MUC

Corbus Announces Dosing of First Patient in U.S. Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC

Retrieved on: 
Tuesday, April 2, 2024
MUC, Brentuximab vedotin, Patient, Doctor of Philosophy, Clinical trial, Safety, Pharmacokinetics, ADC, Shijiazhuang Pharma Group, Pharmaceutical industry

NORWOOD, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, announced today the first patient in the U.S. has been dosed in the Phase 1 clinical trial of CRB-701 (SYS6002), a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4.

Key Points: 
  • NORWOOD, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, announced today the first patient in the U.S. has been dosed in the Phase 1 clinical trial of CRB-701 (SYS6002), a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4.
  • The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose.
  • “The initiation of our clinical trial is a significant milestone for Corbus and builds on the encouraging CRB-701 data presented by our development partner CSPC Pharmaceutical Group at ASCO-GU 2024 from the phase 1 study in China,” said Yuval Cohen, PhD.
  • Chief Executive Office of Corbus.

Corbus Pharmaceuticals Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, March 12, 2024
MUC, Human, Biotechnology, CSPC, Drug discovery, Carcinoma, Cervical cancer, Rash, Patient, MMAE, Tumor microenvironment, Peripheral neuropathy, IND, PH1b, Insulin resistance, Investment, Investigational New Drug, Therapy, CB1, ATM, Safety, Liraglutide, CMO, FDA, PD-1, Pharmaceutical industry

We expect to dose the first patient in our US Ph1 study in March 2024.

Key Points: 
  • We expect to dose the first patient in our US Ph1 study in March 2024.
  • For CRB-601, the FDA cleared our Investigational New Drug (“IND”) application in January 2024, and we expect to dose the first patient this summer.
  • The Company presented CRB-913 pre-clinical data at Obesity Week as an oral presentation and as a late breaking poster in October 2023.
  • The Company is currently conducting IND enabling studies and expects to file an IND in the fourth quarter of 2024.

Bicycle Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 20, 2024
Biotechnology, General Health, Pharmaceutical, Health, Toxicity, Growth, Ovarian cancer, Radiopharmaceutical, Patient, Anal cancer, Bicycle, McKinsey & Company, Head, Cervical cancer, EV, Neoplasm, ATM, Therapy, Food and Drug Administration, TNBC, Net, Former, CMC, Thromboxane A2, Immune system, NSCLC, MUC, Peripheral neuropathy, SunOpta, Safety, Ovary, Participation, Knowledge, Novartis, Lazard, BRC, FDA, Cancer, Food, Pembrolizumab, Government, ADC, Brentuximab vedotin, CD137, Pharmaceutical industry

Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided recent corporate updates.

Key Points: 
  • Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided recent corporate updates.
  • We continue to demonstrate our ability to develop highly differentiated, precision-guided therapeutics that may offer greater tolerability and lead to enhanced benefit for patients,” said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics.
  • Validating the company’s Bicycle® Radio Conjugates (BRC™) pipeline and partner for success, with updates expected from its wholly owned BRC program by mid-2024.
  • Advancing the company’s Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) immune-oncology pipeline through innovative partnerships.

Multifamily Utility Company Welcomes Maliece Sorrows to the Leadership Team

Retrieved on: 
Thursday, February 29, 2024
MUC, SAN, Utility, Growth, Sorrow, Management

SAN DIEGO, Feb. 29, 2024 /PRNewswire/ -- Multifamily Utility Company continues to add bench strength to the leadership team with the most recent addition of Vice President of Operations, Maliece Sorrows.

Key Points: 
  • SAN DIEGO, Feb. 29, 2024 /PRNewswire/ -- Multifamily Utility Company continues to add bench strength to the leadership team with the most recent addition of Vice President of Operations, Maliece Sorrows.
  • "Joining Brian and the MUC leadership team is an exciting opportunity, and I can't wait to dive in," said Sorrows.
  • With over three decades of multifamily industry expertise, she brings a wealth of dynamic leadership and proven success to our team.
  • "Joining Brian and the MUC leadership team is an exciting opportunity, and I can't wait to dive in," said Sorrows.

CRB-701 (SYS6002) A Next Generation Nectin-4 Targeting Antibody Drug Conjugate Demonstrates Encouraging Safety and Efficacy in Patients with Nectin-4 Positive Tumors in First-In-Human Study Presented at ASCO-GU 2024

Retrieved on: 
Friday, January 26, 2024
MMAE, Neoplasm, Patient, PST, Yale school, CSPC, Shijiazhuang Pharma Group, Yale School of Medicine, ADC, Rash, Peripheral neuropathy, Brentuximab vedotin, ASCO, MUC, Poster, Society, Cervical cancer, Safety, EV, GU, Corbus, Urology, Tab, Trial of the century, Pharmaceutical industry

The poster is titled Phase 1 Dose Escalation of SYS6002(CRB-701), a Next Generation Nectin-4 Targeting Antibody Drug Conjugate by DingWei Ye, et al and is being presented today at the poster session between 11:30 am-1pm PST.

Key Points: 
  • The poster is titled Phase 1 Dose Escalation of SYS6002(CRB-701), a Next Generation Nectin-4 Targeting Antibody Drug Conjugate by DingWei Ye, et al and is being presented today at the poster session between 11:30 am-1pm PST.
  • The poster will also be available on the Corbus website at the start of the poster presentation.
  • We are grateful to CSPC for the work that has gone into conducting this ongoing study and to the clinicians and study participants."
  • Dose escalation and expansion are ongoing and additional data presentations are planned for later this year.

Phase 1 Clinical Data for SYS6002 (CRB-701) to be presented at 2024 ASCO GU

Retrieved on: 
Tuesday, January 23, 2024
Patient, Maxima and minima, PST, Carcinoma, CSPC, Shijiazhuang Pharma Group, ADC, Poster, ASCO, MUC, Society, Cervical cancer, Plasma, Triple-negative breast cancer, Safety, EV, Index, TNBC, CRC, Phase, Colorectal cancer, Data, MTD, Pharmaceutical industry

The data referred to in the abstract dates to September of 2023; the upcoming presentation will include data as of December 2023.

Key Points: 
  • The data referred to in the abstract dates to September of 2023; the upcoming presentation will include data as of December 2023.
  • ASCO GU will be held January 25-27, 2024 in San Francisco, CA and online.
  • Additionally, by administering SYS6002 (CRB-701) on a Q3W schedule there is an opportunity to increase clinical convenience and patient compliance.
  • Continued development of SYS6002 (CRB-701) as both a monotherapy and in combination is planned both in China (CSPC), U.S. and Europe (Corbus Pharmaceuticals Holdings, Inc.).

U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

Retrieved on: 
Friday, January 19, 2024
Potassium, Death, Xerostomia, Patient, State, Overalls, Hyperphosphatemia, Shanda, OS, Bladder cancer, Stomatitis, PD-1, MUC, Survival, Fatigue, Sodium, Calcium, Cohort, Risk, FGFR, PD-L1, Xeroderma, Food, Constipation, Disease, Nail, Creatinine, Johnson & Johnson, Erdafitinib, Neoplasm, FDA, Confidence interval, Diarrhea, New Drug Application, FGFR3, Drug, Appetite, Pharmaceutical industry

RARITAN, N.J., Jan. 19, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study. BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.

Key Points: 
  • BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
  • This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study.
  • BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.
  • This model is part of the Company's ongoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.

Multifamily Utility Company Welcomes Industry Trailblazer Larry Bellack as Chief Revenue Officer

Retrieved on: 
Thursday, January 18, 2024
SAN, Carbon, MUC, Growth

"In the pursuit of organizational growth, we recognize the impact of expertise and innovation in the multifamily industry," said Brian Stone, Chief Executive Officer. "Adding Larry to our team -- a talented and experienced Chief Revenue Officer -- is a strategic investment in driving revenue, fostering client relationships, and propelling the company towards unparalleled success. I look forward to working closely with Larry in the coming months to move our business forward."

Key Points: 
  • SAN DIEGO, Jan. 18, 2024 /PRNewswire/ -- Revolutionizing the multifamily industry, Larry Bellack, a visionary leader with over 30 years of experience, has joined Multifamily Utility Company as its dynamic Chief Revenue Officer.
  • "In the pursuit of organizational growth, we recognize the impact of expertise and innovation in the multifamily industry," said Brian Stone, Chief Executive Officer.
  • "Adding Larry to our team -- a talented and experienced Chief Revenue Officer -- is a strategic investment in driving revenue, fostering client relationships, and propelling the company towards unparalleled success.
  • "I'm thrilled to be part of MUC's journey – a company that truly stands out in transforming multifamily operations," said Bellack, who has previously led growth for industry tech solutions including revenue management, customer engagement, app solutions and eviction management.

Bicycle Therapeutics Provides Data Updates for Three Clinical Programs and Strategy Overview at First R&D Day

Retrieved on: 
Thursday, December 14, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Webcast, MT1-MMP, Peripheral neuropathy, Brain, Safety, Immune system, Cervical cancer, Food, Therapy, Toxicity, Head, Diabetic neuropathy, Nobel Prize, Patient, CD137, Bicycle, FDA, Non-small-cell lung cancer, Pembrolizumab, Neoplasm, Ionis, Investigational New Drug, Brentuximab vedotin, MUC, ORR, Ovary, Anal cancer, Cancer, Ovarian cancer, Toxic leukoencephalopathy, Pain, R, Drug combination, EV, Central nervous system, TNBC, NSCLC, BRC, Pharmaceutical industry, Vaccine, Birth control, Medical imaging, Thromboxane A2

“In totality, the data support the emerging differentiated profile of our Bicycle® molecules, paving the way to deliver best-in-class or first-in-class therapies for many cancers.

Key Points: 
  • “In totality, the data support the emerging differentiated profile of our Bicycle® molecules, paving the way to deliver best-in-class or first-in-class therapies for many cancers.
  • BT8009 is a Nectin-4 Bicycle toxin conjugate (BTC®) designed to overcome the significant toxicity associated with other toxin conjugate approaches.
  • Over 2024, Bicycle Therapeutics intends to generate early human imaging data from its wholly owned BRC pipeline.
  • Bicycle Therapeutics will continue to develop Bicycle® molecules to address disease outside of oncology through innovative partnerships.

Seagen to Highlight Overall Survival Data for PADCEV® and TIVDAK® during Presidential Symposium at ESMO Congress 2023

Retrieved on: 
Monday, October 16, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Diabetes, Fatal, Weakness, Female, Skin, PD-L1, Creatinine, DKA, Nausea, Swelling, Keratitis, Pneumonia, Birth, PD-1, Hair, Neutrophil, Male, Peripheral neuropathy, Lipase, Acute kidney injury, Blood, Stevens–Johnson syndrome, Toxic epidermal necrolysis, Diabetic neuropathy, Toxicity, Bulla, Temperature, Appetite, Itch, SJS, Fetus, Cornea, Conjunctivitis, Hyperglycemia, Dermatitis, Evaluation, Hypoxia, Pain, Diabetic ketoacidosis, Pembrolizumab, ILD, Risk, Liver, Lymphocyte, Grade 2, Rash, Erythema, Fatigue, Acral lentiginous melanoma, Pneumonitis, Papule, Incidence, Dysgeusia, Anemia, Cough, Urinary tract infection, Diarrhea, Erythroderma, Periodic breathing, TEN, Patient, MUC, PN, Drug eruption, Septic shock, Pharmaceutical industry, Medical imaging, Palladium

Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.

Key Points: 
  • Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.
  • When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate.
  • Skin reactions occurred in 72% (all grades) of the 121 patients treated with PADCEV in combination with pembrolizumab in clinical trials.
  • The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash.