BioNTech chief business officer and chief commercial officer Sean Marett

BioNTech said today it has completed a $325 million Series B financing, with proceeds to be used not only toward advancing its pipeline of immuno-oncology candidates, but adding to its manufacturing capacity and exploring an expanded global footprint as well.

Based in Mainz, Germany, BioNTech has brought its total capital raised to $1.4 billion through the latest financing, about $400 million above what the company had raised when it was ranked GEN’s top privately-held company in the A-List of Top 10 RNA-Based Biopharmas of 2018, published December 17, 2018.

BioNTech’s Series B financing attracted a syndicate of investors that included the company’s first from the Asia-Pacific region. Among new investors were Shanghai-based BVCF Management; Hong Kong-based Jebsen Capital; MiraeAsset Financial Group, headquartered in Seoul; and Platinum Asset Management, based in New South Wales, Australia.

“We want to build a global company, and therefore, it’s important for us to be able to have investors from all parts of the world, where we believe there’s an importance in having those investors,” BioNTech chief business officer and chief commercial officer Sean Marett told GEN. “We don’t have an Asian partnership currently. We’re not present in Asia in any form whatsoever. Yet if you just look at China, it’s the second largest healthcare market now. [The series B financing] does allow us to further explore options for that part of the world, from a corporate perspective.”

Fidelity Management & Research Co. led the upsized Series B financing, one of the largest single private funding rounds for a biotech company in European history. The financing comes 18 months after BioNTech garnered $270 million in a Series A led by Redmile Group of San Francisco.

Joining Redmile and the Asia-Pacific investors in the Series B were Invus, Steam Athena Capital, and the Struengmann Family Office.

Marett said proceeds from the financing will also help BioNTech expand its manufacturing capabilities. The company is adding a second cell and gene therapy manufacturing suite in Idar-Oberstein, Germany, about an hour’s drive southwest of Mainz; and is preparing to break ground later this year on an expanded peptide synthesis unit in Berlin.

The company is not yet disclosing expanded capacity figures for the new facilities.

Seven candidates, eight trials

Marett said the financing will especially help BioNTech advance its pipeline, which includes seven candidates in eight clinical trials.

Most recently last month, BioNTech launched a first-in-human Phase I/IIa study of the bispecific antibody DuoBody®-PD-L1x4-1BB being developed jointly with Genmab, indicated for patients with metastatic or unresectable malignant solid tumors, who are not candidates for standard therapy.

DuoBody-PD-L1x4-1BB is designed to enhance the proliferation of activated T cells to efficiently target cancer cells by combining checkpoint blockade of the inhibitory PD-1:PD-L1 signaling axis with conditional stimulation of T cells by activation of the 4-1BB receptor. It is the first product candidate from the companies’ worldwide 50% cost-sharing 50% profit-sharing collaboration to enter the clinic since the companies launched their partnership in 2015.

“There is another program that’s in the preclinical phase, and if all goes well, we hope to be in the clinic with that as well,” Marett said, referring to a CD40-targeting potential next-generation checkpoint immunomodulator program.

In May, BioNTech acquired the Phase I lead candidate of MabVax Therapeutics, MVT-5873, as well as other preclinical antibody assets for an undisclosed price. The deal was designed to expand and complement BioNTech’s antibody portfolio and RiboMABS® platform for generating a novel class of mRNA-encoded antibody drug candidates.

MVT-5873 is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), an epitope expressed in pancreatic and other GI cancers that plays a role in tumor adhesion and metastasis formation.

Antibody development is one of BioNTech’s priorities. Back in January, the company acquired the operational antibody generation unit of MAB Discovery for an undisclosed price, in a deal that built on two collaborations by the companies stretching back nearly six years.

Furthest along of BioNTech’s pipeline candidates is the individualized neoepitope-specific immunotherapy RO7198457 partnered with Genentech, a member of the Roche Group, in advanced melanoma. RO719457 is under study in a Phase II trial alone and with Merck & Co.’s Keytruda® (pembrolizumab) (NCT03815058). BioNTech and Genentech are also running a Phase I/Phase II basket trial in multiple solid tumor indications, alone and with Genentech’s Tecentriq® (atezolizumab) (NCT03289962).

Genentech and BioNTech agreed to develop, manufacture, and commercialize novel messenger RNA (mRNA)-based, individualized cancer vaccines when they launched a potentially $310 million-plus collaboration in 2016.

Three mRNA platforms

The Genentech programs apply one of three mRNA platforms that BioNTech has moved into the clinic, all using pharmacologically optimized protein coding mRNA with targeted in vivo delivery.

On its own, BioNTech is developing its FixVAC® or fixed vaccine combination or shared tumor-associated antigens against cancer for numerous cancer indications, three of which have advanced to Phase I: advanced melanoma (adjuvant and metastatic), HPV+ head and neck cancer; and a triple negative breast cancer program. “We will progress those, and bring others into the clinic,” Marett said

BioNTech has also partnered with Sanofi to develop SAR441000, an intratumoral immunotherapy that has begun a Phase I trial (NCT03871348) in multiple undisclosed solid tumors, alone and in combination with Regeneron Pharmaceuticals’ Libtayo® (cemiplimab). Sanofi in January made an €80 million (approximately $90 million) equity investment in BioNTech, in an extension of a collaboration launched in 2015 that included an agreement to co-develop the first cancer immunotherapy candidate from the collaboration.

Sanofi is one of numerous partners with which BioNTech has established collaborations. The company is partnering with Pfizer on developing vaccines for seasonal flu, and with the University of Pennsylvania on a strategic research collaboration designed to help the partners develop novel nucleoside-modified mRNA vaccine candidates to prevent and treat various infectious diseases.

Last year, BioNTech teamed up with Genevant to develop five mRNA therapeutic programs for rare diseases with high unmet medical need—part of Genevant’s effort to have 5 to 10 clinical programs by 2020 across RNAi, mRNA, and gene editing modalities.

“We’re hoping to see something with Genevant in late 2020 in terms of being in the clinic,” Marett said.

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