PROC

Sutro Biopharma Reports Full Year 2023 Financial Results, Business Highlights and Select Anticipated Milestones

Retrieved on: 
Monday, March 25, 2024
CBFA2T3, Endometrial cancer, NSCLC, ASH, AML, International, Part, Patient, SAN, STRO, Acute myeloid leukemia, Cancer, Spacecraft, Lung cancer, RAM, PROC, Investment, Phenotype, Society, ADC, Hematology, Nursing

SOUTH SAN FRANCISCO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today reported its financial results for the full year 2023, its recent business highlights, and a preview of select anticipated milestones.

Key Points: 
  • “The year 2023 was pivotal for Sutro, with the initiation of REFRαME-O1, our registration-directed study of luvelta for platinum-resistant ovarian cancer (PROC) patients, further validating our next-generation ADC capabilities.
  • The registration-directed trial, REFRαME-O1, for treatment of PROC is enrolling, with an anticipated ~140 sites in ~20 countries to be opened by the end of 2024.
  • Upon exercising the option, Vaxcyte paid Sutro $50 million and is obligated to pay Sutro an additional $25 million within six months.
  • Upon the occurrence of certain regulatory milestones, Vaxcyte would be obligated to pay Sutro up to an additional $60 million.

Nuvation Bio Doses First Patient in Phase 1/2 Study of NUV-1511 for the Treatment of Advanced Solid Tumors

Retrieved on: 
Thursday, March 14, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, NUVB, Safety, Therapy, Patient, Food and Drug Administration, FDA, PROC, DDC, Food, Pharmaceutical industry

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company’s first DDC to enter the clinic.

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company’s first DDC to enter the clinic.
  • “Dosing the first patient with NUV-1511 marks a significant milestone for our proprietary DDC platform, from which we are developing potent oncology-focused chimeric small molecules designed to selectively deliver anti-cancer therapeutics to cancer cells, while mitigating effects on healthy non-target tissues,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio.
  • “DDCs are the core technology upon which the Company was founded and we are excited to bring our first DDC clinical candidate to patients.”
    The dose escalation portion of the study employs a flexible design that allows for the potential to explore two dosing schedules for NUV-1511 with the goal of establishing the recommended Phase 2 dose.
  • The study will initially evaluate safety and tolerability, pharmacokinetic profile, and assess for signs of clinical activity in patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved U.S. Food and Drug Administration (FDA) labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), advanced pancreatic cancer, and platinum-resistant ovarian cancer (PROC).

INNOVATE-3 Late Breaking Abstract Selected as a Best Oral Presentation at ESGO

Retrieved on: 
Monday, March 11, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Toxicity, Catholic higher education, Congress, Survival, Partnership, Patient, Doxorubicin, Doctor of Philosophy, Overalls, PROC, Clinical trial, Paclitaxel, ESGO, Pharmaceutical industry

Novocure (NASDAQ: NVCR) today announced a late breaking abstract which reviews the results of an exploratory subgroup analysis of the phase 3 ENGOT-ov50 / GOG-3029 / INNOVATE-3 (INNOVATE-3) clinical trial has been selected for presentation at the “Best Oral Session – Late Breaking Abstracts” on Sunday, March 10, 2024 at the European Society on Gynaecological Oncology (ESGO) 2024 Congress in Barcelona.

Key Points: 
  • Novocure (NASDAQ: NVCR) today announced a late breaking abstract which reviews the results of an exploratory subgroup analysis of the phase 3 ENGOT-ov50 / GOG-3029 / INNOVATE-3 (INNOVATE-3) clinical trial has been selected for presentation at the “Best Oral Session – Late Breaking Abstracts” on Sunday, March 10, 2024 at the European Society on Gynaecological Oncology (ESGO) 2024 Congress in Barcelona.
  • Of the 558 total patients enrolled in the INNOVATE-3 clinical trial, 201 patients (36%) were PLD-naïve.
  • “We are extremely pleased to share these data with our colleagues at ESGO and humbled by the selection for a best oral presentation session,” said primary investigator Professor Ignace Vergote, MD, PhD, Professor at the Catholic University of Leuven, Belgium.
  • “I would like to thank our collaborators, ENGOT and The GOG Foundation, for their partnership designing and conducting the INNOVATE-3 trial.

U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients

Retrieved on: 
Friday, March 22, 2024
AbbVie, Ovarian cancer, Survival, ImmunoGen, Progression-free survival, Patient, Neoplasm, ABBV, Malignancy, University, Mirvetuximab soravtansine, PROC, Cancer, PFS, ADC, Food, FDA, Medicine, Pharmaceutical industry

NORTH CHICAGO, Ill., March 22, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as ELAHERE.  

Key Points: 
  • Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy.
  • They may become resistant to this treatment and require another therapy, such as ELAHERE.
  • "The full FDA approval of ELAHERE for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team.
  • "As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, ELAHERE provides an effective new option for patients with folate receptor alpha positive tumors.

Biotech's Role in Addressing the Pancreatic Cancer Emergency

Retrieved on: 
Thursday, March 14, 2024
Ovarian cancer, Immunotherapy, Patient, History, Lutetium (177Lu) oxodotreotide, IND, Cancer, NVS, NUVB, NCI, Novartis, Science, Colorectal cancer, Risk, American Cancer Society, FOLFIRINOX, PDAC, Pancreatic Cancer Action Network, Safety, Immune system, Interim, University, Translational research, Survival rate, Disease, Clinical professor, Associate, Tumor microenvironment, Death, TSX, Pancreatic cancer, Sunnybrook Health Sciences Centre, ACRS, FDA, DCP, Diagnosis, Entrepreneurship, Environment, Physician, Triple-negative breast cancer, Mortality, News, PROC, DDC, Hereditary nonpolyposis colorectal cancer, Optimism, ONC, Pharmaceutical industry

VANCOUVER, BC, March 14, 2024 /PRNewswire/ -- USA News Group - Known as one of the most deadly forms of cancer, pancreatic cancer still has the highest mortality rate of all major cancers today. However, researchers and the biotech sector are working diligently to improve the chances of those who receive this dire diagnosis. Recently, in late 2023, researchers at the Mayo Clinic made a discovery that advances knowledge of how pancreatic cancer spreads and identified a new potential therapeutic target along the way. With the American Cancer Society projecting a record year for new cancer cases in 2024, and Europe facing a pancreatic cancer emergency, it's important to focus on the advances being made in the biotech sector that are giving hope to patients and their families. Among the developers making gains include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), ImmunityBio, Inc. (NASDAQ: IBRX), Aclaris Therapeutics, Inc. (NASDAQ: ACRS), and Nuvation Bio Inc. (NYSE: NUVB). 

Key Points: 
  • There is a point of optimism to build upon, as the Pancreatic Cancer Action Network (PanCAN) has stated the five-year survival rate for pancreatic cancer has increased to 13% .
  • "Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients."
  • It will focus on patients with pancreatic cancer, HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), and platinum-resistant ovarian cancer (PROC).
  • Nuvation is already undergoing dosing in the Phase 1 monotherapy study of NUV-868 in solid tumors in patients with pancreatic cancer, ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer and other solid tumors.

Biotech's Role in Addressing the Pancreatic Cancer Emergency

Retrieved on: 
Thursday, March 14, 2024
Ovarian cancer, Immunotherapy, Patient, History, Lutetium (177Lu) oxodotreotide, IND, Cancer, NVS, NUVB, NCI, Novartis, Science, Colorectal cancer, Risk, American Cancer Society, FOLFIRINOX, PDAC, Pancreatic Cancer Action Network, Safety, Immune system, Interim, University, Translational research, Survival rate, Disease, Clinical professor, Associate, Tumor microenvironment, Death, TSX, Pancreatic cancer, Sunnybrook Health Sciences Centre, ACRS, FDA, DCP, Diagnosis, Entrepreneurship, Environment, Physician, Triple-negative breast cancer, Mortality, News, PROC, DDC, Hereditary nonpolyposis colorectal cancer, Optimism, ONC, Pharmaceutical industry

VANCOUVER, BC, March 14, 2024 /PRNewswire/ -- USA News Group - Known as one of the most deadly forms of cancer, pancreatic cancer still has the highest mortality rate of all major cancers today. However, researchers and the biotech sector are working diligently to improve the chances of those who receive this dire diagnosis. Recently, in late 2023, researchers at the Mayo Clinic made a discovery that advances knowledge of how pancreatic cancer spreads and identified a new potential therapeutic target along the way. With the American Cancer Society projecting a record year for new cancer cases in 2024, and Europe facing a pancreatic cancer emergency, it's important to focus on the advances being made in the biotech sector that are giving hope to patients and their families. Among the developers making gains include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), ImmunityBio, Inc. (NASDAQ: IBRX), Aclaris Therapeutics, Inc. (NASDAQ: ACRS), and Nuvation Bio Inc. (NYSE: NUVB). 

Key Points: 
  • There is a point of optimism to build upon, as the Pancreatic Cancer Action Network (PanCAN) has stated the five-year survival rate for pancreatic cancer has increased to 13% .
  • "Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients."
  • It will focus on patients with pancreatic cancer, HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), and platinum-resistant ovarian cancer (PROC).
  • Nuvation is already undergoing dosing in the Phase 1 monotherapy study of NUV-868 in solid tumors in patients with pancreatic cancer, ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer and other solid tumors.

Zentalis Pharmaceuticals Reports Full Year 2023 Financial Results and Operational Updates

Retrieved on: 
Tuesday, February 27, 2024
BRAF, Therapy, SAN, Eventide, Research, AML, GSK, PARP, Cancer, Platinum, Portfolio manager, Drug development, Uterine serous carcinoma, Medication, Webcast, Ovarian cancer, Administration, PROC, USC, Patient, Pharming, MPH, Link, Development, NDA, WEE1, Acute myeloid leukemia, Partnership, Pharmaceutical industry

NEW YORK and SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced financial results for the year ended December 31, 2023, and highlighted recent corporate accomplishments.

Key Points: 
  • "Zentalis is making remarkable progress in advancing our clinical development program for azenosertib, our potentially groundbreaking WEE1 inhibitor, across various tumor types," stated Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis.
  • "In November 2023, we disclosed promising clinical data demonstrating the potential of azenosertib as an effective monotherapy in ovarian cancer and uterine serous carcinoma.
  • On November 10, 2023, Zentalis participated in a webcast with Joyce F. Liu, M.D., MPH, to discuss azenosertib ovarian cancer clinical data.
  • General and Administrative Expenses: General and administrative expenses for the year ended December 31, 2023 were $64.4 million, compared to $54.6 million during the year ended December 31, 2022.

Epsilogen and Lonza Announce Successful Large-Scale GMP Manufacturing of MOv18, an IgE Antibody Targeting Ovarian Cancer

Retrieved on: 
Tuesday, March 5, 2024
Science, Biotechnology, Research, Pharmaceutical, Finance, Oncology, Health, Professional Services, Immunoglobulin E, GMP, Safety, Immunoglobulin G, PROC, Patient, Clinical trial, Good, Knowledge, Nature Communications, CGMP, Good manufacturing practice, Cancer, Vaccine

Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, today announced successful completion of Good Manufacturing Practice (“GMP”) manufacturing of MOv18 IgE, Epsilogen’s lead IgE antibody drug candidate.

Key Points: 
  • Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, today announced successful completion of Good Manufacturing Practice (“GMP”) manufacturing of MOv18 IgE, Epsilogen’s lead IgE antibody drug candidate.
  • Current research and monitoring indicate that this is the first time GMP manufacturing of a therapeutic IgE antibody has been completed at scale.
  • Epsilogen intends to use this new material for its upcoming Phase Ib study in platinum-resistant ovarian cancer (PROC) patients, scheduled to start later in 2024.
  • Lonza and Epsilogen have worked together to apply Lonza’s knowledge and experience to MOv18 IgE.

Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-1511 for the Treatment of Advanced Solid Tumors

Retrieved on: 
Monday, January 8, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, PROC, Patient, Safety, Food, NUVB, DDC, Pancreatic cancer, IND

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-1511, the first clinical candidate from the company’s novel drug-drug conjugate (DDC) platform.

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-1511, the first clinical candidate from the company’s novel drug-drug conjugate (DDC) platform.
  • “This IND clearance expands our clinical pipeline and validates the approach of our proprietary DDC platform to design potent oncology-focused chimeric small molecules which combine tumor-targeting specificity with the anti-cancer activity of known oncology agents,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio.
  • “We believe NUV-1511 has the potential to provide favorable clinical benefit for patients with various solid tumors and we look forward to initiating the Phase 1/2 study.”
    The dose escalation portion of the Phase 1/2 study will initially evaluate safety and tolerability, and explore the potential for clinical efficacy, in patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved FDA labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), pancreatic cancer, and platinum-resistant ovarian cancer (PROC).

Shattuck Labs Provides Corporate Update and Highlights Upcoming Key Milestones in 2024

Retrieved on: 
Monday, January 8, 2024
Autoimmune disease, Completeness, Ovarian cancer, PROC, AZA, TP53, Anemia, Society, Clinical trial, Cancer, Event, Azacitidine, Investment, Webcast, Patient, Safety, PLD, Acceleration, AML, Mirvetuximab soravtansine, Pharmaceutical industry

AUSTIN, TX and DURHAM, NC, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today provided a corporate update and highlighted upcoming key milestones anticipated in 2024.

Key Points: 
  • AUSTIN, TX and DURHAM, NC, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today provided a corporate update and highlighted upcoming key milestones anticipated in 2024.
  • “In 2023, we delivered key safety and efficacy data across our clinical development program for SL-172154 and further strengthened our financial resources, which we believe will carry us beyond upcoming milestones in the year ahead,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck Labs.
  • On December 21, 2023, Shattuck announced a $50 million registered offering of common stock and concurrent private placement of pre-funded warrants.
  • Initial combination data from the Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC expected mid-year 2024.