On April 7, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization of the subcutaneous (SC) formulation of RYBREVANT (amivantamab), in combination with LAZCLUZE (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations (Press release, Halozyme, APR 7, 2025, View Source [SID1234651821]). Additionally, it is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy.

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Subcutaneous amivantamab is co-formulated Halozyme’s ENHANZE drug delivery technology.

"We are delighted to announce the European approval of the subcutaneous formulation of amivantamab, developed using our innovative ENHANZE drug delivery technology. This marks our tenth approved partner product," said Dr. Helen Torley, President and CEO of Halozyme. "The data supporting this approval showed a reduced administration time and decrease in infusion-related reactions, which could have a positive impact on the healthcare system."

The EC approval is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For detailed information on the study and its findings, please refer to Johnson & Johnson’s press release issued today.1

1 Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO (Free ASCO Whitepaper) Journal of Clinical Oncology. 2024;42(3):3593-3605.

On April 7, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported details about its Investor Day program to be held on Tuesday, April 15, 2025, at 10:00 am PDT (Press release, ImmunityBio, APR 7, 2025, View Source [SID1234651818]). The program will include an in-depth update on the company’s business operations, U.S. and global regulatory advances of its clinical-stage products, with fireside chats hosted by Dr. Patrick Soon-Shiong and key opinion leaders involved in the company’s research programs.

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The discussions will include clinical and regulatory updates on the company’s bladder cancer program, regenerative medicine advanced therapy (RMAT) designations, including results on non-small cell lung cancer (NSCLC) and metastatic pancreatic cancer trials, as well as lymphopenia rescue data related to these trials (Cancer BioShield).

In addition, updates will be provided on the natural killer (NK) cell therapy program, the Lynch syndrome accrual and fireside chats on virally induced cancers, including discussions on Long-COVID.

The key opinion leaders participating in the fireside chats with ImmunityBio leadership include:

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 Heinrich – Professor, School of Medicine UC San Francisco
Dr. Carlos Cardo-Cardon – Chairman for the Mount Sinai Health System Dept. of Pathology
Key timelines for catalysts of product candidates will be presented, along with a discussion of ongoing clinical trials.

The program will feature a presentation by ImmunityBio Founder, Executive Chairman and Global Chief Scientific and Medical Officer, Dr. Patrick Soon-Shiong, outlining the fundamental science underpinning the company’s technology platforms. This technology harnesses the immune system to deliver long-term disease protection and prevention.

This limited space event will be held in person in El Segundo, California. Individuals wishing to attend in person must RSVP in advance via email ([email protected]). The event will also be live-streamed.

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

On April 7, 2025 Epsilogen, the global leader in the development of immunoglobulin E (IgE) antibody therapeutics, reported that it has completed the acquisition of TigaTx, Inc., a biotechnology company developing engineered immunoglobulin A (IgA) antibodies, to create the world’s leading pan-isotype cancer antibody company (Press release, Epsilogen, APR 7, 2025, View Source [SID1234651817]).

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As a result of the combination of these two privately held companies, US-based TigaTx becomes a wholly owned subsidiary of Epsilogen. Financial terms of the transaction have not been disclosed. Additionally, Dr Sonia Gulati, a Principal at Global BioAccess Fund has joined the Epsilogen Board of Directors.

Commenting on the acquisition, Epsilogen CEO Tim Wilson said: "We are excited to create the world’s leading pan-isotype antibody company with the goal of bringing improved therapeutics to cancer patients. Combining the capabilities of Epsilogen with those of TigaTx gives us the ability to choose the most relevant isotype for a given cancer, whether a cold tumour environment we want to drive multiple immune effector cells into or leverage neutrophils. The transaction also facilitates the combination of different isotype functions into a single antibody molecule. We are looking forward to working with our new colleagues in Boston and creating additional opportunities in our pipeline."

Sonia Gulati PhD, a Principal at the Global BioAccess Fund said: "We are thrilled about the merger with Epsilogen and believe deeply in the potential of IgA and IgE-based therapies to transform cancer treatment. Together, we are advancing a new frontier in immunotherapy to bring innovative solutions to patients in need."

Pete Finan, Epsilogen’s Non-Executive Chairman and a General Partner at Epidarex Capital commented: "Nature has evolved five different antibody isotypes to perform specific biologic functions. Following the acquisition, Epsilogen is in a unique position with in-house deep expertise in three of these, IgE, IgA and IgG. We very much look forward to the company turning this potential into innovative new medicines for cancer patients".

Rationale: Creating the world’s leading pan-isotype cancer antibody company

The primary purpose of this transaction is to create the world’s leading pan-isotype antibody company with the goal of pioneering radically new antibody therapeutics in oncology. The acquisition not only gives Epsilogen the capability of selecting the appropriate antibody isotype for a given cancer, given the differentiated therapeutic mechanisms of each, but also allows it to mix and match IgE, IgA and IgG functionality into a single antibody molecule. Such hybrid antibodies have the potential to activate multiple compartments of the immune system as well as possessing improved PK/PD profiles. This is especially powerful in the light of the importance of the epitope in determining the clinical performance of antibodies.

The human immune system has evolved five main antibody isotypes (IgG, IgM, IgE, IgA and IgD) which it can call upon depending upon the challenge faced. All cancer antibodies and antibody derivatives to date, and virtually all in clinical development, are based on the IgG isotype. IgG utilises the gamma chain constant region whereas antibodies of the IgE and IgA isotypes use the epsilon and alpha chain constant regions respectively; the variable regions of all wild type antibodies are structurally the same.

IgE and IgA antibodies have distinct and potent immunological effector functions predominantly working through myeloid cells and neutrophils respectively. Each of these broad classes can bring about solid tumour destruction in a variety of preclinical models.

The acquisition bolsters Epsilogen’s pipeline by adding EPS 401 (formerly TIGA-001), an anti-EGFR IgA antibody, scheduled to enter the clinic in 2026. MOv18 IgE is currently in a Phase Ib trial for treatment of platinum-resistant ovarian cancer (PROC). Phase I trial data previously showed the antibody to be safe and well tolerated with preliminary signs of anti-cancer activity. Epsilogen’s earlier stage pipeline also features a number of other IgE antibody candidates targeting a variety of tumour antigens.

On April 7, 2025 Genoscience Pharma reported that it has granted Genfit exclusive rights to develop and commercialize GNS561 for oncology indications (Press release, GenoScience, APR 7, 2025, View Source [SID1234651816]). This strategic agreement marks a significant step in advancing GNS561’s clinical potential in cancer treatment. Genfit will lead the development efforts, leveraging its strong expertise and infrastructure in oncology drug development. In return, Genoscience Pharma secures a potential return on investment through upfront payments, milestone-based compensations, and royalties on future sales. The agreement is designed to maximize the value of GNS561 while ensuring its accelerated path to market. GNS561 has shown promise in preclinical and early clinical studies, particularly in hard-to-treat cancers. This partnership allows both companies to focus on their core strengths while sharing the value creation. Genoscience Pharma retains a financial stake in GNS561’s success without bearing the full burden of clinical and commercial development. The deal reflects a shared commitment to innovation and patient impact. It also strengthens Genfit’s pipeline with a differentiated oncology asset.

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On April 7. 2025 CureVac N.V. (Nasdaq: CVAC) ("CureVac"), a global biotech company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1 clinical study of CVHNLC in patients with squamous non-small cell lung cancer (sqNSCLC) (Press release, CureVac, APR 7, 2025, View Source [SID1234651815]). CVHNLC is CureVac’s investigational mRNA-based precision immunotherapy consisting of two different mRNA constructs encoding eight tumor-associated antigens (TAAs) with prevalence across sqNSCLC patients. Encoded antigens include a novel class of TAAs that have not been previously tested in cancer immunotherapy trials.

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The phase 1, dose-finding, open-label study will assess the safety and tolerability of CVHNLC plus pembrolizumab in patients with advanced sqNSCLC. The study comprises a dose-escalation part (Part A) of first-line maintenance treatment after either chemotherapy combined with pembrolizumab or pembrolizumab monotherapy. This is followed by an optional dose expansion part (Part B) in which CVHNLC is tested in combination with first-line chemotherapy and pembrolizumab.

"Immune checkpoint blockade has become a new standard of care for patients with metastatic squamous non-small cell lung cancer; however, overall prognosis still remains poor in advanced as well as in early settings of this disease, highlighting the urgent need for new therapeutic options," said Dr. Myriam Mendila, CureVac’s Chief Scientific Officer. "Squamous non-small cell lung cancer exhibits a high prevalence of shared tumor antigens among patients, presenting a unique opportunity for developing targeted off-the-shelf mRNA immunotherapies. We believe by administering CVHNLC with checkpoint inhibition, we will trigger an amplified and targeted immune response, thereby increasing the efficacy against the cancer. Our goal is to take this combination also into earlier setting of the disease."

In Part A, patients with metastatic Stage IV sqNSCLC, who have received at least three cycles of pembrolizumab, either as monotherapy or in combination with chemotherapy, will be enrolled. CVHNLC doses between 100µg and 400 µg plus pembrolizumab maintenance therapy for up to 12 months or until disease progression or undue toxicity occurs, will be administered with dose escalation. Primary endpoints include incidence of dose-limiting toxicities and treatment-related and emergent adverse events; secondary endpoints include overall response rate, progression-free survival, duration of response, and disease control rate.

"CVHNLC is our second oncology program to enter the clinical stage, highlighting the continued progress we are making with our mRNA-based precision immunotherapies. Importantly, we have been able to design CVHNLC using both known, shared tumor antigens and novel proprietary antigens discovered using our differentiated in-house technology platform," said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. "We are leveraging this approach in the design of multiple novel cancer mRNA programs in our collaboration with MD Anderson Cancer Center, which we anticipate entering the clinic in the next 18-24 months."

About CVHNLC

CVHNLC has been built on CureVac’s advanced second-generation mRNA backbone, featuring two different constructs utilizing unmodified mRNA formulated in lipid nanoparticles (LNPs). Its multi-epitope design encodes eight shared antigens, four of which are well-known with established relevance in solid tumors. The other four antigens are a novel class of TAAs uniquely derived from CureVac’s proprietary whole-genome discovery platform.

About Squamous Non-Small Cell Lung Cancer

In the U.S., there are approximately 225,000 new cases of lung cancer each year, 87 % of which are NSCLC, according to the American Cancer Society. Squamous non-small cell lung cancer (sqNSCLC) represents approximately 20-30% of all NSCLC cases and is considered a more aggressive form, posing significant challenges in disease control and treatment. Patients with sqNSCLC often face a tougher prognosis compared to other types of NSCLC. In the early sqNSCLC setting after neoadjuvant treatment, there is a 30-40% relapse rate within two years, with median overall survival of 15-17 months in metastatic setting.