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.

On April 7, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported the start of BELLA, a Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab evaluating efficacy and safety in patients with platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, APR 7, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-initiates-trial-relacorilant-plus-nab-paclitaxel-and [SID1234651814]).

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BELLA is a single-arm, open-label trial with a planned enrollment of 90 women with recurrent, platinum-resistant ovarian cancer at approximately 50 sites in North America, Europe and Asia-Pacific. Patients will receive relacorilant in combination with nab-paclitaxel and bevacizumab.

"In our pivotal Phase 3 ROSELLA trial, treatment with relacorilant and nab-paclitaxel improved patients’ progression-free and overall survival, without increasing their side effect burden," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "BELLA will examine whether combining relacorilant with two medications – nab-paclitaxel and bevacizumab – will offer patients an additional treatment option."

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

About Cortisol’s Role in Oncology

Cortisol helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response, which weakens its ability to fight disease.

On April 7, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, reported receipt of U.S. Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application for ALX2004, the company’s potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors (Press release, ALX Oncology, APR 7, 2025, View Source [SID1234651813]). Based on this clearance, ALX Oncology will initiate a single-agent dose-escalation and expansion Phase 1 clinical trial for ALX2004 in mid-2025.

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"Clinical advancement of our first ADC and the first drug candidate developed on our proprietary linker-payload platform is an important milestone in our mission to deliver breakthrough therapies that will help transform the future of cancer treatment," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "We meticulously designed all aspects of ALX2004 – the antibody backbone, linker and payload – to optimize the targeted delivery of a powerful chemotherapy payload to tumor cells while minimizing systemic toxicity. The resulting, highly differentiated molecule has demonstrated potent anti-tumor activity in preclinical models and is a strategic addition to our clinical pipeline, which also includes multiple trials evaluating our lead therapeutic candidate, evorpacept."

EGFR is a transmembrane protein located on the surface of cells that regulates cell growth; overexpression occurs across various tumor types, including breast cancer, colorectal carcinoma, head and neck squamous cell carcinoma and non-small cell lung cancer. EGFR is clinically validated as a therapeutic target with several FDA-approved targeted antibodies and small molecules. However, there are currently no approved EGFR-targeted ADCs. Early-generation attempts to develop EGFR-targeted ADCs were limited by drug design, on-target off-tumor toxicities and toxicity of older generation payloads.

Utilizing the company’s proprietary, highly differentiated topoisomerase I inhibitor payload platform, ALX Oncology scientists designed ALX2004 to optimize ADC-based mechanisms of anti-tumor activity and improve outcomes in patients with EGFR-expressing tumors. The ALX2004 molecule, created entirely in ALX Oncology labs, comprises an antibody backbone engineered to optimize anti-EGFR activity, a linker with enhanced stability and a proprietary topoisomerase I payload that can generate an enhanced bystander effect.

ALX Oncology plans to conduct an R&D call focused on ALX2004 in Q2 2025 and to initiate a Phase 1 clinical trial of the investigational therapy in mid-2025.