On September 15, 2020 Physicians at the University of California, San Diego (UCSD) School of Medicine and Cofactor Genomics, the company bridging the precision medicine gap, reported a partnership aimed at improving a physician’s ability to predict tumor response to immunotherapy, specifically in recurrent and metastatic squamous cell carcinoma of the head and neck (RM-HNSCC) (Press release, Cofactor Genomics, SEP 15, 2020, View Source [SID1234565148]). Guiding and prioritizing therapy selection is especially important given last year’s FDA approval of pembrolizumab as a first line treatment for RM-HNSCC. The partnership is championed by Ezra Cohen, MD, Chief of the Division of Hematology‐Oncology at the UCSD Moores Cancer Center, and leverages Cofactor’s recently-patented Predictive Immune Modeling technology.

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The current clinical care pathway for recurrent and metastatic head and neck cancer patients relies on using underpowered, antiquated technologies for treatment decisions. New tools that provide physicians with higher confidence in therapy selection are needed.

"Predicting tumor response prior to treatment is a necessary part of the precision medicine challenge," explained Dr. Cohen. "Working with immune checkpoint inhibitors, a class of therapies that are already approved and proven to work in a subset of patients, is a low-risk, high-reward approach."

The terms of the partnership include providing Cofactor Genomics with access to patient specimens and clinical metadata, a resource well-curated by the team at UCSD. The data generated in this collaboration will further expand clinical evidence presented earlier this year by Washington University physicians, where Cofactor’s technology showed superiority over the incumbent PD-L1 IHC assay in predicting responders to therapy.

"Cofactor is approaching diagnostic development in a number of ways that are unique. Integrating multiple immune signals into a single clinical decision simultaneously simplifies and expands how we leverage this information," noted Dr. Cohen.

Dr. Cohen is a global leader in this space, serving as Co-Director of the San Diego Center for Precision Immunotherapy, and leader of the Solid Tumor Therapeutics research program. He brings his expertise and an exceptional reputation in head and neck cancer research and patient care to solid tumor therapeutics. He has served as chair of the National Cancer Institute (NCI) Head and Neck Cancer Steering Committee (which oversees NCI-funded clinical research in this disease), currently chairs the SITC (Free SITC Whitepaper) Cancer Immunotherapy Guidelines Head and Neck Expert Panel, and previously served on the Board of the Head and Neck Cancer Alliance.

"The UCSD Moores Cancer Center is well-recognized as both a leader in clinical research, and perhaps more importantly, patient care," noted Natalie LaFranzo, PhD, Vice President of Market Development for Cofactor. "As Cofactor’s technology moves into clinical practice, partnerships with leaders in cancer care, such as Dr. Cohen, are an integral part of adoption."

Multidimensional biomarkers have been described by many, including the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Immune Biomarkers Task Force, as the ideal approach to obtaining a complete view of the tumor microenvironment, necessary for predicting immunotherapy response. Cofactor’s RM-HNSCC diagnostic development is the outcome of Predictive Immune Modeling, which leverages immune-specific multidimensional biomarkers. These biomarkers integrate the distinct differences in the tumor profile between the tumors of responders and non-responders to immunotherapy. RM-HNSCC is one of 16 indications approved for treatment with immune checkpoint inhibitors, the sum of which represents 50% of U.S. cancer cases annually. Predictive diagnostics are an integral part of achieving UCSD’s precision medicine goals, as supported by the Center for Personalized Cancer Therapy.

On September 15, 2020 Idera Pharmaceuticals, Inc. ("Idera") (Nasdaq: IDRA) reported that final data from the ILLUMINATE-204 trial investigating intratumoral tilsotolimod, Idera’s investigational Toll-like receptor 9 (TLR9) agonist, will be presented in a Mini Oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, to be held September 19-21, 2020 (Press release, Idera Pharmaceuticals, SEP 15, 2020, View Source [SID1234565174]). In addition, final results from ILLUMINATE-101 will be shared in a poster presentation.

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ILLUMINATE-204 is a multi-center, two-arm phase 1/2 trial in patients with anti-PD-1 refractory advanced melanoma. The phase 1 portion of the trial tested the safety and efficacy of increasing doses of tilsotolimod in combination with either Yervoy* (ipilimumab) or Keytruda† (pembrolizumab). The phase 2 expansion of the trial enrolled additional patients at the recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy, which is the treatment regimen being evaluated for the same indication in the Company’s registrational trial, ILLUMINATE-301. Adi Diab, M.D., of The University of Texas MD Anderson Cancer Center, will be delivering the Mini-Oral presentation as part of the Mini Oral Session on Melanoma and Other Skin Tumors.

ILLUMINATE-101 is a phase 1b trial evaluating intratumoral tilsotolimod monotherapy in patients with refractory solid tumors, which was completed in December 2019. Final results for ILLUMINATE-101 will be presented by Hani M. Babiker, M.D., of the University of Arizona Cancer Center.

In addition to presentations on these Idera-sponsored trials, AbbVie will be presenting a trial-in-progress poster on their phase 1b study to determine the safety, tolerability, pharmacokinetics, and preliminary efficacy of combinations of ABBV-368 plus tilsotolimod in subjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This trial is being conducted as part of an immuno-oncology clinical research collaboration between Idera and AbbVie.

The presentation titles are as follows:

1083MO: Final Results from ILLUMINATE-204, a Phase 1/2 Trial of Intratumoral Tilsotolimod in Combination with Ipilimumab in PD-1 Inhibitor Refractory Advanced Melanoma
1031P: Tilsotolimod Engages the TLR9 Pathway to Promote Antigen Presentation and Type I IFN Signaling in Solid Tumors
975TiP: Phase 1b Trial of ABBV-368 + Tilsotolimod in Combination With Nab-Paclitaxel and/or Budigalimab (ABBV-181) in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
The on-demand poster and oral presentations will be available beginning on Thursday, September 17 and Friday, September 18, respectively.

"We are very pleased that Dr. Diab will present final data from our phase 2 trial exploring tilsotolimod plus ipilimumab in advanced melanoma patients," stated Elizabeth Tarka, M.D., Idera’s Chief Medical Officer. "We are looking forward to completing our registrational trial for this indication, ILLUMINATE-301, where a comparator arm is included, and moving this potential therapy one step closer to those patients in need."

Idera also announced that the company will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 1:30 pm EDT. A live audio webcast of Idera’s presentation will be accessible in the Investor Relations section of Idera’s website at www.iderapharma.com.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate and adaptive immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint and costimulation therapies. For more information on tilsotolimod trials, please visit ClinicalTrials.gov.

On September 15, 2020 Taiho Oncology, Inc. reported data from three abstracts for futibatinib (TAS-120) in intrahepatic cholangiocarcinoma (iCCA) and in advanced solid tumors will be presented during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 from September 19-21, 2020 (Press release, Taiho, SEP 15, 2020, View Source [SID1234565202]). Key presentations include:

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Efficacy and Safety of Futibatinib in Intrahepatic Cholangiocarcinoma (iCCA) Harboring FGFR2 Fusions/Other Rearrangements: Subgroup Analyses of a Phase 2 Study (FOENIX-CCA2) (Abstract 4493). Results will be shared online as a poster presentation on September 17, 2020. The abstract for this presentation is available on the ESMO (Free ESMO Whitepaper) website: View Source
Quality of Life (QOL) Outcomes With Futibatinib Treatment in FOENIX-CCA2, a Phase 2 Study in Patients (Pts) With Intrahepatic Cholangiocarcinoma (iCCA) Harboring FGFR2 Gene Fusions/Rearrangements (Abstract 4513). Results will be shared online as a poster presentation on September 17, 2020. The abstract for this presentation is available on the ESMO (Free ESMO Whitepaper) website: View Source
Phase 1 Study of the Irreversible FGFR inhibitor (i) Futibatinib (FBN; TAS-120) in Japanese Patients (pts) With Advanced (adv) Solid Tumors (Abstract 2243). Results will be shared online as a poster presentation on September 17, 2020. The abstract for this presentation is available on the ESMO (Free ESMO Whitepaper) website: View Source
Additional information can be found here: View Source

"We are pleased to present these new analyses of futibatinib in intrahepatic cholangiocarcinoma, as well as the results of our Phase 1 experience in Japanese patients," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "We look forward to further exploration of safety, efficacy and quality of life outcomes of this investigational compound to determine who may see the most benefit from it."

In May 2018, the U.S. Food and Drug Administration Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of cholangiocarcinoma.

About Cholangiocarcinoma
Cholangiocarcinoma (CCA), also known as bile duct cancer, is not common. About 8,000 people in the U.S. are diagnosed with CCA each year.1 This includes both intrahepatic (inside the liver) and extrahepatic (outside the liver) cancers. CCA can occur at younger ages, but it is seen mainly in older people. The average age of people in the U.S. diagnosed with cancer of the intrahepatic bile ducts is 70, and for cancer of the extrahepatic bile ducts it is 72.2 The five-year survival rates of localized iCCA is 24%.1

The main treatment for CCA is surgery. Radiation therapy and chemotherapy may be used if the cancer cannot be entirely removed with surgery and in cases where the edges of the tissues removed at the operation show cancer cells (also called a positive margin). Both stage III and stage IV cancers cannot be completely removed surgically. Currently, standard treatment options are limited to radiation, palliative therapy, liver transplantation, surgery, chemotherapy and interventional radiology.2

About Futibatinib (TAS-120)
Futibatinib (TAS-120) is an investigational, oral, selective, and irreversible small-molecule inhibitor of FGFR1, 2, 3, and 4 being studied as a potential treatment for patients with advanced solid tumors, with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies. Futibatinib selectively and irreversibly binds to the ATP binding pocket of FGFR1-4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations.

On September 15, 2020 Obsidian Therapeutics, Inc., a biotechnology company pioneering controllable cell and gene therapies, reported that Bristol Myers Squibb (NYSE:BMY) has exercised its option to an exclusive worldwide license to a cell therapy candidate based on Obsidian’s cytoDRiVE technology for the controlled expression of the immunomodulatory factor CD40L (Press release, Obsidian Therapeutics, SEP 15, 2020, View Source [SID1234565149]). This announcement marks the first opt-in decision by Bristol Myers Squibb since the companies announced their collaboration to develop novel cell therapies in January 2019. Under the terms of the agreement, Obsidian is eligible to receive potential future milestone and royalty payments.

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"We are very interested in exploring innovative approaches to developing engineered cell therapies, including the cytoDRiVE platform," said Rupert Vessey, D. Phil., Executive Vice President, Research and Early Development, Bristol Myers Squibb. "By controlling the expression of armed payloads like CD40L, Obsidian’s cell therapy candidates may have the potential to overcome tumor microenvironment resistance and unlock the power of cell therapy in solid tumors and other malignancies."

"This announcement marks an important milestone validating Obsidian’s cytoDRiVE platform, and we look forward to continuing to work with Bristol Myers Squibb to bring powerful new immunotherapies to patients," said Paul K. Wotton, Ph.D., Chief Executive Officer of Obsidian Therapeutics. "We are also pleased with the pace with which our own pipeline programs are progressing as we continue to advance our lead controllable tumor infiltrating lymphocyte (TIL) therapy to the clinic."

On September 15, 2020 Exelixis, Inc. (Nasdaq: EXEL) and Iconic Therapeutics reported new preclinical data that support the continued development of ICON-2, an ADC comprised of an anti-Tissue Factor (TF) antibody and Zymeworks’ proprietary linker-payload, for the treatment of diverse solid tumors (Press release, Exelixis, SEP 15, 2020, View Source [SID1234565175]). Exelixis has an exclusive option and license agreement for ICON-2 in oncology indications under its May 2019 agreement with Iconic Therapeutics, which discovered and is developing this novel ADC. The new data, which demonstrate the superior tolerability and exposure of ICON-2 compared with an MMAE anti-TF ADC, are being presented this week in a poster at the World ADC Digital Conference, which is being held online September 15-18.

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"These data provide additional preclinical validation both of our platform of proprietary anti-TF molecules designed to efficiently but safely bind TF, which is overexpressed in a variety of solid tumors, and specifically for Iconic Therapeutics’ strategy to advance its next generation ADC targeting TF," said William L. Greene, M.D., Chief Executive Officer of Iconic Therapeutics. "Other anti-TF ADCs that use MMAE as a linker-payload have been associated with side effects that can reduce tolerability, including bleeding, neutropenia and skin toxicities. The data presented today demonstrate ICON-2 effectively kills solid tumor cells in a variety of preclinical studies with an improved tolerability profile, and support continued development of ICON-2 as a treatment for solid tumors. We are currently conducting additional preclinical and nonclinical studies in support of initiating human clinical trials of this potentially best-in-class anti-TF ADC."

TF plays a critical role in the coagulation cascade and its expression is generally restricted in normal tissue. However, solid tumors, including gastrointestinal, head and neck, cervical, ovarian and bladder tumors, frequently express TF at high levels, which is associated with poor prognosis. Although TF is an attractive target for ADC therapy, previous approaches have demonstrated the potential to interfere with the coagulation cascade and may have additional toxicities that could negatively impact their risk-benefit profile.

The data presented today include results from several preclinical studies of ICON-2. Key findings from these studies are:

ICON-2 binds to TF on human and non-human primate (NHP) cells with high affinity but does not affect coagulation as measured by FXa conversion and thrombin generation assays.
ICON-2 does not induce neutropenia in NHPs.
ICON-2 is more potent than an ADC containing MMAE conjugated to the same anti-TF antibody in mouse xenograft model of human pancreatic tumor cells.
ICON-2 is highly active in patient-derived xenograft models derived from multiple tumor types.
ICON-2 exhibits superior tolerability and exposure when compared directly with an MMAE ADC using the same anti-TF antibody in a NHP study.
"We entered into our exclusive option and license agreement with Iconic Therapeutics because its expertise in TF biology and access to proprietary ADC technology provide a robust foundation for developing potentially best-in-class therapies for solid tumor indications with significant unmet clinical need," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. "The data presented today continue to support that potential and differentiate ICON-2 from other anti-TF ADCs. These promising results also underscore Exelixis’ ability to identify promising licensing opportunities as part of our ongoing pipeline expansion strategy, which includes both internally developed and in-licensed programs."

Under the terms of the May 2019 agreement, Exelixis has an exclusive option to license ICON-2 in exchange for an upfront option payment to Iconic of $7.5 million and a commitment of preclinical development funding. Exelixis can exercise its option at any time up to a potential IND application, and upon doing so would make an option exercise payment to Iconic and assume responsibilities for all subsequent clinical development and commercialization activities. Should Exelixis elect to exercise its option, Iconic will become eligible for future development, regulatory and commercialization milestone payments, as well as royalties on potential sales.