IO Biotech raises $155m to develop breakthrough cancer vaccine

IO Biotech, an oncology specialist formed and backed by Denmark’s Novo Holdings, has raised €127 million ($155 million) to further develop its cancer vaccine technology that has boosted efficacy of PD-1 immunotherapy in early trials.

The Series B fundraiser follows the FDA’s decision to grant Breakthrough Therapy designation last month for a combination of its lead immune-oncology therapies IO102 and IO103, with anti-PD-1 monoclonal antibodies for patients with metastatic melanoma.

IO Biotech intends to use the proceeds from the financing to advance clinical trials for its early and late-stage immune-oncology programs, including a large randomised trial for the IO102 and IO103 with anti-PD-1 combination in metastatic melanoma.

IO102 and IO103 are cancer first-in-class vaccines based on IO Biotech’s proprietary T-win technology platform.

The company said this enables the identification of compounds with a dual mechanism of action targeting and killing immunosuppressive cells and tumour cells while indirectly activating other T-effectors.

They are designed to engage and activate IDO and PD-L1 specific human T-cells, which leads to strong anti-tumour responses without adding additional safety concern.

The FDA’s 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  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% was reached and 45% of patients achieved a complete response (CR), or complete disappearance of their tumours. Vaccine specific T-cells were located in the peripheral blood mononuclear cells (PBMCs) and at the tumour site.

The financing round was led by HBM Healthcare Investments with the participation of existing investors Novo Seeds, Lundbeckfonden Emerge and Sunstone Life Science Ventures.

Other new investors joining the round included Vivo Capital, Kurma Partners, Avoro Capital, RA Capital, Samsara Biocapital, Idinvest Partners (Subsidiary of Eurazeo), PFM Health Sciences, Soleus Capital, Eir Ventures and Serrado Capital.

IO biotech was created and launched by Novo Seeds in 2015, which is the investment arm of Novo Holdings, a private company wholly owned by the Novo Nordisk Foundation.

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Regeneron pairs with BioNTech on melanoma immunotherapy

Regeneron and Sanofi’s PD-1 inhibitor Libtayo will be tested in tandem with a cancer vaccine developed by BioNTech in melanoma in people who have failed treatment with other checkpoint inhibitors.

The two companies will carry out a phase 2 trial of Libtayo (cemiplimab) alongside BioNTech’s mRNA cancer immunotherapy BNT111, which is designed to stimulate immune responses against four cancer-related antigens: NY-ESO-1, MAGE-A3, tyrosinase, and TPTE.

The recruitment of BioNTech as a partner in melanoma comes after Regeneron and Sanofi decided to abandon development of Libtayo with their recently-approved anti-CD38 drug Sarclisa (isatuximab) in that indication.

Melanoma was the first cancer to be targeted by the checkpoint inhibitor class several years ago when Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck & Co/MSD’s Keytruda (pembrolizumab) were both approved as second-line treatments for the disease within a few weeks of each other.

Since then, PD-1/PD-L1 inhibitors have moved into the first-line setting, and at the moment the combination of Opdivo and BMS’ CTLA4 inhibitor Yervoy (ipilimumab) – another immune checkpoint inhibitor – has become the go-to therapy for many oncologists.

The problem is that while 30% to 40% of melanoma patients get a long-lasting response to checkpoint inhibitor therapy, in the majority the drugs either don’t work at all or lose their potency over time allowing the cancer to come back.

Regeneron and BioNTech are hoping that adding BNT111 to anti-PD-1 therapy with Libtayo will overcome the resistance mechanisms that are present in some tumours, and increase the proportion of patients who respond to immunotherapy.

The phase 2 trial will recruit patients with advanced melanoma that can’t be treated with surgery who are refractory to or have relapsed after PD-1 drugs, and the costs of running it will be shared by the two partners. It is due to start before the end of the year.

“The combination of Libtayo and BNT111…has the potential to augment the immune system’s ability to effectively recognise melanoma in multiple ways and hopefully improve immune targeting to control the cancer,” commented Regeneron’s head of translational science and oncology Israel Lowy.

Libtayo was a late entrant into the PD-1/PD-L1 inhibitor market and while it has been able to carve out a small niche in cutaneous squamous cell carcinoma (CSCC), another form of skin cancer, it’s still a bit player.

Sanofi reported ex-US sales of €27 million ($32 million) for Libtayo in the first half of this year. Regeneron records US sales, but isn’t due to report its second quarter until later this week. It made just under $62 million from the drug in the first quarter.

The two partners are hoping to grow the drug with new indications such as basal cell carcinoma – another form of skin cancer – and non-small cell lung cancer (NSCLC), although they will face still competition in the latter from Merck’s market leader Keytruda.

Meanwhile, BNT111 is the lead candidate in BioNTech’s FixVacc cancer vaccines programme, which dominates its pipeline despite the recent close attention to the German biotech’s coronavirus candidate, partnered with Pfizer.

It is one of five FixVacc vaccines in early-stage clinical testing, along with candidates for prostate, head and neck,  ovarian and triple-negative breast cancer.

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Roche’s Tecentriq claims melanoma OK, but don’t expect a sales surge

Roche’s checkpoint inhibitor Tecentriq has been cleared for another new use in the US – in melanoma – but could struggle to displace rival drugs from Bristol-Myers Squibb and Merck & Co.

The FDA has approved the PD-L1 inhibitor as a combination with two targeted drugs – MEK inhibitor Cotellic (cobimetinib) and BRAF inhibitor Zelboraf (vemurafenib) – as a first-line treatment for patients with advanced melanoma with BRAF V600 mutations.

The approval stems from the IMspire150 trial, which showed that the triplet therapy reduced the risk of disease progression or death compared to Cotellic, Zelboraf and placebo.

The median progression-free survival (PFS) was 15.1 months in the Tecentriq (atezolizumab) group compared with 10.6 months, although objective response rates in the two groups were similar at 66% and 65%, respectively.

That’s a solid result, and a compelling comparison to make when IMspire150 was started three years ago. Unfortunately for Roche, melanoma treatment has evolved in the interim and the standard of care for these patients has moved on.

BMS’ Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) have been approved for use in melanoma since 2014, and right now the combination of Opdivo with BMS’ CTLA4-targeting checkpoint inhibitor Yervoy (ipilimumab) looks set to become the go-to therapy in the US.

Opdivo/Yervoy was cleared for BRAF V600-positive melanoma in 2015, and for all-comer melanoma patients the following year, giving oncologists years of experience with its use and – crucially – plenty of impressive follow-up data.

Last year, BMS reported updated results from the CheckMate-067 study showing that 52% of patients on the regimen were still alive five years later, with the benefit present even in patients who stopped taking the drugs early due to side effects.

Over the same period, Cotellic sales have shrunk from around $400 million to a little over $50m last year as immunotherapy displaced targeted therapy in this type of melanoma.

That said, there are tolerability issues with Opdivo/Yervoy that could encourage some doctors to consider the Tecentriq triple for their BRAF V600-positive patients. Overall however, melanoma is considered to be a nice addition to Tecentriq’s approved indications that won’t be a big driver for new sales.

That’s more likely to come from other new indications for Roche’s drug, including new approvals as a monotherapy and in combination with chemotherapy in previously-untreated non-small cell lung cancer (NSCLC) and as a combination with Roche’s Avastin (bevacizumab) in liver cancer.

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Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Shots:

  • The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma
  • Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was consistent with the known safety profiles of the individual medicines. The review was conducted under Project Orbis
  • Tecentriq is a mAb targeting PD-L1, acts by blocking is its interactions with both PD-1 and B7.1 receptor. Cotellic is a MEK1/2 inhibitor in a cell signaling pathway that helps control cell growth and survival while Zelboraf is a prescription medicine for melanoma that has spread to other parts of the body or cannot be removed by surgery and has a BRAF V600 mutation

Click here ­to­ read full press release/ article | Ref: Roche | Image: StraitTimes