OSE Immunotherapeutics Announces

Corporate Update and H1 2022 Results

Corporate

  • Alexis Vandier appointed new Chief Executive Officer to guide the Company through its next phase of growth
  • Strategy focused on leveraging both the Company's clinical portfolio of first-in-class assets in immuno-oncology and immuno-inflammation along with its two unique pioneering pre-clinical platforms
  • Newly formed international Scientific Advisory Board

Pipeline

  • Tedopi® (T-cell specific immunotherapy) - New clinical advances and analyses presented at ASCO and ESMO 2022
  • €10 million milestone payment received from Boehringer Ingelheim for the initiation of the Phase 1 clinical expansion trial of BI 765063, SIRPα antagonist monoclonal antibody, in advanced hepatocellular carcinoma and head and neck cancer patients
  • €5 million milestone payment received from Veloxis Pharmaceuticals, Inc., for CD28 antagonist VEL-101/FR104 following acceptance of the US Investigational New Drug (IND) Application

Financials

  • €16 million turnover and €31 million available cash as of June 30, 2022, providing financial visibility until Q3 2023

Conference call with live webcaston September 23rd at 2:00 p.m. CET / 8:00 a.m. ET.

Nantes, France - September 22nd, 2022, 6:00 p.m. CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), an integrated biotech company focused on developing first- in-class assets targeting cancer and inflammatory diseases, today provides updates on key

milestones achieved during H1 2022 and reports its consolidated half-year financial results as of June 30, 2022.

Alexis Vandier, Chief Executive Officer of OSE Immunotherapeutics, comments: "It is a great honor to have joined OSE Immunotherapeutics as Chief Executive Officer. OSE is at the forefront of the science needed to develop first-in-classassets to break the efficacy ceiling of immunotherapeutics targeting immuno-oncology(IO) and immuno-inflammation(I&I) indications. In the first half of 2022, we have continued to make important progress, including with our most advanced product Tedopi®, which had demonstrated positive results in a Phase 3 trial in Non-SmallCell Lung Cancer (NSCLC) patients in secondary resistance after checkpoint inhibitor failure. We intend

to further leverage this lead asset Tedopi® in NSCLC and in other cancer indications explored in partnership with clinical oncology groups, both as a monotherapy and in combination.

We continue to focus our research efforts on developing next-generationfirst-in-class therapies from our unique proprietary drug discovery platforms to generate significant value: the BiCKI® platform focused on immuno- oncology, and its most advanced BiCKI® candidate targeting anti-PD1xIL-7; and the Myeloid platform, focused on optimizing the therapeutic potential of myeloid cells in IO and I&I where our most advanced preclinical product, OSE-230, has the potential to resolve chronic inflammation.

We have also seen important progress in the first half of 2022 with our partnered products. This has resulted in OSE Immunotherapeutics receiving a €10 million milestone payment from Boehringer Ingelheim for the initiation of the Phase 1 clinical expansion trial of BI 765063 in advanced hepatocellular carcinoma and head and neck cancer patients and a further €5 million milestone payment from Veloxis Pharmaceuticals, Inc., for FR104, a CD28 antagonist, following US Investigational New Drug (IND) acceptance for kidney transplant immunosuppression.

I am very confident that the globally advanced clinical pipeline that we have today addressing high medical unmet needs, as well as our pioneering platforms, will allow us to deliver on our ambitious goals, and ultimately to improve the lives of patients with cancer and inflammatory diseases."

CORPORATE GOVERNANCE - NEW CHIEF EXECUTIVE OFFICER (CEO) AND SCIENTIFIC ADVISORY BOARD (SAB)

Appointment of Alexis Vandier as CEO

Alexis Vandier was appointed CEO of OSE Immunotherapeutics, effective July 13, 2022. Mr. Vandier brings more than 20 years of experience with extensive international management and leadership experience in the pharmaceutical industry. He joins OSE Immunotherapeutics from Ipsen, where he latest served as Vice-President

  • Global Asset Lead, heading their efforts to build a leading oncology platform.

As CEO, Mr. Vandier will lead OSE's corporate, business and development strategy focused on maximizing the value potential of the Company's lead clinical assets, including its ongoing partnered clinical programs and its two proprietary drug discovery platforms BiCKI® and Myeloid.

A newly formed SAB combining the expertise of renowned scientific and international key-opinion leaders in the fields of immunology, immuno-oncology, inflammation and immunotherapy

  • The SAB, appointed in June 2022, will work with the Company's leadership team and advise its Board of
    Directors on its scientific, medical, translational and developmental strategy.
  • The SAB includes Pr. Wolf-Hervé Fridman (Université de Paris), Dr. Sophie Brouard (CRTI, Nantes), Dr. Bernard Malissen (CIML, Marseille), Pr. Miriam Merad (Mount Sinai, New-York), Pr. Charles Serhan (Harvard, Boston) and Dr. Jennifer Wargo (MD Anderson Cancer Center, Houston).

STRATEGY UPDATE

The Company pursues the ambition "to become a fast-growing biotech company combining a clinical portfolio of first-in-class assets in immuno-oncology and immuno-inflammation with a unique pioneering, highly productive pre-clinical platform engine."

OSE Immunotherapeutics is in a unique position to achieve this ambitious goal based on its:

  • Ability to master complex biology, particularly with regards to T-cells and myeloid cells and their ability to improve the treatment of IO and I&I indications,
  • Strong clinical development expertise and
  • Well-balancedclinical portfolio of wholly owned and partnered assets.

The Company is continuing to focus significant resources on Tedopi®, its most advanced asset and is working diligently to ensure it can start an additional Phase 3 study, in NSCLC patients with secondary resistance after failure with a first line immune checkpoint inhibitor treatment. The Company is further preparing a submission for early access to make this treatment available for patients with a high unmet medical need as soon as possible. Beyond use in monotherapy, Tedopi® is being developed in combination in several phase 2 trials led by clinical oncology groups.

OSE Immunotherapeutics will also continue to support its partners, Boehringer Ingelheim, Servier and Veloxis, to ensure their assets can progress into late-stage clinical trials.

In parallel, OSE Immunotherapeutics expects to be able to generate further significant value from its two proprietary drug discovery platforms:

  • BiCKI® platform focused on immuno-oncology (IO) is a bispecific fusion protein platform relying on the proprietary anti-PD1 backbone (OSE-279) to increase anti-tumor efficacy. The most advanced BiCKI® candidate is targeting anti-PD1xIL-7.
  • Myeloid platform, which is focused on optimizing the therapeutic potential of myeloid cells in IO and immuno-inflammation (I&I). OSE-230 (ChemR23 agonist mAb) is the most advanced candidate generated by the platform, with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

MAJOR CLINICAL PROGRESS IN IMMUNO-ONCOLOGY AND IMMUNO-INFLAMMATION

TEDOPI®, a T-cell specific immunotherapy: Positive clinical results and analyses shared at the American Society of Clinical Oncology (ASCO) and at the European Society for Medical Oncology (ESMO) annual meetings

ASCO (June 2022)

  • In advanced HLA-A2+non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint

inhibitors, final data of Phase 3 Atalante-1 randomized trial were presented by Prof. Benjamin Besse (Gustave Roussy Institute, Villejuif, France). This presentation featured final positive Patient Reported Outcomes (PROs) significantly better with Tedopi® than with chemotherapy in the primary analysis for the population of interest (n=118 patients), defined as NSCLC patients in secondary resistance after checkpoint inhibitor failure. These PROs results and secondary endpoints were also confirmed as significant in the global population as sensitivity analysis (n=219 patients).

  • In advanced pancreatic ductal adenocarcinoma, a randomized non-comparative Phase II study of maintenance with Tedopi®, in monotherapy or in combination with nivolumab, or FOLFIRI after induction with FOLFIRINOX was presented by Dr. Anthony Turpin (Lille University Hospital, Lille, France). This presentation featured the first interim results from this Phase 2 clinical trial of Tedopi® in advanced or metastatic pancreatic cancer. The primary endpoint of the trial is the one-year survival rate (Fleming- futility analysis; null hypothesis <25%), and the key secondary endpoint was the Time to maintenance Strategy Failure (TSF= time maintenance + FOLFIRI reintroduction). The GERCOR oncology clinician group and the PRODIGE Intergroup, are sponsors of this study named TEDOPaM.

ESMO (September 2022)

  • A first analysis compared Tedopi® to the Standard of Care (SoC) in patients with advanced NSCLC after secondary resistance to sequential use of chemotherapy followed by immunotherapy (CT-IO).

The results have shown that in advanced HLA-A2+ NSCLC patients with IO secondary resistance after sequential CT-IO (n=118), overall survival (OS) was longer with Tedopi® versus SoC regardless of the use (or not) of post progression anticancer treatment (with 13.5 months versus 10.6, HR=0.71; without 6.3 months versus 4.5, HR=0.76).

  • A second analysis assessed the overall benefit/risk of Tedopi® versus SoC chemotherapy in patients with NSCLC who failed therapy with immune checkpoint inhibitors. The Net Treatment Benefit (NTB), a new statistical method combining efficacy, safety and quality of life, was assessed in the overall population (n=219). NTB of Tedopi® was of 19% and reached statistical significance (p=0.035).

BI 765063, a myeloid checkpoint inhibitor being developed in partnership with Boehringer Ingelheim

  • In May 2022, the initiation of the Phase 1 clinical expansion trial with BI 765063 sponsored and conducted by Boehringer Ingelheim triggered a €10 million milestone payment from Boehringer Ingelheim to OSE Immunotherapeutics. The trial is being conducted in advanced hepatocellular carcinoma and head and neck cancer patients in combination, in particular with anti-PD-1 antibody ezabenlimab.

VEL-101/FR104, a monoclonal antibody antagonist of CD28 developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation

  • In January 2022, Veloxis obtained acceptance of the IND from the Food & Drug Administration (FDA) for a clinical trial with VEL-101/FR104 sponsored and conducted by Veloxis in the US. Based on the global license agreement signed in April 2021, this first milestone triggered a €5 million payment from Veloxis to OSE
    Immunotherapeutics.
  • In February 2022, Veloxis obtained Fast Track Designation from the FDA for VEL-101/FR104 being developed for prophylaxis of renal allograft rejection in recipients of kidney transplants.
  • In May 2022, dosing of the first participant in the Phase 1 occurred.

CoVepiT, a prophylactic vaccine candidate against COVID-19: Positive long-term immune T cell memory responses

  • In March 2022, positive long term immunological results at 6 months induced by CoVepiT in healthy volunteers with strong T cell memory responses against virus proteins were announced. In parallel, the resolution of local indurations related to T cell mechanism of action and the good safety profile were confirmed.
  • However, new treatments like monoclonal antibodies or anti-viral treatments and new vaccines covering emerging variants are already available for targeted immunocompromised patients. Given these new therapeutic alternatives and multiple boosters recommended for these patients, additional clinical development of CoVepiT is made difficult. The Company's strategy is now to select the most relevant peptides allowing for an easier industrial scale-up to be ready at the request of Health Authorities for any new pandemic crisis with a novel variant.

R&D PROGRAMS IN IMMUNOTHERAPY

BiCKI®-IL-7, a novel bispecific therapy combining anti-PD-1 and the cytokine IL-7

  • Presentation at the American Association for Cancer Research (AACR) in April 2022: Update on the advancements made with BiCKI®-IL-7 in an oral session dedicated to an overview of the novel trends in cytokine immunotherapy. This presentation highlighted the differentiation of the novel bispecific therapy

combining anti-PD1 and IL-7 cytokine and positioned it as a high potential asset for cancer patients suffering from immune escape following checkpoint inhibitor treatments.

New myeloid checkpoint target CLEC-1* (a C type lectin receptor) and first monoclonal antibody antagonists

of CLEC-1 blocking the "Don't Eat Me" signal

  • Presentations at the Immuno-Oncology Summit Europe in May 2022 and Tumor Myeloid-Directed Therapies Summit in June 2022:
    • CLEC-1,a novel checkpoint to regulate the antigen cross-presentation properties of dendritic cells.
    • The identification and validation of novel immune checkpoint targets and development of their antagonists as an innovation in cancer immunotherapy to enhance myeloid cells and promote antigen presentation to bridge the innate and adaptative immune system.
    • How the SIRPα-CD47 axis stimulates macrophages to recruit the adaptive immune arm via chemoattraction, and inhibition of this pathway may avoid T cell exclusion in synergy with T cell immune checkpoint and clinical translation.

*Collaborative program between OSE Immunotherapeutics and Dr Elise Chiffoleau's (https://cr2ti.univ-nantes.fr/research/team-1)research teams (Center for Research in Transplantation and Translational Immunology (CR2TI), UMR1064, INSERM, Nantes University at Nantes University Hospital).

A strong intellectual property (IP) with a broad scope to strengthen candidates' position in our portfolio

  • Three new patents granted: in January 2022, a Japanese patent for use of Tedopi® after failure with PD-1 or PD-L1 immune checkpoint inhibitor treatment in HLA-A2 positive cancer patients, until 2037; in March 2022, a US patent for OSE-279 and its use in cancer treatment, until 2039; in May 2022, a European patent covering CLEC-1, novel myeloid immune checkpoint target for cancer immunotherapy, until 2037.

H1 2022 RESULTS

The key figures of the 2022 consolidated half-year results are reported below:

In k€

June 30, 2022

June 30, 2021

Operating result

(3,425)

(11,580)

Net result

(1,979)

(11,488)

In k€

June 30, 2022

December 31, 2021

Available cash

31,193

33,579

Consolidated balance sheet

102,266

101,876

As of June 30, 2022, available cash amounted to €31 million, giving a financial visibility until Q3 2023.

During the first half of 2022, OSE Immunotherapeutics secured:

  • €10 million milestone payment as part of the global collaboration and license agreement with Boehringer
    Ingelheim for BI 765063, a SIRPα inhibitor on the SIRPα/ CD47 myeloid pathway.
  • €5 million milestone payment as part of the license agreement with Veloxis Pharmaceuticals Inc. for
    VEL-101/FR104,anti-CD28, in transplant indications.

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OSE Immunotherapeutics SA published this content on 22 September 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 22 September 2022 16:09:07 UTC.