Welcome to our dedicated page for Phio Pharmaceuticals news (Ticker: PHIO), a resource for investors and traders seeking the latest updates and insights on Phio Pharmaceuticals stock.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company whose news flow centers on the development of its INTASYL® gene silencing technology and lead compound PH-762. Company announcements describe INTASYL as a gene silencing platform focused on immuno-oncology therapeutics, with PH-762 targeting the PD-1 gene implicated in various forms of skin cancer.
News about Phio frequently covers clinical trial milestones for PH-762. The company has reported completion of enrollment in its ongoing Phase 1b dose escalation trial (NCT 06014086), interim pathology results in cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma, and safety reviews by its Safety Monitoring Committee. Updates have included detailed response rates, such as complete, near complete, and partial responses based on tumor clearance, as well as statements that no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects were observed in the cohorts reported.
Phio also issues regulatory and development updates, including acceptance by the U.S. Food and Drug Administration of its nonclinical protocol study design for a toxicology study required before a pivotal trial of PH-762. Additional news items describe agreements with a U.S. manufacturer for cGMP clinical supply of PH-762 and progress toward delivering commercially viable drug product.
Investors following PHIO news will also see financing and corporate announcements, such as warrant inducement transactions, cash runway commentary, and board-level changes, including the appointment of a Lead Independent Director. The company regularly participates in investor conferences and scientific meetings, where it presents INTASYL technology and PH-762 data, and has highlighted external recognition such as PH-762 being named “Immunomodulatory Solution of the Year” in the BioTech Breakthrough Awards.
This news page aggregates these clinical, regulatory, financing, and governance updates so readers can track how Phio’s INTASYL platform and PH-762 program are progressing over time.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) presented promising preclinical data at the AACR Annual Meeting 2023, showcasing the efficacy of its dual-targeting INTASYL therapy targeting PD-1 and CTLA-4 in mouse models of colon cancer. This innovative approach demonstrated enhanced anti-tumor activity compared to single-target therapies while maintaining a favorable safety profile. Dr. Mary Spellman emphasized the potential of intratumoral administration to mitigate the high incidence of immune-related adverse events associated with systemic treatments. This breakthrough could represent a significant advancement in immuno-oncology, reflecting Phio's commitment to developing effective cancer therapies.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announced new findings from a preclinical study, revealing that its investigational drug mPH-762 induces anti-tumor responses through immune system activation. The study, showcased at the AACR Annual Meeting 2023, demonstrated that mPH-762, when administered intratumorally, generates systemic CD8 T cells that combat untreated tumors, indicating an 'abscopal effect'. Dr. Mary Spellman noted that these results support the clinical use of PH-762, which is currently in a phase 1b trial for advanced melanoma. Additionally, the approach may reduce adverse effects commonly associated with systemic PD-1 inhibition.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) has opened enrollment for the second cohort of its Phase 1b clinical study of PH-762 for advanced melanoma following a positive safety review by the Data Monitoring Committee (DMC). The FDA has confirmed the company can proceed with a planned Phase 1 clinical trial in advanced solid tumors in collaboration with AgonOx. Financially, Phio reported a decreased net loss of $11.5 million for 2022, down 14% from 2021, and a 21% reduction in R&D expenses to $7.0 million. As of December 31, 2022, the company had $11.8 million in cash, which is expected to support operations through Q4 2023.
Phio Pharmaceuticals (Nasdaq: PHIO) appointed Robert Bitterman as President and CEO, effective February 20, 2023. Bitterman has been serving as Interim CEO since September 2022 and will continue as Chair of the Board. The Board of Directors emphasized his strategic leadership and extensive experience as key factors for his appointment during this critical period for the company.
Bitterman stated his commitment to advancing Phio's clinical pipeline and achieving key milestones in 2023 and 2024. Phio specializes in immuno-oncology therapeutics, leveraging its proprietary INTASYL™ RNAi technology to enhance immune cell effectiveness against tumors.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announced on February 13, 2023, that it has regained compliance with Nasdaq's minimum bid price listing requirement. The company has satisfied the Nasdaq Listing Qualifications Panel by ensuring its stock price meets the minimum threshold of $1.00 per share, thereby fulfilling all criteria for continued listing. This marks a significant milestone for Phio as it continues to advance its proprietary INTASYL™ RNAi platform, which enhances the efficacy of immune cells against tumor cells. The matter regarding compliance is now considered closed by Nasdaq.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announced a positive recommendation from an independent Data Monitoring Committee following a review of safety data from its Phase 1b trial of PH-762, aimed at treating advanced melanoma. Conducted at the Gustave Roussy Institute in France, the trial showed no dose-limiting toxicity or severe adverse events, allowing for the continuation of patient enrollment. Phio plans to initiate a US Phase 1b trial targeting cutaneous squamous cell carcinoma in the latter half of 2023. The INTASYL™ RNAi platform aims to enhance immune cell effectiveness against tumor cells by inhibiting PD-1 expression.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) announced a 1-for-12 reverse stock split, effective January 26, 2023, to increase its share price above the minimum $1.00 bid for continued listing on The Nasdaq Capital Market. The outstanding shares will decrease from approximately 13.7 million to 1.1 million. The reverse split will be uniform for all shareholders, with no fractional shares issued—cash payments will be provided instead. This action aims to ensure compliance with Nasdaq's listing standards while maintaining shareholder percentage interests unchanged, barring fractional adjustments.
Phio Pharmaceuticals (Nasdaq: PHIO) announced that its Principal Executive Officer, Robert Bitterman, will present at the Entrepreneurial Showcase during the Dermatology Summit in San Francisco on January 8, 2023. He will highlight the company's proprietary INTASYL™ RNAi platform, which aims to enhance the effectiveness of immune cells against tumor cells. INTASYL is distinguished as the only self-delivering RNAi technology tailored for immuno-oncology therapeutics. Bitterman has a history of leading dermatological product development and commercialization.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) has received FDA clearance for its Phase 1 clinical trial targeting advanced solid tumors. Conducted in collaboration with AgonOx, Inc. and the Providence Cancer Institute, this trial will evaluate the safety and therapeutic potential of Phio’s PH-762 in combination with double positive CD8 tumor infiltrating lymphocytes (AGX148) for melanoma and other tumors. Preclinical data shows that PH-762 enhances tumor-killing activity of AGX148 two-fold. This milestone paves the way for future cancer therapies.
Phio Pharmaceuticals Corp. announced plans to file an IND for PH-762, its INTASYL™ compound, targeting cutaneous squamous cell carcinoma (cSCC). The Phase 1b clinical trial is expected to commence in the second half of 2023 following regulatory approval. PH-762 aims to address the unmet medical needs in treating cSCC, which comprises 51% of solid tumors in the U.S. The company emphasizes its unique RNAi technology's potential to enhance T cell functionality against tumors, positioning PH-762 as a promising option for patients unresponsive to existing monoclonal antibody therapies.