Paul Ehrlich Institute

Immutep Receives Constructive Regulatory Feedback on TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, December 21, 2023
Lung cancer, ASX, Autoimmune disease, Food, PEI, FDA, Paul Ehrlich Institute, IMM, Cancer, Committee, Safety, NSCLC, PD-L1, CHMP, Pharmaceutical industry

SYDNEY, AUSTRALIA, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces constructive feedback has been received from the Paul-Ehrlich-Institut (“PEI”), a German regulatory authority and part of the Committee for Medicinal Products for Human Use (CHMP), regarding the planned TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (NSCLC).

Key Points: 
  • The PEI is supportive of Immutep moving into a registrational trial in first line NSCLC and evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy.
  • Also, the PEI acknowledged the good safety profile of efti in combination with anti-PD-1 therapy.
  • Immutep plans to announce its final trial design for TACTI-004 in Q1 of CY2024.
  • Immutep CEO, Marc Voigt, commented: “We appreciate the valuable feedback from the PEI and look forward to additional discussions with other regulatory agencies in the coming months.

Valo Therapeutics Announces Regulatory Approval to Expand Phase I Immuno-oncology Trial into Sarcoma

Retrieved on: 
Wednesday, November 29, 2023
NY-ESO-1, Lung cancer, Neoplasm, Antigen, Tumor microenvironment, Immune system, Research, Sarcoma, American Cancer Society, Melanoma, Cancer, Swelling, Abdomen, Paul Ehrlich Institute, MAGE-A3, Patient, Pembrolizumab, Medical imaging

PeptiCRAd-1 is made up of ValoTx’s proprietary oncolytic virus, VALO-D102, coated with MAGE-A3 and NY-ESO-1 peptides.

Key Points: 
  • PeptiCRAd-1 is made up of ValoTx’s proprietary oncolytic virus, VALO-D102, coated with MAGE-A3 and NY-ESO-1 peptides.
  • ValoTx’s Phase I, first-in-human trial of PeptiCRAd-1 is currently in three tumor types: melanoma, triple negative breast cancer and non-small cell lung cancer.
  • These sub-types of sarcoma are particularly interesting as they have very high expression levels of our two target antigens.
  • If you are a cancer patient interested in participating in the study, please see the “For Patients” section on valotx.com for more information.

Immatics Announces Second Quarter 2023 Financial Results and Business Update

Retrieved on: 
Thursday, August 17, 2023
Synovial sarcoma, MAGEA4, Paul Ehrlich Institute, Prevalence, Half-life, CRS, DL, Cohort, Clinical trial, Lung cancer, BRAF, Uveal melanoma, CTA, Head, Bristol Myers Squibb, Research, Cohort study, PRAME, TCR, Development, State Administrative Expenses, Sarcoma, ATM, Protein, Cytokine release syndrome, Patient, PEI, Administration, Melanoma, Corr, Entrepreneurship, Uterine cancer, Toxic shock syndrome toxin-1, Ovarian cancer, ORR, Safety, Breast cancer, Nivolumab, Pharmaceutical industry, Vaccine, Medical imaging, Cryptocurrency

“Beyond our recent IMA203 updates, we are pleased to report that we closed the second quarter with a cash position funding operations into late 2025.

Key Points: 
  • “Beyond our recent IMA203 updates, we are pleased to report that we closed the second quarter with a cash position funding operations into late 2025.
  • As per the latest data cut-off of April 4, 2023, ACTengine® IMA203 TCR-T monotherapy Cohort A showed a 67% confirmed objective response rate (cORR) in an interim clinical update announced on May 2, 2023.
  • Next update on Immatics’ IMA203 Phase 1b cohorts, including the projected clinical development path for PRAME-targeted TCR-T monotherapy towards registration-directed trials is planned for 4Q 2023.
  • TCER® IMA402 (PRAME) – Immatics submitted a clinical trial application (CTA2) to the Paul-Ehrlich-Institute (PEI) in April 2023.

Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in Lupus Nephritis

Retrieved on: 
Thursday, June 1, 2023
Priority review, Therapy, Paul Ehrlich Institute, Clinical trial, Anti-CD19 immunotoxin, CTA, Fast Track, Lupus, Lupus nephritis, Accelerated approval (FDA), CAR, Patient, PEI, Engineering, Autoimmune disease, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, EU, LN

EMERYVILLE, Calif., June 1, 2023 /PRNewswire/ -- Kyverna Therapeutics ("Kyverna"), a cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KYV-101 for the treatment of patients with refractory lupus nephritis (LN). KYV-101 is a novel anti-CD19 chimeric antigen receptor T-cell (CAR T) therapy designed to deplete B cells, including autoreactive B cells, in autoimmune disease patients. 

Key Points: 
  • KYV-101 is a novel anti-CD19 chimeric antigen receptor T-cell (CAR T) therapy designed to deplete B cells, including autoreactive B cells, in autoimmune disease patients.
  • "The FDA granting us Fast Track designation for KYV-101 means we can move more quickly toward bringing this potentially transformative and life-saving medicine to patients with lupus," said Peter Maag, Ph.D., chief executive officer (CEO) of Kyverna.
  • Fast Track designation is designed to facilitate the development and expedite the review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, thus enabling drugs to reach patients sooner.
  • Therapies granted Fast Track designation are given the opportunity for more frequent interactions with the FDA and may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

Immatics Announces First Quarter 2023 Financial Results and Business Update

Retrieved on: 
Tuesday, May 16, 2023
Synovial sarcoma, Paul Ehrlich Institute, Prevalence, Half-life, CRS, Clinical trial, Lung cancer, CTA, Uveal melanoma, Head, Bristol Myers Squibb, Research, Cohort study, PRAME, TCR, CTA4, Development, State Administrative Expenses, Cytokine release syndrome, Patient, PEI, Administration, Entrepreneurship, Toxic epidermal necrolysis, Uterine cancer, Ovarian cancer, Resuscitation, Safety, Breast cancer, Pharmaceutical industry, Cryptocurrency, Vaccine, Medical imaging

Objective responses were observed independent of solid tumor type at low, medium and high PRAME expression levels above Immatics’ MS-guided RNA threshold.

Key Points: 
  • Objective responses were observed independent of solid tumor type at low, medium and high PRAME expression levels above Immatics’ MS-guided RNA threshold.
  • Next update on Immatics’ IMA203 Phase 1b cohorts, including the projected clinical development path for PRAME TCR-T monotherapy towards registration-directed trials and potential commercialization is planned for 4Q 2023.
  • The trial is expected to commence in 2H 2023 with a first clinical data interim report planned in 2024.
  • Nancy Valente, M.D., resigned from her position on Immatics’ Board of Directors effective May 12, 2023.

Immatics Reports Interim Clinical Data from Ongoing Phase 1b Cohort A Monotherapy with ACTengine® IMA203 TCR-T Targeting PRAME

Retrieved on: 
Tuesday, May 2, 2023
Synovial sarcoma, Paul Ehrlich Institute, PD, Prevalence, DSMB, Half-life, CRS, DL, RECIST, DLT, Cancer, Lung cancer, BOR, Uveal melanoma, Head, Cohort study, RNA, EDT, PRAME, TCR, ORR, CTA4, Data monitoring committee, Cytokine release syndrome, MD, PEI, Patient, Data, Blood, CEST, Webcast, Ovarian cancer, Uterine cancer, Resuscitation, SD, PR, Safety, Breast cancer, Nivolumab, Pharmaceutical industry, Platinum, Fine chemical, Vaccine, Medical imaging

These data further increase our confidence in the success and broad potential of targeting PRAME, and our product candidate IMA203.

Key Points: 
  • These data further increase our confidence in the success and broad potential of targeting PRAME, and our product candidate IMA203.
  • No dose-dependent increase of CRS was observed across Phase 1a and Phase 1b Cohort A (N=38 patients infused with IMA203 in total).
  • Clinical activity for IMA203 TCR-T monotherapy in Phase 1b Cohort A: IMA203 monotherapy demonstrates a high rate of deep objective responses with ongoing durability of more than 9 months after treatment in some patients.
  • Immatics will host a conference call today, May 2nd, 2023, at 8:30 am EDT / 2:30 pm CEST to discuss the clinical data.

Immutep Receives Approval to Initiate INSIGHT-005 Trial Evaluating Eftilagimod Alpha and Anti-PD-L1 Therapy BAVENCIO®

Retrieved on: 
Monday, May 1, 2023
Carcinoma, MHC, Cancer, Paul Ehrlich Institute, Merck Group, Bladder cancer, ASX, B cell, Cell, Transitional cell carcinoma, IMM, National Cancer Institute, Death, MHC class II, Patient, Autoimmune disease, Research, Vaccine, Eftilagimod alpha, PD-L1, Avelumab, Safety, Transitional epithelium, Pharmaceutical industry, Biomedicine

SYDNEY, AUSTRALIA, May 01, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received regulatory approval from the Paul-Ehrlich-Institut (“PEI”), German Federal Institute for Vaccines and Biomedicines, to initiate INSIGHT-005, an investigator-initiated, open-label Phase I trial evaluating the safety and efficacy of eftilagimod alpha (“efti”) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma.

Key Points: 
  • Urothelial carcinoma is the most common type of bladder cancer.
  • “We are excited to get this important trial underway.
  • Encouragingly, deep and durable responses were achieved in patients with low or negative PD-L1 expression as well as immuno-oncology insensitive tumours.
  • INSIGHT currently consists of 5 different arms from stratums A to E (INSIGHT-005 is Stratum E).

EQS-News: Biotest AG: Biotest treats first COVID-19 patients with trimodulin in TRICOVID phase III trial

Retrieved on: 
Sunday, January 22, 2023
Tony Schumacher (German author), Federal Ministry of Health (Germany), III, COVID-19, Education, Inflammation, Paul Ehrlich Institute, Disease, Research, Patient, Plasma, Community-acquired pneumonia, Health, II, German, Pharmaceutical industry, SCAP

Trimodulin is a worldwide unique, innovative human plasma protein preparation in advanced development

Key Points: 
  • Trimodulin is a worldwide unique, innovative human plasma protein preparation in advanced development
    COVID-19 were treated in the TRICOVID (TRImodulin against COVID-19) trial.
  • This multinational phase III clinical trial plans to enrol more than 330 adult hospitalized patients with moderate or severe COVID-19.
  • After confirmation of SARS-CoV-2 infection, the patients will be treated either with trimodulin or with placebo as add-on therapy to standard of care.
  • “We are very pleased to continue the development of trimodulin for a substantial group of hospitalized patients suffering from COVID-19.

BiondVax CEO Issues Letter to Shareholders

Retrieved on: 
Friday, December 30, 2022
PEI, Non-governmental organization, Infection, GMP, Neutralizing antibody, Drug development, BVXV, Failure, Macular degeneration, Contraindication, Max Planck, Pfizer, VHH, COVID-19, SARS-COV-2, Lead, Optimism, European Investment Bank, Risk, Comorbidity, Creativity, CDMO, Mab, MPI, Growth, Patient, Degenerative disease, Letter, Exercise, Collaboration, Omicron, Consultant, Paul Ehrlich Institute, Safety, Max Planck Society, Therapy, UMG, Psoriasis, BiondVax, EIB, Life, University Medical Center, Asthma, Library, Vaccine, Caregiver, Pharmaceutical industry, Risk management, Fine chemical

The letter reads as follows:

Key Points: 
  • The letter reads as follows:
    BiondVax’s 2022 achievements leave me incredibly optimistic about BiondVax’s growth potential and ability to deliver value to our stakeholders.
  • As compared to mAbs, NanoAbs being generated at MPI demonstrate several unique attributes such as greater binding affinity, stability at high temperatures, and formulation advantages.
  • We reported the successful first readout results in the preclinical in vivo study of our innovative inhaled COVID-19 NanoAb therapy.
  • I also want to thank our shareholders for their continued support as we progress toward our objectives.

EQS-News: Biotest AG: Biotest receives approval for new intravenous immunoglobulin Yimmugo® (IgG Next Generation)

Retrieved on: 
Sunday, November 27, 2022
Degenerative disease, Paul Ehrlich Institute, PID, Immunomodulation, SID, VIII, MMN, Dreieich, Multifocal motor neuropathy, Natural Resources, Physician, Patient, Progressive lens, Immunoglobulin G, GBS, Chronic inflammatory demyelinating polyneuropathy, Fibrinogen, Guillain, IVIG, CIDP, ITP, Plasma, Safety, Pharmaceutical industry, Vaccine, Primary

BiotestAG announced today that the German competent authority, the Paul-Ehrlich-Institute, has approved the new intravenous immunoglobulin Yimmugo (IgGNextGeneration) in Germany.

Key Points: 
  • BiotestAG announced today that the German competent authority, the Paul-Ehrlich-Institute, has approved the new intravenous immunoglobulin Yimmugo (IgGNextGeneration) in Germany.
  • "Biotest is expanding its immunoglobulin product portfolio with an innovative new product.
  • Yimmugo offers patients and physicians another important treatment option whose safety, efficacy and tolerability have been proven in the approval studies," emphasises Dr Jrg Schttrumpf, Chief Scientific Officer of Biotest AG.
  • Yimmugo is a newly developed polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIG).