Ellipses

Ellipses' next generation selective RET inhibitor EP0031/A400 granted Fast Track designation by US Food and Drug Administration

Retrieved on: 
Tuesday, March 5, 2024
Fast Track, FDA, Food, RET, Drug development, Ellipses, Safety, Patient, NDA, Cancer, Pharmaceutical industry

LONDON, March 5, 2024 /PRNewswire/ -- Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its next generation selective RET inhibitor EP0031/A400 for the potential treatment of RET-fusion positive Non-Small Cell Lung Cancer (NSCLC).

Key Points: 
  • LONDON, March 5, 2024 /PRNewswire/ -- Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its next generation selective RET inhibitor EP0031/A400 for the potential treatment of RET-fusion positive Non-Small Cell Lung Cancer (NSCLC).
  • Responses appeared to be durable regardless of tumour type, RET fusion type, previous treatment or presence of brain metastases.
  • This announcement follows the FDA's decision in November 2023 to grant Orphan Drug Designation to EP0031/A400.
  • Ellipses will now enter more frequent discussion with the FDA to advance rapidly towards an NDA for EP0031/A400 and earlier access by patients.

Ellipses EP0031/A400 granted Orphan Drug Designation from the US Food and Drug Administration

Retrieved on: 
Thursday, November 23, 2023
Safety, Food, ODD, US Food Sovereignty Alliance, IND, Patient, FDA, Partnership, Drug development, RET, Orphan, Serotonin reuptake inhibitor, AACR, Pharmaceutical industry, SRI, Ellipses

LONDON, Nov. 23, 2023 /PRNewswire/ -- Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announces today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its compound, EP0031/A400, a potential treatment for tissue-agnostic RET fusion-positive solid tumours.

Key Points: 
  • LONDON, Nov. 23, 2023 /PRNewswire/ -- Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announces today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its compound, EP0031/A400, a potential treatment for tissue-agnostic RET fusion-positive solid tumours.
  • The FDA grants ODD for investigational treatments for rare diseases, such as RET fusion-positive solid tumours, defined as affecting fewer than 200,000 people in the United States.
  • ODD qualifies the developer for certain incentives with the goal of accelerating drug development for patients, including tax credits and seven years of market exclusivity in the US upon approval by the FDA.
  • [1]
    It is estimated that RET mutations and rearrangements may be responsible for ~2% of all solid tumours.

Ellipses Pharma Announces Intent to Accelerate Clinical Programme Following ‘Encouraging’ Data on Next Generation Selective RET Inhibitor

Retrieved on: 
Monday, June 5, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Drug, Partnership, Brain, Drug development, American Society of Clinical Oncology, Cancer, NSCLC, CMO, ASCO, Ellipses, Neoplasm, Patient, Society, RET, Safety, Pharmaceutical industry, EU, SRI

Ellipses Pharma (“Ellipses”), a global drug development company focused on accelerating the development of new oncology treatments, today announces its intention to expedite further global clinical development of the next generation selective RET inhibitor (SRI) EP0031/A400 following the publication of ‘very encouraging’ clinical data.

Key Points: 
  • Ellipses Pharma (“Ellipses”), a global drug development company focused on accelerating the development of new oncology treatments, today announces its intention to expedite further global clinical development of the next generation selective RET inhibitor (SRI) EP0031/A400 following the publication of ‘very encouraging’ clinical data.
  • Professor Tobias Arkenau, Global Head of Drug Development & CMO at Ellipses, commented:
    “The data presented today gives everyone involved great confidence to further progress our clinical trial programme.
  • The results have been marked in terms of significant tumour shrinkage across RET-altered tumours and importantly EP0031 had an encouraging safety and tolerability profile.
  • We welcome the very striking clinical data presented by our partners at Kelun-Biotech, which marks an important step in the development of this agent.

Ellipses Pharma: Expansion of Scientific Affairs Group

Retrieved on: 
Thursday, March 30, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Johns Hopkins School of Medicine, Uttar Pradesh State Board of High School and Intermediate Education, American Board of Commissioners for Foreign Missions, SAG, Ellipses, Acquisition, Patient, Risk, Internal medicine, MENA, Ovarian cancer, Wertheim, National Board of Physician Nutrition Specialists, Breast cancer, Pharmaceutical industry, Risk management, Medicine

Ellipses Pharma (“Ellipses”), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, today announces a significant expansion of its Scientific Affairs Group (SAG).

Key Points: 
  • Ellipses Pharma (“Ellipses”), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, today announces a significant expansion of its Scientific Affairs Group (SAG).
  • Ellipses now has more than 200 oncology experts from 106 institutions worldwide providing analysis and advice on selection of the most promising potential cancer medicines.
  • Ellipses has built a cloud-based platform to crowdsource scientific and clinical insight from its key opinion leaders (KOLs) that allows them to provide responses anonymously.
  • “We are delighted and very proud that so many eminent oncologists from around the world have enthusiastically embraced what we believe is the largest scientific affairs group in oncology and a unique model.

Ellipses Pharma: EP0042 Receives Orphan Drug Designation from the US Food and Drug Administration

Retrieved on: 
Tuesday, March 14, 2023
Oncology, Health, FDA, Research, Science, Pharmaceutical, Biotechnology, Aurora, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Drug development, The Institute, AML, Ellipses, Cancer research, Breast Cancer Now, Risk, ASH, FLT3, Rare, Patient, ODD, Breast cancer, Food, Safety, Institute of Cancer Research, Drug discovery, IND, Acute leukemia, Pharmaceutical industry

Ellipses Pharma (“Ellipses”), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to EP0042, a dual FLT-3 and Aurora kinase inhibitor, for the treatment of acute myeloid leukaemia (AML).

Key Points: 
  • Ellipses Pharma (“Ellipses”), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to EP0042, a dual FLT-3 and Aurora kinase inhibitor, for the treatment of acute myeloid leukaemia (AML).
  • In February 2023, the FDA approved EP0042’s Investigational New Drug Application, which allowed for the opening of additional trial sites in the US for this compound.
  • EP0042 is being developed as a new potential treatment to combat acquired resistance to FLT3 inhibitors in patients with AML.
  • The designation is an important milestone in the development of EP0042, and underscores the work we are already undertaking towards accelerating its potential access to patients.

Ellipses Pharma Announces FDA Approval of IND Application for EP0042 for Patients With Acute Myeloid Leukaemia

Retrieved on: 
Wednesday, February 1, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Aurora, Breast Cancer Now, AML, Drug development, Institute of Cancer Research, Safety, ASH, Patient, Clinical trial, Cancer research, Food, FLT3, Risk, Investigational New Drug, FLT-3, Society, The Institute, Drug discovery, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breast cancer, IND, Pharmaceutical industry, Ellipses

Ellipses Pharma (“Ellipses”), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, today announces that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for EP0042, a dual FLT-3 and Aurora kinase inhibitor.

Key Points: 
  • Ellipses Pharma (“Ellipses”), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, today announces that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for EP0042, a dual FLT-3 and Aurora kinase inhibitor.
  • EP0042 is being developed as a new potential treatment to combat acquired resistance to FLT3 inhibitors in patients with AML.
  • Once a recommended Phase 2 dose is confirmed, Ellipses will continue to evaluate EP0042 as a monotherapy and explore EP0042 in combination with established standard treatments.
  • This will help us in achieving our strategic goal of bringing potential new treatment options to patients in need at unprecedented speed, whilst also allowing us to engage with key industry and academic partners.

Joyful Math: Prisms VR’s Spatial Learning Platform Will Change The Way Your Child Feels About Math - Now Available on Meta Quest Store

Retrieved on: 
Thursday, January 19, 2023
Primary, Secondary, Education, Technology, Other Technology, Software, Other Education, Wearables, Mobile Technology, Reading, Student, Parent, VR, Learning, Heart, Vector (mathematics and physics), Vocabulary, Memorial Day, School, Polar coordinate system, Exponentiation, Strategic planning, Linear regression, Virtual reality, STEM, Quadratics, Matrix, Complex number, System of equations, Science, Movement, Table, Tutoring, Toy, Telescopic sight, Ellipses, Probability, Prism

“The math gap in America has become a serious problem that if left unchecked will continue to widen the relentless economic divides that preclude large swathes of people from contributing to STEM fields,” said Anurupa Ganguly, founder and chief executive officer at Prisms. “That’s why I launched Prisms. I’m committed to changing how our students grasp, retain and successfully apply mathematical concepts to important problems across industries -- never again having to ask ‘When am I going to use this?’”

Key Points: 
  • Prisms VR , a learning platform pioneering a new paradigm for math education, today announced the consumer launch of its virtual reality (VR) math learning solution on the Meta Quest store.
  • Built for Grade 8 to 11 math students, tutors and teachers, Prisms VR content and multiplayer practice modules are now available here via the Meta Quest store for $24 USD as an annual subscription model.
  • “VR is the first scalable technology that enables students to learn through experiential and spatial learning, the way math deserves to be taught.
  • To better understand the technology problem at the heart of America’s math gap, check out this report from Prisms.

Ellipses Announces First Patient Dosed with EP0031, a Next Generation Selective RET Inhibitor

Retrieved on: 
Wednesday, December 14, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Monroe Dunaway Anderson, MTC, Drug, NMPA, IND, UCLA, Partnership, Medullary thyroid cancer, Patient, RET, Cancer, NSCLC, Thyroid, Serotonin reuptake inhibitor, CMO, SRI, Clinical trial, University, Safety, University of Kentucky, Neoplasm, Pharmaceutical industry, EU, Ellipses

Ellipses Pharma (Ellipses), a global drug development company focused on accelerating the development of new oncology treatments, today announces the first dosing of a patient in EP0031-101, a trial investigating Ellipses next generation selective RET inhibitor (SRI) EP0031.

Key Points: 
  • Ellipses Pharma (Ellipses), a global drug development company focused on accelerating the development of new oncology treatments, today announces the first dosing of a patient in EP0031-101, a trial investigating Ellipses next generation selective RET inhibitor (SRI) EP0031.
  • Next generation SRIs offer the potential to expand the armamentarium against RET-driven cancers and further improve patient outcomes.
  • We are pleased that the EP0031-101 trial has dosed the first patient in the United States and congratulate our partner Ellipses on this important milestone.
  • EP0031 is a potent next generation SRI with broad activity against common RET fusions and mutations, including solvent front resistance mutations.

Ellipses Pharma Presents Preliminary Data From the First in Human Phase-1/2 Trial of EP0042, a Dual FLT-3 and Aurora Kinase Inhibitor, at ASH

Retrieved on: 
Monday, December 12, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Aurora, Dizziness, FLT3, Survival, International Journal of Molecular Sciences, Institute of Cancer Research, Monocyte, Canadian International Council, Diagnosis, Leukemia, Acute leukemia, Acute myeloid leukemia, Society, Patient, Cancer, Cerebral edema, Royal Marsden Hospital, Aurora kinase, Treatment, Survival rate, Ellipses, Febrile neutropenia, American Cancer Society, Drug resistance, Drug development, NHS foundation trust, Bone marrow, AML, Clinical trial, Safety, Ataxia, FIH, Cancer research, Granulocyte, Pulmonary toxicity, ASH, The Royal Marsden NHS Foundation Trust, Risk, Pharmaceutical industry, Dietary supplement, Hematology

EP0042 is being developed as a new potential treatment to combat acquired resistance to FLT3 inhibitors in patients with AML.

Key Points: 
  • EP0042 is being developed as a new potential treatment to combat acquired resistance to FLT3 inhibitors in patients with AML.
  • The preliminary data is based upon 25 patients across 6 dose cohorts including patients with FLT3 mutated and wild type AML at the point of enrolment.
  • The median number of prior treatments was 2 (range 1-6), with a number of patients having received a prior FLT3 inhibitor.
  • EP0042 is a dual FLT3 and Aurora kinase inhibitor under development as a potential treatment for AML patients who have developed FLT3 inhibitor resistance.

Ellipses Pharma Presents Design of Newly Initiated Phase 1/2a Trial of Vosilasarm (EP0062) at SABCS

Retrieved on: 
Monday, December 5, 2022
General Health, Other Health, Health, Pharmaceutical, Oncology, Clinical trial, Drug development, Safety, Breast cancer, Ellipses, SARM, Patient, Lorusso, Breast, AR, ER, Pharmaceutical industry, Dietary supplement

We look forward to presenting further details on this trial, including results, in the future.

Key Points: 
  • We look forward to presenting further details on this trial, including results, in the future.
  • The initiation of this trial for vosilasarm is another key milestone towards our goal of accelerating the development of promising cancer drugs.
  • I am excited by the potential across our pipeline to make available much-needed drugs for patients with cancer.
  • Vosilasarm is an oral, non-steroidal, SARM currently being developed for the treatment of AR+/HER2-/ER+ advanced breast cancer.