Ovarian cancer

New to The Street TV Features Five Corporate Guest Interviews, Episode 537 Airs on the FOX Business Network, Monday, December 11, 2023, at 10:30 PM PT

Retrieved on: 
Friday, December 8, 2023

Grant provides a corporate overview and talks about organic growth as the Company consolidates all its subsidiaries as "OneFirm."

Key Points: 
  • Grant provides a corporate overview and talks about organic growth as the Company consolidates all its subsidiaries as "OneFirm."
  • What makes RELI different is that they acquire well-run agencies but allow them to maintain their successful business operations without disruptive and massive immediate changes.
  • Any data mining or reselling of information is a significant violation in Switzerland , the strictest privacy law in the world.
  • Viewers, please tune in next time for the newest cybersecurity topic on the "Sekur Privacy & Sekur Security– Weekly Hack" segment.

New to The Street TV Announces Its Episode 536 Lineup, Five Corporate Guest Interviews, Broadcasted as Sponsored Program on Bloomberg TV, Tonight, Thursday, December 7, 2023, at 9:30 PM PT

Retrieved on: 
Thursday, December 7, 2023

Grant provides a corporate overview and talks about organic growth as the Company consolidates all its subsidiaries as "OneFirm."

Key Points: 
  • Grant provides a corporate overview and talks about organic growth as the Company consolidates all its subsidiaries as "OneFirm."
  • Any data mining or reselling of information is a significant violation in Switzerland , the strictest privacy law in the world.
  • The Company is offering PROMO CODE: PRIVACY that gives 15% savings toward monthly and yearly subscriptions to any of its services.
  • Viewers, please tune in next time for the newest cybersecurity topic on the "Sekur Privacy & Sekur Security– Weekly Hack" segment.

Regeneron to Share Progress of Novel Combination Therapies in Oncology at ESMO IO

Retrieved on: 
Thursday, December 7, 2023

TARRYTOWN, N.Y., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the presentation of new and updated data on multiple combination therapies from its oncology pipeline at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2023 from December 6 to 8 in Geneva, Switzerland. Highlights include first Phase 1 dose-escalation data for the investigational costimulatory bispecific antibody REGN5668 (MUC16xCD28) in combination with PD-1 inhibitor Libtayo® (cemiplimab) showing encouraging initial activity in patients with recurrent ovarian cancer. Additionally, a late-breaking oral presentation will detail the first results from a Phase 2 trial investigating neoadjuvant Libtayo in combination with low-dose stereotactic body radiotherapy (SBRT) in patients with early-stage hepatocellular carcinoma (HCC).

Key Points: 
  • Additionally, a late-breaking oral presentation will detail the first results from a Phase 2 trial investigating neoadjuvant Libtayo in combination with low-dose stereotactic body radiotherapy (SBRT) in patients with early-stage hepatocellular carcinoma (HCC).
  • “Our ESMO IO presentations highlight the continued progress of Regeneron’s oncology pipeline, which was strategically curated to have the potential to offer novel and differentiated combinations targeting several types of difficult-to-treat cancers.
  • Dose escalation is ongoing and has included administration of REGN5668 doses beyond 300 mg in combination with Libtayo.
  • Regeneron presentations at ESMO IO:

Gradalis Highlights Importance of Targeting Clonal Neoantigens in Achieving Durable Benefit in Cancer Treatment

Retrieved on: 
Tuesday, December 5, 2023

It reviews the potential limitations of certain immunotherapies designed without explicit consideration of clonal neoantigens.

Key Points: 
  • It reviews the potential limitations of certain immunotherapies designed without explicit consideration of clonal neoantigens.
  • This may also explain why clonal neoantigen targeting immunotherapies like Gradalis’ Vigil have shown longer-term overall survival benefits in a randomized controlled trial of patients with solid tumors.
  • Clonal mutations expressed on the cancer surface provide a distinguishing difference between cancer cells and normal non-cancer cells.
  • Emerging research shows that targeting clonal mutations may be critical in achieving a durable clinical benefit,” stated John Nemunaitis, MD, Chief Scientific Officer of Gradalis and co-author of the paper.

Allarity’s Early Phase 2 Stenoparib Data Indicates Clinical Benefit in Women with Advanced Ovarian Cancer Selected with DRP® Companion Diagnostic

Retrieved on: 
Tuesday, December 5, 2023

Each woman was assigned a DRP®-score, and those with scores above 50%, which suggested a higher likelihood of benefiting from treatment with stenoparib, were selected for treatment.

Key Points: 
  • Each woman was assigned a DRP®-score, and those with scores above 50%, which suggested a higher likelihood of benefiting from treatment with stenoparib, were selected for treatment.
  • “We are enthusiastic about these early, promising data since the observed clinical benefit indicates that stenoparib is active in advanced ovarian cancer patients selected with the DRP® -Stenoparib CDx, even though these women had prior PARP inhibitor therapy and chemotherapy.
  • While still early, these data suggest that BID dosing of this drug, and the use of the DRP® -Stenoparib CDx for patient selection and treatment, may provide advanced ovarian cancer patients meaningful benefit.
  • Early trial results may not be a reliable indicator of subsequent trial results based on a larger patient population.

Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Ovarian Cancer

Retrieved on: 
Tuesday, November 28, 2023

WATERTOWN, Mass., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics or AP3, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the ACR-368 OncoSignature assay, a multiplex immunofluorescence assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment. The designation reflects FDA’s determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.

Key Points: 
  • The designation reflects FDA’s determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
  • “We are pleased that our ACR-368 OncoSignature assay, developed specifically to predict tumor sensitivity to ACR-368 and used in our ongoing registrational-intent clinical study to treat patients based on OncoSignature-predicted sensitivity, has been designated by the FDA as a Breakthrough Device,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon Therapeutics.
  • We believe this designation is the first of its kind for such an assay, and represents yet another powerful validation of our AP3 platform.
  • Acrivon has partnered with Akoya Biosciences to co-develop, validate, and commercialize Acrivon’s ACR-368 OncoSignature assay.

Aspira Women’s Health Secures Reimbursement for Ova1Plus(R) from California Medicaid (Medi-Cal)

Retrieved on: 
Tuesday, November 28, 2023

AUSTIN, Texas, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or “the Company”) (Nasdaq: AWH), a bio-analytical company focused on the development and commercialization of women’s health diagnostic tools for gynecologic diseases, today announced that California Medicaid (Medi-Cal) added Ova1Plus® to its fee schedule.

Key Points: 
  • AUSTIN, Texas, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or “the Company”) (Nasdaq: AWH), a bio-analytical company focused on the development and commercialization of women’s health diagnostic tools for gynecologic diseases, today announced that California Medicaid (Medi-Cal) added Ova1Plus® to its fee schedule.
  • The California Department of Health Care Services who is responsible for establishing policy and covered health care services for the California Medicaid (Medi-Cal) program, inclusive of both the fee-for-service and managed care delivery systems has added the Ova1Plus® CPT 81503 to its Provider Manual and fee schedule at the Medicare rate of $897.
  • “We are pleased to announce Medi-Cal’s decision to add Ova1Plus® to its fee schedule,” said Nicole Sandford, President and CEO of Aspira.
  • “This means that women in California facing an ovarian cancer diagnosis, regardless of economic status, will have expanded access to this ground-breaking technology.”

Aspira Women’s Health Receives Final Crosswalk Pricing Determination from the Centers for Medicare & Medicaid Services (CMS)

Retrieved on: 
Monday, November 27, 2023

AUSTIN, Texas, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or “the Company”) (Nasdaq: AWH), a bio-analytical company focused on the development and commercialization of women’s health diagnostic tools for gynecologic diseases, today announced that during the 2024 Clinical Laboratory Fee Schedule (CLFS) rate setting process, the Centers for Medicare & Medicaid Services (CMS) has approved the crosswalk of the fee to be paid to the company for OvaWatch to the fee paid historically for Ova1. Aspira will be reimbursed at a rate of $897 for all OvaWatch and Ova1 tests processed for Medicare patients meeting applicable coverage requirements beginning on January 1, 2024.

Key Points: 
  • Aspira will be reimbursed at a rate of $897 for all OvaWatch and Ova1 tests processed for Medicare patients meeting applicable coverage requirements beginning on January 1, 2024.
  • “Crosswalking” refers to a process for setting the Medicare reimbursement rate for a new laboratory test by assigning the new code the same rate as a comparable existing test.
  • “Nothing is more important than reliable clinical data when a patient is facing a possible ovarian cancer diagnosis.
  • With CMS’s approval of OvaWatch's price on the 2024 laboratory fee schedule, we are closer than ever to ensuring that our ground-breaking technology is available to all women with an adnexal mass," said Nicole Sandford, President and Chief Executive Officer of Aspira.

Genelux Corporation Receives FDA Fast Track Designation for Olvi-Vec in Platinum Resistant/Refractory Ovarian Cancer

Retrieved on: 
Monday, November 27, 2023

WESTLAKE VILLAGE, Calif., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for the development program of Olvi-Vec (olvimulogene nanivacirepvec) for the treatment of patients with platinum resistant/refractory ovarian cancer.

Key Points: 
  • WESTLAKE VILLAGE, Calif., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for the development program of Olvi-Vec (olvimulogene nanivacirepvec) for the treatment of patients with platinum resistant/refractory ovarian cancer.
  • “The Fast Track designation granted for Olvi-Vec underscores its potential to address unmet medical needs in ovarian cancer, a significant recognition as we continue to enroll our Phase 3 OnPrime study,” said Thomas Zindrick , President, Chairman and CEO of Genelux.
  • The purpose of Fast Track designation is to facilitate the development and hasten the review process of drugs aimed at treating serious and life-threatening conditions, ensuring that an approved product can swiftly enter the market.
  • Notable aspects of Fast Track designation encompass regular engagements with the FDA review team, and, if specific criteria are satisfied, potential eligibility for Priority Review and Rolling Review.

Medicovestor, Inc announces the completion of an oversubscribed Seed Financing round to advance its novel Antibody Drug-Conjugate (ADC) platforms

Retrieved on: 
Monday, November 20, 2023

NEW YORK, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Medicovestor, Inc, a privately-held biopharmaceutical company focused on the development of novel antibody drug-conjugate (ADC) therapies, proudly announces the successful completion of its oversubscribed Seed financing round.

Key Points: 
  • NEW YORK, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Medicovestor, Inc, a privately-held biopharmaceutical company focused on the development of novel antibody drug-conjugate (ADC) therapies, proudly announces the successful completion of its oversubscribed Seed financing round.
  • This momentous achievement propels the company forward in advancing pioneering research, expanding its patent portfolio, and enhancing the capabilities of Medicovestor's two state-of-the-art ADC platforms.
  • Concurrently, the company is also progressing with pre-clinical proof-of-concept for its two proprietary ADC platforms: ADoBind, for ultra-high potency ADCs, and ADoFuse, for synergistic combination ADCs.
  • "We are exhilarated by the overwhelming response from investors who echo our commitment to revolutionizing cancer treatment," declared Dr. Lim.