On February 12, 2025 Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, reported that the FDA has granted orphan drug designation (ODD) to one of its lead programs, OPN-6602, for the treatment of multiple myeloma (MM) (Press release, Opna Bio, FEB 12, 2025, View Source [SID1234650226]). OPN-6602 is an oral, small molecule inhibitor of the E1A binding protein (EP300) and CREB-binding protein (CBP) currently being tested in a Phase 1 trial in patients with relapsed or refractory MM.

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Multiple myeloma is a rare and aggressive cancer of the plasma cells in the bone marrow that often leads to serious complications such as bone damage, kidney failure and immune suppression. The disease is typically diagnosed in older adults, with limited treatment options available for patients with relapsed or refractory disease.

"We are pleased to have received ODD for OPN-6602 for the treatment of multiple myeloma, a further validation of the drug’s therapeutic potential in patients with this disease who have limited treatment options once they have relapsed," said Gideon Bollag, PhD, chief scientific officer.

Orphan Drug Designation is granted by the FDA to encourage the development of therapies for rare diseases, which are defined as those affecting fewer than 200,000 people in the U.S. The designation provides several benefits, including tax credits for clinical trial costs, a waiver of certain FDA fees, and eligibility for seven years of market exclusivity upon approval.

Opna recently presented data at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2024 showing that in human-derived multiple myeloma models, OPN-6602 suppresses tumor growth, while downregulating key MM driving genes. Synergistic effects were observed with OPN-6602 in combination with dexamethasone, pomalidomide and mezigdomide. OPN-6602’s distinct pharmacokinetic profile allows for continuous daily dosing that potentially results in a lower incidence of toxicities and improved efficacy.

The Phase 1 study in patients with relapsed or refractory multiple myeloma (NCT06433947) is taking place at multiple sites in the U.S. Opna Bio expects to complete the single agent, dose-escalation phase of the trial in 2026. Further development of OPN-6602 in combination with other standard-of-care agents in multiple myeloma is planned.

On February 12, 2025 OnCusp Therapeutics, Inc., a clinical stage biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CUSP06, a Cadherin-6 targeting Antibody-Drug Conjugate (CDH6 ADC) and the company’s lead program, for the treatment of patients with platinum-resistant ovarian cancer (PROC) (Press release, OnCusp Therapeutics, FEB 12, 2025, View Source [SID1234650224]).

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"We are extremely pleased that the FDA granted Fast Track Designation to CUSP06," said Eric Slosberg, PhD, Chief Development Officer of OnCusp Therapeutics. "The early results from our Phase 1 trial have been encouraging, and this designation will expedite our efforts to bring this potentially transformative therapy to patients. Given the need for new therapeutic options in this underserved population, we are committed to working closely with the FDA to accelerate its development."

The ongoing Phase 1 multicenter study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of CUSP06 in adults with platinum-refractory/resistant ovarian cancer and other advanced solid tumors (CUSP06-1001). Early data from the trial have shown promising anti-tumor activity and a manageable safety profile, supporting further development of the program.

About CUSP06

CUSP06, a CDH6 ADC, is composed of a proprietary antibody with high CDH6 binding affinity, a protease-cleavable linker, and an exatecan payload (a potent and clinically validated topoisomerase-1 inhibitor). The linker is designed to complement the exatecan payload, enabling a stable and homogenous ADC. The payload is a weak substrate for BCRP/P-gp, which are drug efflux pumps that drive chemoresistance to many therapies. In preclinical data, this linker-payload has been shown to have an increased "bystander effect" compared to competitor ADCs. CUSP06 has a drug-to-antibody ratio of eight. OnCusp obtained the exclusive global rights (outside of China) to lead the development and commercialization of CUSP06 from Multitude Therapeutics in 2022. CUSP06 is being evaluated in a Phase 1 study in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors. Additional information on the CUSP06-1001 (NCT06234423) trial can be found at clinicaltrials.gov.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the leading cause of death from gynecologic malignancies in the United States, with approximately 20,000 new cases diagnosed annually.[1] Platinum-based chemotherapy is a standard first-line treatment, but approximately 80% of patients who respond to initial treatment will develop platinum resistance, typically within two years.[2] Platinum-resistant ovarian cancer is defined as disease progression within six months of completing platinum-based therapy and carries a particularly poor prognosis, with median survival of only 9-12 months and limited effective treatment options.[2] Despite recent therapeutic advances, the 5-year survival rate for patients with platinum-resistant disease remains around 15%, highlighting a critical unmet need for new therapeutic approaches.[1],[3]

About Fast Track Designation

Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. Programs with FTD may benefit from more frequent meetings with the FDA, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and the potential for a rolling review of the Biologics License Application (BLA).

On February 12, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, and Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, reported the initial phase of a program to improve provider access to GRAIL’s Galleri multi-cancer early detection (MCED) test (Press release, Grail, FEB 12, 2025, View Source [SID1234650223]). Providers can now order the Galleri test directly from GRAIL through the Quest Diagnostics connectivity system. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest’s Quanum laboratory portal and more than 900 electronic health record (EHR) systems. More than 500,000 providers used the Quest connectivity system last year.

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The integration will help streamline the process of ordering the Galleri test for physicians. It will also increase availability by allowing patients access to the test at any of Quest’s approximately 7,400 patient access points nationwide. Patients with a test order from their physician can now go directly to Quest without needing to bring a Galleri test kit to the blood draw appointment.

"Quest Diagnostics and GRAIL share a commitment to improving access to cancer screening and have worked productively together to enable patient access to GRAIL’s Galleri test via Quest’s phlebotomy network since 2021," said Mark Gardner, Senior Vice President, Molecular Genomics and Oncology for Quest Diagnostics. "Integrating GRAIL’s Galleri test into the Quest connectivity system is the next step in this collaboration. We expect it to increase patient access by giving Quest’s provider clients the ability to seamlessly order the test through Quest, same as they do for other blood work. This collaboration brings to life the tremendous value of Quest’s ability to scale diagnostic innovation to make it accessible for all."

Cancers growing in the body shed DNA into the bloodstream. These DNA fragments act like a unique "fingerprint" of cancer. With a single blood draw, the Galleri test screens for the "fingerprint" of many of the deadliest cancers before they become symptomatic, including those with no recommended screening tests today. It can also provide doctors with information on the cancer’s origin to help predict the tissue type or organ associated with the cancer signal. The Galleri test is prescription only, recommended for adults with an elevated risk for cancer, such as those age 50 or older, and is to be used in addition to recommended cancer screenings.

"We know every minute counts for busy providers, their staff and their patients, which is why we’re so pleased to work with Quest to offer a seamless experience that fits into providers’ existing ordering process," said Josh Ofman, MD, MSHS, President at GRAIL. "While today there are recommended screenings for five cancers, nearly 70% of deaths are caused by cancers with no recommended screening test. We believe this integration will help to make it easier to incorporate the Galleri test into routine exams to help screen for cancer before it becomes symptomatic when outcomes may be improved."

On February 12, 2025 AVEO Oncology, an LG Chem company ("AVEO"), is a biopharmaceutical company that is trying to provide differentiated solutions to improve cancer patients lives, reported two poster presentations at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) 2025 meeting this February 13-15, 2025, in San Francisco, CA (Press release, AVEO, FEB 12, 2025, View Source [SID1234650222]).

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"We are excited to be presenting the latest tivozanib data at ASCO (Free ASCO Whitepaper) GU," said Edgar Braendle, AVEO’s Chief Medical Officer, "and we look forward to sharing this important data with the genitourinary community and continue to build on the extensive tivozanib clinical story."

Presentation Details

Title: Integrated efficacy and safety exposure response (ER) analysis of tivozanib (TIVO) for the treatment of renal cell cancer (RCC)
First Author: Bradley McGregor, MD, Dana-Farber Cancer Institute
Abstract Number: 461
Poster Session: Poster Session C: Renal Cell Cancer; Penile, Testicular and Urethral Cancers
Poster Board: D29
Date and Time: Saturday, February 15, 2025, 7:10-8:10 AM PT and 11:30 AM-12:45 PM PT
Location: Level 1, West Hall

Title: Patient-reported outcomes (PROs) for tivozanib (TIVO) + nivolumab (NIVO) vs TIVO monotherapy in patients with renal cell carcinoma (RCC) following an immune checkpoint inhibitor (ICI): results of the phase 3 TiNivo-2 study
First Author: Katy Beckermann, MD, PhD, Vanderbilt University
Abstract Number: 459
Poster Session: Poster Session C: Renal Cell Cancer; Penile, Testicular and Urethral Cancers
Poster Board: D27
Date and Time: Saturday, February 15, 2025, 7:10-8:10 AM PT and 11:30 AM-12:45 PM PT
Location: Level 1, West Hall

About FOTIVDA (tivozanib)
FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Hypertension was reported in 45% of patients (22% ≥ Grade 3). Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Cardiac failures were reported in 1.6% of patients (1% ≥ Grade 3); 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure during treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.

Cardiac ischemia were reported in 3.2% of patients; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of patients, including death due to ischemic stroke (0.1%). Closely monitor patients at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thrombotic Events (VTE) were reported in 2.4% of patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue in patients who develop serious VTEs.

Hemorrhagic Events were reported in 11% of patients; 0.2% of events were fatal. Use FOTIVDA with caution in patients who are at risk for or who have a history of bleeding.

Proteinuria was reported in 8% of patients (2% = Grade 3). Monitor during treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment. Discontinue in patients who develop nephrotic syndrome.

Gastrointestinal (GI) Perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of GI perforation or fistula formation periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening GI perforation.

Thyroid Dysfunction events were reported in 11% of patients (0.3% ≥ Grade 3). Monitor thyroid function before and during treatment with FOTIVDA.

Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery and do not administer for at least 2 weeks after major surgery and until adequate wound healing is observed.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue if signs or symptoms of RPLS occur.

Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.

Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS
Common adverse reactions include fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis.

Serious adverse reactions include bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).

DRUG INTERACTIONS
Avoid coadministration with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS
Advise women not to breastfeed during treatment and for at least 1 month after the last dose.

The recommended dosage for patients with end-stage renal disease has not been established.

Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for FOTIVDA (tivozanib).

On February 12, 2025 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported financial results for its fiscal third quarter ended December 31, 2024 and provided an update on recent developments (Press release, Aethlon Medical, FEB 12, 2025, View Source [SID1234650221]).

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Company Updates

During the third quarter, and subsequently, the company made significant progress in its oncology trial efforts in Australia while executing cost-cutting measures to enhance operational efficiency. Management is pleased to highlight the following key developments:

Clinical Trials:

Steady progress in our Australian Oncology trial of the Hemopurifier in patients with solid tumors was made. To date, three patients have been enrolled. Two patients did not advance to the treatment phase due to pre-specified stopping criteria during the run-in period – one showed a clinical response to anti PD-1 therapy, while the other experienced toxicity related to anti-PD-1 therapy. The third patient, who did not respond to anti-PD-1 therapy, successfully underwent a single 4-hour Hemopurifier treatment at Royal Adelaide Hospital on January 29, 2025. The treatment was completed with no device-related issues or complications. Samples collected before and after treatment will be analyzed to assess extracellular vesicle removal and changes in anti-tumor T cell activity. This data will be available once all 3 patients in this patient cohort are treated.

Following the investigator meeting with the three clinical sites, Aethlon received valuable feedback suggesting protocol modifications that could possibly improve enrollment speed, reduce screen failures, and shorten the time to Hemopurifier treatment and time to data. In response, the Aethlon team swiftly developed a protocol amendment incorporating these recommendations.

Key changes include enrolling patients only after they have been confirmed not to be responding to anti-PD-1 therapy. This adjustment eliminates the need to identify patients within the first 2 weeks of starting anti-PD-1 therapy and removes the two-month run-in period previously required to assess response to therapy. Additionally, restrictions on commonly prescribed concomitant medications that do not impact patient safety have been lifted. The amended protocol also broadens eligibility to include patients receiving all approved dosing regimens of Pembrolizumab and Nivolumab, rather than limiting enrollment to specific schedules.

The company is pleased to announce that the Human Research Ethics Committees (HREC) and Research Governance Offices (RGO) have approved this amendment at all three clinical sites. The two currently active clinical sites, Royal Adelaide Hospital and Pindara Private Hospital, can enroll under the amended protocol. The third site, Genesis Care/ Royal North Shore Hospital, can begin enrollment under this amendment following a Site Initiation Visit (SIV) on February 14, 2025.

The company continues to pursue approval of a similar clinical trial in India. HREC approval has been obtained at Medanta Medicity Hospital, and we are currently awaiting approval from the regulatory agency CDSCO in India. Recent regulatory changes in India have introduced additional documentation requirements that were previously not necessary. Aethlon is actively responding to CDSCO’s queries through the company’s India CRO, Qualtran.

Operational Efficiency:

Aethlon has implemented strategic cost-cutting measures to optimize company resources, enabling it to maintain a strong focus on the high-impact oncology trials in both Australia and India. These initiatives are designed to improve resource allocation, reduce operational expenses, and support the continued advancement of our clinical programs.

"During the third fiscal quarter and subsequent period, we continued to advance our oncology trials, including treatment of the first patient at Royal Adelaide Hospital in late January. We are pleased to report that the patient tolerated the procedure without complications, making a critical milestone for the safety, feasibility and dose-finding trials of the Hemopurifier in patients with solid tumors who have not responded to anti-PD-1 antibodies," stated James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. "We currently have two clinical sites activated and open for enrollment in Australia, with a third site expected to be activated in February 2025. In addition, we have received ethics committee approval from a site in India. We also anticipate continued enrollments in our Hemopurifier cancer trial as these sites progress.

"While two previously recruited patients were withdrawn from the study due to outcomes related to their anti-PD-1 therapies, we believe that the recent protocol amendment will shorten trial timelines and support improved patient enrollment. As previously announced, we believe these studies will help inform future oncology efficacy trials. Furthermore, we have implemented strategic cost-cutting measures to optimize company resources, enabling us to maintain a strong focus on the high-impact oncology trials in both Australia and India."

As a reminder, the primary endpoint of the approximate nine to 18-patient, safety, feasibility and dose-finding trials, is safety. The trials will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda or Opdivo monotherapy. Patients who do not respond to the PD-1 antibody therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of subsequent efficacy and safety trials, including a Premarket Approval (PMA) study required by the FDA and other regulatory agencies.

Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples.

The company is closely monitoring developments related to Bird Flu in the United States, Marburg virus in Rwanda and Ebola virus in Uganda. Aethlon has direct experience with these viruses, having previously generated in vitro viral binding data for all three viruses and treated an Ebola patient in Germany under Emergency Use conditions. Aethlon will continue to monitor these situations carefully and be poised to respond if currently available treatment strategies are deemed ineffective.

Financial Results for the Fiscal Third Quarter Ended December 31, 2024

As of December 31, 2024, Aethlon had a cash balance of approximately $4.8 million.

Consolidated operating expenses for the fiscal quarter ended December 31, 2024, decreased by approximately $1.8 million, or approximately 50%, to $1.8 million compared to $3.6 million for the fiscal quarter ended December 31, 2023. This reduction was driven by a $1.3 million decrease in payroll and related expenses, a $300,000 decrease in professional fees, and a $200,000 decrease in general and administrative expenses.

The approximate $1.3 million decrease in payroll and related expenses was primarily attributable to a reduction of $900,000 in separation expenses related to the Separation Agreement with the former Chief Executive Officer that had been recorded in the December 2023 period, as well as a decrease of approximately $400,000 due to a reduction in headcount. Of the approximate $900,000 of separation expenses related to the departure of the former CEO, approximately $400,000 related to the acceleration of vesting of stock options.

The approximate $300,000 decrease in professional fees was primarily due to an approximate reduction of $200,000 in legal fees resulting from the transition to a new legal firm, and a decrease of $200,000 in scientific and operational consulting fees largely attributable to completed projects. These decreases were partially offset by an approximate $100,000 increase in investor relations and accounting fees.

The approximate $200,000 decrease in general and administrative expenses was primarily driven by a $300,000 reduction in supplies, largely related to the raw materials and components used in the manufacturing of the Hemopurifier, with no comparable purchases during the current period. Additionally, there was an approximate $100,000 decrease in insurance expenses associated with a reduced headcount and various other operating expenses. These reductions were partially offset by a $200,000 increase in expenses related clinical trial expenses related to our ongoing oncology clinical trials in Australia and India.

As a result of the factors noted above, the company’s net loss decreased to approximately $1.8 million in the fiscal quarter ended December 31, 2024, from approximately $3.5 million in the fiscal quarter ended December 31, 2023.

The consolidated balance sheet for December 31, 2024, and the consolidated statements of operations for the three- and nine-month periods ended December 31, 2024 and 2023 follow at the end of this release.

Conference Call

Management will host a conference call today, Wednesday, February 12, 2025, at 4:30 p.m. ET to review the company’s financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference call by navigating to View Source Please note that registered participants will receive their dial-in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741

PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through March 12, 2025. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 7828175.