Injection site reaction

Synthekine Presents Positive Initial Results from Phase 1a/1b Clinical Trial of α/β Biased IL-2, STK-012, for Treatment of Advanced Solid Tumors

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Tuesday, April 9, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Arthralgia, Toxicity, Cell, NSCLC, RECIST, HNSCC, Patient, Diarrhea, Maculopapular rash, Lung cancer, Renal cell carcinoma, Injection site reaction, AACR, Nausea, Lymphocyte, Hypotension, RCC, Transaminase, Poster, Itch, CLS, Capillary leak syndrome, Fatigue, Vomiting, NK, Inc., Pharmaceutical industry

Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.

Key Points: 
  • Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.
  • The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego.
  • In the results presented, which included 47 patients treated in Phase 1a dose escalation, STK-012 monotherapy demonstrated a favorable safety, efficacy, pharmacokinetic and pharmacodynamic profile.
  • The poster, titled “Initial results from a Phase 1a/1b study of STK-012, a first-in-class α/β IL-2 receptor biased partial agonist in advanced solid tumors (NCT05098132),” will be presented today at AACR from 9 am to 12:30 pm PT.

SPEVIGO® approved for expanded indications in China and the US

Retrieved on: 
Tuesday, March 19, 2024
Arthralgia, Urinary tract infection, Uncertainty, Human, NMPA, Psoriasis, Disease, Multiple organ dysfunction syndrome, Incidence, Risk, GPP, Boehringer Ingelheim, Patient, Ageing, Executive officer, Immunoglobulin G, Anxiety, Doctor of Philosophy, MD, Quality of life, Flare, Injection site reaction, Clinical trial, Skin, Fever, Immune system, Pain, Itch, Food, FDA, Yale University, Fear

In the trial with 123 patients, no flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30).13,14,15,16 In the Effisayil® 2 trial, SPEVIGO® was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.

Key Points: 
  • In the trial with 123 patients, no flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30).13,14,15,16 In the Effisayil® 2 trial, SPEVIGO® was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.
  • “Until now, people living with GPP have not had any approved options to treat their disease,” said Bruce Strober, MD, PhD, Clinical Professor, Dermatology, Yale University and Central Connecticut Dermatology.
  • “Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode.
  • Therefore, expanding the treatment of GPP is a critical step towards addressing patients’ needs.”

Astria Therapeutics Announces Positive Initial Proof-of-Concept Results from the ALPHA-STAR Phase 1b/2 Trial of STAR-0215 for HAE

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Monday, March 25, 2024
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Interest, Dizziness, Attack, Disease, PD, Webcast, Patient, HAE, Allergy, Quality of life, IND, Injection site reaction, Rash, Plasma kallikrein, Investment, Therapy, Hereditary angioedema, Safety, Charité, Pharmacokinetics, Pain, Multimedia, Pharmaceutical industry

Based on the positive results, Astria plans to advance STAR-0215 to Phase 3 development with trial initiation expected in Q1 2025 and top-line results expected by year-end 2026.

Key Points: 
  • Based on the positive results, Astria plans to advance STAR-0215 to Phase 3 development with trial initiation expected in Q1 2025 and top-line results expected by year-end 2026.
  • Initial safety and efficacy data from Q3M and Q6M dosing in the ALPHA-SOLAR trial are expected mid-2025.
  • Pending regulatory feedback, the Company expects to start a pivotal Q3M Phase 3 trial in Q1 2025, with top-line results expected by year-end 2026.
  • Interested parties may join the webcast via the Investors section of the Astria website, www.astriatx.com or with following the link https://lifescievents.com/event/astriatx/ .

Rallybio Reports Fourth Quarter and Full Year 2023 Financial Results

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Tuesday, March 12, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Pregnancy, Administration, Risk, C5, Patient, Corporation, Acquisition, EMA, European Medicines Agency, Woman, Injection site reaction, Research and development, Clinical trial, Workforce, Pharmacokinetics, Safety, Antiphospholipid syndrome, Data, Pharmaceutical industry

The workforce reduction included 19 roles and will be substantially complete by the end of the first quarter of 2024.

Key Points: 
  • The workforce reduction included 19 roles and will be substantially complete by the end of the first quarter of 2024.
  • In November 2023, Rallybio announced preliminary data from the completed multiple dose cohort of the Phase 1 safety and pharmacokinetics (PK) study for RLYB212.
  • Research & Development (R&D) Expenses: R&D expenses were $15.9 million for the fourth quarter of 2023, compared to $10.8 million for the same period in 2022.
  • General & Administrative (G&A) Expenses: G&A expenses were $5.2 million for the fourth quarter of 2023, compared to $6.3 million for the same period in 2022.

FDA Approves New Antibiotic for Three Different Uses

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Wednesday, April 3, 2024
Daptomycin, Research, Hypersensitivity, Hypokalemia, Fungal infection, Aztreonam, Dizziness, Pneumonia, Survival, Dysgeusia, Potassium, Seizure, Abdominal pain, Dietary supplement, CABP, Headache, Patient, Public, Insomnia, Bacterial pneumonia, Food and Drug Administration, Animal, Bilirubin, Diarrhea, History, Mortality, Vancomycin, Leukopenia, Clostridioides, Human services, Injection site reaction, Nausea, Rash, Priority review, Bronchopneumonia, Skin, Fever, Heated tobacco product, Ceftriaxone, Safety, SAB, Anemia, Division, Phlebitis, Cosmetics, Vaccine, Infection, Food, Vomiting, Blood, Multimedia, FDA, Periodic breathing, ABSSSI, Pharmaceutical industry

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

Rallybio Highlights Portfolio Advances and Outlines Expected Milestones in 2024

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Thursday, January 4, 2024
Research, Finance, Clinical Trials, Professional Services, Biotechnology, Health, Pharmaceutical, General Health, Science, Conference, Geographic atrophy, Food, GMG, Risk, Woman, EMA, Paratriathlon, Data, Injection site reaction, AbCellera, HPP, Antiphospholipid syndrome, European Medicines Agency, Pregnancy, Corporation, DSM-IV codes, C5, Hypophosphatasia, ENPP1, Investment, Webcast, Patient, Therapy, Pharmaceutical industry

Rallybio expects to initiate its Phase 2 dose confirmation study for RLYB212 in the second half of 2024.

Key Points: 
  • Rallybio expects to initiate its Phase 2 dose confirmation study for RLYB212 in the second half of 2024.
  • Rallybio expects to complete this manufacturing work and provide an update on the development plan for RLYB116 in the second half of 2024.
  • Rallybio and EyePoint expect to provide an update on this collaboration in the first half of 2024.
  • Rallybio and Exscientia plan to provide an update on the progress of the program in the second half of 2024.

Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers

Retrieved on: 
Tuesday, December 5, 2023
Chills, CRS, Melanoma, RP1, CRC, Food, Melanoma Research, RECIST, NMSC, Transplant, Diarrhea, FDA, Cytokine release syndrome, Colorectal cancer, SCCHN, Type, RP3, CRR, Fatigue, Headache, Nausea, Itch, Myocarditis, Incidence, Nivolumab, Influenza-like illness, Research, Clinical trial, Injection site reaction, Myalgia, CSCC, Skin cancer, HCC, Weakness, Society, Head, Appetite, RP2, Regeneron Pharmaceuticals, Carcinoma, Investment, Webcast, Patient, Lipase, Angiosarcoma, MCC, Vomiting, Neck, Uveal melanoma, Rash, BLA, Pharmaceutical industry

The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.

Key Points: 
  • The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.
  • The ORR was comparable between the two study groups (52.5% for RP1 plus cemiplimab vs. 51.4% for cemiplimab alone, p=0.692).
  • The registration directed anti-PD1 failed melanoma cohort from the IGNYTE clinical trial includes 140 patients and completed enrollment earlier this year.
  • RP1 monotherapy was well tolerated, and the safety profile was similar to that observed in non-immunocompromised patients with advanced skin cancers.

Rallybio Announces Preliminary Phase 1 Multiple Ascending Dose Data for RLYB116, an Innovative Subcutaneously Injected Inhibitor of Complement Component 5

Retrieved on: 
Wednesday, December 20, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, GMG, ISR, Aes, Half-life, Incidence, Injection site reaction, Pharmacokinetics, PD, History, Hepatitis, Antiphospholipid syndrome, Corporation, C5, Investment, Webcast, Patient, Safety, Pharmaceutical industry

Rallybio Corporation (Nasdaq: RLYB) today announced preliminary Phase 1 multiple ascending dose (MAD) data for RLYB116, an innovative, long-acting, low volume subcutaneously injected inhibitor of complement component 5 (C5), in development for patients with complement-mediated diseases.

Key Points: 
  • Rallybio Corporation (Nasdaq: RLYB) today announced preliminary Phase 1 multiple ascending dose (MAD) data for RLYB116, an innovative, long-acting, low volume subcutaneously injected inhibitor of complement component 5 (C5), in development for patients with complement-mediated diseases.
  • The Phase 1 MAD study for RLYB116 evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous RLYB116 in healthy participants with multiple dose administration.
  • The reduction in free C5 at 24 hours after the first dose of 100 mg was greater than 99%.
  • “The preliminary results from this Phase 1 multiple ascending dose study of RLYB116 support continued development in patients with gMG,” said Eric Watsky, M.D., RLYB116 Program Lead for Rallybio.

New Pivotal Data for Bispecific Antibody Epcoritamab (DuoBody® CD3xCD20) Demonstrates High Overall and Complete Responses in Patients with Hard-To-Treat Relapsed/Refractory Follicular Lymphoma (FL)

Retrieved on: 
Saturday, December 9, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Fever, Bispecific monoclonal antibody, Research, NYSE, Injection site reaction, ASH, CRS, Risk, Disease, Fatigue, Patient, Abstract, PFS, MRD, AbbVie, Follicular lymphoma, COVID-19, Exposition, Neutropenia, ORR, University of Paris, Diarrhea, APHP, ABBV, Society, Overalls, Lymphoma, Cytokine release syndrome, Pharmaceutical industry

An estimated 85 percent and 74 percent of patients who experienced a CR remained in response at 12 and 18 months, respectively.

Key Points: 
  • An estimated 85 percent and 74 percent of patients who experienced a CR remained in response at 12 and 18 months, respectively.
  • Safety findings were consistent with previous epcoritamab trials, and epcoritamab was generally well tolerated.
  • TEAEs leading to treatment discontinuation occurred in 19 percent of patients, and Grade 5 TEAEs occurred in 13 patients (10 percent).
  • “The data presented at ASH reinforce what we have seen from our epcoritamab research and believe that this investigational bispecific antibody could potentially represent an important treatment option for patients living with relapsed or refractory follicular lymphoma.

European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma

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Friday, December 8, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Multiple myeloma, Lymphocytopenia, Fever, Bispecific monoclonal antibody, NYSE, Cytokine release syndrome, PFE, European Medicines Agency, Rash, European Commission, Pneumonia, Upper respiratory tract infection, CRS, Risk, Febrile neutropenia, Fatigue, EMA, Civil service commission, Patient, Sepsis, Thrombocytopenia, Probability, Periodic breathing, Appetite, CHMP, B-cell maturation antigen, Injection site reaction, Committee, Neutropenia, Diarrhea, Nausea, Arthralgia, RRMM, Anemia, BCMA, Immunotherapy, Hypokalemia, Urinary tract infection, Inc., HIV disease progression rates, Vaccine, Pharmaceutical industry, Pfizer, Nature Medicine

Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).

Key Points: 
  • Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).
  • "More than 50,000 Europeans are diagnosed with multiple myeloma each year, and too often, they face relapse and treatment resistance,” said Chris Boshoff, Chief Oncology Research and Development Officer and Executive Vice President, Pfizer.
  • The conditional marketing authorization for ELREXFIO is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway.
  • This authorization follows the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation for a conditional marketing authorization on October 12, 2023.