements in multiple domains on the validated Gross Motor Function Measure and Mullen Scales of Early Learning were demonstrated.
  • Treated patients were routinely observed to outperform untreated age-matched natural history patients on the Mullen Scale of Early Learning.

Model Informed Drug Development: Application to Project Optimus, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, October 4, 2023
MTD, FIH, MIDD, Index, Drug development, FDA, Food and Drug Administration Amendments Act of 2007, Food, Medical imaging, Pharmaceutical industry

TORONTO , Oct. 4, 2023 /PRNewswire-PRWeb/ -- Discover a groundbreaking webinar delving into the application of model informed drug development (MIDD) in oncology to support dose selection. The Food and Drug Administration's (FDA) increased recommendations for oncology dose justification beyond maximum tolerated dose (MTD) have increased interest in quantitative methods and their application to oncology.

Key Points: 
  • In this free webinar, gain insights into how to use model-informed drug development in oncology to support dose selection in agreement with the FDA's Project Optimus Goals.
  • The FDA's increased recommendations for oncology dose justification beyond maximum tolerated dose (MTD) have increased interest in quantitative methods and their application to oncology.
  • TORONTO , Oct. 4, 2023 /PRNewswire-PRWeb/ -- Discover a groundbreaking webinar delving into the application of model informed drug development (MIDD) in oncology to support dose selection.
  • Join this webinar to gain insights into how to use model informed drug development in oncology to support dose selection in agreement with the FDA's Project Optimus Goals.

IAMA Therapeutics Announces Multi-Phase, Strategic Provider Agreement with Evotec

Retrieved on: 
Monday, October 2, 2023
Professional Services, Health, General Health, Pharmaceutical, Small Business, Neurology, Other Science, Research, Science, Clinical Trials, Finance, Epilepsy, Volunteering, PK, Male, IndiGo, Drug development, PD, Clinical trial, Pharmacokinetics, IAMA, CTA, SAD, Toxicity, MBA, Female, DSM-IV codes, NKCC1, Spectrum, MAD, FIH, Therapy, IND, Safety, Pharmaceutical industry, EU, Evotec

IAMA Therapeutics, a pharmaceutical company focused on the discovery, development, and commercialization of novel medicines for children affected by brain disorders, today announced that it has signed a multi-phase agreement with Evotec, which offers integrated drug development solutions.

Key Points: 
  • IAMA Therapeutics, a pharmaceutical company focused on the discovery, development, and commercialization of novel medicines for children affected by brain disorders, today announced that it has signed a multi-phase agreement with Evotec, which offers integrated drug development solutions.
  • The agreement expands the companies' existing relationship, which entails collaborating on IND-enabling preclinical studies for IAMA-6.
  • IAMA plans to submit a CTA filing in the EU and initiate a Phase 1 clinical trial by the end of 2023.
  • "We look forward to adding further rapid, efficient, and seamlessly integrated services to build on our successful relationship with IAMA."