Genmab Announces Net Sales of DARZALEX® (daratumumab) for First Quarter of 2026

On April 17, 2026 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 3,964 million in the first quarter of 2026. Net trade sales were USD 2,208 million in the U.S. and USD 1,756 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.

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(Press release, Genmab, APR 14, 2026, View Source [SID1234664356])

ImmuVia Selects Quantori’s Q-Scientist Platform to Accelerate Development of First-in-Class Cancer Therapy

On April 14, 2026 ImmuVia Inc., a biotechnology company developing first-in-class therapies for solid tumors, reported that it has selected Quantori, a leading provider of digital transformation services and technology for the life sciences and healthcare industries, as a strategic technology partner. ImmuVia will deploy Quantori’s Q-Scientist platform to streamline computational workflows across its preclinical programs, with the goal of compressing development timelines and reducing costs as it advances its lead candidate, IMV-M, towards clinical trials.

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The Science: A New Approach to an Old Problem

Death Receptor agonists – molecules designed to trigger a tumor cell’s built-in self-destruct program (apoptosis) – have long been considered one of the most promising approaches in oncology. Yet clinical programs have failed, stymied by insufficient potency, off-target toxicity, or both.

ImmuVia’s proprietary Cancerlysin platform was built to solve this problem at the molecular level. Its lead candidate is IMV-M, a bispecific antibody that functions as a conditional switch: it first binds MUC16 – a protein overexpressed on ovarian, pancreatic, and other solid tumors – and only then activates the Death Receptor 5 pathway via clustering to trigger apoptosis. The result is a molecule specifically engineered for high-potency tumor killing with a wide therapeutic window.

The Partnership: Doing the Work Faster and at Lower Cost

The complexity of Cancerlysin programs generates significant computational demands across molecular modeling, pharmacokinetic simulation, and regulatory data preparation. Rather than build these capabilities in-house, ImmuVia has chosen to partner with Quantori, whose Q-Scientist platform provides an integrated environment for orchestrating these workflows. Under the partnership, Quantori will support ImmuVia’s preclinical programs in three key areas:

Molecular Modeling and Simulation: Running computational analyses of Cancerlysin molecules’ binding behavior and selectivity profile, reducing the number of iterative bench experiments required to optimize candidates.
In Silico Pharmacology: Modeling Cancerlysin molecule’s pharmacokinetic and pharmacodynamic properties across tumor microenvironments, enabling the team to test hypotheses computationally before committing to further costly in vivo studies.
Regulatory Data Preparation: Transforming high-volume laboratory and analytical data into structured, submission-ready documentation, compressing timelines for IND-enabling toxicology and CMC deliverables.
Executive Commentary

"ImmuVia is a biology company. Our edge is the science behind IMV-M and the Cancerlysin platform," said Iosif M. Gershteyn, Chief Executive Officer at ImmuVia. "What we need from technology partners is straightforward: help us do our work faster and at lower cost. Quantori’s platform does exactly that. It lets a lean team operate with the analytical throughput of a large organization, that’s a practical advantage we intend to leverage."

"What makes this collaboration compelling is the quality of the underlying science," said Yuriy Gankin, PhD, Chief Scientific Officer at Quantori. "ImmuVia’s platform represents a genuinely differentiated approach to harnessing the biology of apoptosis, and the computational demands of a program this sophisticated are exactly where Q-Scientist delivers the most value. We can construct detailed in silico models of IMV-M’s behavior – its conformational dynamics, its interactions within the tumor microenvironment – and deliver those insights at a speed and cost that would be impossible to replicate through traditional methods."

(Press release, ImmuVia, APR 14, 2026, View Source [SID1234664373])

EpimAb Biotherapeutics to Present a Novel Prodrug T-Cell Engager (ProTCE) Platform at the 2026 American Association for Cancer Research Annual Meeting

On April 14, 2026 EpimAb Biotherapeutics, a clinical stage biotechnology company specializing in the development of bispecific antibodies and T-cell engagers, reported that the company will be presenting a Novel Prodrug T-Cell Engager (ProTCE) Platform poster presentation at the upcoming 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place at the San Diego Convention Center in San Diego, California, from April 17-22, 2026.

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The posters will feature: ProTCE Platform and Initial Pre-clinical Proof of Concept for EM33. Details for the presentation are as follows:

ProTCE Platform and its Candidate ProTCE EM33

Title: A novel and versatile Prodrug T cell engager platform with a novel candidate demonstrating potent and tumor-restricted activity
Presentation Number: 1610
Presentation Date: Monday, April 20, 2026
Presentation Time: 9:00AM – 12:00PM, local time (Location: Poster Section 10)

"We are pleased to present our Prodrug T-cell engager technology platform at AACR (Free AACR Whitepaper) annual conference. This achievement validates the global competitiveness and clinical translation potential of our proprietary innovations, marking a key milestone in advancing the company’s R&D capabilities," said Dr. Chengbin Wu, Founder and CEO of EpimAb. "Moving forward, the platform aims to address key unmet medical needs and advance the development of safer and more effective therapeutic options for patients worldwide."

(Press release, EpimAb Biotherapeutics, APR 14, 2026, View Source [SID1234664389])

Greenwich LifeSciences Provides Update on Financing Strategy

On April 14, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported additional updates on its financing strategy.

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The Company’s ATM financing vehicle allows the Company to sell its common stock directly into the trading market at market price. The amount raised through our ATM for Q1 2026 exceeded the Company’s Q1 2026 cash burn rate, leading to a Q1 2026 cash balance of approximately $10.5 million as of March 31, 2026. The above preliminary financial figures are unaudited and are subject to change following completion of the Company’s financial review for Q1 2026.

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, APR 14, 2026, View Source [SID1234664357])

Antiva Biosciences Presents Data from Phase 1b/2 Study of ABI-2280 for Treatment of Cervical High-Risk HPV Infection at SGO 2026

On April 14, 2026 Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of high-risk infections and pre-cancerous lesions caused by human papillomavirus (HPV) in women, reported expanded data from the company’s Phase 1b/2 clinical trial of ABI-2280 for the treatment of persistent oncogenic (high-risk) cervical HPV (hrHPV) infection in a Rapid Fire Oral Presentation at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer April 10-13 in San Juan, Puerto Rico.

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The study achieved its primary endpoint and all secondary endpoints with the top dosing regimen of 1 mg dosed three times over two weeks for a cumulative dose of 3 mg. Patients receiving ABI-2280 demonstrated statistically significant improvements in the rate of hrHPV negativity at Week 12 and Week 24 as compared with placebo. Additionally, the trial showed ABI-2280 treatment to be safe and well tolerated with the most commonly reported adverse events (AEs) categorized as mild and moderate and localized to the treatment area.

Rapid Fire Oral Presentation Highlights (3mg Dosing Regimen):

For the primary efficacy endpoint, 46% of patients achieved hrHPV negativity at Week 12 for all hrHPV genotypes present at baseline as compared to only 16% of placebo patients (p=0.0077).
In a subgroup analysis of patients with the HPV16 genotype at baseline, 78% patients achieved HPV16 negativity at Week 12 and Week 24, compared to 0% and 25% of placebo patients at Week 12 and Week 24, respectively.
At Week 24, 65% of patients achieved hrHPV negativity for all hrHPV genotypes present at baseline as compared to only 32% of placebo patients (p=0.0127).
Week 12 data was highly predictive of Week 24; 100% of patients who were hrHPV negative at Week 12 following ABI-2280 treatment maintained hrHPV negativity at Week 24 suggesting the potential for durable viral clearance rather than transient suppression following just two weeks of treatment.
Patients in the study overall had a mean duration of hrHPV positivity at baseline of 29 months and 23.7% of patients had a persistent infection (defined as documented infection for >12 months) at baseline despite being previously vaccinated.
"Women with persistent high-risk HPV face a meaningful risk of disease progression to pre-cancer or cancer of the cervix, yet there are currently no approved treatment options. Patients are asked to ‘wait-and-see’ if the infection resolves or persists, while facing risks of disease progression and transmission to partners, creating significant psychosocial burden," said Warner K. Huh, MD, MSHA, presenting author and Chair of the Department of Obstetrics and Gynecology at the University of Alabama at Birmingham. "Against this backdrop, the data from the ABI-2280 study are clinically significant, demonstrating a 30 percent absolute improvement in hrHPV negativity compared with placebo, alongside a favorable safety and tolerability profile. Importantly, the durability of response observed is particularly encouraging and suggests the potential for ABI-2280 to maintain HPV at undetectable levels over extended periods of time."

The Phase 1b/2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability and efficacy of ABI-2280 administered intravaginally in women diagnosed with persistent cervical hrHPV infection. The study dosed a total of 139 female patients ranging in age between 25 and 55 years old who have had a documented hrHPV infection for at least one year without evidence of precancerous lesions worse than low grade cervical intraepithelial neoplasia (CIN1). Part A of the trial evaluated multiple placebo-controlled sentinel cohorts enrolled sequentially to determine the safety, tolerability and preliminary efficacy of various dose levels of ABI-2280 in two-week and six-week dosing regimens. Following the completion of the sentinel cohorts, the top cumulative dose from each of the two-week and six-week dosing regimens was advanced into Part B expansion cohorts for further evaluation of efficacy.

"We are encouraged by results from this study of ABI-2280, which we believe support advancing into a Phase 2b trial in women with persistent high-risk HPV infections," said Elaine Chien, MD, FACOG, Chief Medical Officer for Antiva. "The demonstration of clinically meaningful and statistically significant hrHPV negativity out to 24 weeks in our top dosing regimen, after only two weeks of treatment in women with a mean duration of infection exceeding two years, is particularly promising and informs a clear path forward. We are also pleased to have recently received FDA clearance of our Investigational New Drug (IND) application, which further enables the continued clinical development of ABI-2280."

ABI-2280 is expected to have potent activity across all genotypes of HPV worldwide and works by blocking HPV replication and inducing apoptosis in HPV-infected cells. Antiva has leveraged its development expertise to formulate a vaginal insert of ABI-2280 that enables at home self-administration at diagnosis.

About HPV-Related Diseases and Cervical Cancer

Human Papilloma Virus (HPV) is so common that nearly all sexually active men and women are infected with the virus at some point in their lives. Many of these are transient infections that the body is capable of clearing, but this typically takes months to years. When HPV infections persist, they are known to drive the formation of malignancies, including cervical, anal, vulvar, penile, and head and neck cancers.

The prevalence of cervical high-risk HPV (hrHPV) infection is estimated to be 20% among U.S. females of reproductive age, or approximately 19 million women. Each year in the U.S., it is estimated that over 6 million women become newly infected with hrHPV. There are currently no treatment options for hrHPV and these patients are counseled to wait and see if their infection clears or progresses to higher grade disease. During this wait and see period, patients are also at risk of transmitting this oncogenic virus to sexual partners. Approximately 30 percent of women with hrHPV fail to clear the virus within 12 months. These patients are considered to have persistent hrHPV and have an estimated 20 percent chance of having their infection progress to pre-cancer or cancer over the following four-to-six years. Women diagnosed with hrHPV often experience significant stress due to the social stigma of a sexually transmitted infection and the association with cervical cancer. The lack of available treatments further contributes to increased anxiety and emotional distress.

Globally, cervical cancer is the fourth most common cancer in women and as such represents a major public health problem. According to the World Health Organization, an estimated 660,00 women were diagnosed with cervical cancer worldwide and approximately 350,000 women died from the disease in 2022.

(Press release, Antiva Biosciences, APR 14, 2026, View Source [SID1234664374])