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Tuesday, September 26, 2023

Ideaya fast tracked for ovarian cancer treatment

 

  • Fast Track designation granted by U.S. FDA for evaluation of IDE161 in adult patients with BRCA1/2 mutant advanced or metastatic ovarian cancer who are platinum resistant and have received prior antiangiogenic and PARP inhibitor therapies

  • Enables IDE161 development program to access expedited regulatory review processes, including potential eligibility for accelerated approval / priority review

  • Ongoing Phase 1 expansion, with focus in ER+, Her2(-), HRD+ breast cancer, HRD+ ovarian cancer and other HRD+ solid tumors, including endometrial and colon cancer

Cano Health sells substantially all of its Primary Care Centers in Texas & Nevada

 Cano Health, Inc. ("Cano Health") (NYSE: CANO) today announced that it sold substantially all of the assets associated with the operation of Cano Health's senior-focused primary care centers in Texas and Nevada to CenterWell Senior Primary Care ("CenterWell"). The total value of the transaction to Cano Health is approximately $66.7 million, consisting of approximately $35.4 million in cash paid at closing (of which approximately $1.9 million was withheld for satisfaction of potential indemnification claims), plus the release of certain liabilities owed by Cano Health. As of August 1, 2023, the primary care centers in Texas and Nevada cared for approximately 15,200 members.

https://finance.yahoo.com/news/cano-health-sells-substantially-primary-130000284.html

Exelixis started at Buy by Wainwright

 Target $28

https://finviz.com/quote.ashx?t=EXEL&ty=c&ta=1&p=d

Avalo Therapeutics Successfully Eliminates $35 Million Debt

 In a major achievement, Avalo Therapeutics (Nasdaq: AVTX) proudly announces the payoff of the remainder of its $35 million debt owed to Horizon Technology Finance Corporation (Nasdaq: HRZN). This significant milestone not only signifies the company's steadfast commitment to financial stability but also paves the way for future accelerated growth and progress toward executing its ambitious plans to advance its most promising drug candidates, including its anti-LIGHT mAb (quisovalimab or AVTX-002) and its BTLA agonist fusion protein (AVTX-008).

https://finance.yahoo.com/news/avalo-therapeutics-successfully-eliminates-35-110000091.html

Phathom: Vonoprazan NDA Submission for Non-Erosive GERD

 

  • Submission based on positive results from Phase 3 PHALCON-NERD-301 in which vonoprazan 10 mg and 20 mg controlled heartburn symptoms through the entire 6 months of the study with a safety profile consistent with prior vonoprazan studies

  • New drug application (NDA) seeks U.S. Food and Drug Administration (FDA) approval for vonoprazan as a daily treatment for Non-Erosive GERD, the largest subcategory of GERD with an estimated U.S. adult population of 38 million

  • FDA action date for Non-Erosive GERD NDA expected in the third quarter of 2024

BioVie near completion of Phase 3 Trial of NE3107 in Mild to Moderate Alzheimer's Disease

  • Expects to announce topline data expected in the November/December timeframe.

  • Enrolled patients had underlying medical conditions that are known risk factors for dementia that NE3107 has the potential to improve.

 

Omega Therapeutics Inc OMGA announced preliminary data from the initial two dose level cohorts (n=8) from Part 1 of its Phase 1/2 MYCHELANGELO I study of OTX-2002 in hepatocellular carcinoma and other solid tumors associated with the c-MYC (MYC) gene

OTX-2002, the company's lead development candidate, is designed to pre-transcriptionally downregulate MYC, a master oncogene implicated in more than 50% of all cancers and approximately 70% of HCC cases.

MYCHELANGELO I is an ongoing Phase 1/2 open-label trial evaluating OTX-2002 as a monotherapy (Part 1) and in combination with standard-of-care therapies (Part 2).

Highly specific on-target engagement and intended epigenetic changes at the target genomic loci were observed for all eight patients across both dose levels, as evidenced by a robust increase in cell-free DNA MYC methylation signal following administration with OTX-2002. 

The increased methylation signal persisted throughout the two-week dosing interval.

Epigenetic modulation of MYC translated to rapid, robust, and durable downregulation of MYC expression in all eight patients, with mean reductions across both dose levels of approximately 55% observed seven days following administration with OTX-2002.

The increased methylation and corresponding downregulation of MYC expression observed clinically are within the ranges that led to anti-tumor activity in preclinical xenograft models.

Consistent pharmacokinetic (PK) data across both dose levels with rapid clearance and minimal variability observed within and between patients.

No accumulation was observed following repeat administration and low, transient levels of immune response were observed with no related adverse events or impact on PK.

OTX-2002 was generally well tolerated, with no dose-limiting toxicities.

https://www.benzinga.com/general/biotech/23/09/34911032/omega-therapeutics-cancer-program-shows-encouraging-anti-tumor-activity-in-liver-cancer