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ImmunityBio Announces FDA Submissions of Supplemental BLA for NMIBC Papillary Disease and for Expanded Access of ANKTIVA® to Treat Lymphopenia

On April 15, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported that it has completed multiple submissions to the FDA including an sBLA for BCG-unresponsive NMIBC in papillary disease and an EAP for ANKTIVA (nogapendekin alfa inbakicept-pmln) for the treatment of lymphopenia (Press release, ImmunityBio, APR 15, 2025, View Source [SID1234651934]).

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Supplemental Biologics License Application (sBLA):

In Q1, ImmunityBio completed the submission to the FDA of an sBLA for the use of ANKTIVA plus BCG in BCG-unresponsive NMIBC in the papillary indication. Subject to regulatory approvals, the addition of the papillary indication expands the patient population benefiting from this therapy beyond the currently approved indication of bladder carcinoma in situ (CIS) with or without papillary disease and allows more patients to avoid the high morbidity and mortality associated with radical cystectomy. The data submitted to the FDA included efficacy results demonstrating durable complete remissions in patients with BCG unresponsive NMIBC papillary disease. In 88% and 82% of subjects, the probability of avoiding surgical removal of the bladder was achieved for as long as 2 and 3 years respectively, following treatment with ANKTIVA plus BCG. The mortality and morbidity associated with a radical total cystectomy is high and this long-term bladder sparing therapy has the potential to provide a significant benefit and quality of life to patients suffering from BCG unresponsive papillary disease.

In a pivotal study published in NEJM Evidence, BCG plus ANKTIVA resulted in a disease-free survival (DFS) rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months in participants with papillary NMIBC. In addition, patients receiving the novel treatment achieved a 93% avoidance of cystectomy (surgical removal of the bladder) with a median follow up of 20.7 months. This combination immunotherapy wherein ANKTIVA rescues BCG efficacy, currently approved in the BCG-unresponsive carcinoma in situ (CIS) indication, may provide an effective therapeutic option for papillary patients who did not respond to BCG alone and face the prospect of a radical cystectomy. Papillary disease is estimated to be approximately 6-10 times more common than bladder cancer CIS, representing a large patient population that may benefit from ANKTIVA plus BCG.

Expanded Access Protocol for ANKTIVA in the Treatment of Lymphopenia:

The company also announced it has submitted to the FDA an EAP to make available ANKTIVA for the treatment of lymphopenia. Lymphopenia is the loss of natural killer cells and T cells, the very cells necessary to fight cancer. To date, no treatment exists to overcome lymphopenia which is induced by the cancer itself and by the standards of care including chemotherapy, radiation, steroids and checkpoint inhibitors. ImmunityBio received designation from the Agency for Regenerative Medicine Advanced Therapy (RMAT) for the indication of ANKTIVA to treat lymphopenia. The EAP, subject to authorization, would provide early access to patients and physicians desiring ANKTIVA in combination with standards of care.

Update of Product Revenue, Net Preliminary Results of Operations:

With the issuance of the permanent J-code (J9028) in January 2025, ImmunityBio has seen increased sales momentum supporting a trend of increases month-over-month as well as quarter-over-quarter, with March unit sales volume increasing 69% over February, and Q1 2025 unit sales exceeding unit sales achieved for all of FY 2024. ImmunityBio earned net product revenue of approximately $16.5 million during the three-month period ended March 31, 2025, which represented an increase of 129% over the $7.2 million of net revenue earned during the fourth quarter of 2024.

The amounts reported in this press release reflect the company’s preliminary estimates based solely upon information available to it as of the date of this press release, and the amounts reported are not a comprehensive statement of its financial results or position as of March 31, 2025. Any actual amounts that the company reports in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, will be subject to its financial closing procedures and any final adjustments that may be made prior to the time its financial results for the period ended March 31, 2025 are finalized. As a result, these preliminary estimates may differ materially from the actual results that will be reflected in the company’s consolidated financial statements for the quarter when they are completed and publicly disclosed.

Update on ImmunityBio Platforms

Fireside chats with Dr. Patrick Soon-Shiong and the following Key Opinion Leaders (KOLs) discussing the science and current status of ImmunityBio platforms are expected to take place during the Investor Day program:

Dr. Christopher Pieczonka – Chief Executive Officer, Associated Medical Professionals of New York & Corporate Director of Clinical Research of US Urology Partners
Dr. Steven Finkelstein – National Director of Radiation Oncology, US Urology Partners. Director of the Center of Advanced Radiation Excellence (CARE) and Director Radiation Oncology Research
Dr. Mark Lanasa – Senior Vice President, Chief Medical Officer, Solid Tumors, BeiGene
Dr. Jennifer Buell – President & Chief Executive Officer, MiNK Therapeutics
Dr. Krishnansu Tewari – Gynecologic Oncology, Obstetrics & Gynecology at UC Irvine Health
Dr. David Kerr – Professor of Cancer Medicine Genetics and Genomics, University of Oxford
Dr. Timothy Henrich – Professor, School of Medicine UC San Francisco
Dr. Carlos Cordon-Cardo – Chairman for the Mount Sinai Health System Dept. of Pathology
The live stream can be found at:

View Source;tp_key=40dc7065b5

Participant Listening (Listen Only)

1-844-539-3703 or 1-412-652-1273

Hoth Therapeutics Announces Positive Initial Data in Phase 2a Clinical Trial Reports 50% Reduction in Pruritus (Mean Score Dropped from 1.6 to 0.8) by Day 21 in
Open-Label Portion of CLEER HT-001 Phase 2a clinical Trial for Cancer EGFR Inhibitor-Induced Skin Toxicities

On April 15, 2025 Hoth Therapeutics, Inc.(NASDAQ: HOTH), a biopharmaceutical company focused on developing innovative therapies for patients with high unmet medical needs, reported positive interim data from the open-label portion of its Phase 2a clinical trial, CLEER-001, evaluating HT-001 for the treatment of pruritus associated with skin toxicities caused by Epidermal Growth Factor Receptor (EGFR) inhibitors (Press release, Hoth Therapeutics, APR 15, 2025, View Source [SID1234651942]).

EGFR inhibitors, widely used in oncology, are often associated with skin-related adverse effects, including intense itching, which can impair quality of life and reduce treatment compliance. HT-001 is designed to address this significant unmet need.

Key Interim Results (Day 1–21):

● Patients experienced a 50% reduction in pruritus severity, with mean scores dropping from 1.6 on Day 1 to 0.8 by Day 21.

● Rapid symptom relief was observed, with mean scores improving to 1.0 by Day 7.

● Some patients achieved complete resolution of pruritus within the 21-day period.

● HT-001 was well tolerated, with no treatment-related serious adverse events reported.

"These findings support the potential of HT-001 to deliver meaningful relief for cancer patients experiencing EGFR-related pruritus," said Robb Knie Chief Executive Officer of Hoth Therapeutics. "Cutaneous toxicities can significantly impact quality of life and may interfere with treatment. Our goal is to provide a safe and effective therapy that enhances patient comfort and continuity of care. This data along with our initial results released in January give us further belief in the promise of HT-001."

The CLEER-001 study is ongoing, with both cohorts in effect including the randomized, double-blind portion of the trial.

Hoth would like to thank Mr. Graig Springer who will be leaving our board as his professional position and family life both expand. Mr. Springer has not only been a superb board member, but he has been a great sounding board for the company and we wish Graig much success in all his endeavors.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for First Quarter of 2025

On April 15, 2025 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 3,237 million in the first quarter of 2025 (Press release, Genmab, APR 15, 2025, View Source [SID1234651941]). Net trade sales were USD 1,829 million in the U.S. and USD 1,409 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.

Flamingo Therapeutics Announces Poster Presentation on the Immune-Modulatory Effects of Danvatirsen at the American Association for Cancer Research (AACR) Annual Meeting

On April 15, 2025 Flamingo Therapeutics ("Flamingo") reported that an abstract has been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting being held in Chicago, IL from April 25-30, 2025 (Press release, Flamingo Therapeutics, APR 15, 2025, View Source;utm_medium=rss&utm_campaign=flamingo-therapeutics-announces-poster-presentation-on-the-immune-modulatory-effects-of-danvatirsen-at-the-american-association-for-cancer-research-aacr-annual-meeting [SID1234651940]).

Poster presentation details are as follows:

Poster Title: "ASO-mediated STAT3 knockdown relieves immunosuppression sensitizing tumors to immunotherapies"

Session Category/Title: Immunology/Modulation of Tumor Microenvironment: Enhancing Immunogenicity and Counteracting Suppression

Session Time: 4/28/2025 9:00:00 AM – 12:00:00 PM

Location: Poster Section 38

Published Abstract Number: 2244

For more information, please visit the AACR (Free AACR Whitepaper) Annual Meeting 2025 website.

SECuRE trial update: First patient treated in the Phase II Cohort Expansion

On April 15, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the treatment of the first participant with their first dose of 8 GBq of 67Cu-SAR-bisPSMA in the Cohort Expansion Phase of the SECuRE trial (NCT04868604) (Press release, Clarity Pharmaceuticals, APR 15, 2025, View Source [SID1234651939]).

The dosing of this participant follows the recent successful completion of the Dose Escalation Phase (Phase I) of the trial and subsequent SRC recommendation to progress to the Cohort Expansion Phase (Phase II) at the 8 GBq dose level, with an increase in the total number of cycles from up to 4 to up to 6. This recommendation is based on the favourable safety profile and efficacy of 67Cu-SAR-bisPSMA observed to date.

This participant will be receiving the combination of 8 GBq of 67Cu-SAR-bisPSMA and enzalutamide (ARPI), allowed by a recent protocol amendment. This amendment incorporated an increase in the number of participants in this cohort from 14 to 24, in which a subset of participants will receive this combination therapy. These changes are aligned with the positive results from the Enza-p trial3 and the ongoing discussions with and advice from key global medical experts in the field of prostate cancer, including the Company’s Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.

The recently amended SECuRE trial protocol will also focus on the evaluation of metastatic castration-resistant prostate cancer (mCRPC) participants in the pre-chemotherapy setting. This aligns with Clarity’s strategy of bringing 67Cu-SAR-bisPSMA to earlier stages of the disease and is based on its promising safety and efficacy data, especially in pre-chemotherapy participants treated in the SECuRE trial to date. In the Dose Escalation Phase, preliminary data showed that 92% of pre-chemotherapy participants (12/13) demonstrated prostate-specific antigen (PSA) drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants. These outstanding results were achieved despite many of the 13 pre-chemotherapy participants having considerable disease burden, being heavily pre-treated, and the majority of them only receiving a single dose of 67Cu-SAR-bisPSMA2.

In preparation for the Cohort Expansion Phase, Clarity rolled out its improved 67Cu-SAR-bisPSMA product formulation. The enhanced formulation allows for room temperature stability, supply and scalability, which are essential for late-stage clinical trials and streamlined commercial-scale manufacture.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are incredibly excited about the progress we’ve achieved in the SECuRE trial to date and look forward to continuing to generate promising data in the Cohort Expansion Phase.

"With the latest protocol amendments ensuring that we are utilising the most recent advances and knowledge in the radiopharmaceutical space, we continue to be driven by the highest standards of clinical trial management and research. At Clarity, we are committed to working with various key opinion leaders in the field and incorporating the most recent findings into our study design to maximise the probability of clinical trial success and positive patient outcomes. As a result, we are focused on bringing 67Cu-SAR-bisPSMA to earlier lines of prostate cancer therapy, especially in the pre-chemotherapy setting, where we have seen very promising safety and efficacy to date. We are also investigating the benefits of combination therapy, where SECuRE participants are being treated with 67Cu-SAR-bisPSMA and enzalutamide based on the results from Prof Emmett’s Enza-p trial and in consultation with global thought leaders in the prostate cancer space.

"We are committed to continuously improving our product and took the opportunity to advance our 67Cu-SAR-bisPSMA formulation prior to dosing our first patients in the Cohort Expansion Phase of the trial. The improvements also help us prepare for the large-scale manufacture in a potential Phase III trial and during commercialisation, allowing for room temperature stability with considerable advantages for supply and scalability. The ability to manufacture 67Cu-SAR-bisPSMA under room temperature reduces the likelihood of batch failures which lead to common supply issues and subsequent product shipment delays. Through the improvements in formulation, we hope that no patient is left waiting for their 67Cu-SAR-bisPSMA treatments.

"We thank our community, our team, Principal Investigators, members of the SRC, and especially the participants who have contributed to the SECuRE study so far. Armed with favourable safety and efficacy data from the Dose Escalation cohorts and with 3 US Food and Drug Administration (FDA) Fast Track Designations for the SAR-bisPSMA molecule, 1 for therapy and 2 for diagnostics, we are closer than ever to delivering on our ultimate goal of improving treatment outcomes for people with cancer."

About the SECuRE trial
The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US and Australia. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.