Genmab CEO Jan van de Winkel, PhD

Genmab wrapped up an eventful week on Friday as the Danish biotech launched an up to $200 million-per-product cancer therapy collaboration with BliNK Biomedical, and raised $503 million through an American initial public offering (IPO).

Genmab has signed an exclusive commercial license for BliNK Biomedical antibodies targeting CD47, which Genmab plans to combine with its DuoBody® Platform technology to create new cancer-fighting bispecific antibodies.

“CD47 has shown potential as a target for cancer and we believe that a bispecific approach may open up potential for differentiated therapies,” Genmab CEO Jan van de Winkel, PhD, said in a statement.

Based in Marseille, France, privately-held BliNK Biomedical focuses on discovery and development of therapeutic antibodies in oncology and immuno-oncology.

Genmab agreed to pay BliNK Biomedical $2.25 million upfront, and up to $200 million-per-product tied to achieving development, regulatory, and commercial milestones. BliNK Biomedical is also eligible for tiered royalties on net sales.

The collaboration with BliNK Biomedical reflects one of Genmab’s priorities as stated in its prospectus for the U.S. IPO: “Advancing our pipeline of differentiated and well-tolerated antibodies.”

Genmab’s pipeline includes five proprietary product candidates in clinical development, and approximately 20 proprietary and partnered preclinical programs, including two proprietary product candidates for which the company has either submitted or intends to submit an IND application to the FDA, and/or a clinical trial application (CTA) to the European Medicines Agency in 2019.

Among Genmab’s proprietary antibody candidates are HexaBody-DR5/DR5 (GEN1029), for which the company dosed its first patient in a Phase I/II clinical in May 2018; and DuoBody-CD3xCD20 (GEN3013), for which the first patient was dosed in a Phase I/II study of a subcutaneous formulation for the treatment of B-cell malignancies in July 2018.

Another proprietary candidate is the Genmab-owned Enapotamab vedotin (HuMax®-AXL-ADC), which is in Phase I/II development for multiple types of solid tumors: ovarian, cervical, endometrial, thyroid, non-small cell lung cancer, melanoma, and sarcoma. Enapotamab vedotin is an antibody-drug conjugate (ADC) targeted to Axl (from anexelekto, or uncontrolled growth), using ADC technology licensed from Seattle Genetics.

Together with Seattle Genetics, Genmab is developing another clinical candidate, tisotumab vedotin, which is in Phase II in cervical cancer, ovarian cancer, and solid cancers. Tisotumab vedotin is an ADC targeted to tissue factor (TF), a protein involved in tumor signaling and angiogenesis.

$472.6M in net proceeds

The partnership with BliNK Biomedical was announced three days after Genmab launched its initial offering of 27.8 million American Depositary Shares (ADSs), representing 2.7 million ordinary shares, at $18.11 per ADS on the NASDAQ Global Select Market under the symbol “GMAB.” That price is the U.S equivalent of Genmab’s closing share price July 5 on NASDAQ Copenhagen, where the company’s shares have been traded since 2000.

Genmab filed in May for the U.S. IPO.

In its amended prospectus, filed Tuesday, Genmab estimated it will generate approximately $472.6 million in net proceeds—a figure that would rise to approximately $543.9 million should the underwriters of its U.S. IPO exercise in full their option to purchase additional ADSs at the offering price.

“We intend to use the net proceeds from this offering to continue the development of our proprietary product candidates, to continue our pre-commercial activities, to continue building our commercial capabilities and to advance earlier stage product candidates,” Genmab stated.

Genmab said it would use approximately $100 million of its net proceeds to advance tisotumab vedotin to commercialization in recurrent and/or metastatic cervical cancer; advance tisotumab vedotin in other solid tumor indications; and “continue building our commercial capabilities in connection with the potential future approval of tisotumab vedotin.”

The largest share of net proceeds, approximately $275 million, will fund development of the company’s earlier stage clinical and preclinical programs, Genmab said. These include:

  • The ongoing Phase I/II clinical trial of HexaBody-DR5/DR5 for the treatment of solid tumors;
  • The ongoing Phase I/II clinical trial of DuoBody-CD3xCD20 for the treatment of B-cell malignancies;
  • Ongoing development of enapotamab vedotin in various solid tumor indications;
  • The launch and conduct of Phase I/II clinical trials following submission of INDs and/or CTAs in 2019 for DuoBody-PD-L1x4-1BB, DuoBody-CD40x4-1BB, and DuoHexaBody-CD37.

First patient dosed

DuoBody-PD-L1x4 (GEN1046) and DuoBody-CD40x4-1BB are solid tumor candidates being developed with BioNTech.

On June 17, BioNTech said the first patient was dosed in a Phase I/IIa trial of DuoBody-PD-L1x4, indicated for patients with metastatic or unresectable malignant solid tumors, who are not candidates for standard therapy.

DuoBody-PD-L1x4 combines Genmab’s DuoBody technology platform and PD-L1 antibody with BioNTech’s 4-1BB antibody. DuoBody-PD-L1x4 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.

DuoBody-CD40x4-1BB is a bispecific antibody designed to target CD40 and 4-1BB (CD137) using an inert Fc backbone that Genmab created with BioNTech using the DuoBody platform and BioNTech’s CD40 and 4-1BB antibodies.

DuoHexaBody-CD37 is a bispecific immunoglobulin G 1 (IgG1) with an E430G hexamerization-enhancing mutation in the IgG Fc domain created with the DuoHexaBody platform. According to Genmab, DuoHexaBody-CD37 is designed to target two non-overlapping epitopes on CD37.

Also in its prospectus, Genmab restated its goal of launching its own proprietary product by 2025. The company now markets two treatments co-developed with partners. One is Darzalex® (daratumumab), the first human CD38 mAb to reach the market and the first mAb to receive FDA approval to treat multiple myeloma, developed with and marketed by Johnson & Johnson’s Janssen Biotech. The other is Arzerra® (ofatumumab) for certain indications of chronic lymphocytic leukemia, developed with and marketed by Novartis.

On Monday, Genmab reported positive topline data from its Phase II GRIFFIN (MMY2004) trial (NCT02874742) showing that transplant eligible, newly-diagnosed patients with multiple myeloma treated with Darzalex® in combination with lenalidomide, bortezomib, and dexamethasone met the study’s primary endpoint.

A higher percentage of stringent complete responses, 42.4%, was shown by patients in the Darzalex arm compared with 32.0% of patients who received Celgene’s Revlimid® (lenalidomide), the Takeda Pharmaceutical/Janssen Biotech (Johnson & Johnson) co-marketed Velcade® (bortezomib), and dexamethasone alone, Genmab said.

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