Clinical Update from the Ongoing Phase 2 Trial of PRV111, the First Non-Surgical Therapy in Development for Early-Stage Oral Cancer

On October 5, 2026 Privo Technologies reported results from the CLN-004 Phase 2 (Cohort 1) trial evaluating PRV111, a nanoengineered, cisplatin-releasing patch for the treatment of non-invasive oral cancer and high-grade dysplasia (HGD). These conditions are common, recur frequently, and typically require repeated surgical excision, which can impair speech, swallowing, and appearance.

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The CLN-004 clinical study was conducted at four major U.S. hospitals known for treating head and neck cancers. PRV111 was studied in 22 patients and achieved a 95.5% pathologic complete response (pCR) rate, defined as the absence of any residual dysplastic cells in post-treatment punch biopsy specimens, as determined by histopathology. PRV111 also eliminated the need for standard-of-care surgery in 100% of patients and demonstrated durable local control, with no recurrence observed in the treated areas. Dr. Eric Lamarre, an investigator in the study and Chief of Head and Neck Surgical Oncology at Cleveland Clinic, commented:

"The complete response rate of 95.5% and the treatment durability achieved with PRV111 is among the highest reported for localized therapies in this setting. Patients typically face repeated surgical resections, which can lead to scar formation, anatomic distortion and functional impairments that can permanently affect speech and swallowing. This non-surgical patch not only cleared the disease but preserved native tissue function without causing significant scar formation. These results reinforce PRV111’s potential to redefine the standard of care for oral carcinoma in situ and dysplasias. We are one step closer to providing patients with a non-surgical alternative to repeated operative procedures."

The CLN-004 study builds upon Privo’s earlier clinical experience with PRV111 (CLN-001), which showed promising local tumor responses with no systemic toxicity in a first-in-human setting. The results of that earlier trial were published in Nature Communications and highlighted by Forbes for their innovative approach to localized cancer drug delivery.

Detailed Results:

Twenty-two patients with biopsy-confirmed non-invasive oral cancer or high-grade dysplasia received a single cycle of PRV111. Twenty-one patients achieved centrally confirmed pathologic complete responses; the remaining patient was downstaged to low-grade dysplasia, eliminating the need for standard-of-care surgery. All treated lesions resolved, and mucosal surfaces regenerated without scarring or distortion. At a median follow-up of about 14 months, no recurrences were observed; several patients have maintained responses beyond 14 months, and the longest ongoing response is now greater than 21 months. No systemic toxicities or dose-limiting toxicities were reported. Treatment-related events were primarily mild, transient oral symptoms.

Transforming the Treatment Paradigm:

"We at Privo and the investigators in our CLN-004 study are excited by these encouraging results. We are one step closer to providing patients with a non-surgical alternative to repeated operative procedures." said Manijeh Goldberg, PhD, MBA, CEO, President and Founder of Privo Technologies.

Current management of non-invasive oral cancer and HGD relies on surgical excision, which is associated with high recurrence rates and morbidity. PRV111 is designed to deliver high concentrations of cisplatin directly into dysplastic tissue through a brief, outpatient procedure, avoiding systemic side effects associated with traditional chemotherapy and standard-of-care surgery.

About PRV111:

PRV111 is a nanoengineered, polymeric topical patch designed to deliver high-dose cisplatin directly into oral lesions and adjacent mucosa while minimizing systemic exposure. The patch adheres to the lesion, achieves rapid drug permeation into dysplastic tissue and regional lymphatics, and is removed after treatment.

(Press release, Privo Technologies, OCT 5, 2026, View Source [SID1234673191])

GRAIL to Present New Data From NHS-Galleri and PATHFINDER 2 at EDCC and ESMO Congress 2026

On October 5, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported it will present additional data from both the NHS-Galleri trial and the PATHFINDER 2 study further evaluating the Galleri multi-cancer early detection (MCED) test at the Early Detection of Cancer Conference (EDCC) in Edinburgh, the United Kingdom, taking place Oct. 6-8, 2026, and at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain taking place Oct. 23-27, 2026.

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Data across both meetings will include:

A rapid oral presentation highlighting the efficiency and safety of Cancer Signal Origin (CSO) guided diagnostic workups.
A poster showing Galleri cancer detection of more than 200 cancers across histologically distinct cancer types, including rare cancers.
A poster showing Galleri cancer detection performance and accuracy across self-reported racial and ethnic groups.
A poster presenting new NHS-Galleri data on the preclinical window for cancer detection with findings compatible with annual MCED screening.
A poster showing a reduction of cancer diagnoses in emergency presentations associated with annual Galleri screenings.
"Ongoing analyses of PATHFINDER 2 and NHS-Galleri trial data continue to strengthen the evidence for integrating multi-cancer early detection into routine care," said Josh Ofman, MD, MSHS, CEO at GRAIL. "Across large, diverse populations, these data continue to demonstrate Galleri’s strong performance and favorable safety profile, and reinforce its potential to fundamentally improve how we screen for cancer by finding more cancers, before symptoms are present, in early stages, when there is the greatest opportunity for curative intent treatment."

EDCC Data Presentations

Title: Estimating Preclinical Detection Window, Multi-Cancer Early Detection (MCED) Test Sensitivity, and Episode Sensitivity in the NHS-Galleri Trial Using the Incidence Method
Presentation Type: Poster
Date: Oct. 6

Title: Spectrum of Histologically Distinct Cancer Types Detected by a Methylation-Based Multi-Cancer Early Detection (MCED) Test
Presentation Type: Poster
Date: Oct. 7

Title: Performance of a multi-cancer early detection (MCED) test across racial and ethnic groups: Descriptive report from PATHFINDER 2
Presentation Type: Poster
Date: Oct. 7

Title: Loss of Life Expectancy by Stage at Diagnosis and Cancer Type in England: Illustrating the Burden of Premature Mortality From Late-Stage Cancer
Presentation Type: Poster
Date: Oct. 6

Title: High adherence to mammography screening before and after MCED testing
Presentation Type: Poster
Date: Oct. 7

Title: Population Impact of MCED Screening by Reducing the Diagnosis of Cancer in Emergency Settings in England
Presentation Type: Poster
Date: Oct. 7

More information about timing of the EDCC presentations can be found here.

ESMO Data Presentations

Title: Efficiency and Safety of Cancer Signal Origin (CSO)-Guided Diagnostic Workups Following Multi-Cancer Early Detection (MCED) Testing: Results from PATHFINDER 2 (PF2)
Abstract Number: 1151
Presentation Type: Rapid Oral
Date/Time: Oct. 26, 2:45 p.m.-4:15 p.m.
Location: Salamanca Auditorium, Hall 10

Title: Diagnostic Workups Following a Positive Multi-Cancer Early Detection (MCED) Blood Test in Clinical Practice
Presentation Number: 1164P
Presentation Type: Poster
Date/Time: Oct. 25, 12 p.m.-12:45 p.m.

More information about timing of the ESMO (Free ESMO Whitepaper) presentations can be found here.

(Press release, Grail, OCT 5, 2026, View Source [SID1234673190])

ORIC® Pharmaceuticals Announces Agreement with Cancer Research UK to Advance a Potential First-in-Class CIP2A-Targeted Therapy Into Clinical Development

On October 5, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing and commercializing treatments that address mechanisms of therapeutic resistance, reported an agreement with Cancer Research UK, one of the world’s largest funders of cancer research, to advance a potential first-in-class CIP2A-targeted therapy into clinical development.

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Under the agreement, Cancer Research UK’s Centre for Drug Development (CDD) will fully fund, sponsor, design, and execute CTA-enabling studies and early clinical development of ORIC-259 for patients with cancer. ORIC retains an option to reacquire rights to ORIC-259 following Phase 1/2 data, with Cancer Research UK eligible to receive downstream milestone payments and royalties.

Cancerous Inhibitor of PP2A (CIP2A) is a protein that contributes to the development and progression of many cancer types due to its role in protein phosphorylation, mitosis, and DNA damage response. ORIC-259 is a potent, selective, orally bioavailable small molecule degrader of CIP2A mRNA. This potential first-in-class mRNA degrader is designed to modify mRNA splicing to incorporate a premature stop codon, leading to mRNA degradation and loss of CIP2A protein, which is critical for cell proliferation and survival of cancers with homologous recombination deficiency (HRD). Promising preclinical data highlight robust antitumor activity in PARP inhibitor sensitive and resistant settings, indicating broad potential for patients with HRD cancers, and supports the path to clinical development for ORIC-259.

"We are excited to partner with Cancer Research UK to advance ORIC-259, a potential first-in-class CIP2A-targeted therapy, into the clinic," said Lori Friedman, PhD, chief scientific officer. "Cancer Research UK’s proven expertise and capabilities in developing innovative cancer therapies make it an ideal partner for the program, while this structure allows us to remain disciplined in allocating our internal resources to our late-stage clinical pipeline."

"ORIC-259 represents an innovative approach to targeting CIP2A, a protein with significant potential in cancer but one that has proven difficult to drug," said Lars Erwig, Director of the CDD. "We share ORIC’s mission to overcome treatment resistance in cancer, and we look forward to applying our expertise to explore new treatment options for patients."

(Press release, ORIC Pharmaceuticals, OCT 5, 2026, View Source [SID1234673189])

Aprea Therapeutics to Present at October Conferences

On October 5, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported that Oren Gilad PhD, President and CEO, will participate in the 2026 Maxim Growth Summit, to take place October 12-14 in New York City and the Regional Biotechnology Conference, to take place October 15 in Doylestown, PA.

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Maxim Growth Summit

Date and Time: Wednesday, October 14, 9am ET
Format: Fireside Chat
Location: Hard Rock Hotel, New York City

A webcast of the fireside chat will be available on demand to registered conference attendees. For more information and a complete agenda, please refer to View Source

If you would like to arrange a 1on1 meeting with Aprea management during the conference, please contact your Maxim representative.

Regional Biotechnology Conference 2026

Date and Time: Thursday, October 15, 9am – 12noon ET
Format: Panel Discussions
Location: Pennsylvania Biotechnology Center
3805 Old Easton Road, Doylestown, PA 18902

For more information and a complete agenda, please refer to View Source

(Press release, Aprea, OCT 5, 2026, View Source [SID1234673188])

Revolution Medicines Begins Treating Patients in Phase 3 RASolute 309 Trial Evaluating RASONQUE™ (daraxonrasib) Plus Zoldonrasib as First-Line Treatment for Metastatic RAS G12D Pancreatic Cancer

On October 5, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers, reported that it has begun treating patients in RASolute 309, a global, randomized Phase 3 clinical trial evaluating the combination of RASONQUE (daraxonrasib), a RAS(ON) multi-selective inhibitor, and zoldonrasib, an investigational RAS(ON) G12D-selective inhibitor, as a first-line treatment in adult patients with metastatic RAS G12D pancreatic adenocarcinoma (PDAC).

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"RAS G12D is the most common RAS variant in PDAC," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "In preclinical studies, the combination of RAS(ON) multi-selective and G12D-selective inhibitors achieved deeper and more sustained suppression of RAS signaling than either agent alone, accompanied by greater tumor control. Likewise, initial clinical data showed that RASONQUE plus zoldonrasib delivered compelling antitumor activity in patients with previously treated metastatic PDAC, with a manageable safety and tolerability profile. In the context of the unmet need in this patient population, these findings informed the design of the first-line RASolute 309 trial in patients with PDAC. RASolute 309 is the first Phase 3 study evaluating a RAS(ON) inhibitor doublet approach and it marks an important milestone in our efforts to advance a range of potential treatment options for patients with RAS-driven cancers across tumor types and treatment settings."

RASolute 309 (NCT07805954) is a global, randomized, open-label Phase 3 trial evaluating RASONQUE plus zoldonrasib compared with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment in adult patients with metastatic RAS G12D PDAC. The dual primary endpoints are progression-free survival (PFS) and overall survival. Key secondary endpoints include PFS, objective response rate, duration of response, safety and tolerability, pharmacokinetics, and patient-reported outcomes.

About Pancreatic Adenocarcinoma

Pancreatic adenocarcinoma, or PDAC, is the most common form of pancreatic cancer and among the most challenging malignancies. Approximately 55,000 people are diagnosed with PDAC in the U.S. each year, and more than 50,000 die from the disease.1,2 Because early-stage pancreatic cancer often causes few or no symptoms, approximately 80% of patients are diagnosed after the disease has spread, when treatment options are more limited. For patients with metastatic PDAC, the five-year relative survival rate is approximately 3% in the U.S.3,4 RAS G12D is the most prevalent RAS mutation subtype in PDAC, occurring in 40% of patients.5

About Zoldonrasib

Zoldonrasib is an investigational, oral, RAS(ON) G12D-selective, covalent tri-complex inhibitor that binds to cyclophilin A, creating a binary complex that binds to and inhibits the active, oncogenic RAS(ON) G12D mutation. RAS G12D is the most prevalent RAS mutation, accounting for 29% of all RAS-driven cancers.5 Across tumor types, approximately 61,000 new patients with RAS G12D cancers are estimated each year in the U.S., and no targeted therapy is currently approved for these patients.6 Zoldonrasib is currently being evaluated as a monotherapy and in combination with other therapies, including with RASONQUE, Revolution Medicines’ RAS(ON) multi-selective inhibitor, as well as standard of care regimens in lung and gastrointestinal cancers.

About RASONQUE (daraxonrasib)

RASONQUE (daraxonrasib) is an oral, RAS(ON) multi-selective, noncovalent, tri-complex inhibitor, approved by the U.S. FDA for the treatment of adult patients with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.7 RASONQUE is being investigated through a global Phase 3 registrational program in patients with PDAC and metastatic RAS mutant non-small cell lung cancer. Outside the U.S., RASONQUE is an investigational agent that has not been approved by any regulatory authority.

U.S. FDA APPROVED INDICATION

RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.

IMPORTANT SAFETY INFORMATION FOR U.S. APPROVED INDICATION

RASONQUE is associated with the following Warnings and Precautions: Dermatologic and Soft Tissue Toxicity, Stomatitis and Oral Disorders, Diarrhea, Gastrointestinal Perforation, Interstitial Lung Disease (ILD)/Pneumonitis, and Embryo-Fetal Toxicity.

Serious adverse reactions occurred in 30% of patients treated with RASONQUE. Serious adverse reactions occurring in ≥ 2% of patients treated with RASONQUE were diarrhea (3.7%), pyrexia (3.3%), sepsis (2.9%), fatigue (2.1%), and hemorrhage (2.1%).

The most common (≥ 20%) adverse reactions in patients treated with RASONQUE were rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.

(Press release, Revolution Medicines, OCT 5, 2026, View Source [SID1234673187])