A Phase Ib Study of OBT076 or OBT076 Followed by Balstilimab in Patients With Recurrent or Metastatic (R/M) Adenoid Cystic Carcinoma (AdCC) of the Head and Neck (H&N)

Adenoid cystic carcinoma (AdCC) is a rare salivary gland malignant tumor that accounts for approximately 1-3% of all head and neck cancers. AdCC is often charaterised by a long natural history with a propensity for indolent but relentless growth and dissemination. Local recurrences and late distant metastases are common findings in about 35% of the patients and associated with a poor prognosis1. AdCC is among the most lethal salivary gland tumors2 with no proven therapy for metastatic disease. Little is known about endogenous immune response directed against AdCC. However, in a relatively large series of 28 AdCC tumor, the immune profiling has shown in most tumors high and frequent programmed death ligand 2 (PD-L2) expression and PD-L1 was generally not expressed on tumor and infiltrating cells3.
The Antibody Drug Conjugates (ADCs) are emerging as a novel therapeutic option in cancer treatment that looks promising for solid tumors. An experimental CD205/Ly75-directed ADC, OBT076 induce potent cytotoxic and antitumor activity. Recently, the combination of immunohistochemistry (IHC) and tissue micro array (TMA) was performed in a series of 46 AdCC, showing a unique profile with both frequent and high expression of CD205/Ly75, much higher than for other solid tumors. In a phase I study, OBT076 demonstrated promising results for 3 patients with 2 partial responses and 1 complete response for a gastric cancer4. In this last patient, analysis showed an increase in PD1+, CD4+ and CD8+ cells suggesting that OBT076 activates the patient's immune response against the tumor, especially PD-1 targeted therapies4.
Based on this rational and on the high level of expression of CD205/Ly75 in AdCC, the hypothesis tested in this study is that OBT076 could be a potential effective treatment for R/M AdCC, which is an orphan lethal disease. The efficacy of OBT076 will be tested either alone or followed by an anti PD-1 inhibitor (Balstilimab) with the hypothesis that OBT076 will induce immune infiltrate that could restore sentivity to PD-1 targeting.

Start Date29 Nov 2023

Sponsor / Collaborator-

NCT04064359 / RecruitingPhase 1

A Phase I, Open-label, Dose Finding Study to Assess the Safety, Tolerability, PK, and Preliminary Efficacy of OBT076, a CD205-directed ADC, in Recurrent and/or Metastatic CD205+ Solid Tumors

The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an "Investigational Drug", which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational.
This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness.

Start Date25 Jul 2019

Sponsor / Collaborator

Oxford BioTherapeutics Ltd.

NCT03403725 / TerminatedPhase 1

Open-Label, Multicenter, Phase I Dose Escalation Study of MEN1309, a CD205 Antibody-Drug Conjugate,in Patients With CD205-Positive Metastatic Solid Tumors and Non-Hodgkin Lymphoma

The purpose of this clinical trial is to identify the highest dose of MEN1309 drug with acceptable safety profile and that can be used in patients affected by CD205-positive solid tumors and Non-Hodgkin Lymphoma

Start Date28 Aug 2017

Sponsor / Collaborator

A. Menarini Industrie Farmaceutiche Riunite SRL

100 Clinical Results associated with MEN-1309

100 Translational Medicine associated with MEN-1309

100 Patents (Medical) associated with MEN-1309

Literatures (Medical) associated with MEN-1309

01 Sep 2019·Molecular cancer therapeuticsQ2 · MEDICINE

MEN1309/OBT076, a First-In-Class Antibody–Drug Conjugate Targeting CD205 in Solid Tumors

Q2 · MEDICINE

Article

Author: Merlino, Giuseppe ; Dusek, Rachel L. ; Lynch, Carmel M. ; Wilson, Keith E. ; Ackroyd, James E. ; Swaminathan, Sudha ; Bressan, Alessandro ; Trang, Michael ; Bellarosa, Daniela ; Arribas, Joaquin ; Rohlff, Christian ; Bigioni, Mario ; Attanasio, Nickolas ; Boyd, Robert ; Pellacani, Andrea ; Aud, Dee ; Binaschi, Monica ; Salerno, Massimiliano ; Bugianesi, Rossana ; Bisht, Arnima ; Kaplan, Angelo ; Lou, San Lin ; Bernadó Morales, Cristina ; Manno, Rosanna ; Manzini, Stefano ; Pham, Phuoc Huy ; Fiascarelli, Alessio ; Carrisi, Corrado ; Awdew, Rahel ; Terrett, Jonathan ; Do, Uyen T.

Abstract:

CD205 is a type I transmembrane glycoprotein and is a member of the C-type lectin receptor family. Analysis by mass spectrometry revealed that CD205 was robustly expressed and highly prevalent in a variety of solid malignancies from different histotypes. IHC confirmed the increased expression of CD205 in pancreatic, bladder, and triple-negative breast cancer (TNBC) compared with that in the corresponding normal tissues. Using immunofluorescence microscopy, rapid internalization of the CD205 antigen was observed. These results supported the development of MEN1309/OBT076, a fully humanized CD205-targeting mAb conjugated to DM4, a potent maytansinoid derivate, via a cleavable N-succinimidyl-4-(2-pyridyldithio) butanoate linker. MEN1309/OBT076 was characterized in vitro for target binding affinity, mechanism of action, and cytotoxic activity against a panel of cancer cell lines. MEN1309/OBT076 displayed selective and potent cytotoxic effects against tumor cells exhibiting strong and low to moderate CD205 expression. In vivo, MEN1309/OBT076 showed potent antitumor activity resulting in durable responses and complete tumor regressions in many TNBC, pancreatic, and bladder cancer cell line–derived and patient-derived xenograft models, independent of antigen expression levels. Finally, the pharmacokinetics and pharmacodynamic profile of MEN1309/OBT076 was characterized in pancreatic tumor–bearing mice, demonstrating that the serum level of antibody–drug conjugate (ADC) achieved through dosing was consistent with the kinetics of its antitumor activity. Overall, our data demonstrate that MEN1309/OBT076 is a novel and selective ADC with potent activity against CD205-positive tumors. These data supported the clinical development of MEN1309/OBT076, and further evaluation of this ADC is currently ongoing in the first-in-human SHUTTLE clinical trial.

HaematologicaQ1 · MEDICINE

Targeting CD205 with the antibody drug conjugate MEN1309/OBT076 is an active new therapeutic strategy in lymphoma models

Q1 · MEDICINE

Article

Author: Lucchini, Renzo ; Rossi, Davide ; Zucca, Emanuele ; Adjeiwaa Mensah, Afua ; Bernasconi, Elena ; Spriano, Filippo ; Bisht, Arnima ; Sartori, Giulio ; Golino, Gaetanina ; Bordone, Roberta ; Boyd, Robert S ; Rohlff, Christian ; Bigioni, Mario ; Stathis, Anastasios ; Stussi, Georg ; Attanasio, Nickolas ; Pellacani, Andrea ; Gaudio, Eugenio ; Fiascarelli, Alessio ; Dusek, Rachel L ; Bressan, Alessandro ; Cascione, Luciano ; Arribas, Alberto J ; Guidetti, Francesca ; Tarantelli, Chiara ; Binaschi, Monica ; Bertoni, Francesco ; Merlino, Giuseppe

Antibody drug conjugates represent an important class of anti-cancer drugs in both solid tumors and hematological cancers. Here, we report preclinical data on the anti-tumor activity of the first-in-class antibody drug conjugate MEN1309/OBT076 targeting CD205. The study included preclinical in vitro activity screening on a large panel of cell lines, both as single agent and in combination and validation experiments on in vivo models. CD205 was first shown frequently expressed in lymphomas, leukemias and multiple myeloma by immunohistochemistry on tissue microarrays. Anti-tumor activity of MEN1309/OBT076 as single agent was then shown across 42 B-cell lymphoma cell lines with a median IC50 of 200 pM and induction of apoptosis in 25/42 (59.5%) of the cases. The activity appeared highly correlated with its target expression. After in vivo validation as the single agent, the antibody drug conjugate synergized with the BCL2 inhibitor venetoclax, and the anti-CD20 monoclonal antibody rituximab. The first-in-class antibody drug targeting CD205, MEN1309/OBT076, demonstrated strong pre-clinical anti-tumor activity in lymphoma, warranting further investigations as a single agent and in combination.

News (Medical) associated with MEN-1309

07 Mar 2024

·www.biospace.com

Oxford BioTherapeutics Announces Launch of Enhanced Discovery Platform, OGAP®-Verify, at World ADC Conference 2024

OGAP®-Verify allows for significantly enhanced sensitivity and specificity for improved target selection, dramatically accelerating drug target discovery OGAP-Verify is now more sensitive than Immunohistochemistry (IHC), measuring membrane proteins as low as 50 copies-per-cell in patient biopsies with quantitative mass spectrometry; this removes the ambiguities of IHC antibody specificity and sensitivity OBT will also present two posters focussing on OGAP-Verify for novel target discovery and cancer specific splice-variant discovery at the 14th Annual World ADC Conference in London Oxford, UK, San Jose, Calif., 7th March 2024 - Oxford BioTherapeutics (‘OBT’), a clinical stage oncology company with a pipeline of immuno-oncology and antibody-drug conjugate (ADC)-based therapies, today announces significant technological advances to its drug discovery platform OGAP® with a new version to be launched at the 14th Annual World ADC Conference in London named OGAP®-Verify. OBT will also present two posters focusing on OGAP-Verify’s capacity to identify novel cancer-specific targets for the development of first-in-class therapies, particularly ADCs and other therapeutic antibodies, addressing unmet clinical needs in oncology. “I am delighted to announce major technological advances with the launch of OBT’s OGAP-Verify target discovery platform. OGAP-verify is now more sensitive than IHC and allows for enhanced sensitivity with improved target selection, solving some of the challenges in antibody specificity,” saidChristian Rohlff, CEO, Oxford BioTherapeutics. “OBT is dedicated to discovering and validating the next generation of ADC targets for safe and effective medicines. The OGAP-Verify platform’s enhanced sensitivity, specificity, and reliability will significantly accelerate biopharma’s capabilities to identify and validate human targets with robust scientific support. Our commitment to leveraging OGAP capabilities underscores our dedication to advancing the forefront of cancer therapy development.” “We are very pleased to have a significant company presence at this year’s World ADC Conference with Dr Ben Thomas presenting OGAP-Verify together with two posters highlighting the enhanced target discovery and validation capabilities of OGAP-Verify. We are very much looking forward to meeting peers in the industry and discussing the latest science that could have significant positive impacts for patients." Despite recent progress in ADC development, only 10% of cancer patients are eligible for treatment with existing ADCs with ADC-target expression on patient tumors a major factor in patient eligibility. However, the majority of ADCs in development target the same nine proteins as those already approved. Leveraging OGAP®-Verify, OBT can identify first-in-class targets to treat patients who are currently ineligible for existing treatments. With its enhanced sensitivity, OGAP-Verify can detect protein expression levels as low as 50 copies-per-cell (which is more sensitive than IHC), uncovering targets missed by mRNA analysis. Moreover, it provides insights into normal tissue expression improving target selection and accelerating the drug target discovery process. By evaluating factors such as therapeutic index, protein abundance and benchmarking against known clinical ADC targets during target selection, OGAP®-Verify enhances the likelihood of success in ADC development. Details of the presentations are as follows: Presentation Title: Oxford Biotherapeutics’ OGAP Target Discovery Platform: Use of Quantitative Membrane Tissue Proteomics to Identify new ADC Drug Target Session: Track 1 Discovery Chemistry - Next-Generation Approaches to Target Selection: Advancing ADC Precision for Improved Delivery & Reduced Toxicity Presenter: Benjamin Thomas, Senior VP External Innovation Date/Time: 13 March 2024, from 18:35 GMT Poster No. 30 Title: Addressing Unmet Clinical Oncology Needs Through A Novel Therapeutic ADC Target Space in Cancer Patient Tissue Biopsies Using OGAP-Verify. Authors: Abigail Houghton et al. Date/Time: 13 March 2024, from 18:00 GMT Poster No. 30 describes the innovative use of the OGAP-Verify Membrane Protein Expression Database and its ability to identify novel therapeutic targets for ADCs by analyzing membrane protein expression in patient tissues. OGAP-Verify is the world’s largest quantitative membrane protein expression library generated using proteomics. Among other applications, it is used to identify targets overexpressed in cancers that are otherwise overlooked when using mRNA-based discovery techniques. Poster No. 31 Title: Identification of Novel Cancer-Specific Splice Variants Using Oxford Biotherapeutics' Ultra-High Sensitivity Tissue Membrane Proteomics Database, OGAP-Verify, for First-in-class ADCs and Other Therapeutic Antibodies. Authors: Somdatta Basu et al. Date/Time: 13 March 2024, from 18:00 GMT Poster No. 31 describes OBT's use of its proprietary proteomic discovery platform, OGAP-Verify, to identify novel cancer-specific splice variants for the development of first-in-class therapies, including ADCs and Immuno-Oncology (IO) agents. OBT is conducting complex analyses to identify clean, novel cancer-specific protein targets bypassing the limitations of mRNA-based approaches. OBT is a Partner of the Annual World ADC Conference 2024 in London, UK. xxx About Oxford BioTherapeutics Oxford BioTherapeutics (OBT) is a clinical stage oncology company with a pipeline of first-in-class immuno-oncology (IO) and antibody-drug conjugate (ADC) based therapies designed to fulfil major unmet patient needs in cancer therapeutics. These include bispecific, Chimeric Antigen Receptor T Cell (CAR-T), Antibody Drug Conjugate (ADC) and Antibody Dependent Cell-mediated Cytotoxicity (ADCC) therapeutics. OBT's lead clinical program, OBT076, initiated expansion in a US Clinical Trial in 2021 in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian and lung cancer, where CD205 is overexpressed. Infiltration of tumors by immunosuppressive cells correlates with adverse outcomes (lower progression free and overall survival), suggesting that this process contributes to the progression of several cancers. OBT’s proprietary OGAP® target discovery platform is based on one of the world’s largest proprietary cancer membrane proteomic databases, with data on over 5,000 cancer cell proteins providing unique, highly qualified oncology targets, of which three programs are in clinical development in the US and Europe. OBT's IO discovery process provides unique insights into the cancer-immune cell synapse and has identified several novel IO monoclonal and bispecific antibody candidates for cancer therapies. OBT’s pipeline and development capabilities have been validated through multiple strategic partnerships including with Boehringer Ingelheim, ImmunoGen and our cell therapy research collaboration with Kite Pharma as well as other world leaders in antibody development (such as Amgen, WuXi, Medarex (BMS), Alere (Abbott) and BioWa). OBT has a strong oncology focused management team and board with significant experience in developing IO and antibody-based therapies. For more information on Oxford BioTherapeutics, please visit and follow us on LinkedIn. Contacts For OBT Investors: Dr Christian Rohlff, CEO christian.r@oxfordbiotherapeutics.com Media: MEDiSTRAVA Sylvie Berrebi, Sandi Greenwood, Erica Hollingsworth E : OBT@medistrava.com T : +44 (0) 203 928 6900

ImmunotherapyADC

19 Jan 2024

·www.globenewswire.com

Oxford BioTherapeutics Announces First Patient Dosed with OBT076 in Phase 1b Trial in Adenoid Cystic Carcinomas of the Head and Neck

OBT, in collaboration with GORTEC, is evaluating OBT076, an innovative Antibody Drug Conjugate (ADC) targeting CD205 receptor that is highly overexpressed in solid and liquid tumors 18 January 2024 - Oxford BioTherapeutics (‘OBT’), a clinical stage oncology company with a pipeline of immuno-oncology and antibody-drug conjugate (ADC)-based therapies, today announces that the first patient has been dosed in a Phase 1b trial investigating OBT’s lead candidate, OBT076, in patients with Adenoid Cystic Carcinoma (ACC) of the head and neck. This Phase 1b trial is being sponsored by Groupe d'Oncologie Radiothérapie Tête Et Cou (GORTEC), an established, internationally renowned European oncology and radiotherapy consortium specializing in clinical and laboratory research specifically for the benefit of head and neck cancer patients. OBT076, is an innovative ADC with a potential dual mechanism of action in treating patients with ACC, a rare, aggressive type of cancer which represents 2% of head and neck cancers and about 20% of salivary gland malignancies. OBT076 targets the CD205 receptor on tumor cells as well as certain immune suppressive cells in high-risk cancer patients. The CD205 receptor is highly overexpressed in solid and liquid tumors with high unmet need, including gastric, lung and ovarian cancer. Led by Professor Jean Bourhis, MD, PhD, Chief of Radiation Oncology at Lausanne University Hospital & Chairman at GORTEC, the trial (NCT05930951) will be carried out in patients with recurrent or metastatic ACC of the head and neck from an anticipated 15 study sites across the GORTEC network in France, Belgium and Switzerland. It will investigate OBT076 both as a monotherapy and in combination with balstilimab, a PD-1 blocking antibody, accessed through a clinical collaboration agreement from Agenus (Nasdaq: AGEN). Prof Bourhis commented: “Recurrent or metastatic adenoid cystic carcinoma (ACC) is an orphan disease since there is no established and validated treatment that could significantly improve the patients’ outcome. With such an unmet clinical need, OBT076 is opening new avenues and creating a major interest among GORTEC investigators since it is targeting the CD205 protein which is overexpressed in a large proportion of ACCs, a much higher proportion compared to other types of solid tumors.” Christian Rohlff, PhD, Chief Executive Officer of Oxford BioTherapeutics, said: “The start of this Phase 1b trial investigating our lead asset OBT076 in Adenoid Cystic Carcinoma (ACC) is a major milestone for OBT. We look forward to demonstrating the potential value of OBT076, with the hope to provide meaningful benefit for ACC patients. Additionally, it will contribute to the expanding pool of data affirming the potential of OBT076, both as an ADC monotherapy and as immune primer to boost the effectiveness of CPI immunotherapies, particularly in patients with advanced and/or refractory tumors and those with low PD-L1 expression.” OBT076 is also currently being evaluated in Phase 1 clinical trials in the US and Europe across several advanced solid tumor indications, including gastric, endometrial, ovarian and non-small cell lung (NSCLC) cancer. Trial arms are investigating OBT076 both as a monotherapy and in combination with a CPI in these tumors. In preliminary data, OBT076 showed signs of clinical activity as a single agent and in combination with a CPI, including near-complete responses after 2-5 cycles of OBT076 and 1-2 cycles of a CPI, in two chemo-refractory patients with low PD-L1 expression. OBT076 was discovered using OBT’s proprietary OGAP® platform, and is the world’s largest cancer specific, membrane protein library used to identify novel, high specific antigens for cancer targets. GORTEC (Head and Neck Oncology and Radiotherapy Group) was created in 1999 with the aim of running clinical and/or laboratory studies in the field of head and neck oncology towards improving care, and promoting research, for the benefit of patients. It is currently one of the most prominent cooperative groups in this field and its multidisciplinary network consists of >100 cancer treatment centers in France, Switzerland, Belgium, Germany and Spain and represents around 500 investigators in the field of head and neck cancer. Oxford BioTherapeutics (OBT) is a clinical stage oncology company with a pipeline of first-in-class immuno-oncology (IO) and antibody-drug conjugate (ADC) based therapies designed to fulfil major unmet patient needs in cancer therapeutics. These include bispecific, Chimeric Antigen Receptor T Cell (CAR-T), Antibody Drug Conjugate (ADC) and Antibody Dependent Cell-mediated Cytotoxicity (ADCC) therapeutics. OBT's lead clinical program, OBT076, initiated expansion in a US Clinical Trial in 2021 in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian and lung cancer, where CD205 is overexpressed. Infiltration of tumors by immunosuppressive cells correlates with adverse outcomes (lower progression free and overall survival), suggesting that this process contributes to the progression of several cancers. OBT’s proprietary OGAP® target discovery platform is based on one of the world’s largest proprietary cancer membrane proteomic databases, with data on over 5,000 cancer cell proteins providing unique, highly qualified oncology targets, of which three programs are in clinical development in the US and Europe. OBT's IO discovery process provides unique insights into the cancer-immune cell synapse and has identified several novel IO monoclonal and bispecific antibody candidates for cancer therapies. OBT’s pipeline and development capabilities have been validated through multiple strategic partnerships including with Boehringer Ingelheim, ImmunoGen and our cell therapy research collaboration with Kite Pharma as well as other world leaders in antibody development (such as Amgen, WuXi, Medarex (BMS), Alere (Abbott) and BioWa). OBT has a strong oncology focused management team and board with significant experience in developing IO and antibody-based therapies. 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Phase 1ImmunotherapyADC

29 Nov 2023

·www.globenewswire.com

Oxford BioTherapeutics Announces Partner Boehringer Ingelheim Received U.S. FDA Fast Track Designation for BI 764532 for the Potential Treatment of Advanced or Metastatic Large-Cell Neuroendocrine Carcinoma of the Lung

BI 764532 is an investigational T-cell engager that redirects T cells towards cancer cells expressing the DLL3 protein DLL3 antigen was discovered using OBT’s proprietary OGAP® drug discovery platform This is the third Fast Track designation for BI 764532 Oxford, UK, San Jose, Calif., 29 November 2023 – Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and Antibody Drug Conjugate (ADC)-based therapies, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BI 764532 for the potential treatment of advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC-Lung) expressing DLL3 whose disease has progressed following at least one prior line of treatment including platinum-based chemotherapy. BI 764532 is an investigational DLL3/CD3 IgG-like T-cell engager for potential treatment of patients with LCNEC-Lung that is being developed by Boehringer Ingelheim. The discovery of BI 764532 (OBT620) was enabled through a successful partnership initiated in 2013, leveraging OBT’s proprietary OGAP® drug discovery platform for identification of the DLL3 antigen and Boehringer Ingelheim’s longstanding expertise in oncology and development of biotherapeutics. As of November 2023, the FDA granted Fast Track designation to BI 764532 for the potential treatment of extensive-stage small cell lung cancer (SCLC) whose disease has progressed following at least two prior lines of treatment including platinum-based chemotherapy, and of advanced or metastatic extrapulmonary neuroendocrine carcinomas (epNEC) whose disease has progressed following at least one prior line of treatment including platinum-based chemotherapy. BI 764532 was also granted Orphan Drug designation by the FDA for the treatment of SCLC, and is currently being investigated in a Phase 2 study, ‘DAREON™-5’ (NCT05882058), in patients with relapsed/refractory extensive-stage SCLC and other relapsed/refractory NEC. Christian Rohlff, Chief Executive Officer of OBT, commented: “We are delighted about the clinical development to help address unmet needs for people living with small cell lung cancer and other neuroendocrine carcinomas. This is an important milestone for our teams and exciting news for the community” FDA’s Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs. *** About Oxford BioTherapeutics Oxford BioTherapeutics (OBT) is a clinical stage oncology company with a pipeline of first-in-class immuno-oncology (IO) and antibody-drug conjugate (ADC) based therapies designed to fulfil major unmet patient needs in cancer therapeutics. These include bispecific, Chimeric Antigen Receptor T Cell (CAR-T), Antibody Drug Conjugate (ADC) and Antibody Dependent Cell-mediated Cytotoxicity (ADCC) therapeutics. OBT's first clinical program, OBT076, initiated expansion in a US Clinical Trial in 2021 in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian and lung cancer, where CD205 is overexpressed. Infiltration of tumors by immunosuppressive cells correlates with adverse outcomes (lower progression free and overall survival), suggesting that this process contributes to the progression of several cancers. OBT’s proprietary OGAP® target discovery platform is based on one of the world’s largest proprietary cancer membrane proteomic databases, with data on over 5,000 cancer cell proteins providing unique, highly qualified oncology targets, of which three programs are in clinical development in the US and Europe. OBT's IO discovery process provides unique insights into the cancer-immune cell synapse and has identified several novel IO monoclonal and bispecific antibody candidates for cancer therapies. OBT’s pipeline and development capabilities have been validated through multiple strategic partnerships including with Boehringer Ingelheim, ImmunoGen and our cell therapy research collaboration with Kite Pharma as well as other world leaders in antibody development (such as Amgen, WuXi, Medarex (BMS), Alere (Abbott) and BioWa). OBT has a strong oncology focused management team and board with significant experience in developing IO and antibody-based therapies. For more information on Oxford BioTherapeutics, please visit www.oxfordbiotherapeutics.com/ and follow us on LinkedIn. ContactsInvestors:Dr Christian Rohlff, CEOchristian.r@oxfordbiotherapeutics.com Media:MEDiSTRAVA ConsultingSylvie Berrebi, Sandi Greenwood, Erica HollingsworthE : OBT@medistrava.comT : +44 (0) 203 928 6900

Fast TrackPhase 2Orphan DrugImmunotherapy

100 Deals associated with MEN-1309

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Relapsed Solid Neoplasm	Phase 1	US	Oxford BioTherapeutics Ltd.	25 Jul 2019
Relapsed Solid Neoplasm	Phase 1	BE	Oxford BioTherapeutics Ltd.	25 Jul 2019
Relapsed Solid Neoplasm	Phase 1	FR	Oxford BioTherapeutics Ltd.	25 Jul 2019
Relapsed Solid Neoplasm	Phase 1	GR	Oxford BioTherapeutics Ltd.	25 Jul 2019
Relapsed Solid Neoplasm	Phase 1	ES	Oxford BioTherapeutics Ltd.	25 Jul 2019
Metastatic Solid Tumor	Phase 1	BE	A. Menarini Industrie Farmaceutiche Riunite SRL	28 Aug 2017
Metastatic Solid Tumor	Phase 1	IT	A. Menarini Industrie Farmaceutiche Riunite SRL	28 Aug 2017
Metastatic Solid Tumor	Phase 1	ES	A. Menarini Industrie Farmaceutiche Riunite SRL	28 Aug 2017
Metastatic Solid Tumor	Phase 1	GB	A. Menarini Industrie Farmaceutiche Riunite SRL	28 Aug 2017
Non-Hodgkin's lymphoma refractory	Phase 1	BE	A. Menarini Industrie Farmaceutiche Riunite SRL	28 Aug 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04064359 (ASCO2022) Manual	Phase 1	Solid tumor	20	OBT076 1.6 mg/kg	krqlhaythp(wrsibbyszp) = nljaejjuwr lmxkbtyzzz (wgpaqfanlc )	Positive	02 Jun 2022
				OBT076 2.5 mg/kg	krqlhaythp(wrsibbyszp) = jcfzngxqnm lmxkbtyzzz (wgpaqfanlc )

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