On October 11, 2016 Kymab, a leading human monoclonal antibody biopharmaceutical company, and EpimAb Biotherapeutics, an emerging biopharmaceutical company specializing in bispecific antibodies, reported a cross-licensing and development agreement to develop bispecific therapeutic antibodies against multiple targets (Press release, EpimAb Biotherapeutics, OCT 11, 2016, View Source [SID:SID1234515754]). The parties will focus their efforts on immuno-oncology and will combine EpimAb’s proprietary Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to generate multiple bispecific antibodies combined with antibodies sourced from Kymab’s proprietary Kymouse platform. Kymab will have the development and commercialization rights to these bispecifics in all geographical regions outside of China, and, under the terms of the cross license agreement, EpimAb will have the rights for the China market. Each party is eligible to receive milestone payments and royalties for development programs pursued by the other party.

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"Today’s agreement with Kymab represents our first license agreement outside of China and we are looking forward to combining our complementary antibody technologies to create novel treatments for severe human diseases," said Dr. Chengbin Wu, CEO and founder of EpimAb. "Kymab’s expertise in generating world class antibodies specifically in the immuno-oncology area is a perfect strategic fit for EpimAb. The candidates from this collaboration will significantly strengthen EpimAb’s proprietary pipeline with highly innovative molecules."

"Bispecific antibodies have enormous potential to exploit our growing molecular and cellular understanding of the tumor microenvironment as it relates to immuno-oncology," said Dr. David Chiswell, CEO of Kymab. "This provides new opportunities to realize genuinely synergistic therapeutic activities and our collaboration with EpimAb will allow us to generate innovative bispecific molecules based on parental antibodies from our KymouseTM platform quickly and efficiently".
EpimAb’s innovative FIT-Ig technology offers a novel approach for generating bispecific antibodies, with the resulting molecules fully retaining the biological properties of their parental monoclonal antibodies without the need to significantly modify the basic structural elements of the bispecific antibody. FIT-Ig molecules generated to date have demonstrated excellent biological and pharmacological characteristics, as well as excellent physical-chemical properties. The combination of Kymab’s Kymouse human antibody discovery platform with the FIT-Ig technology will assure the highest probability of finding the best-in-class bispecific antibodies with highly attractive drug properties.

On October 11, 2016 Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of cancer, reported the expansion of its pipeline with CA-327, an oral, small molecule immune checkpoint antagonist targeting programmed death ligand-1 (PD-L1) and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3) (Press release, Curis, OCT 11, 2016, View Source [SID:SID1234515734]).

Curis licensed the PD-1/ TIM-3 antagonist program, and designated CA-327 as the development candidate, by exercising its option under the collaboration, license and option agreement established with Aurigene in January 2015. The collaboration is focused on the discovery, development and commercialization of small molecule drug candidates in the fields of immuno-oncology and selected precision oncology targets. The previous licensed programs within the collaboration include CA-170, a first-in-class oral, small molecule antagonist targeting PD-L1 and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints that is currently being studied in a Phase 1 trial in patients with solid tumors and lymphomas, and CA-4948, an oral small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 (IRAK4) that is completing IND-enabling studies.

In addition to targeting PD-L1, a negative regulator of immune activation, CA-327 also targets TIM-3, an inhibitory checkpoint molecule that plays an important role in immune suppression and is co-expressed with programmed cell death-1 (PD-1) receptors on exhausted cytotoxic T cells in tumor tissues as well as expressed on certain regulatory T cells.

The in-license of CA-327 comes three months after the collaboration’s first oral immuno-oncology program entered the clinic and less than a month after a $24.5M investment in Curis by Aurigene.

“We are pleased with the progress of our collaboration,” said Dr. Ali Fattaey, Curis’s CEO, “and look forward to working with our partner, Aurigene, to complete IND-enabling studies for CA-327 in the coming months and expect to file an IND in 2017.”

“We are delighted that our collaboration is advancing its third small molecule program in less than two years,” said CSN Murthy, Aurigene’s CEO. “We continue to work closely with Curis to focus our collective resources, creating and developing innovative drug candidates in the field of oncology, including multiple first-in-class oral small molecule checkpoint antagonists within immuno-oncology.”

On October 11, 2016 Heat Biologics, Inc. (Nasdaq:HTBX), reported that they have advanced their biomarker discovery collaboration with Adaptive Biotechnologies. Adaptive will use its patented immune profiling assay, immunoSEQ, to enable an in-depth characterization of the immune response to Heat’s ImPACT and ComPACT-based immunotherapies, including HS-410, Heat’s Phase 2 product candidate for non-muscle invasive bladder cancer (Press release, Heat Biologics, OCT 11, 2016, View Source [SID:SID1234515727]). The immunoSEQ Assay, when used to evaluate the mechanism of action of the ImPACT platform, provides a significant biomarker identification opportunity to better select patients and accelerate future enrollment based on immune status.

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"Previously reported data using Adaptive’s immunoSEQ Assay, demonstrated a trend between established anti-tumor immune responses and clinical outcomes with HS-410," stated Taylor Schreiber, M.D., Ph.D., Heat’s Chief Scientific Officer. "The Adaptive Assay allows us to quantify the clonality of a T-cell response generated by our ImPACT platform. Future work should continue to be fruitful as we advance our understanding of the patients that benefit most from treatment."