On June 12, 2025 Enterome SA, a clinical-stage company developing first-in-class OncoMimics immunotherapies to treat cancer, reported it has raised $19 million in a new private financing to advance its lead clinical program EO2463 OncoMimics immunotherapy to treat indolent non-Hodgkin lymphoma (iNHL) (Press release, Enterome, JUN 12, 2025, View Source [SID1234653842]). The new funds will be used to expand and finalize the ongoing Phase 1/2 SIDNEY clinical trial of EO2463 and prepare the candidate for a registrational trial.

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New U.S. investor The Institute for Follicular Lymphoma Innovation (IFLI), a global non-profit foundation dedicated to advancing research and treatment for follicular lymphoma, invested $9 million in the round, of which $5 million will be allocated to Enterome upon closing and an additional $4 million in conditional tranched funding.

Existing shareholders invested an additional $10 million including: SymBiosis, a U.S. venture capital firm; Seventure Partners, based in France; Lundbeckfonden BioCapital from Denmark; Primo Capital, an Italian venture capital and private equity firm; and The U.S. Leukemia & Lymphoma Society Therapy Acceleration Program (LLS TAP).

"Attracting highly specialized blood cancer investor IFLI to this financing demonstrates the conviction of our new and existing investors in the potential of OncoMimics for blood and solid tumor cancers," said Pierre Bélichard, Enterome’s Chief Executive Officer. "We currently are generating exciting clinical proof of concept data for EO2463 monotherapy in several iNHL patient populations included in the Phase 1/2 SIDNEY clinical trial. Most importantly, EO2463 has shown robust clinical efficacy and exceptional safety and tolerability – which is especially impressive for such a potent immunotherapy. This offers a new hope for these patients and a rare opportunity to create an entirely new market segment for an impactful therapeutic. This financing will enable us to continue the SIDNEY trial of EO2463 and prepare to launch a first pivotal Phase 3 trial of this candidate for the ‘watch-and-wait’ iNHL population."

The company presented interim SIDNEY dataat the American Society of Hematology (ASH) (Free ASH Whitepaper) conference in December 2024, showing highly encouraging responses in the Cohort 2 of "watch and wait" iNHL patients in the ongoing SIDNEY study. This population, as the name suggests, is generally not eligible to receive other treatments due to the unacceptable risk-benefit ratio (in this iNHL sub-population) of the most commonly used blood cancer therapies.

The company also recently disclosed having held positive meetings with both FDA (Type C meeting) and EMA (Scientific Advice), outlining a clear regulatory path to registration for marketing authorizations in "watch-and-wait" iNHL.

"This investment aligns with IFLI’s mission to accelerate the development of innovative therapies and precision biomarkers for follicular lymphoma," said Michel Azoulay, MD, Chief Medical Officer at IFLI. "EO2463 represents a novel class of synthetic, off-the-shelf Immunotherapeutics with a unique mechanism of action that selectively targets malignant B cells. We are particularly interested in supporting Enterome’s efforts to demonstrate EO2463’s clinical efficacy across multiple lines of therapy, including in relapsed and refractory settings."

Enterome recently announced that it will present new data showing EO2463 also has a meaningful impact when tested in combination with standard of care in relapsed and refractory iNHL patients at the International Conference on Malignant Lymphoma (ICML) in Lugano on June 21. Previous findings presented at ASCO (Free ASCO Whitepaper) in 2024 in the relapsed and refractory patient population further suggested the potential to identify individuals most likely to benefit from EO2463 treatment, supported by biomarker analyses.

Lore Gruenbaum, Chief Scientific Officer at LLS, said, "It is important for us to continue to support Enterome, a company working to develop novel therapeutics based on our shared commitment to create better therapies for blood cancers. LLS has invested over $1.8 billion in groundbreaking research since our inception in 1949. Our active partnership with Enterome, through our Therapy Acceleration Program, will continue to advance the clinical development of the OncoMimics family of novel immunotherapeutics for the benefit of blood cancer patients. We are particularly excited to help advance EO2463 which has shown promising signs of efficacy as monotherapy with excellent safety and tolerability in ‘watch-and-wait’ iNHL patients, who currently have no approved treatment options."

EO2463 is an innovative, off-the-shelf immunotherapy candidate that combines four synthetic OncoMimics peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that mimic the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). EO2463 also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2). The unique ability of EO2463 immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms such as antigen escape.

SIDNEY is an ongoing 12-month open label Phase 1/2 study that aims to assess safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in up to about 55 patients with follicular lymphoma and marginal zone lymphoma including divided into three cohorts: newly diagnosed patients eligible to watch-and-wait (monotherapy); newly diagnosed patients in need of therapy / first line (combo with rituximab); patients with relapsed/refractory disease (combo with R2). In addition to safety, survival, response rates and other measures of efficacy are being collected.

OncoMimics were inspired by the microbial origin of certain autoimmune diseases. The Company uses AI and machine learning to identify microbial proteins that closely mimic the structure, effect or actions of specific cancer antigens (as well as hormones or cytokines). Memory T cells against microbial antigen are created during early development, sometimes leading to autoimmune disorders. In the case of OncoMimics, however, this means that the immune system can mount a rapid, robust and durable immune response that is highly targeted and specific for the OncoMimics and the cancer antigens they closely resemble.

This is possible because, unlike cancer antigens, OncoMimics bypass the biological process, known as thymic deletion, that prevents the immune system from mounting an attack against the "self" proteins (e.g. antigen) on tumor and blood cancer cells. Once activated, the immune system attacks with high specificity and potency the cancer antigens targeted by the OncoMimics, killing the cancer cells that carry them. OncoMimics are synthetic peptides that are easy to manufacture, store, distribute and administer as an off-the-shelf subcutaneous injection. In clinical testing to date they have been shown to be extremely well tolerated, especially compared to other potent immunotherapies.

On June 12, 2025 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported 5 posters presented at the EHA (Free EHA Whitepaper) 2025 annual meeting in Milan, Italy (Press release, Disc Medicine, JUN 12, 2025, View Sourcenews-releases/news-release-details/disc-medicine-presents-positive-clinical-data-updates-across" target="_blank" title="View Sourcenews-releases/news-release-details/disc-medicine-presents-positive-clinical-data-updates-across" rel="nofollow">View Source [SID1234653841]). This year’s presentations included data from HELIOS, an ongoing open-label extension study of bitopertin in EPP, which showed favorable long-term efficacy and safety with sustained protoporphyrin IX (PPIX) reductions, improvement in quality of life, and improved liver biomarkers. Disc is advancing development and registrational activities for bitopertin in EPP, with plans to submit an NDA in H2 2025. The company has initiated APOLLO, a confirmatory clinical trial of bitopertin in adults and adolescents with EPP. Disc recently launched a campaign to raise awareness of EPP among physicians, patients, and caregivers with emphasis on the causative role of PPIX accumulation in the disease. Learn more at PPIXisWhy.com.

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Disc also presented longer term data from the continuation phase of its Phase 1b trial in MF anemia, showing sustained activity on key biomarkers and durable anemia response among major responders. Enrollment for the Phase 2 RALLY-MF trial of DISC-0974 is ongoing with the exploratory cohort for patients on concomitant momelotinib or pacritinib fully enrolled. The company expects to present initial RALLY-MF data in H2 2025. Additionally, Disc shared an update of the Phase 1 healthy volunteer trial of DISC-3405, initially presented at ASH (Free ASH Whitepaper) 2024, which demonstrated deep, sustained reductions in serum iron and meaningful changes in hematologic parameters, establishing proof of mechanism. Based on these data, the company has initiated a Phase 2 trial of DISC-3405 in polycythemia vera (PV). Disc also presented an iron pulse study of DISC-3405 in healthy volunteers which showed inhibition of dietary iron uptake, further confirming the mechanism of action and supporting DISC-3405’s potential in diseases of iron overload.

The collection of data presented at EHA (Free EHA Whitepaper) adds to the evidence base supporting Disc’s continued advancement of all three clinical candidates and provides support for expansion opportunities in new indications. Management will host a call to review these updates on June 16 at 8:00 am ET. Please register for the event on the Events and Presentations page of Disc’s website (View Source)

Bitopertin, DISC-0974, and DISC-3405 are investigational agents and are not approved for use as therapies in any jurisdiction worldwide.

Summary of Poster Presentations

Bitopertin:

HELIOS:

HELIOS is an ongoing Phase 2, open-label, long-term extension trial that enrolled 86 adult and adolescent patients with EPP from the BEACON and AURORA trials. Patients were randomized to receive 20 mg or 60 mg bitopertin in BEACON and 20 mg or 60 mg bitopertin or placebo in AURORA, with all patients transitioning to a 60 mg daily dose of bitopertin in HELIOS.

Longer term treatment with bitopertin was associated with sustained reductions in the disease-causing toxin PPIX, with additional benefit for patients receiving the 60 mg dose continuously
Continuous treatment with 60 mg of bitopertin reduced ALT and other exploratory hepatobiliary biomarkers
Nearly all participants reported substantial improvements in quality of life measures
Bitopertin exhibited a favorable longer-term safety profile with up to 2+ years of exposure and similar safety across adults and adolescents with EPP and XLP
DISC-0974:

DISC-0974 Phase 1b in MF anemia:

Data from the continuation phase of the Phase 1b trial of DISC-0974 in MF anemia as of October 2024 were presented. This multi-center, open-label trial included patients who were: non-transfusion dependent receiving no transfusions (nTD, n=23), transfusion dependent with low transfusion burden (TD Low, n=5) and transfusion dependent with high transfusion burden (TD High, n=7). The trial was comprised of both patients receiving concomitant JAK inhibitor therapy (n=13) and not receiving JAK inhibitor therapy (n=22). DISC-0974 was administered subcutaneously at 14 mg (n=1), 28 mg (n=7), 50 mg (n=12), 75 mg (n=9), or 100 mg (n=6) every 4 weeks for up to 6 treatments. Long-term results demonstrated:

Sustained hepcidin suppression, iron mobilization, and reduction in Zinc PPIX, a measure of iron restricted hemoglobin production
nTD patients:
50% of evaluable patients achieved major response of sustained mean hemoglobin increase of ≥1.5 g/dL
Hematologic improvement was durable through the continuation phase
TD Low patients:
80% of evaluable patients achieved major response of transfusion independence over 16 weeks
Hematologic improvement was durable, and all major responders remained transfusion independent during the continuation phase
TD High patients:
40% of evaluable patients achieved major response of transfusion independence over 12 weeks
1 of 2 patients with a major response entered the continuation phase and remained transfusion independent at Day 225, with follow-up ongoing
DISC-0974 was safe and well-tolerated at all evaluated dose levels
DISC-0974 in combination with luspatercept and ESA (mouse model):

The effect of DISC-0974, luspatercept, and ESA as single agents and DISC-0974 combined with luspatercept or ESA on hematological parameters in wild type mice was evaluated. Results showed:

Treatment with DBIO-100 (a mouse analog of DISC-0974) suppressed hepcidin, enhanced iron availability, and boosted erythropoiesis in wild-type mice
Combining with DPO (ESA) or RAP-536 (mouse analog of luspatercept) led to additional hematological benefits beyond those agents alone
These results demonstrate that DISC-0974 has a distinct mechanism of action among anemia-targeted agents and highlight the potential for synergistic anemia benefits when combining DISC-0974 with other anemia-targeted agents.

DISC-3405:

Phase 1 Healthy Volunteer Study:

Updated SAD/MAD data from the Phase 1 trial of DISC-3405 in healthy volunteers were presented. In the SAD portion of this trial, healthy males and females ages 18 to 65 were given a single dose of placebo (n=10) or DISC-3405 at 75 mg intravenously (IV) (n=6), 37.5 mg subcutaneously (SC) (n=6), 75 mg SC (n=6), 150 mg SC (n=6), or 300 mg SC (n=6). The MAD portion included placebo (n=4), 75 mg SC (n=6), and 150 mg SC (n=6) cohorts dosed every 4 weeks for a total of 2 doses. Consistent with data presented at ASH (Free ASH Whitepaper) 2024, results showed:

DISC-3405 produced dose-related increases in serum hepcidin with corresponding reductions in serum iron across all dose levels
DISC-3405 resulted in deep reductions in serum iron (ranging from 50-80% from baseline) that were sustained and support a once-monthly SC dosing regimen
Single and repeat dosing of DISC-3405 demonstrated meaningful reductions in hematologic parameters, including reticulocyte hemoglobin, hemoglobin, and hematocrit
DISC-3405 was generally well-tolerated at all evaluated dose levels, with no serious adverse events (AEs), greater than Grade 2 AEs, or AEs leading to study withdrawal
These results provide proof of mechanism and support the advancement DISC-3405 into proof of concept studies. Disc has now initiated a Phase 2 trial of DISC-3405 in PV with initial results expected in 2026.

Iron Pulse Study:

Disc conducted an iron pulse study in healthy volunteers to evaluate the effectiveness of DISC-3405 in inhibiting dietary iron uptake. N=8 healthy volunteers received placebo treatment followed by oral ferrous sulfate tablets on two sequential occasions to establish baseline iron absorption profiles. Participants were then given a single 150mg IV dose of DISC-3405, followed by oral ferrous sulfate "iron pulses" on the 2nd and 15th days following treatment. DISC-3405 resulted in an average 94% reduction in iron absorption at Day 2 and 68% at Day 15.

These results confirm the mechanism of DISC-3405 and demonstrate its ability to block dietary iron absorption, supporting the potential for treating diseases associated with iron overload.

On June 12, 2025 Bristol Myers Squibb (NYSE: BMY) reported the presentation of new data from its targeted protein degradation platform during the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress being held from June 12-15 in Milan, Italy (Press release, Bristol-Myers Squibb, JUN 12, 2025, View Source [SID1234653840]). Presentations feature updated clinical findings on the company’s investigational oral CELMoD agents mezigdomide and iberdomide in multiple myeloma, and golcadomide in non-Hodgkin lymphoma, as well as the first results evaluating the company’s first-in-class, oral BCL6 ligand-directed degrader (LDD) (BMS-986458) in non-Hodgkin lymphoma.

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The latest data presented for the three lead CELMoD agents and BCL6 LDD underscore the potential impact that these therapies may have in addressing significant unmet medical needs in hematologic malignancies. These agents are part of continuing research across targeted protein degradation at Bristol Myers Squibb, which also encompasses additional CELMoD agents, LDDs and degrader antibody conjugates (DACs) across blood cancers and solid tumors, as well as non-malignant hematologic disorders.

Protein degraders, like CELMoD agents and LDDs, are therapies designed to target and degrade specific proteins that drive diseases, including many proteins that are difficult to target through conventional small-molecule inhibitors. These innovative agents have the possibility to enhance the efficacy of existing therapies and overcome resistance in various malignancies, potentially improving patient outcomes.

"As a leader in the field of targeted protein degradation, we are committed to applying our decades of expertise to the development of these next wave of agents. The efficacy and safety data presented at the EHA (Free EHA Whitepaper) Annual Meeting this year is promising and reinforces the potential of CELMoD agents in combination with other standard treatments," said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology and Cell Therapy for Bristol Myers Squibb. "These analyses also add to the body of evidence for these programs as we continue pivotal studies for each of the agents that we anticipate reading out in the next year and onwards."

Key targeted protein degradation data being presented by Bristol Myers Squibb at the EHA (Free EHA Whitepaper) Annual Congress include:

Mezigdomide (MEZI):

Abstract #4160130: Updated results were presented from the dose-escalation phase of the MM-002 study for the combinations of mezigdomide, dexamethasone, and bortezomib (Cohort A MeziVd; n=28), and mezigdomide, dexamethasone, and carfilzomib (Cohort C MeziKd; n=27) in patients with relapsed/refractory multiple myeloma (RRMM) who had received 2–4 prior therapies:

Overall response rate (ORR) was 75.0% for Cohort A and 85.2% for Cohort C, respectively.
Median (95% CI) duration of response (DOR) for Cohort A and Cohort C was 10.9 (8.8–18.7) and 11.9 (6.4–35.9) months, respectively.
Median (95% CI) progression-free survival (PFS) for Cohort A and Cohort C was 12.3 and 13.5 months, respectively.
Results from the dose-expansion cohort (Cohort D) of the study were also presented for the MeziVd combination (n=49) in patients with RRMM who had received 1–3 prior therapies:

ORR was 85.7%
Median (95% CI) DOR was 19.4 months (9.7-NA)
Median PFS (95% CI) was 17.5 months
The most common grade 3/4 treatment-emergent adverse event (TEAE) across arms was neutropenia and was managed with G-CSF and dose modifications.

Abstract #4160802: New data was presented evaluating mezigdomide in all-oral triplet combinations with other oral novel agents in RRMM.

Results showed that the ORR was:
50% for mezigdomide plus EZH2 inhibitor tazemetostat and dexamethasone (n=16)
35% for mezigdomide plus BET inhibitor BMS-986158 and dexamethasone (n=20)
80% for mezigdomide plus MEK inhibitor trametinib and dexamethasone (n=20)
The most frequent grade 3/4 TEAE was neutropenia, and grade 3/4 nonhematologic TEAEs were low.
A separate analysis(Abstract #4160749) showed that these combinations lead to the activation and proliferation of NK and T cells, including in patients previously treated with T cell-redirecting therapies.
Iberdomide (IBER):

Abstract #4160144: Updated results were presented from MM-001, evaluating the combination of iberdomide, bortezomib, and dexamethasone (IberVd) in patients with transplant-ineligible, newly diagnosed multiple myeloma (NDMM), confirming durable, deep responses in the study.

At a median follow-up of 25 months, the ORR in the intent-to-treat (ITT) population (n=18) was 88.9%, with 66.6% having a complete response or better.
44% of patients in CR achieved minimal residual disease (MRD) negativity at a sensitivity of 10-5.
The most common hematologic grade 3/4 TEAE was neutropenia (29.4%); 2 (11.8%) patients had grade 3/4 peripheral neuropathy. Overall, the most common grade 3/4 TEAEs were infections (47.1%).
Golcadomide (GOLCA):

Abstract #4160953: Updated results were presented from a study evaluating golcadomide with or without rituximab for the treatment of R/R follicular lymphoma (FL). Patients with R/R FL who had received ≥2 prior lines of treatment received golcadomide monotherapy in the dose-escalation part of the study (Part A), followed by golcadomide once daily at 0.2 or 0.4 mg with or without rituximab in the expansion part (Part B). Results continued to show promising efficacy with durable responses in heavily pre-treated patients with R/R FL.

In Part A, the ORR was 67%, with a complete response rate (CRR) of 42% for patients treated with golcadomide monotherapy.
In Part B, the ORR was 94% and the CRR was 63% for patients treated with golcadomide 0.4mg + rituximab. The median DOR was 4.8 months at a median follow-up of 5.75 months. Responses were consistent in patients who received prior lenalidomide-based and/or T cell-redirecting therapy.
The most common grade 3/4 treatment-related adverse events across dose levels in Part B (n=60) were neutropenia and anemia, occurring in 60% and 13% of patients, respectively. No patients discontinued therapy due to side effects related to golcadomide. Non-hematologic side effects were infrequent and mostly low-grade.
Abstract #4161005: Updated results were presented from a study evaluating golcadomide with or without rituximab for the treatment of R/R diffuse large b-cell lymphoma (DLBCL). Patients received golcadomide once daily at either 0.2 mg (n=39) or 0.4 mg (n=38). Results continued to show durable responses in heavily pre-treated patients with R/R DLBCL and a consistent safety profile.

For patients treated with golcadomide 0.4mg + rituximab, the ORR was 58% and the CRR was 44%, with a median DOR of 14.5 months. Among patients who had prior T cell–redirecting therapy, the ORR was 56%, and the CRR was 38%.
The most common grade 3/4 treatment-related adverse events across dose levels (n=77) were neutropenia and anemia, occurring in 64% and 20% of patients, respectively. Most adverse events were manageable, with discontinuation due to AE occurring in 7% of patients.
Based on the results of early studies, mezigdomide, iberdomide and golcadomide are being evaluated in multiple phase 3 studies:

SUCCESSOR-1: mezigdomide, bortezomib, and dexamethasone vs. pomalidomide, bortezomib, and dexamethasone in patients with RRMM (projected data in 2026)
SUCCESSOR-2: mezigdomide, carfilzomib, and dexamethasone vs. carfilzomib and dexamethasone in patients with RRMM (projected data in 2026)
EXCALIBER RRMM: iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone in patients with RRMM (projected MRD data in 2025)
EXCALIBER Maintenance: iberdomide maintenance vs. lenalidomide maintenance following autologous stem cell transplant in patients with NDMM (projected data in 2029)
GOLSEEK-1: golcadomide and R-CHOP chemotherapy vs. placebo and R-CHOP in patients with previously untreated high-risk LBCL (projected data in 2028)
GOLSEEK-4: golcadomide and rituximab vs. investigator’s choice in patients with R/R FL who received at least 1 prior systemic therapy (projected data in 2030)
BMS-986458 BCL6 LDD:

Abstract #4160340: First clinical findings were presented from the dose-escalation part of the first-in-human, multicenter, open-label study of BMS-986458 in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). Initial results evaluating 31 heavily pre-treated patients treated with BMS-986458 were promising and support continued development for the treatment of NHL.

BMS 986458 was well-tolerated, with the most common treatment-related adverse events (TRAEs) being grade 1/2 arthralgia (19.4%) and fatigue (16.1%); no grade ≥3 treatment-related cytopenias or treatment-related discontinuations were observed.
Rapid and sustained degradation of BCL6 was demonstrated in peripheral blood and in the tumor at all doses evaluated.
Antitumor activity was evident from the first dose level in DLBCL and FL patients. Among 21 efficacy-evaluable patients, the ORR was 81% (N=17), and CRR was 23.8% (N=5).

On June 12, 2025 GO2 for Lung Cancer (GO2) and the Addario Lung Cancer Medical Institute (ALCMI) reported to have launched SUCCEED, a landmark, remote-participation, observational clinical study in small cell lung cancer (SCLC), one of the deadliest and most under-researched cancers (Press release, Bonnie J Addario Lung Cancer Foundation, JUN 12, 2025, View Source [SID1234653839]).

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Despite comprising up to 15% of all lung cancer cases, SCLC has seen minimal treatment advancements in nearly four decades. Even with the introduction of immunotherapy to standard chemotherapy treatment, survival gains have been modest, extending median overall survival by just two months. With a 5-year survival rate of just 6%, the need for deeper biological understanding and new treatment approaches has never been more urgent.

One of the key innovations of the SUCCEED study is its remote, decentralized design, allowing patients with SCLC across the United States to enroll and participate from home. This inclusive approach is critical, as many SCLC patients are older, live farther from the center where they receive treatment, and face multiple co-morbidities. These reasons, and the fact that SCLC progresses quickly, have historically limited their participation in clinical research.

"The SUCCEED study is an important step forward for people with small cell lung cancer, who have long faced limited treatment options and barriers to participating in research," said GO2 for Lung Cancer President and CEO, Laurie Ambrose. "By bringing the study directly to patients, SUCCEED makes it easier for them to get involved, have their voices heard, and contribute to research that could lead to better treatments and, ultimately, more time with their loved ones."

The SUCCEED study will test whether this remote, direct-to-patient approach works well with this population while collecting blood samples from people with SCLC. The samples will be bio-banked and could potentially support future studies aimed at finding new treatments.

"In order to best serve patients with small cell lung cancer, the SUCCEED study will seek to learn about patient preferences and goals," said Principal Investigator Christine Lovly, MD, PhD, from Vanderbilt University Medical Center. "We will do so in a unique way, bringing the study to the patient so that patients can join while being close to home, hopefully making it easier for them to take part."

"SCLC research has long been left behind," said ALCMI Board Member and Chief Operating Officer Richard Erwin. "The SUCCEED study is designed to change that by harnessing real-world data and samples from patients often excluded from traditional clinical trials."

For information on study eligibility and participation, visit here.

On June 12, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech") and CureVac N.V. (Nasdaq: CVAC, "CureVac") reported that they have entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all of the shares of CureVac, a clinical-stage biotech company developing a novel class of transformative medicines in oncology and infectious diseases based on messenger ribonucleic acid ("mRNA") (Press release, BioNTech, JUN 12, 2025, View Source [SID1234653838]). The all-stock transaction will bring together two highly complementary companies based in Germany and will build on BioNTech’s proven track record and established position in the global mRNA industry.

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With the acquisition, BioNTech aims to strengthen the research, development, manufacturing, and commercialization of investigational mRNA-based cancer immunotherapy. The strategic transaction will complement BioNTech’s capabilities and proprietary technologies in mRNA design, delivery formulations, and mRNA manufacturing. For BioNTech, this transaction marks the next milestone in the execution of its oncology strategy which focuses on two pan-tumor programs, mRNA-based cancer immunotherapy candidates, and BNT327, a PD-L1xVEGF-A bispecific antibody candidate.

Under the terms of the Purchase Agreement, each CureVac share will be exchanged for approx. $5.46 in BioNTech ADSs, resulting in an implied aggregate equity value for CureVac of approx. $1.25 billion (subject to the adjustments described below). The consideration is subject to a collar mechanism, such that if the 10-day volume weighted average price of the BioNTech ADSs ending on the fifth business day prior to the closing of the offer ("VWAP") exceeds $126.55, the exchange ratio would be 0.04318, and if the VWAP is lower than $84.37, the exchange ratio would be 0.06476. Upon closing of the transaction, CureVac shareholders are expected to own between 4% and 6% of BioNTech.

"This transaction is another building block in BioNTech’s oncology strategy and an investment in the future of cancer medicine," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "We intend to bring together complementary capabilities and leverage technologies with the goal of advancing the development of innovative and transformative cancer treatments and establishing new standards of care for various types of cancer in the coming years."

"To me, this transaction is more than a business decision, it represents a shared commitment to leverage the full potential of mRNA as a disruptive technology to develop transformative therapies with greater scale and speed," said Dr. Alexander Zehnder, CEO of CureVac. "For more than two decades, both companies have operated with related ambitions, often tackling challenges from different angles. This transaction aims at combining complementary scientific capabilities, proprietary technologies, and manufacturing expertise in the mRNA field under one roof."

BioNTech will start preparing an integration plan in alignment with BioNTech’s ongoing group-wide transformation. Following the closing of the transaction, CureVac’s operating subsidiary will become a wholly owned subsidiary of BioNTech. As part of this plan, BioNTech will integrate CureVac’s state-of-the-art research and manufacturing site in Tübingen.

BioNTech’s all-stock acquisition of CureVac is expected to create long-term value for shareholders of both companies, building on BioNTech’s proven track record in mRNA research, development, manufacturing, and commercialization, in particular the COVID-19 vaccine, which was developed in collaboration with Pfizer Inc. and marked the first approved mRNA product in the history of medicine. Based on BioNTech’s strong financial position with €15.9 billion in cash, cash equivalents and security investments as of March 31, 2025, its global presence, late-stage clinical pipeline, and sustained investment in mRNA research across a broad range of solid tumor types, the acquisition positions the company to accelerate and broaden the development of mRNA-based medicines for patients in need.

Following the closing of the exchange offer BioNTech and CureVac will effectuate a corporate reorganization of CureVac and its subsidiaries, resulting in BioNTech owning 100% of CureVac’s business and interests in CureVac and its subsidiaries. As part of this corporate reorganization, CureVac shareholders who do not tender their shares in the exchange offer will receive the same consideration received for each CureVac share tendered in the exchange offer (without interest and subject to applicable withholding taxes). An extraordinary general meeting of CureVac’s shareholders will be convened in connection with the exchange offer to adopt, among other things, certain resolutions relating to the transaction.

The transaction was unanimously approved by both BioNTech’s and CureVac’s management and supervisory boards. The transaction, which is expected to close in 2025, is subject to the satisfaction of customary closing conditions, including a minimum acceptance threshold of at least 80% of CureVac’s shares (which threshold may be reduced to 75% unilaterally by BioNTech under certain circumstances) and required regulatory approvals.

Certain shareholders of CureVac representing 36.76% of CureVac’s shares, including dievini Hopp BioTech holding GmbH & Co. KG and certain of its affiliates and all members of CureVac’s management and supervisory boards, have entered into tender and support agreements, pursuant to which they have agreed, among other things, and subject to the terms and conditions of such agreements, to tender their shares in the exchange offer and to vote in favor of the resolutions relating to the transaction at the CureVac extraordinary general meeting to be held in connection with the transaction. In addition, the German Federal government has confirmed to generally have a positive view on the transaction. BioNTech therefore assumes that Kreditanstalt für Wiederaufbau – which holds 13.32% of the shares in CureVac on behalf of the Federal Republic of Germany – will support the transaction by tendering its shares in CureVac. As a result, BioNTech expects to have contractual commitments to support the transaction from shareholders of CureVac representing a total of 50.08% of CureVac shares towards the 80% minimum condition required under the exchange offer.

Covington & Burling LLP, Hengeler Mueller Partnerschaft von Rechtsanwälten mbB and Loyens & Loeff N.V. served as legal counsel to BioNTech. Skadden, Arps, Slate, Meagher & Flom LLP and NautaDutilh N.V. served as legal counsel to CureVac. PJT Partners served as exclusive financial advisor to BioNTech. Goldman Sachs Bank Europe SE served as exclusive financial advisor to CureVac.