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IO Biotech Completes Oversubscribed EUR 127 Million Series B Financing to Accelerate Clinical Programs in Oncology

Copenhagen, Denmark – January 13, 2020:  IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune-modulating anti-cancer therapies based on its proprietary T-win® technology, announced today that it has raised EUR 127 million in Series B financing. The financing round was led by HBM Healthcare Investments, and other new investors joining the round included Vivo Capital, Kurma Partners, Avoro Capital, RA Capital Management, Samsara Biocapital, Idinvest Partners1, PFM Health Sciences, Soleus Capital, Eir Ventures and Serrado Capital, with the participation of existing investors Novo Seeds, Lundbeckfonden Emerge and Sunstone Life Science Ventures. Additionally, Dr. Priyanka Belawat of HBM Partners, Jack B. Nielsen of Vivo Capital and Vanessa Malier of Kurma Partners will join IO Biotech's board of directors as part of the closing of the financing.

On December 15, 2020, the U.S. Food and Drug Administration (FDA) granted IO Biotech breakthrough therapy designation for a combination of the potential therapies IO102 and IO103 with anti-PD-1 monoclonal antibodies for patients with unresectable or metastatic melanoma. IO Biotech intends to use the net proceeds of the transaction towards the funding of clinical trials for its early and late-stage immuno-oncology programs, including a large randomized trial for IO102 and IO103 with anti-PD-1 monoclonal antibodies in metastatic melanoma.

“We are excited to have such a strong group of investors backing our company at this stage, and I am proud that this financing round had such high interest and can close oversubscribed," said Mai-Britt Zocca, PhD, Chief Executive Officer, and founder of IO Biotech. “The funding will enable us to execute on our breakthrough therapy designation grant and advance our lead programs in late-stage clinical development, as we are committed to bringing our treatment to patients as soon as possible.”

“HBM is excited to be joining IO Biotech as a shareholder. IO Biotech offers a unique treatment modality in oncology, harnessing novel immunomodulatory mechanisms through proprietary vaccine candidates. The financing will help the company bring forward its promising clinical and pre-clinical pipeline closer to the patients in medical need,” said Dr. Priyanka Belawat, Investment Advisor at HBM Partners.

“IO Biotech is building a significant immunotherapy pipeline based on compelling scientific and clinical validation. On behalf of existing investors, I warmly welcome the new investors to the company,” said Christian Elling, Managing Partner at Lundbeckfonden Emerge. “Together we can accelerate the development of the company’s unique breakthrough cancer medicines to the benefit of patients and physicians”.

About IO102 and IO103
IO102 and IO103 are IO Biotech’s lead immuno-oncology candidates. Both compounds are based on IO Biotech’s proprietary T-win® technology platform which enables the identification of compounds with a dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses without adding additional safety concern. Specifically, IO102 and IO103 are first-in-class, immune modulatory vaccines designed to engage and activate IDO and PD-L1 specific human T-cells.

The FDA decision to grant breakthrough therapy designation was based on data from the MM1636 Phase 1/2 clinical trial of 30 patients with metastatic melanoma receiving IO102, IO103 and anti-PD-1 monoclonal antibodies. According to the data recently presented in a late-breaking abstract at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, the combination of IO102 and IO103 vaccines and nivolumab was shown to be safe with encouraging early efficacy data; an overall response rate (ORR) of 79 percent was reached and 45 percent of patients achieved a complete response (CR), or complete disappearance of their tumors. Vaccine specific T-cells were located in the peripheral blood mononuclear cells (PBMCs) and at the tumor site.

About IO Biotech
IO Biotech is a clinical stage biotech company developing disruptive immune therapies for the treatment of cancer. The pipeline of first-in-class immune modulating anti-cancer therapies is developed by a unique technology platform, T-win®, enabling the activation of T cells that are specific for immune-suppressive molecules. IO Biotech has a proven track record of progressing preclinical and clinical compounds. The two lead compounds targeting IDO and PD-L1 are in clinical development and several pipeline compounds are in pre-clinical phase. For further information, please visit www.iobiotech.com.

Contacts
Mai-Britt Zocca, PhD, CEO and founder of IO Biotech       E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Media Inquiries
Jennifer Williams, Cook Williams Communications, Inc.    E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

1) Subsidiary of Eurazeo

The Food and Drug Administration (FDA) grants IO Biotech breakthrough therapy designation for IO102 and IO103 in combination with anti-PD-1 in unresectable/metastatic melanoma

Copenhagen, Denmark – December 15, 2020:  IO Biotech today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a combination of the potential therapy IO102 and IO103 with anti-PD-1 mAb for patients with unresectable/ metastatic melanoma.

IO102 and IO103 are IO Biotech’s lead immuno-oncology candidates. Both compounds are based on IO Biotech’s proprietary T-win® technology platform which enables the identification of compounds with a dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses without adding additional safety concern. Specifically, IO102 and IO103 are first-in-class, immune modulatory vaccines designed to engage and activate IDO and PD-L1 specific human T-cells.

The FDA decision to grant breakthrough therapy was based on data from the MM1636 Phase 1/2 clinical trial with 30 patients with metastatic melanoma receiving IO102, IO103 and anti-PD-1. According to the data recently presented in a late-breaking abstract at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, the combination of IO102 and IO103 vaccines and nivolumab was shown to be safe with encouraging early efficacy data; an overall response rate (ORR) of 79 percent was reached and 45 percent of patients achieved a complete response (CR), or complete disappearance of their tumors. Vaccine specific T-cells were located in the peripheral blood mononuclear cells (PBMCs) and at the tumor site.  

“A breakthrough designation is an expedited program in which FDA will work closely with IO Biotech to provide guidance on subsequent development of “Synthetic Peptide Vaccines (IO103) Encoding Human PD-L1 (9-27) and (IO102), targeted to IDO, Indoleamine 2,3-dioxygenase and anti-PD-1" for treatment of unresectable/metastatic melanoma, including providing advice on generating evidence needed to support approval of the drug in an efficient and potentially expedited manner"," said Mai-Britt Zocca, PhD, Chief Executive Officer and founder of IO Biotech. “This is an important achievement for IO Biotech’s clinical program and we are committed to bring this forward to patients as soon as possible.”

About MM1636 trial
The MM1636 trial is an investigator-initiated trial at the Copenhagen University Hospital, Herlev which entered 30 patients with metastatic melanoma. In this Phase 2 clinical trial, patients were treated with IO Biotech’s multi antigen vaccine, IO102-IO103 in combination with anti-PD-1 antibody, as first line treatment. IO102-IO103 are administered every second week until 12 weeks and thereafter every fourth week up to one year. The trial objectives are to assess safety, immune responses in blood and biopsies as well as efficacy.

About Melanoma
Globally, about 290,000 new cases of cutaneous melanoma, the most aggressive type of skin cancer, are diagnosed and annually more than 60,000 will die (Bray et al. 2018). The incidence of cutaneous melanoma is increasing (Forman et al. 2014) and advanced melanoma (unresectable or metastatic) will have a fatal outcome if left untreated. The median overall survival (OS) in patients with stage IV melanoma (untreated or treated with BRAF inhibitor and MEK inhibitor) is between 22-25 months and a 3-5-year OS is around 40% (Ascierto et al. 2016; Long et al. 2017).

Therefore, there is a clear unmet need for improved combination therapies enhancing anti-PD-1 efficacy without a significant increase in toxicity.

About IO Biotech
IO Biotech is a clinical stage biotech company developing disruptive immune therapies for the treatment of cancer. The pipeline of first-in-class immune modulating anti-cancer therapies is developed by a unique technology platform, T-win®, enabling the activation of T cells that are specific for immune-suppressive molecules. IO Biotech has a proven track record of progressing preclinical and clinical compounds. The two lead compounds targeting IDO and PD-L1 are in clinical development and several pipeline compounds are in pre-clinical phase. For further information, please visit www.iobiotech.com.

Contacts
Mai-Britt Zocca, PhD, CEO and founder of IO Biotech       E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. 

IO Biotech Announces First Patient Dosed in Phase 2 Trial in Head and Neck Cancer Conducted in a Collaboration with Cliniques Universitaires Saint-Luc in Belgium

Copenhagen, Denmark – November 4, 2020: IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune modulating anti-cancer therapies based on its proprietary T-win® technology, announced that the first patient has received the first dose in a Phase 2 study (HN1901) investigating activity and safety of peptide-based immunotherapy in the preoperative setting for in-patients with squamous cell carcinoma of the head and neck (SCCHN). The study is being conducted in collaboration with Cliniques universitaires Saint-Luc in Brussels and is designed as an umbrella trial enabling the testing of several of IO Biotech’s compounds after initial testing of IO102 in a monotherapy setting.

“We are very happy to start this interesting study that will help us to improve our knowledge in immunotherapy for head and neck cancer patients,” said Professor Jean-Pascal Machiels, MD, PhD.

“We are excited to start this collaboration led by Professor Jean-Pascal Machiels from Institut Roi albert II Cancer Center of Cliniques universitaires Saint-Luc in Brussels,” said Mai-Britt Zocca, PhD, Chief Executive Officer and founder at IO Biotech. “This study will enable IO Biotech to further validate our technology in a new indication, SCCHN, and broaden our scope to a third indication within solid tumors beyond non-small cell lung cancer (NSCLC) and melanoma.”

IO Biotech’s lead candidate, IO102, is an Indoleamine 2,3-dioxygenase (IDO) derived immune modulating therapy with a dual mode of action-killing both cancer cells and immune-suppressive cells. IO Biotech’s IDO-derived immune modulating therapies have previously demonstrated both a favorable safety profile and promising anti-tumor activity in its first human clinical trial of heavily pre-treated patients with NSCLC.

About the Study
HN1901
is an open-label, randomized, Phase 2, window of opportunity trial investigating immunological changes in tumor and antitumor activity of vaccine-based immunotherapy in the pre-operative setting of patients with squamous cell carcinoma of the head and neck (SCCHN). This clinical trial is planned to sequentially test IO Biotech’s proprietary immune modulatory vaccines as monotherapy and as multi antigene vaccines at the Cliniques universitaires Saint-Luc in Brussels.

About SCCHN
Squamous cell carcinoma of the head and neck (SCCHN) is one of the most common tumor types worldwide and accounts for more than 550,000 new cases and 380,000 deaths per year. The five-year survival rate for patients suffering from locally advanced head and neck cancer is estimated between 40 and  60 percent depending on the anatomical location of the primary tumor.
IO Biotech is currently conducting studies with T-Win® compounds in combination with Pembrolizumab and Nivolumab, both of which are approved for SCCHN.

About T-win® Technology Platform
IO Biotech’s proprietary T-win technology platform enables identification of compounds with a dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses.  The company’s compounds are administered as “off-the-shelf” subcutaneous injections, distinguishing these treatments from many immuno-oncology therapies.

About IO Biotech 
IO Biotech is a clinical stage biotech company developing disruptive immune therapies for the treatment of cancer. The pipeline of first-in-class immune modulating anti-cancer therapies is developed by a unique technology platform, T-win®, enabling the activation of T cells that are specific for immune-suppressive molecules. IO Biotech has a proven track record of progressing preclinical and clinical compounds. The two lead compounds targeting IDO and PD-L1 are in clinical development and several pipeline compounds are in pre-clinical phase. For further information, please visit www.iobiotech.com.

Contacts
Mai-Britt Zocca, PhD, CEO and founder of IO Biotech       E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.