SERM

EvolveImmune Therapeutics Presents New Preclinical and Translational Data on Novel CD2 Costimulatory T Cell Engager Platform at 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

Retrieved on: 
Monday, November 6, 2023
Neoplasm, SERM, CD3, EVOLVE, Breast, Therapy, ULBP2, SERD, Salk Institute for Biological Studies, Immunology, Research, Selective estrogen receptor degrader, SITC, B7-H4, Immunotherapy, Estrogen receptor, Cancer, Triple-negative breast cancer, Breast cancer, TNBC, Society, Patient, CD2, Vaccine, Pharmaceutical industry

In addition, presented data highlighted the robust anti-tumor efficacy exhibited by lead molecules for the EV-104 and EV-106 programs in patient-derived solid tumor models.

Key Points: 
  • In addition, presented data highlighted the robust anti-tumor efficacy exhibited by lead molecules for the EV-104 and EV-106 programs in patient-derived solid tumor models.
  • The EVOLVE platform uniquely unleashes potent, selective and integrated T cell costimulation, which amplifies and sustains the tumor killing capacity of these T cells.
  • The platform also takes advantage the company’s understanding of specific tumor cell characteristics to guide tumor antigen prioritization and program differentiation.
  • In a poster presentation at SITC, EvolveImmune spotlighted advances to the company’s first-in-class EV-104 program, a novel multi-functional T cell engager with integrated CD2 costimulation which conditionally targets ULBP2.

Quantum Leap Healthcare Collaborative Initiates Landmark Phase 2 RECAST DCIS Platform Trial to Evaluate Alternative DCIS Treatments with Atossa Therapeutics, Havah Therapeutics, and the Menarini Group

Retrieved on: 
Monday, October 30, 2023
DCIS, FDA, NCI, Atossa, Testosterone, Biomarker, SERM, MD, Breast disease, Growth, Ductal carcinoma, Disease, Risk, Tamoxifen, National Cancer Institute, Breast cancer, SAN, Woman, Safety, Anastrozole, Patient, Toxicity, Breast, Pharmaceutical industry, Birth control

SAN FRANCISCO, Oct. 30, 2023 /PRNewswire/ -- Quantum Leap Healthcare Collaborative (QLHC) announces the enrollment launch for the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. The study is evaluating three investigational endocrine therapy arms: (Z)-endoxifen, a selective estrogen receptor modulator (SERM) in development by Atossa Therapeutics (Nasdaq: ATOS); HAVAH T+Ai™, a proprietary combination of testosterone (T) and anastrozole (Ai) that targets the androgen and estrogen receptor pathways in development by Havah Therapeutics; and ORSERDU® (elacestrant), the only FDA approved oral selective estrogen receptor degrader (oSERD) in development by Stemline Therapeutics Inc. (Stemline), a wholly-owned subsidiary of the Menarini Group. 

Key Points: 
  • Surgery is the current standard treatment for DCIS even though many patients never progress to breast cancer, which means that patients are often over-treated with invasive procedures.
  • A key element in reducing overtreatment of DCIS is identifying biomarkers that reflect the risk of progression so that those with low-risk lesions are spared surgery.
  • RECAST DCIS features the assessment of imaging and molecular-based biomarkers in addition to evaluating new investigational agents in this setting.
  • The three collaborators for this trial, Atossa Therapeutics, Havah Therapeutics, and Stemline, all aim to find alternative solutions for DCIS patients and are providing different agents for assessment.

Atossa Therapeutics Receives Approval from Health Canada to Conduct Phase 2 EVANGELINE Clinical Trial in Canada

Retrieved on: 
Thursday, July 20, 2023
Exemestane, Ki-67, Goserelin, Woman, Atossa, SERM, Clinical trial, Patient, ESD, Therapy, Health Canada, Breast cancer, Pharmaceutical industry

SEATTLE, July 20, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that Health Canada has issued a “No Objection Letter” following the Company’s Clinical Trial Application for its Phase 2 EVANGELINE study.

Key Points: 
  • SEATTLE, July 20, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that Health Canada has issued a “No Objection Letter” following the Company’s Clinical Trial Application for its Phase 2 EVANGELINE study.
  • This means Atossa can open sites and enroll patients in their Phase 2 EVANGELINE study throughout Canada.
  • The study is expected to enroll approximately 175 patients at sites across the United States and Canada.
  • Once the dose is confirmed, we expect the pace of enrollment to increase as we activate additional sites in the United Sates and Canada.”

Atossa Therapeutics Announces Sponsored Research Agreement with Weill Cornell Medicine to Address Treatment Challenges in Triple Negative Breast Cancer

Retrieved on: 
Thursday, July 6, 2023
Triple-negative breast cancer, TNBC, ER, Breast, Cancer, Woman, Research, Atossa, Annals of Pediatric Cardiology, SERM, Seminal vesicles, Patient, Risk, Cardiology, Weill Cornell Medicine, Neoplasm, Progesterone, Therapy, Recurrence, Estrogen receptor, Phenotype, Metastasis, Breast cancer, Medical imaging, Birth control

SEATTLE, July 06, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in oncology with a focus on breast cancer, today announces a strategic, sponsored research agreement with Weill Cornell Medicine to study the potential of inducing estrogen receptor (ER) expression in triple-negative breast cancer (TNBC).

Key Points: 
  • SEATTLE, July 06, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in oncology with a focus on breast cancer, today announces a strategic, sponsored research agreement with Weill Cornell Medicine to study the potential of inducing estrogen receptor (ER) expression in triple-negative breast cancer (TNBC).
  • “We look forward to working with Atossa and think this project could provide proof of principle for novel approaches to estrogen receptor reinduction in triple negative breast cancer,” said Dr. Lyden.
  • “It’s called triple-negative breast cancer because it does not have any of the receptors that are commonly found in most breast cancers.
  • Activating the estrogen receptor and converting the tumor to ER+ would fundamentally transform the treatment paradigm for these patients.”

Atossa Therapeutics and Quantum Leap Healthcare Provide Enrollment Update for (Z)-Endoxifen Arm of Ongoing I-SPY 2 Clinical Trial

Retrieved on: 
Wednesday, June 28, 2023
FNIH, University, Neoplasm, University of California, San Francisco, Clinical trial, Breast, Woman, EOP, Bangladesh Technical Education Board, Biomarker, SERM, Quantum Leap, Patient, Risk, SAN, FDA, Therapy, Recurrence, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Breast cancer, Pharmaceutical industry

The I-SPY 2 TRIAL is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium.

Key Points: 
  • The I-SPY 2 TRIAL is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium.
  • The (Z)-endoxifen treatment arm, which is expected to enroll approximately 20 patients, is part of the I-SPY 2 Endocrine Optimization Pilot Protocol (EOP).
  • Patients will receive 10 mg of (Z)-endoxifen daily for up to 24 weeks prior to surgery.
  • But one of the biggest challenges in breast cancer is the hormone positive breast cancers that are slow growing.

Atossa Completes Enrollment of Pharmacokinetic Run-In Cohort in Phase 2 EVANGELINE Clinical Trial Evaluating (Z)-Endoxifen as a Neoadjuvant Treatment for ER+ / HER2- Breast Cancer

Retrieved on: 
Monday, June 12, 2023
PK, Exemestane, Goserelin, Woman, Plasma, SERM, Patient, Therapy, Breast cancer

The PK run-in cohort consists of six patients, all of whom will be treated with (Z)-endoxifen at 40mg/day for four weeks.

Key Points: 
  • The PK run-in cohort consists of six patients, all of whom will be treated with (Z)-endoxifen at 40mg/day for four weeks.
  • Once the optimal dose of (Z)-endoxifen is determined, the Treatment Cohort will commence.
  • Participants in the treatment cohort will receive neoadjuvant treatment for up to six months, followed by surgery.
  • The study is expected to enroll approximately 175 patients at up to 25 sites across the United States.

Societal CDMO Enters Agreement With Atossa Therapeutics to Provide Clinical Trial Services (CTS) for Innovative Selective Estrogen Receptor Modulator

Retrieved on: 
Tuesday, May 23, 2023
Clinical Trial Service Unit, Society, CTS, SERM, CDMO, SAN, Engineering, R, Technology transfer, Fine chemical, Atossa

SAN DIEGO and GAINESVILLE, Ga., May 23, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; Nasdaq: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected by Atossa Therapeutics (Nasdaq: ATOS ) to provide a range of its Clinical Trial Services (CTS) offerings focused on Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen.

Key Points: 
  • SAN DIEGO and GAINESVILLE, Ga., May 23, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; Nasdaq: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected by Atossa Therapeutics (Nasdaq: ATOS ) to provide a range of its Clinical Trial Services (CTS) offerings focused on Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen.
  • The agreement spans a range of activities including analytical method transfer/development and validation, cleaning verification method validation, manufacturing of multiple R&D engineering batches, and stability testing of the R&D engineering batches.
  • “Societal’s demonstrated expertise in the technology transfer of established drug products, along with our long track record of successfully formulating and manufacturing innovative small molecules, positions us well to align with Atossa and support the ongoing clinical development of the company’s proprietary oral formulation of (Z)-endoxifen.
  • We are eager to initiate this important work and deliver exceptional results for Atossa,” said David Enloe, chief executive officer of Societal CDMO.

Atossa Therapeutics to Participate in Tribe Public’s Webinar Event “Redefining Breast Cancer Prevention and Treatment”

Retrieved on: 
Thursday, April 27, 2023
SERM, Therapy, Q&A, Breast cancer

Dr. Quay will provide an update on the clinical development of Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, which is currently being investigated in three separate Phase 2 studies.

Key Points: 
  • Dr. Quay will provide an update on the clinical development of Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, which is currently being investigated in three separate Phase 2 studies.
  • To join the event, which will be hosted by Tribe Public’s Managing Member, John F. Heerdink, Jr., please register at ATOS5423.TribePublic.com.
  • Registration is complimentary and should be completed in advance of the event.
  • Once registered, participants can send their questions for Dr. Quay to [email protected].

Global Infertility Drugs Market Report 2023: Sector to Reach $5.2 Billion by 2028 at a CAGR of 5.37% - ResearchAndMarkets.com

Retrieved on: 
Tuesday, April 25, 2023
Health, Pharmaceutical, Urbanization, Pregnancy, Obesity, Prevalence, Diabetes, Ovary, SERM, Biguanide, Ovulation, Cancer, Estrogen receptor, Dopamine, Woman, Research, Traction, PCOS, Enzyme inhibitor, Testosterone, Miscarriage, Conditional sentence, R, Smoking, Birth control, Pharmaceutical industry, Dietary supplement, Infertility

Infertility drugs refer to various medications used to treat infertility and enhance the reproductive health of an individual.

Key Points: 
  • Infertility drugs refer to various medications used to treat infertility and enhance the reproductive health of an individual.
  • Some commonly used infertility drugs include gonadotrophins, aromatase inhibitors, selective estrogen receptor modulators (SERMs), biguanides, ovulatory stimulants, dopamine agonists, and tricyclic antidepressants.
  • The publisher provides an analysis of the key trends in each sub-segment of the global infertility drugs market report, along with forecasts at the global, regional and country level from 2023-2028.
  • Our report has categorized the market based on drug class, route of administration, distribution channel and end user.

Diaccurate Announces Updated Data on its Novel PAM Pathway Inhibitor DIACC3010 in Patients with ER+ HER2- Metastatic Breast Cancer to be Presented at AACR 2023

Retrieved on: 
Thursday, April 6, 2023
Communication, AACR, Progression-free survival, ESR1, Doctor of Philosophy, SERM, MD, Patient, Poster, American Association for Cancer Research, FDA, Tamoxifen, SERD, ER, Medical imaging, Pharmaceutical industry

Abstract title: DIACC3010, optimized inhibitor of S6 kinase, combined with endocrine therapy, has potent antitumor activity in treatment-resistant ER-positive HER2-negative metastatic breast cancer.

Key Points: 
  • Abstract title: DIACC3010, optimized inhibitor of S6 kinase, combined with endocrine therapy, has potent antitumor activity in treatment-resistant ER-positive HER2-negative metastatic breast cancer.
  • The communication features an exploratory correlative analysis from DIACC3010 Phase 1 study focused on the combination cohort of DIACC3010 and tamoxifen, in highly refractory ER+ HER2- metastatic breast cancer patients.
  • In addition, nonclinical efficacy results of DIACC3010 in combination with the SERM tamoxifen and the SERD elacestrant were performed.
  • Combinations of DIACC3010 with CDK4/6 inhibitors such as palbociclib and abemaciclib, in various mouse models of ER+ HER2- breast cancer, will also be disclosed.