MAB

FibroGen Announces Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate FibroGen’s Immuno-Oncology Assets, FG-3165 (anti-Galectin 9) and FG-3175 (anti-CCR8), in Combination with LIBTAYO® in Upcoming Clinical Trials

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星期一, 六月 3, 2024
PD-1, Lymphocyte, IND, Patient, Trial of the century, SAN, Clinical trial, CCR8, NK, Investigational New Drug, Food, FDA, Regeneron Pharmaceuticals, Pharmaceutical industry

“We are very excited to collaborate with Regeneron Pharmaceuticals to evaluate two separate novel combination approaches to treat patients with select solid tumors,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.

Key Points: 
  • “We are very excited to collaborate with Regeneron Pharmaceuticals to evaluate two separate novel combination approaches to treat patients with select solid tumors,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
  • “We believe that the mechanisms of action for both FG-3165 (anti-Gal9) and FG-3175 (anti-CCR8) have the potential to be synergistic with cemiplimab, providing the possibility for an improvement in clinical outcomes for patients.
  • Under the clinical study collaboration and supply agreement, Regeneron will provide drug supply to FibroGen, who will be the sponsor of each Phase 1 monotherapy and combination trial.
  • Each company retains all rights to their respective compounds, including as a monotherapy or as combination therapies.

Mythic Therapeutics Presents Initial Dose Escalation Data from Ongoing Phase 1 KisMET-01 Study on MYTX-011 at the American Society of Clinical Oncology (ASCO) Annual Meeting

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星期一, 六月 3, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Aes, Histology, Therapy, ASCO, Cancer, MMAE, Patient, Mythic, Annual general meeting, NSCLC, Safety, Society, Pharmacokinetics, ADC, Incidence, Research, Lung cancer, DAR 2, Part, Sarah Cannon Research Institute, Pharmaceutical industry

KisMET-01 ( NCT05652868 ) is a multicenter, first-in-human study of MYTX-011 in patients with previously treated, locally advanced or metastatic NSCLC.

Key Points: 
  • KisMET-01 ( NCT05652868 ) is a multicenter, first-in-human study of MYTX-011 in patients with previously treated, locally advanced or metastatic NSCLC.
  • The primary objectives of Part 1 are to assess safety and tolerability and determine the recommended phase 2 dose.
  • As of April 30, 2024, 42 patients had been enrolled and received at least one dose of MYTX-011.
  • We look forward to seeing additional safety and efficacy data from the Phase 1 study.”

ImmuneOncia Announces Biomarker Results from Phase 1 Clinical Trial of CD47 Antibody at ASCO

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星期一, 六月 3, 2024
Biotechnology, Pharmaceutical, Oncology, Health, Artificial Intelligence, Health Technology, Technology, Clinical Trials, Therapy, Breast cancer, ASCO, DCR, CBR, Hepatocellular carcinoma, Multimedia, Toxicity, Prognosis, Patient, Annual general meeting, ESMO, Cancer, Neutropenia, Society, Thrombocytopenia, Clinical trial, Anemia, Samsung Medical Center, CD47, Infrared spectroscopy correlation table, Pharmaceutical industry

ImmuneOncia (CEO Heung Tae Kim) announced the results of its solid tumour Phase 1a clinical trial of IMC-002, an anti-CD47 mAb, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA on June 1, 2024 (local time).

Key Points: 
  • ImmuneOncia (CEO Heung Tae Kim) announced the results of its solid tumour Phase 1a clinical trial of IMC-002, an anti-CD47 mAb, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA on June 1, 2024 (local time).
  • These results include updates on the Phase 1a clinical trial outcomes, along with biomarker findings achieved through collaboration with Lunit (CEO; Brandon Suh), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics.
  • View the full release here: https://www.businesswire.com/news/home/20240603017832/en/
    ImmuneOncia Announces Biomarker Results from Phase 1 Clinical Trial of CD47 Antibody at ASCO (Graphic: ImmuneOncia Therapeutics, Inc.)
    The study, a dose escalation part of Phase 1, enrolled a total of 12 patients across four dose cohorts starting from May 2022.
  • He further stated, "With the Phase 1b trial for IMC-002 initiated last November, we anticipate additional efficacy confirmation for IMC-002 in specific solid tumours with high unmet needs."

Invivyd Announces General Alignment with U.S. FDA on a Repeatable, Expedient Emergency Use Authorization Pathway for the Prevention and Treatment of Symptomatic COVID-19, Based on Compact Clinical Programs to Establish Safety and Immunobridging for Serial

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星期五, 五月 31, 2024
Hook effect, Patient, Pharmacokinetics, SARS-CoV-2, COVID-19, Food, FDA, Safety, SVP, Engineering, Pre-exposure prophylaxis, Vaccine

Coupled with Invivyd’s proprietary mAb technology platform and engineering capabilities, this pathway provides the company with the opportunity to rapidly, efficiently, and durably deliver high value medicines that prevent and treat symptomatic COVID-19 in vulnerable populations.

Key Points: 
  • Coupled with Invivyd’s proprietary mAb technology platform and engineering capabilities, this pathway provides the company with the opportunity to rapidly, efficiently, and durably deliver high value medicines that prevent and treat symptomatic COVID-19 in vulnerable populations.
  • This compact, repeatable immunobridging pathway is similar to the approach Invivyd used to obtain an EUA for PEMGARDA™ for pre-exposure prophylaxis (PrEP) but would leverage a more efficient route to obtaining the safety and pharmacokinetics (PK) data that could support future potential EUA requests.
  • The direct clinical cost of generating the safety and PK data contemplated in this pathway is estimated at $25-40 million.
  • “We are pleased to gain general alignment with the FDA on a repeatable, rapid pathway toward addressing the ongoing, critical unmet need for novel options for the prevention and treatment of symptomatic COVID-19.

Coherus Presents Preliminary Results from Phase I Dose Escalation Study of its Anti-chemokine receptor 8 (CCR8) Antibody, CHS-114, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

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星期四, 五月 23, 2024
CHRS, Immunosuppression, Half-life, McCormick Place, Patient, CCR8, Immunoglobulin G, TME, Tumor microenvironment, Neoplasm, Poster, Safety, Death, PD-1, GPCR, ASCO, Infrared spectroscopy correlation table, Aes, IO, SAE, Vaccine

REDWOOD CITY, Calif., May 23, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced clinical data from the CHS-114, single agent dose escalation stage of its Phase 1 study at the ASCO Annual Meeting, taking place May 31 to June 4, 2024, at McCormick Place in Chicago. CHS-114 is a novel afucosylated human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that selectively and potently targets human CCR8 with no off-target binding. CCR8 is a G protein-coupled receptor (GPCR) that shows preferential expression on tumor resident Treg cells and has promise as a drug target for selectively targeting immune suppression in the tumor microenvironment (TME) without broadly depleting Treg cells, which has the known unwanted side effect of autoimmune activation.

Key Points: 
  • “The Phase 1 preliminary dose escalation results are an important milestone as we progress our innovative I-O pipeline.
  • Abstract # 2664: Preliminary Results of a Phase 1, First-in-human, Dose Escalation Study of the Anti-CCR8 Cytolytic Antibody, CHS-114 (formerly SRF114) in Patients with Advanced Solid Tumors.
  • Preliminary results and acceptable safety profile support further evaluation of CHS-114 in combination treatment with toripalimab and other I-O agents.
  • In 19 patients evaluable for response, no objective responses were yet noted, while the stable disease rate was 47%.

Bluejay Therapeutics Announces Upcoming Presentations at the European Association for the Study of the Liver (EASL) Congress 2024

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星期三, 五月 22, 2024
HBsAg, Pharmacokinetics, Hepatitis B, CHD, EASL, University, Therapy, Safety, SAN, HBV, Blue jay, Abstract, HDV, Auckland City Hospital, Vaccine

SAN MATEO, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics today announced it will present new data from its ongoing Phase 2 trial evaluating the potential of BJT-778, an investigational anti-HBsAg monoclonal antibody (mAb) that acts against hepatitis B surface antigen, for the treatment of chronic hepatitis D (CHD) at the European Association for the Study of the Liver (EASL) conference taking place June 5-8, in Milan, Italy.

Key Points: 
  • SAN MATEO, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics today announced it will present new data from its ongoing Phase 2 trial evaluating the potential of BJT-778, an investigational anti-HBsAg monoclonal antibody (mAb) that acts against hepatitis B surface antigen, for the treatment of chronic hepatitis D (CHD) at the European Association for the Study of the Liver (EASL) conference taking place June 5-8, in Milan, Italy.
  • Bluejay will also present several posters describing the preclinical profile of BJT-778, its mechanisms of action, and its pharmacokinetics and safety profile in healthy volunteers.
  • Four abstracts have been selected for presentation, including a late-breaker poster presentation that will highlight the safety, tolerability, and antiviral activity data from the Phase 2 trial evaluating BJT-778 for the treatment of chronic hepatitis delta virus (HDV).
  • Additional presentations will focus on the safety and pharmacokinetic profile of BJT-778 in healthy volunteers, the preclinical profile of BJT-778, including its affinity against HBsAg, neutralizing activity against hepatitis B and D viruses, and its pan-genotypic activity, and BJT-778’s preclinical immunomodulatory activity, showcasing its potential for enhancing antiviral T cells functions to potentially clear HBV infection.

Dyadic Announces First Quarter 2024 Financial Results and Highlights Recent Company Progress

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星期二, 五月 14, 2024
Cygnus, Partnership, Infection, Analysis, Food, Vaccine, Poultry, Senior, Primate, Note, Hospital, Research, Therapy, Biofuel, RBD, Massachusetts General Hospital, Human, Rabies, Sale, Rabbit, Trial of the century, Pithing, AVATAR, Cattle, SAHPRA, European, Enzyme, Negotiation, Host cell protein, COVID-19, Protein, Safety, Animal, Immortalised cell line, SME, A-DNA, Melamaravakkadu, Insurance, Antigen, Nature Communications, Innovation, Health, Livestock, C1, Convertible, Manuscript, Virology, Transferrin, Webcast, Clinical study report, Phibro Animal Health

JUPITER, Fla., May 14, 2024 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a biotechnology company focused on the efficient large-scale manufacture of proteins for use in human and animal vaccines and therapeutics, as well as non-pharmaceutical applications including food, nutrition, and wellness, today announced its financial results for the first quarter of 2024 and highlighted recent Company progress.

Key Points: 
  • ET today
    JUPITER, Fla., May 14, 2024 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a biotechnology company focused on the efficient large-scale manufacture of proteins for use in human and animal vaccines and therapeutics, as well as non-pharmaceutical applications including food, nutrition, and wellness, today announced its financial results for the first quarter of 2024 and highlighted recent Company progress.
  • In March 2024, the Company entered into a co-promotion agreement with Biftek Co. for the promotion of growth media supplement for cell culture.
  • The Company is undergoing a beta-lactoglobulin animal-free recombinant whey protein project, expected to begin sampling in the late third quarter.
  • The Company is undergoing a recombinant lactoferrin project, expected to begin sampling the product in the late second or early third quarter.

Aulos Bioscience Provides Positive Interim Phase 1/2 Data From AU-007 at 2024 ASCO Annual Meeting

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星期四, 五月 23, 2024
Research, Technology, Clinical Trials, Health Technology, Biotechnology, Pharmaceutical, Health, Science, Oncology, Artificial Intelligence, Patient, Steroid, Pulmonary edema, Lymphocyte, Renal cell carcinoma, PD, Bladder cancer, Colorectal cancer, Clinical trial, CDT, Lung cancer, Head, Serum, NSCLC, Hypertelorism, Lymphocytopenia, Blood, Neoplasm, Avelumab, IL-2, Melanoma, MSI, ASCO, CD25, Poster, IL-6, Society, Artificial intelligence, Therapy, Hand, PD-L1, ADAS, Annual general meeting, MSS, CRS, RCC, Medical imaging

The data will be presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois.

Key Points: 
  • The data will be presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois.
  • The durability of the tumor reductions seen in several patients suggests the formation of immune memory of the cancerous cells.
  • “While other developmental IL-2 therapies focus on changing IL-2 itself, AU-007 is a human antibody that is a well-established therapeutic modality.
  • The Phase 2 expansion cohorts of the AU-007 study are continuing to enroll patients with a focus on melanoma and RCC.

Parallel Bio Launches Clinical Trial in a Dish to Speed Drug Discovery

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星期四, 五月 16, 2024
Software, Research, Pharmaceutical, Robotics, Data Management, Technology, Genetics, Artificial Intelligence, Health Technology, Clinical Trials, Science, Biotechnology, Health, 3D, Patient, Biology, Human, Laboratory, Clinical trial, Immune system, Organoid, FDA, Disease, Lymph, Safety, Drug development, AI, Animal, Drug discovery, Medicine, Cell, Pharmaceutical industry

Parallel Bio, a biotech company using the immune system to cure disease, today announced the release of its Clinical Trial in a Dish for studying the efficacy and safety of new immunotherapies using human models at the earliest stages of drug discovery.

Key Points: 
  • Parallel Bio, a biotech company using the immune system to cure disease, today announced the release of its Clinical Trial in a Dish for studying the efficacy and safety of new immunotherapies using human models at the earliest stages of drug discovery.
  • Clinical Trial in a Dish creates human models using immune organoids scaled with robotics to represent the biology and diversity of a population.
  • Clinical Trial in a Dish is Parallel Bio’s first commercially available application of its immune system platform, which utilizes lymph-node organoids at scale to replicate the human immune system across diverse populations.
  • Parallel Bio is actively signing on additional pharmaceutical partners for Clinical Trial in a Dish.

Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights

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星期四, 五月 9, 2024
FDA, CMS, Risk, SARS-CoV-2, Food, Webcast, U.S. FDA, Administration, Research and development, Pre-exposure prophylaxis, COVID-19, Patient, Immunodeficiency, Medicine, Medicare, Clinical trial, HCPCS, Vaccine

“The recent months have been incredibly productive for Invivyd.

Key Points: 
  • “The recent months have been incredibly productive for Invivyd.
  • At the beginning of April, Invivyd announced that PEMGARDA is available for purchase in the U.S. through a network of authorized specialty distributors.
  • The company will begin reporting PEMGARDA net product revenue with its second quarter 2024 financial results.
  • First Quarter 2024 Financial Results:
    Cash Position: Cash and cash equivalents were $189.4 million as of March 31, 2024.