Agomab Receives FDA Orphan Drug Designation for AGMB-447 in Idiopathic Pulmonary Fibrosis

— AGMB-447 is an inhaled lung-restricted ALK5-inhibitor currently in a Phase 1 clinical trial —

ANTWERP, Belgium–(BUSINESS WIRE)–Agomab Therapeutics NV (‘Agomab’) today announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for AGMB-447, its inhaled, small molecule inhibitor of ALK5. Agomab is evaluating AGMB-447 as a potential treatment for Idiopathic Pulmonary Fibrosis (IPF) in a Phase 1 clinical trial (NCT06181370).

The FDA’s Orphan Drug Designation program is designed to facilitate development of medicinal treatments for rare diseases that affect fewer than 200,000 people in the U.S. The designation provides companies with various development and commercial benefits, including market exclusivity and a range of financial incentives, such as tax relief for clinical research costs.

Receiving Orphan Drug Designation from the FDA provides further support that AGMB-447’s mechanism of action has the potential to achieve meaningful therapeutic benefits to IPF patients,” said Philippe Wiesel, Chief Medical Officer at Agomab Therapeutics. “As we progress through our ongoing first-in-human Phase 1 trial, we look forward to evaluating the data from the single ascending dose and multiple ascending dose evaluation of AGMB-447 in healthy subjects and IPF patients.”

AGMB-447 is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established.

About AGMB-447

AGMB-447 is a small molecule lung-restricted inhibitor of ALK5 (or TGFβRI) for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic respiratory indications. IPF is a devastating disease affecting 100,000 patients in the U.S. IPF is characterized by unregulated production of fibrotic, scar-like tissue that builds up in the lungs. As a result, the fibrotic lung becomes stiff which hampers breathing and reduces the absorption of inhaled oxygen in the blood. Even though some medicinal treatments are available, without a lung transplant, the average survival following diagnosis is only three to five years. TGFβ is a known master regulator of fibrosis in IPF and preliminary clinical data supports targeting the pathway. AGMB-447 is specifically designed to potently and safely inhibit ALK5 only in the lung due to its rapid metabolism through hydrolysis in plasma, which prevents clinically relevant systemic exposure.

About Agomab

Agomab is focused on achieving disease modification by modulating fibrosis and regeneration in chronic indications such as Fibrostenosing Crohn’s Disease and Idiopathic Pulmonary Fibrosis. We do this by targeting biologically validated pathways – including Transforming Growth Factor β and Hepatocyte Growth Factor – and by applying specialized capabilities in organ-restricted small molecules and high affinity antibodies. With a differentiated clinical pipeline across several fibrotic disorders, end-to-end research and development capabilities, a proven BD track-record and a strong investor base, Agomab is building a leading European biopharma company.


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ExeVir Bio Announces Exceptional Virus Neutralization Potency of its Variant-proof XVR013m Antibody Against the SARS-CoV-2 Variant JN.1

Developed to provide protection for millions of immunocompromised and elderly individuals who are most vulnerable to COVID-19

GHENT, Belgium, June 04, 2024 (GLOBE NEWSWIRE) — ExeVir Bio, a biotech company developing robust heavy chain-only antibody therapies for broad protection against infectious diseases, today announced new data demonstrating that its antibodies are exceptionally potent in neutralizing the SARS-CoV-2 variant JN.1, the parental strain of the currently most dominantly circulating variants worldwide.

ExeVir’s COVID-19 program focuses on addressing the high unmet medical need to protect and treat immunocompromised and elderly individuals that account for respectively 4% and 10% of the global population. Despite the availability of effective vaccines, the immunocompromised and elderly remain at a higher risk for severe COVID-19 as they are often not able to elicit an adequate immune response to vaccination and therefore would strongly benefit from additional protection in the form of antibody therapeutics.

ExeVir’s variant-proof lead clinical candidate XVR013m is a heavy chain-only antibody that targets a unique membrane-proximal epitope in the S2 subunit of the spike protein. This binding region remains completely unmutated across all variants of concern, variants of interest and variants under monitoring that have circulated to date. XVR013m demonstrates exceptional neutralization potency against JN.1, the parental strain of the currently most dominantly circulating variants worldwide, with an IC50 of 2.8 ng/mL in a pseudovirus neutralization assay, unchanged compared to all previously tested variants. The activity against new circulating variants under monitoring is continually being tested.

ExeVir is currently gearing up to start the clinical development of the variant-proof XVR013m in 2025 as a solution for the prevention of COVID-19 in the target populations of immunocompromised and elderly individuals.

Jeanne Bolger, interim CEO of ExeVir, said: “COVID-19 is here to stay and is still the most important respiratory infectious disease causing substantially more hospitalizations and deaths compared to influenza and RSV. Today, no real seasonality is observed for COVID-19, in sharp contrast to influenza and RSV. Our antibody XVR013m is differentiated by targeting a unique and highly conserved epitope in the S2 subunit of the SARS-CoV-2 spike protein that makes it virtually variant-proof.”

Viki Bockstal, CSO of ExeVir, said: “XVR013m not only demonstrates exceptional virus neutralization potency against all variants tested to date, it is also anticipated to maintain its activity against future variants because of the unique nature of the epitope. There is still a strong and urgent medical need for novel antibodies that work against both the newest as well as future SARS-CoV-2 variants, and these new data again demonstrate that XVR013m has the potential to become a durable therapeutic solution to protect the most vulnerable patients from this serious infectious disease.”

About ExeVir Bio

ExeVir Bio is a clinical stage biotechnology company developing heavy-chain only antibody therapies focusing on infectious diseases. The company is harnessing its llama-derived antibody (VHH) technology platform to generate multi-specific antibodies for prophylaxis and treatment of infectious diseases. ExeVir’s initial focus is on prevention of COVID-19 for the immunocompromised patient population, including active chemotherapy, immunosuppressive drugs, solid organ transplantation, hematological malignancies, AIDS patients, and for the elderly, where there remains a high unmet need due to the limitations of current vaccines and therapeutic approaches.

ExeVir has demonstrated it can progress its candidates from research to the clinic in under one year, execute on Phase 1a and Phase 1b studies, and conduct scale-up manufacturing. Leveraging this extensive experience, its XVR013m asset is being developed to start a First in Human clinical trial in 2025.

VHHs are smaller in size than whole antibodies, giving them access to hidden epitopes that traditional monoclonal antibodies are unable to reach with potential for deeper tissue penetration and simpler, more cost-effective manufacturing. VHHs can be linked together like building blocks into single multispecific molecules to tackle different epitopes or act through different mechanisms of actions at once, to address the “arms race” in more complex and co-evolving infectious diseases.

ExeVir is a spin out of VIB, the leading Belgium-based life sciences research institute. It is backed by strong investors including Fund+, which led the series A of EUR 42 million, together with an international consortium including UCB Ventures, SFPIM, V-Bio Ventures, VIB, Wallonie Entreprendre, Noshaq, Vives IUF and SambrInvest. ExeVir has received support from VLAIO, the SPW-Recherche and the European Union, leading to a total of EUR 18 million in non-dilutive funding. In 2023, ExeVir secured an option for EUR 25 million venture debt financing from the European Investment Bank.


1. Impact of COVID-19 on immunocompromised populations during the Omicron era: insights from the observational population-based INFORM study, Evans et al, The Lancet, 2023.

2. World population above 65 years old: Population ages 65 and above, total | Data (

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TAR-210 results show 90 percent recurrence-free survival and 90 percent complete response in patients with high-risk and intermediate-risk non-muscle-invasive bladder cancer, respectively

Updated results reinforce the potential of TAR-210 to transform treatment of non-muscle-invasive bladder cancer with fibroblast growth factor receptor (FGFR) alterations1

BEERSE, BELGIUM, May 05, 2024 (GLOBE NEWSWIRE) — Janssen-Cilag International NV, a Johnson & Johnson company, announced today updated results from an open-label, multicentre, multi-cohort Phase 1 study of the safety and efficacy of TAR-210, an intravesical targeted releasing system designed to provide sustained, local release of erdafitinib into the bladder, in patients with non-muscle-invasive bladder cancer (NMIBC) with select FGFR alterations.1 These data were featured today in an Oral Presentation Session (Abstract #PD48-02)1 at the 2024 American Urological Association (AUA) Annual Meeting taking place 3-6 May, 2024, in San Antonio, Texas.

Results featured updated data from Cohort 1 (C1); patients with recurrent, Bacillus Calmette-Guérin (BCG)-unresponsive high-risk (HR) NMIBC (high-grade Ta/T1; papillary only) who refused or were ineligible for radical cystectomy and Cohort 3 (C3); patients with recurrent, intermediate-risk (IR) NMIBC (Ta/T1) low-grade papillary disease left in situ as tumour marker lesions.1 First results were featured at the European Society for Medical Oncology 2023 Congress, with interim results presented at the European Association of Urology (EAU) 2024 Annual Congress.2,3

“Advancement in the treatment landscape of high or intermediate-risk non-muscle-invasive bladder cancer has remained stagnant for more than 50 years,” said Antoni Vilaseca*, M.D., Ph.D., of the Hospital Clínic de Barcelona, presenting author of the Phase 1 TAR-210 study. “Results presented today further underscore that TAR-210 for the localised treatment of bladder cancer may offer a promising alternative for patients with limited treatment options.”

At the data cutoff of 22 March, 2024, 64 patients had been treated with TAR-210 across the two cohorts.1 Of the 21 patients in C1 with HR-NMIBC, the 12-month recurrence free (RF) survival rate was 90 percent (95 percent confidence interval (CI), 66-97).1 In C3, 31 patients were efficacy evaluable with 28/31 achieving a complete response (CR) rate of 90 percent (95 percent CI, 74-98).1

The most common treatment-related emergent adverse events (TEAEs) were Grade 1/2 lower urinary tract events.1 There were no dose-limiting toxicities and no deaths.1 Two patients (3 percent) discontinued the study due to TEAEs of low-grade urinary symptoms and two patients had serious TEAEs with pyelonephritis and sepsis or UTI (urinary tract infection) and sepsis, respectively.1

FGFR genetic alterations are most common in NMIBC,” said Sabine Brookman-May, M.D., Vice President, Late Development Oncology, Johnson & Johnson Innovative Medicine. “These results further support the potential of TAR-210 with quarterly administration as a bladder-sparing and BCG-free treatment option, underscoring our deep commitment to pioneering novel therapies for patients who face limited treatment avenues.”

“At Johnson & Johnson, we are committed to transforming bladder cancer treatment with novel drug delivery technology and precision-based therapies,” said Henar Hevia, Senior Director, EMEA Therapeutic Area Lead, Oncology at Johnson and Johnson Innovative Medicine. “As the data continue to mature, it is encouraging to see sustained positive responses to treatment. We look forward to investigating the full potential of TAR-210 in patients with FGFR-altered non-muscle invasive bladder cancer through an ongoing and comprehensive clinical development programme.”

Europe has one of the highest rates of bladder cancer in the world4 with nearly 225,000 patients diagnosed in 2022,5 a 10 percent increase from 2020.6 NMIBC constitutes approximately 75 percent of all newly diagnosed bladder cancers.7 Currently, adjuvant intravesical immunotherapy with BCG or intravesical chemotherapy is the standard of care for patients with intermediate- and high-risk NMIBC.8 Between 30 to 40 percent of patients do not respond to BCG, facing disease recurrence or progression.9 In such scenarios of HR-NMIBC, radical cystectomy (removal of the bladder) emerges as the primary treatment option.9 This major abdominal procedure requires a urinary diversion to be created to collect and store urine.10

About TAR-210
TAR-210 is an investigational erdafitinib intravesical targeted releasing system.11 The safety and efficacy of TAR-210 is being evaluated in a Phase 1 study (NCT05316155)12 in patients with muscle-invasive bladder cancer (MIBC) and NMIBC. The study categorises patients into four cohorts based on their disease presentation.13 Cohort 1 (C1) includes patients with recurrent, BCG-unresponsive HR-NMIBC with concomitant high-grade papillary disease who have refused or are ineligible for radical cystectomy (RC).13 Cohort 2 (C2) includes patients with the same presentation, but who are scheduled for RC.13 Cohort 3 (C3) includes patients with recurrent, intermediate-risk NMIBC with a history of low-grade papillary disease.13 To be eligible for C3, the presence of visible tumour(s) is required. Cohort 4 (C4) includes patients with MIBC.13 The primary endpoint of the study is safety (adverse events, including dose-limiting toxicity).13 Secondary endpoints include pharmacokinetics (PK), RF survival in patients in C1 and C2, CR rate and duration of CR in patients in C3 and pathologic CR rate in C4.13

About Erdafitinib
Erdafitinib is a once-daily, oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor being evaluated by Johnson & Johnson Innovative Medicine in Phase 2 and 3 clinical trials in patients with advanced urothelial cancer.14 In addition to the Phase 1 study (NCT05316155)12 in patients with MIBC and NMIBC, erdafitinib is also being studied in the Phase 3 THOR study (NCT03390504),15 a study assessing whether erdafitinib provided a survival advantage versus chemotherapy in patients with advanced or metastatic urothelial cancer (mUC) with select FGFR alterations; the Phase 2 THOR-2/BLC2003 (NCT04172675)16 study examining erdafitinib versus investigator choice of intravesical chemotherapy in participants who received BCG and recurred with HR-NMIBC; the Phase 1b/2 NORSE (NCT03473743)17 study of erdafitinib in combination with cetrelimab in patients with locally advanced or mUC and FGFR3 or FGFR2 gene alterations; the Phase 2 RAGNAR (NCT04083976)18 study evaluating the safety and efficacy of erdafitinib in patients with advanced solid tumours, regardless of cancer type or tumour location (tumour-agnostic), driven by FGFR1–4 alterations.

In addition to the marketing authorisation application submitted to the European Medicines Agency (EMA) in September 2023, Johnson & Johnson also submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA), in August 2023, based upon the Phase 3 THOR study.19,20

In 2008, Janssen Pharmaceuticals entered into an exclusive worldwide licence and collaboration agreement with Astex Pharmaceuticals to develop and commercialise erdafitinib.21

About Urothelial Carcinoma
Urothelial carcinoma (UC), also known as transitional cell carcinoma, starts in the innermost lining of the bladder.22 Almost all bladder cancers – more than 90 percent – are UCs.23 Up to one in five patients (20 percent) diagnosed with mUC have a FGFR genetic alteration.24 FGFRs are a family of receptor tyrosine kinases that can be activated by genetic alterations in a variety of tumour types, and these alterations may lead to increased tumour cell growth and survival.25 FGFRs play a key role in several biological processes including tissue repair, inflammatory response and metabolism.26 Fusions or mutations in the genes that control FGFR (known as FGFR1–4 alterations) may lead to the development and progression of certain cancers by increasing tumour cell growth and survival.27 Patients with advanced UC, including FGFR-driven tumours, face a poor prognosis and the need for innovative therapies remains high.28 The five-year survival rate for patients with metastatic bladder cancer that has spread to distant parts of the body is currently eight percent.29

About High-Risk Non-Muscle-Invasive Bladder Cancer
High-risk non-muscle-invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to invasive bladder cancer compared to low-risk NMIBC.30 HR-NMIBC is characterised by a combination of high-grade, large tumour size, presence of multiple tumours, and carcinoma in situ (CIS).30 Radical cystectomy is currently recommended for HR-NMIBC patients who fail BCG therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression.30 Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.30 The high rates of recurrence and progression can pose significant morbidity and distress for these patients.30

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at Follow us at and for our latest news. Janssen-Cilag International NV, Janssen Pharmaceutica NV, and Janssen Research & Development, LLC are Johnson & Johnson companies.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TAR-210 or erdafitinib. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen Pharmaceutica NV, and Janssen Research & Development, LLC and Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Pharmaceutica NV, and Janssen Research & Development, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

© Janssen-Cilag International NV, Inc. 2024. All rights reserved.

*Dr. Vilaseca has not been paid for any media work.

1 Vilaseca A, et al. First-in-Human Study of TAR-210 Erdafitinib Intravesical Delivery System in Patient With Non-Muscle-Invasive Bladder Cancer With Select FGFR Alterations. 2024 Annual Urological Association. Oral presentation, 2024 American Urological Association Annual Meeting. May 2024.
2 Vilaseca A, et al. First Safety and Efficacy Results of the TAR-210 Erdafitinib Intravesical Delivery System in Patients with Non–Muscle-Invasive Bladder Cancer (NMIBC) With Select FGFR Alterations. 2023 European Society for Medical Oncology. Oral presentation, 2023 ESMO Annual Meeting. October 22, 2023. Available at: Last accessed May 2024.
3 Guerrero-Ramos F, et al. First Safety and Efficacy Results of the TAR-210 Erdafitinib Intravesical Delivery System in Patients With Non–Muscle-Invasive Bladder Cancer With Select FGFR Alterations. Poster presented at 2024 EAU Congress. Last accessed May 2024.
4 Wong MCS, et al. The global epidemiology of bladder cancer: a joinpoint regression analysis of its incidence and mortality Itrends and projection. Scientific Reports. 2018;8:11.29.
5 Globocan 2022. Europe Cancer Factsheet. Available at: Last accessed May 2024.
6 Globocan 2020. Europe Cancer Factsheet. Available at: Last accessed May 2024.
7 Jubber I, et al. Epidemiology of Bladder Cancer in 2023: A Systematic Review of Risk Factors. Europ Urol. 2023; 84:176–190. Available at: Last accessed May 2024.
8 Laukhtina E, et al. Urothelial carcinoma working group. Intravesical Therapy in Patients with Intermediate-risk Non-muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis of Disease Recurrence. Eur Urol Focus. 2022 Mar;8(2):447-456. doi: 10.1016/j.euf.2021.03.016. Epub 2021 Mar 21. PMID: 33762203.
Zlotta AR, et al. The management of BCG failure in non-muscle-invasive bladder cancer: an update. Can Urol Assoc J. 2013 May 1;3(6-S4):199
10 Bladder removal surgery: What is a radical cystectomy? Last accessed May 2024.
11 Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer. Available at: Last accessed May 2024.
12 Vilaseca A, et al. Safety and efficacy of the erdafitinib (erda) intravesical delivery system, TAR-210, in patients (pts) with non–muscle-invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer (MIBC) harboring select FGFR mutations or fusions: Phase 1 first-in-human study. Poster presented at ASCO GU 2023 Congress. Abstract available at: Last accessed May 2024.
13 Tabernero J, et al. Phase I dose-escalation study of JNJ-42756493, an oral pan-fibroblast growth factor receptor inhibitor, in patients with advanced solid tumours. J Clin Oncol. 2015;33:3401–3408
14 A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations (THOR). Available at: Last accessed May 2024.
15 A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC). Available at: Last accessed May 2024.
16 A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer. Available at: Last accessed May 2024.
17 A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (RAGNAR). Available at: Last accessed May 2024.
19 Janssen Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of BALVERSA® (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations. Available at: Last accessed May 2024.
20 Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Erdafitinib for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations. Available at: Last accessed May 2024.
21 Astex Therapeutics Limited. Astex Announces New Drug Discovery Alliance with Janssen Pharmaceutica N.V. 2008. Available at: Last accessed May 2024.
22 Tanaka M & Sonpavde G. Diagnosis and Management of Urothelial Carcinoma of the Bladder. Postgraduate Medicine. 2011;123(3):43-55.
23 Milojevic B, et al. Urothelial carcinoma: Recurrence and risk factors. J BUON. 2015;20(2):391-8.
24 Montazeri K & Bellmunt J. Erdafitinib for the treatment of metastatic bladder cancer. Expert Rev Clin Pharmacol. 2020 Jan;13(1):1-6. doi: 10.1080/17512433.2020.1702025. Epub 2019 Dec 22.
25 Presta M et al. Fibroblast growth factors (FGFs) in cancer: FGF traps as a new therapeutic approach. Pharmacol Ther. 2017;179:171-187.
26 Xie Y, et al. FGF/FGFR signaling in health and disease. Sig Transduct Target Ther 5, 181 (2020).
27 Katoh M. Fibroblast growth factor receptors as treatment targets in clinical oncology. Nat Rev Clin Oncol. 2019;16(2):105-122.
28 Loriot Y, et al. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med 2019; 381(4):338-348.
29 American Cancer Society. Survival Rates for Bladder Cancer. Available at: Last accessed May 2024.
30 Brooks NA, O’Donnell MA. Treatment options in non-muscle-invasive bladder cancer after BCG failure. Indian J Urol. 2015;31(4):312-319. doi:10.4103/0970-1591.166475. Last accessed May 2024.

May 2024

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