On January 8, 2018 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported a $230 million non-dilutive royalty transaction with HealthCare Royalty Partners (HCR) (Press release, Agenus, JAN 8, 2018, View Source [SID1234523003]). The transaction is comprised of $190 million of cash proceeds at closing plus up to $40 million in milestone payments. Agenus will use part of these proceeds to redeem its royalty bond from Oberland and the additional monies to advance its registrational studies with anti-CTLA-4 and anti-PD-1 for planned BLA filings in 2019 and 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At closing, HCR will receive the rights to royalties on sales of GlaxoSmithKline’s QS-21 containing vaccines. Agenus retains all rights for the development of QS-21 with its entire portfolio of checkpoint antibodies, vaccines, and cellular therapies* with no third party obligation.

Agenus is advancing its QS-21 powered vaccine, AutoSynVax, in combination with validated checkpoint antibodies to generate immune recognition of tumors unresponsive to checkpoint blockade alone.

"This transaction reflects the significant value that can be generated from our assets and our ability to execute non-dilutive transactions to strengthen our balance sheet," said Dr. Garo Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "Part of the proceeds will fund our pivotal programs designed to achieve our near-term goals to become a commercial company with a planned BLA filing by the second half of 2019."

John Urquhart, Principal at HCR commented, "HealthCare Royalty Partners is pleased to partner with Agenus in this royalty financing transaction that recognizes the significant value of the immune-potent QS-21 adjuvant."

After the repurchase of the Oberland obligation, the transaction is expected to yield net proceeds of approximately $28 million to Agenus at closing, plus the potential for up to an additional $40 million of milestone payments. In the event that certain sales milestones are not met, Agenus will owe HCR approximately $26 million in 2021.

Bank of America Merrill Lynch acted as sole structuring advisor to Agenus for the transaction. Goodwin Procter LLP acted as special counsel to Agenus and Cadwalader, Wichersham & Taft LLP represented HCR.

On January 8, 2018 Aclaris Therapeutics presented Corporate Overview Presentation (Presentation, Aclaris Therapeutics, JAN 8, 2018, View Source [SID1234523002]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On January 8, 2018 Momenta Pharmaceuticals, Inc. presented at the 36th Annual J.P. Morgan Healthcare Conference (Presentation, Momenta Pharmaceuticals, JAN 8, 2018, View Source [SID1234523014]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On January 5, 2018 Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, reported the launch of the DecisionDx-UMSeq panel that uses next-generation sequencing (NGS) to identify somatic mutations in genes relevant to uveal melanoma (UM) (Press release, Castle Biosciences, JAN 8, 2018, View Source [SID1234523025]). The new test will complement Castle Biosciences’ standard-of-care DecisionDx-UM gene expression profile (GEP) test that has been shown to be independent of and superior to mutational analysis in assessing likelihood of metastasis in UM.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The GEP test currently provides the best and most well-validated prognostic information about UM tumors. The additive role that the new DecisionDx-UMSeq results may provide in combination with DecisionDx-UM GEP results is undergoing refinement.

"For patients with uveal melanoma, tumor tissue is very limited, so it is imperative that we gain as much information as possible about a uveal melanoma tumor from a single precious biopsy," noted Federico A. Monzon, M.D. FCAP, Chief Medical Officer of Castle Biosciences. "Offering sequencing services from the same biopsy sample provided for the standard-of-care DecisionDx-UM test enables patients to receive actionable information from the most robust prognostic test available, while also obtaining mutational information that may enable a better understanding of the patient’s tumor and influence future patient care decisions."

The DecisionDx-UMSeq panel is now available to patients undergoing DecisionDx-UM prognostic (GEP) testing and will be run from the same tumor tissue biopsy. The results from the DecisionDx-UMSeq panel, along with the prognostic DecisionDx-UM and DecisionDx-PRAME GEP tests, will now provide a comprehensive genomic profile of a UM tumor from a single biopsy.

The DecisionDx-UMSeq panel will evaluate DNA mutations in seven genes known to be relevant to UM. The test will analyze hotspot mutations in GNAQ, GNA11, PLCB4, CYSLTR2, SF3B1; exons 1-2 of EIF1AX; and the coding exons of BAP1 gene. Mutations in GNAQ, GNA11, PLCB4, and CYSLTR2 are initiating events in the development of melanocytic tumors such as UM, while later driver mutations in EIF1AX, SF3B1, and BAP1 may impact the UM tumor’s ability to grow and metastasize. While no currently available therapies target pathways affected by the gene mutations evaluated in the DecisionDx-UMSeq panel, the genomic information may be useful in the future to inform patient care as UM research and therapeutic options evolve. Additional information about the genes in the DecisionDx-UMSeq panel is available here on the MyUvealMelanoma.com website.

How to order DecisionDx-UMSeq

The DecisionDx-UMSeq test can be ordered for patients who are having DecisionDx-UM GEP testing. The DecisionDx-UMSeq requisition form can be submitted concurrently with the DecisionDx-UM GEP test or after receipt of the GEP results. DecisionDx-UMSeq is currently validated for fine needle aspiration biopsy (FNAB) samples that have not previously been exposed to radiation. The sequencing test can be run from the same FNAB sample taken for the DecisionDx-UM GEP test.

About DecisionDx-UM

The DecisionDx-UM test measures the gene expression profile (GEP), or molecular signature, of an individual’s tumor and identifies with high accuracy the likelihood of metastasis. The DecisionDx-UM test is standard of care in the management of uveal melanoma in the majority of ocular oncology practices. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) has included GEP testing for identification of Class 1 and 2 as a prognostic factor recommended for clinical care. The AJCC is the only national organization that reviews uveal melanoma and the DecisionDx-UM test is the only clinically available GEP test for use in the U.S. The test has been validated in multiple prospective and retrospective studies. It is estimated that nearly 7 in 10 diagnosed patients in the U.S. receive DecisionDx-UM as part of their diagnostic workup. More information about the test and disease can be found at www.MyUvealMelanoma.com.

On January 8, 2018 Scynexis presented Corporate presentation (Presentation, Scynexis, JAN 8, 2018, View Source [SID1234522972]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!