On April 29, 2025 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO), a biopharmaceutical company advancing next-generation cancer therapies through artificial intelligence (AI)-powered drug discovery, reported the presentation of new preclinical data from two of its lead programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Rakovina Therapeutics, APR 29, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-showcases-preclinical-results-of-novel-ai-discovered-cancer-therapies-at-aacr-2025 [SID1234652322]).

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The first presentation highlighted Rakovina’s PARP1-selective inhibitor program. Using the proprietary Deep Docking and generative platforms , Rakovina previously screened more than four billion potential drug-like molecules to identify a shortlist of top candidates. These compounds were synthesized and evaluated in Rakovina’s laboratory facilities at the University of British Columbia.

Data presented at AACR (Free AACR Whitepaper) demonstrated a new class of PARP1 inhibitors with significantly improved metabolic stability, including the lowest in vitro clearance rates and the longest half-life compared to other candidates currently in development. Early animal studies revealed strong plasma exposure and a promising pharmacokinetic profile suggestive of central nervous system (CNS) penetration — a potentially significant advantage in treating brain-involved malignancies.

The second presentation showcased progress from Rakovina’s ATR-specific inhibitor program, developed in partnership with Variational AI. Researchers identified a focused set of lead candidates predicted to be highly potent and selective against ATR, a key DNA damage response target. These candidates are also designed with the potential to cross the blood-brain barrier, an important feature for addressing cancers affecting the CNS. The top candidates are currently being synthesized for laboratory validation.

"Our ability to screen billions of molecules and advance top candidates to in vitro and in vivo validation within months — rather than years — exemplifies the transformative power of AI in drug discovery," said Jeffrey Bacha, Executive Chairman of Rakovina Therapeutics. "This acceleration gives us the opportunity to significantly reduce the time and cost required to bring new life-saving cancer treatments to patients."

The results presented at AACR (Free AACR Whitepaper) reinforce the robustness of Rakovina’s AI-enabled discovery platform. Moving forward, Rakovina will leverage these findings to further refine and train its AI models, with the goal of advancing best-in-class lead candidates for both the PARP1 and ATR programs into clinical development. The Company intends to collaborate with pharmaceutical partners to accelerate the path to the clinic and deliver novel therapies to patients in need.

On April 29, 2025 Bayer reported new post-hoc analyses from the investigational Phase III ARANOTE trial showed that patients receiving NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) were more likely to experience an ultra-low (<0.02 ng/mL) prostate specific androgen (PSA) response (42.6%) at any time versus patients receiving placebo plus ADT (7.8%), with ultra-low response rates in the NUBEQA group being higher than in the placebo group regardless of baseline PSA (Press release, Bayer, APR 29, 2025, View Source [SID1234652339]). The post-hoc analyses from the pivotal ARANOTE trial also showed that in patients receiving NUBEQA plus ADT, achieving ultra-low PSA response correlated with prolonged radiographic progression-free survival (rPFS) time (HR 0.09; 95% CI: 0.05–0.16), time to metastatic castration-resistant prostate cancer (mCRPC) (HR 0.07; 95% CI: 0.04–0.11) and time to PSA progression (HR 0.02; 95% CI: 0.01–0.05).1

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The safety profile of NUBEQA was independent of PSA response, with lower treatment discontinuation rates due to treatment emergent adverse events (TEAEs) in patients receiving NUBEQA plus ADT versus placebo.1

The results were presented today at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada. NUBEQA is indicated in the U.S. for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).2

Prostate cancer is the second most common cancer in men.3 Only 30% of those diagnosed with mHSPC will survive five years or more after diagnosis.4 Most people with mHSPC eventually progress to mCRPC, a condition with limited long-term survival.5,6

"The subgroup analyses of the ARANOTE trial contribute to the valuable insights of the management of metastatic hormone-sensitive prostate cancer and equip physicians with additional data to help inform treatment options," said Dr. Neal Shore, Medical Director, Carolina Urologic Research Center and Urologist at AUC Urology Specialists, Myrtle Beach, South Carolina.

"At Bayer, we are committed to redefining prostate cancer care and enhancing patient outcomes at various stages of the disease. The growing evidence supporting NUBEQA reinforces its potential to meet the needs of men with prostate cancer," said Christine Roth, Global Head of Product Strategy and Commercialization at Bayer’s Pharmaceuticals Division. "These data add to the meaningful insights from the ARANOTE trial which can be leveraged by physicians to inform clinical decisions, helping them to identify the right treatment options for their patients living with prostate cancer."

About the ARANOTE Trial7
The ARANOTE trial (NCT04736199) is a Phase III, randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of NUBEQA in combination with standard ADT in patients with mHSPC. A total of 669 patients were randomized 2:1 to receive either 600 mg of NUBEQA (n=446) or placebo (n=223) twice daily in addition to ADT.

The primary endpoint of the ARANOTE trial was rPFS, which was statistically significant for the NUBEQA arm vs placebo arm (HR: 0.54; 95% CI: 0.41-0.71; P < 0.0001), measured as time from randomization to date of first documented radiological disease progression or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (OS; time to death from any cause), time to first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to PSA progression, PSA undetectable rates, time to pain progression, and safety assessments.

Initial results from pivotal Phase III ARANOTE trial (n=669), published in The Journal of Clinical Oncology and presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, demonstrated a statistically significant improvement in rPFS with a 46% reduction in the risk of radiologic progression or death (HR 0.54; 95% CI: 0.41-0.71; P<0.0001) compared to placebo plus ADT.8

About NUBEQA (darolutamide)2
NUBEQA (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.

NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:

Non-metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel
IMPORTANT SAFETY INFORMATION

Warnings & Precautions
Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether antiepileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions
In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure.

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.

Drug Interactions
Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Hormone-Sensitive Prostate Cancer
Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.3.9 In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, including almost 300,000 cases in the U.S., and about 375,000 died from the disease worldwide.10,11

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 10% of men will already present with mHSPC when first diagnosed.12,13,14 Men with mHSPC will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mHSPC will eventually progress to mCRPC, a condition with limited survival.

On April 28, 2025 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported new data underscoring the ability of cancer vaccine EVX-01 to drive a targeted and robust immune response (Press release, Evaxion Biotech, APR 28, 2025, View Source [SID1234652230]). Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer).

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New immune data from the ongoing phase 2 trial with EVX-01 will be presented at a poster session tomorrow at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Chicago. The data demonstrates that 80% of EVX-01 vaccine targets triggered a tumor-specific immune response.

In earlier interim analyses presented at the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) 2024 meetings, a vaccine target hit rate of 71% and 79%, respectively, was demonstrated. Now, with more long-term patient samples analyzed, we’ve improved this hit rate to 80%, reinforcing the potential of EVX-01 as a new and effective treatment for a broad range of solid tumors.

"We are excited to report yet another positive set of data for our lead vaccine candidate EVX-01. Its ability to trigger an immune response is unprecedented compared to what has been reported by others. We are further encouraged by the data showing this response to be strong and long-lasting and increasing with additional booster immunizations. The data package for EVX-01 gets stronger and stronger and we are eagerly anticipating the two-year clinical readout," says Birgitte Rønø, CSO of Evaxion.

The trial previously yielded strong interim one-year clinical data and remains on track for readout of two-year clinical data in the second half of 2025. Additionally, the trial has been extended with a third year, allowing for a more comprehensive assessment of the full potential of EVX-01.

The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

AACR presentation details:

Abstract title: T-cell immunogenicity and biomarker profiling in advanced melanoma patients receiving the personalized vaccine EVX-01 in combination with pembrolizumab
Abstract#: 4538
Poster#: 9
Session (category): Immune responses to therapies including chemotherapy and radiotherapy (Clinical research)
Location: Poster section 28
Date/Time: April 29, 2025, at 9am-12pm CST/16-19 CET
Presenter: Mads Lausen Nielsen, PhD, Project Manager at Evaxion

About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

EVX-01 is designed with our AI-Immunology platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

In clinical trials, EVX-01 has demonstrated 69% and 67% Overall Response Rates in patients with advanced melanoma. Further, significant correlations between clinical responses and AI-Immunology predictions have been observed, underlining the predictive power of the platform.

On April 28, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the European Commission (EC) has granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma (MM) (Press release, Regeneron, APR 28, 2025, View Source [SID1234652246]). The indication is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. Lynozyfic is a bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

Lynozyfic is the first BCMAxCD3 therapy approved that can be dosed every four weeks due to a response-adapted regimen if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy. The regimen includes monitoring in close proximity of a qualified treatment center for safety during the step-up dosing period (one 24-hour period after the first step-up dose and another 24-hour period after the second step-up dose, if certain safety events occur).

"Despite treatment advances, patients with multiple myeloma inevitably endure relapses, reduced responses to subsequent therapies, and increasingly shorter remissions. For those who develop relapsed and refractory disease after having been exposed to the three major drug classes, it’s important to have new therapies with different mechanisms of action like linvoseltamab," said Paula Rodriguez-Otero, M.D., Department of Hematology, Cancer Center Clínica Universidad de Navarra, Pamplona, Navarra, Spain. "In a clinical trial, linvoseltamab demonstrated compelling and impressive efficacy with the potential for complete remission in this patient population, including those with high disease burden. Furthermore, its response-adapted schedule will provide patients a convenient treatment option."

The EC approval is based on results from the pivotal LINKER-MM1 trial (n=117 at the 200 mg dose of Lynozyfic), which demonstrated robust and durable responses in patients with R/R MM. Results showed a 71% objective response rate (ORR), with 50% of patients achieving a complete response (CR) or better, as determined by an independent review committee. The minimal residual disease (MRD) negativity rate in patients achieving a CR or stringent CR was 41% (24 of 58 patients; 95% confidence interval [CI]: 29 to 55). The median duration of response (DOR) was 29 months (95% CI: 19 to not estimable).

The most frequent adverse reactions were musculoskeletal pain (52%), cytokine release syndrome (CRS; 46%), neutropenia (43%), cough (42%), diarrhea (39%), anemia (38%), fatigue (36%), pneumonia (32%), and upper respiratory tract infection (30%). The majority of CRS cases were Grade 1 (35%) or Grade 2 (10%), and there was one case of Grade 3 CRS (0.9%) and no cases of ≥Grade 4 CRS. The median time to first CRS onset was 11 hours (range: -1.1 to 184 hours), with the median time to resolution within 1 day (16 hours; range: 1-96 hours). Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS; 2.6%) and infections that were Grade 3 or 4 (36%) or fatal (4%) also occurred.

"Lynozyfic is our second approved bispecific antibody – in this case for relapsed/refractory multiple myeloma patients – reinforcing our relentless commitment to transforming cancer care for those who need it most," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. "We are excited by the potential of Lynozyfic and its differentiated clinical profile, dosing and administration. Given the strength of the data, we are pursuing a robust clinical development program exploring its use – in earlier lines of therapy as monotherapy and in novel combinations – with the hope of further advancing care for patients."

In the U.S., the FDA accepted for review the Biologics License Application for linvoseltamab in adults with R/R MM with a target action date of July 10, 2025.

About Multiple Myeloma
As the second most common blood cancer, there are over 35,000 new cases of MM diagnosed in Europe and 187,000 new cases of MM diagnosed globally every year. The disease is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Despite treatment advances, MM is not curable and while current treatments are able to slow the progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies.

About the Lynozyfic (linvoseltamab) Clinical Development Program
Lynozyfic as monotherapy is indicated for the treatment of adult patients with R/R MM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu in due course.

The ongoing, open-label, multicenter Phase 1/2 dose-escalation and dose-expansion LINKER-MM1 trial is investigating linvoseltamab in more than 300 enrolled patients with R/R MM. The Phase 1 dose-escalation portion of the trial – which is now complete – primarily assessed safety, tolerability and dose-limiting toxicities across nine dose levels of linvoseltamab and explored different administration regimens. The ongoing Phase 2 dose expansion portion is assessing the safety and anti-tumor activity of linvoseltamab, with the primary endpoint of ORR. Key secondary endpoints include DOR, progression-free survival, rate of MRD negative status and overall survival.

Eligibility in the Phase 2 portion requires patients to have received at least three prior lines of therapy or have triple-class refractory MM. Linvoseltamab is administered with an initial step-up dosing regimen followed by the full 200 mg dose administered weekly. After week 14, all patients transition to every two-week dosing. A response-adapted regimen further enables patients to shift to every four-week dosing if they achieve a VGPR or better and have completed at least 24 weeks of therapy. The regimen requires a total of two 24-hour hospitalizations for safety monitoring.

Linvoseltamab is being investigated in a broad clinical development program exploring its use as a monotherapy as well as in combination regimens across different lines of therapy in MM, including earlier lines of treatment, as well as plasma cell precursor disorders. They include evaluating linvoseltamab in a Phase 1b trial (LINKER-MM2) in combination with other cancer treatments in R/R MM as well as a Phase 3 confirmatory trial (LINKER-MM3) as a monotherapy in R/R MM. For more information on Regeneron’s clinical trials in blood cancer, visit the clinical trials website, or contact via [email protected] or 844-734-6643.

On April 28, 2025 Privo Technologies, Inc., a clinical-stage biopharmaceutical company pioneering nanotechnology-based cancer therapies, reported the activation of multiple premier clinical sites across the United States for its ongoing CLN-004 trial (Press release, Privo Technologies, APR 28, 2025, View Source [SID1234652262]). This Phase 2/3, open-label, two-arm study is evaluating the safety and efficacy of two of Privo’s lead assets—PRV111 and PRV211—in patients with head and neck squamous cell carcinoma (HNSCC).

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The trial is now actively recruiting at the following esteemed institutions:

University of Chicago Medicine (Chicago, IL)

City of Hope (Los Angeles, CA)

Miami Cancer Institute (Miami, FL)

Cleveland Clinic (Cleveland, OH)
Additional leading cancer centers are in the process of being activated and will be announced in the coming weeks.

"We are honored to collaborate with some of the nation’s leading head and neck oncology experts at these top-tier institutions," said Dr. Manijeh Goldberg, CEO of Privo Technologies. "Their participation underscores the potential impact of our novel therapies in transforming the treatment landscape for patients with HNSCC."

About the CLN-004 Trial

The CLN-004 study comprises two distinct arms:

Arm 1: Evaluates PRV111, a nanoengineered, self-adhesive patch designed for the topical delivery of cisplatin directly to the tumor site. This arm targets patients with carcinoma in situ (CIS) and high-grade dysplasia of the oral cavity, aiming to improve local control and potentially reduce the extent of surgical intervention.

Arm 2: Assesses PRV211, an intraoperative chemotherapy system intended for application into the resected tumor bed during surgery. This approach seeks to eliminate residual microscopic disease and reduce the risk of tumor recurrence in patients with stages T1-T4 HNSCC.
Both PRV111 and PRV211 are part of Privo’s proprietary PRV platform, which utilizes nanotechnology to enhance the locoregional delivery of chemotherapeutic agents, aiming to maximize therapeutic efficacy while minimizing systemic toxicity.