On April 16, 2018 Oregon Health & Science University (OHSU) Knight Cancer Institute and Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) reported the presentation of preclinical data demonstrating that CG’806, a highly potent pan-FLT3/pan-BTK inhibitor, kills malignant cells in samples from patients with various hematologic malignancies and demonstrates superiority to other kinase inhibitors (Press release, Aptose Biosciences, APR 16, 2018, View Source c=116148&p=RssLanding&cat=news&id=2342649 [SID1234525328]). The data were presented in a poster on Sunday, April 15, at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference being held April 14-18, in Chicago, IL.

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The poster, entitled CG’806, a first-in-class pan-FLT3/pan-BTK inhibitor, demonstrates superiority to other FLT3 and BTK inhibitors against primary patient samples, demonstrated the broad activity of CG’806 against primary bone marrow specimens from patients with various hematologic malignancies. CG’806 is a small molecule that potently inhibits wild type (WT) FLT3, as well as FLT3 housing the ITD mutation or with point mutations in the tyrosine kinase domain (TKD, including D835G, D835Y, D835H) or in the gatekeeper region (F691L); it also inhibits BTK WT and BTK-C481S. As part of the Beat AML Initiative, researchers at OHSU tested CG’806 against freshly isolated primary samples from patients with acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL) and other hematologic malignancies to determine its potency and range of action. Against AML patient samples, CG’806 was evaluated relative to other FLT3 inhibitors. In parallel, CG’806 and ibrutinib, a covalent BTK inhibitor approved for CLL and certain other B-cell malignancies, were compared directly for sensitivities on primary CLL samples and various B-cell and other hematologic malignancies. CG’806 was shown to have greater potency against a broader subset of AML samples relative to other FLT3 inhibitors, including midostaurin, gilteritinib, quizartinib, sorafenib, crenolanib, and dovitinib. This was especially true in FLT3-ITD and FLT3-TKD positive cases, although enhanced activity was also observed in FLT3 WT samples. CG’806 was also shown to have greater potency and range of activity on primary CLL samples than ibrutinib.

"The clinical benefit of current FLT3 inhibitors in AML is transient, as resistance develops after several months of treatment," said Stephen E. Kurtz, Ph.D., lead author and Research Assistant Professor at the OHSU Knight Cancer Institute. "Similarly, ibrutinib, a covalent BTK inhibitor approved for CLL and certain other B-cell malignancies, is limited by acquired resistance, as well as refractory disease and tolerance challenges. As a pan-FLT3/pan-BTK inhibitor – especially in the absence of observed toxicity in murine AML models – CG’806 offers important potential to address these limitations."

"CG’806 appears superior to other FLT3 and BTK inhibitors, and the wealth of data supporting its development in AML and B-cell malignancies continues to grow," said William G. Rice, Ph.D., Chairman and Chief Executive Officer of Aptose. "These studies are critical for understanding how to develop and position CG’806 as we prepare for clinical development in these challenging hematologic malignancies."
Separately, Aptose researchers also announced new data on CG’806 presented at AACR (Free AACR Whitepaper) (see press release here). Both poster presentations will be published in the AACR (Free AACR Whitepaper) Conference Proceedings. The posters can also be accessed here or at the Publications & Presentations section of the Aptose website, www.aptose.com.
For more information on Beat AML refer to View Source

About CG’806

CG‘806 is an oral, first-in-class pan-FLT3/pan-BTK multi-kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG’806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG’806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors. CG’806 is currently in preclinical development in partnership with CrystalGenomics

On April 16, 2018 SELLAS Life Sciences Group Inc. (Nasdaq: SLS) ("SELLAS"), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the year ended December 31, 2017 and provided a business update (Press release, Galena Biopharma, APR 16, 2018, View Source [SID1234525344]).

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"In recent months, we have made meaningful progress advancing our business objectives, maturing SELLAS Life Sciences Group Ltd. into a publicly-traded company following the business combination and progressing our pipeline of cancer immunotherapies for patients with limited treatment options," said Angelos Stergiou, MD, ScD h.c., President & Chief Executive Officer of SELLAS. "We are particularly excited about our recent financing and the positive interim results from the Phase 2b NeuVax + Herceptin study announced earlier this month which we believe help position SELLAS for continued success throughout the remainder of 2018. We also look forward to commencing the Phase 1/2 clinical trial of galinpepimut-S in combination with Keytruda under our collaboration and supply agreement with Merck and our planned Phase 3 Acute Myeloid Leukemia program."
Recent Corporate and Pipeline Highlights

In April 2018, SELLAS announced positive interim data from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial (IST) of trastuzumab (Herceptin) +/-nelipepimut-S (NeuVax) in HER 1+/2+ breast cancer patients in the adjuvant setting to prevent recurrences.

In March 2018, open label Phase 2 clinical and immunological data for SELLAS’ lead product candidate, galinpepimut-S (GPS) in patients with multiple myeloma (MM) was presented at the 2018 European Society for Blood and Marrow Transplantation (EBMT) 44th Annual Meeting in Lisbon, Portugal. Median progression-free survival (PFS) of 23.6 months was reported in the high-risk disease setting, compared to historically inferior outcomes while on an immunomodulatory drug (IMID) or proteasome inhibitor post-autologous stem cell transplant maintenance.

In March 2018, SELLAS appointed Barbara Wood as Executive Vice President, General Counsel and Corporate Secretary.

In March 2018, SELLAS entered into a definitive securities purchase agreement to issue up to 10,700 shares of its Series A convertible preferred stock and warrants to purchase 1,363,631 shares of its common stock in a private placement transaction to a select group of institutional investors, in Europe and the United States, for aggregate gross proceeds of $10.7 million. The closing of the first tranche for approximately $6.0 million took place on March 9, 2018. The closing of the second tranche for approximately $4.7 million is expected to occur by the end of April 2018 following stockholder approval.

In December 2017, SELLAS Life Sciences Group Ltd. ("SELLAS Ltd."), a privately-held Bermuda exempted company, completed a business combination (the "Merger") with Galena Biopharma, Inc. ("Galena"). Upon completion of the Merger, Galena was renamed "SELLAS Life Sciences Group, Inc.," began trading under a new ticker symbol "SLS" and the combined company now includes the late-stage pipelines of novel cancer immunotherapies for both hematologic and solid malignancies of SELLAS Ltd. and Galena.

In October 2017, SELLAS Ltd. entered into a clinical trial collaboration and supply agreement with Merck & Co. for a combination clinical trial targeting multiple cancer types, in which GPS will be administered in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase 1/2 trial in five cancer indications, including both hematologic malignancies and solid tumors.

Year End 2017 Financial Results
For accounting purposes, SELLAS Ltd. is considered to have acquired Galena in the Merger; therefore, the financial statements of Galena became those of SELLAS Ltd. and the results reported are those of SELLAS Ltd.
Cash Position: As of December 31, 2017, cash and cash equivalents were $2.3 million, compared to $6.0 million as of December 31, 2016. Net cash used in operating activities was $11.0 million for the year ended December 31, 2017, compared to $11.9 million for the year ended December 31, 2016.
R&D Expenses: Research and development expenses were $6.1 million for the year ended December 31, 2017, as compared to $11.4 million for the year ended December 31, 2016. The $5.3 million decrease was primarily attributable to a decrease of $2.5 million in fees due under licensing and collaboration agreements, a decrease of $1.7 million in clinical trial expense, a $1.3 million decrease in manufacturing expenses, a $1.2 million decrease in consulting fees, and $0.2 million decrease in regulatory expenses. These decreases were partially offset by a $0.7 million increase in stock-based compensation and a $0.9 million increase in personnel related expenses. Overall, research and development expenses were reduced in 2017 as SELLAS Ltd. explored various strategic options.
G&A Expenses: General and administrative expenses were $15.1 million for the year ended December 31, 2017, as compared to $4.6 million for the year ended December 31, 2016. The $10.5 million increase was primarily due to $5.7 million of transaction costs related to the Merger and a $2.1 million increase in stock-based compensation from the acceleration of restricted stock units, and a $1.5 million increase in personnel related expenses due to an increase in headcount, $0.6 million increase in accounting and audit fees, and $0.6 million in outside consulting services. The $5.7 million of transactions costs consist of $2.9 million of banking fees, $1.6 million in legal fees, $1.0 million incentive fee payable through approximately $0.1 million in cash and the issuance of 119,672 shares of our common stock upon consummation, and $0.2 million in accounting and audit fees. The transaction costs incurred related to the Merger are non-recurring expenses for the year 2017.
Non-recurring Severance Costs: Severance costs incurred during the year ended December 31, 2017 include employee-related costs for severance of former Galena employees of $1.9 million.
Net Loss: Net loss was $23.8 million and loss attributable to common stockholders was $24.4 million for the year ended December 31, 2017, or a basic and diluted loss per share to common stockholders of $10.44, as compared to a net loss and loss attributable to common stockholders of $17.7 million for the year ended December 31, 2016, or a basic and diluted loss per share to common stock holders of $18.66.

On April 16, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported new preclinical data showing that SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor currently in a Phase 1 trial in patients with advanced solid tumors, demonstrated potent anti-tumor activity in multiple models of heavily pretreated ovarian cancer (Press release, Syros Pharmaceuticals, APR 16, 2018, View Source [SID1234525362]). These data were presented by Syros and its collaborators from the Dana-Farber Cancer Institute (DCFI) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago.

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"Despite recent advances in treating ovarian cancer, many patients either don’t respond or become resistant to treatment, and the outlook for these patients is poor," said Panagiotis A. Konstantinopoulos, M.D, Ph.D., Director of Translational Research and attending oncologist in the Gynecologic Oncology Program at DCFI and an Associate Professor of Medicine at Harvard Medical School. "SY-1365 stopped tumor growth in multiple preclinical models of ovarian cancer that had progressed following treatment with standard-of-care and targeted therapies. These data suggest SY-1365 has the potential to be an important new therapy for ovarian cancer that warrants further clinical investigation."

Researchers from Syros and DCFI evaluated the anti-tumor activity of SY-1365 in a broad panel of ovarian cancer cell lines, as well as in patient-derived xenograft (PDX) mouse models developed from patients treated with multiple prior therapies, including standard-of-care platinum-based therapies and a new class of targeted therapies known as PARP inhibitors. The data, which were presented in a poster discussion session and a poster session, show that SY-1365:
Induced cell death in numerous ovarian cancer cell lines.
Inhibited tumor growth in 10 of the 17 treatment-relapsed ovarian PDX models studied, including inducing complete regressions. Notably, these responses were observed irrespective of BRCA status or sensitivity to a PARP inhibitor.
Lowered expression of MCL1, a gene in the mitochondrial apoptosis pathway that is known to inhibit apoptosis, or programmed cell death.

The data also showed that sensitivity to SY-1365 was associated with low expression of BCLXL, a known apoptosis inhibitor, and RB1, a known tumor suppressor, pointing to potential biomarkers that may be predictive of response to SY-1365.

"We are very encouraged by these data," said David A. Roth, M.D., Chief Medical Officer of Syros. "CDK7 has emerged as a potentially important new drug target in cancer. By selectively inhibiting CDK7, SY-1365 has been shown to lower the expression of cancer driving genes and hit cancer cells at multiple points in the cell cycle, preferentially killing cancer cells and inhibiting tumor growth in preclinical models of a number of difficult-to-treat solid tumors and blood cancers. These newest data in ovarian cancer provide strong support for the planned expansion of our Phase 1 clinical trial into ovarian cancer and further highlight the promise of SY-1365 to make a profound difference for patients."

The ongoing Phase 1 trial of SY-1365 is a multi-center, open-label trial enrolling patients with advanced solid tumors. The primary objective of the trial is to assess the safety and tolerability of escalating doses of SY-1365, with the goal of establishing a maximum tolerated dose and a recommended Phase 2 dose and regimen. The dose-escalation phase is open and expected to enroll approximately 35 solid tumor patients for whom standard curative or palliative measures do not exist or are no longer effective. Following the dose-escalation phase, Syros plans to open expansion cohorts to further evaluate the safety and anti-tumor activity of SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer populations.
Syros expects to open the expansion phase of the trial in mid-2018 and to report data from the dose escalation portion of the trial in the fourth quarter of 2018.
About SY-1365

SY-1365 is a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor with potential across a range of difficult-to-treat solid tumors and blood cancers. In preclinical studies, SY-1365 has shown significant anti-proliferative and pro-apoptotic activity in difficult-to-treat cancers, including breast and ovarian cancers and acute leukemia. SY-1365 has also been shown to preferentially kill cancer cells over non-cancerous cells and lower the expression of cancer-driving genes, inducing significant anti-tumor activity, including complete tumor regressions, in preclinical models of these cancers. SY-1365 is currently in a Phase 1 clinical trial in patients with advanced solid tumors, with planned expansion cohorts to evaluate SY-1365 in multiple ovarian and breast cancer patient populations as a single agent and in combination with standard-of-care therapies. Additional details about the trial can be found using the identifier NCT03134638 at www.clinicaltrials.gov.

On April 16, 2018 Harpoon Therapeutics, a biotechnology company pioneering a new class of T cell engaging therapeutics based on its proprietary TriTAC platform, reported that preclinical data supporting the ongoing development of the platform and its two lead molecules, HPN424 and HPN536 (Press release, Harpoon Therapeutics, APR 16, 2018, View Source [SID1234525414]). These programs are the first of four programs using TriTAC technology, which has been designed for superior tumor penetration and efficacy in combating solid tumors. The company, which announced a series B financing and a partnership with AbbVie in 2017, anticipates filing investigational new drug (IND) applications and entering the clinic with these two compounds in the next 12 months. Data were presented at the 2018 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, held April 14-18, 2018.

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"Harpoon created TriTAC as a best-in-class T cell engager platform optimized for the treatment of solid tumors," said Jerry McMahon, PhD, President and CEO, Harpoon Therapeutics. "The platform allows us to bring the success of T cell engagers targeting hematologic malignancies, like Blincyto, to solid tumor treatment. At Harpoon, we have optimized serum half-life, maximized tumor penetration, and engineered superior stability and manufacturability. These features have been the foundation for our discovery and development of a robust pipeline of drug candidates targeting PSMA, mesothelin, BCMA and DLL3."

Harpoon presented preclinical data which highlighted the novel aspects of its proprietary TriTAC platform to potentially overcome the limitations of existing bispecific antibody-based and CAR-T therapies. The TriTAC platform uses a single flexible polypeptide comprised of three binding domains, and is designed to be the smallest, half-life extended T cell engaging format without the potential liabilities associated with conventional bispecific antibodies.

"We are excited to share these preclinical data for HPN424 and HPN536, which are designed to elicit targeted tumor cell destruction for both metastatic castration-resistant prostate cancer (mCRPC) and mesothelin-expressing tumors, respectively, such as lung, ovarian and pancreatic cancers," said Holger Wesche, PhD, Senior Vice President, Research. "We believe our new data underscore the significant impact our approach could make in advancing the field of immuno-oncology, and look forward to evaluating our compounds in clinical testing."

HPN424 Data Showed Potent T Cell Killing of Prostate Cancer Cells and Serum Half-Life Extension

HPN424 is a 50-kD single polypeptide containing three binding domains — for human PSMA, human serum albumin (HSA) and human CD3. In preclinical studies, HPN424 demonstrated single-digit picomolar potency for PSMA-dependent T cell killing in a panel of human prostate cancer cell lines, which translated to in vivo efficacy with efficacious doses in the low µg/kg range. HPN424 was well tolerated in a multi-dose safety study in non-human primates and showed a serum half-life of 80 hours supporting once-weekly administration for a Phase 1 dose-escalation study in mCRPC patients planned to begin this year.

HPN536 Data Showed Potent Destruction of Mesothelin-Positive Cancer Cells and Evidence of Mechanism in a Primate Study

HPN536 is a 50-kD single polypeptide containing three binding domains — for human mesothelin (MSLN), HSA and human CD3. In preclinical studies, HPN536 demonstrated single-digit picomolar potency for MSLN-dependent T cell killing in a panel of human cancer cell lines derived from mesothelioma, pancreatic, non-small cell lung and ovarian tumors, and in vivo efficacy with efficacious doses in the low µg/kg range. An exploratory safety study in non-human primates showed that HPN536 was well tolerated and supported weekly dosing in humans. The compound was also shown to elicit T cell activation resulting in mesothelial hypertrophy and lymphocyte infiltration, which strongly supports tissue penetration, the mechanism of action of the TriTAC platform, and the planned Phase 1 study.

ABSTRACT INFORMATION

Abstract #1773
Title: "HPN424, a half-life extended, PSMA/CD3-specific TriTAC for the treatment of metastatic prostate cancer"
Date and Time: April 16, 2018, 8:00 AM – 12:00 PM CT
Session: Therapeutic Antibodies, Including Engineered Antibodies 1

Abstract #1781
Title: "HPN536, a T cell-engaging, Mesothelin/CD3-specific TriTAC for the treatment of solid tumors"
Date and Time: April 16, 2018, 8:00 AM – 12:00 PM CT
Session: Therapeutic Antibodies, Including Engineered Antibodies 1

Abstract #3814
Title: "TriTACs are novel T cell-engaging therapeutic proteins optimized for the treatment of solid tumors and for long serum half-life"
Date and Time: April 17, 2018, 8:00 AM – 12:00 PM CT
Session: Therapeutic Antibodies, Including Engineered Antibodies 3

On April 16,2018 Dynavax Technologies Corporation (NASDAQ: DVAX) reported data from its ongoing Phase 1b/2 study investigating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with KEYTRUDA , an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada) (Press release, Dynavax Technologies, APR 16, 2018, View Source [SID1234525507]). These data were presented in a poster session at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The results from this dose escalation study showed encouraging response rates in patients with advanced head and neck squamous cell carcinoma. In addition, the combination was well tolerated. The full poster presentation can be accessed at View Source

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"Results from our Phase 1b/2 trial of SD-101 in combination with KEYTRUDA are promising in head and neck cancer, a condition for which patients typically have a poor prognosis," said Eddie Gray, Chief Executive Officer of Dynavax. "This is another tumor type in which SD-101, based on early data, has demonstrated encouraging activity while being well tolerated. As understanding of combination therapy matures we believe an effective immune stimulating agonist with an attractive tolerability profile will play a significant role in a wide range of tumors."

"On Tuesday, April 17, 2018 we are also presenting updated data from our Phase1b/2 study at AACR (Free AACR Whitepaper) from a cohort of melanoma patients, where a durable response was observed in patients naïve to anti-PD-1/L1 therapy as well as patients with prior treatment. We are excited about the overall results to date and believe this underscores the potential breadth of our immuno-oncology platform," Mr. Gray added.

Highlights from Poster Presentation of HNSCC Data

Interim data from evaluable patients showed an ORR of 33% (6 out of 18) (38% among patients who received at least one scan on study)

Well tolerated with no dose limiting toxicities

No increase in frequency or severity of the treatment-related adverse events that have been reported in clinical studies of KEYTRUDA as a monotherapy, nor evidence of a unique safety signal for the combination.

Biomarker analyses showed induced broad immune activity, including increase in CD8 T cells, and Th1 response in the tumor microenvironment, consistent with findings reported in advanced melanoma

Highlights from Abstract of Advanced Melanoma Durability Data

86% of initial responses were ongoing after a median of 18 months of follow up in patients that were naïve to anti-PD-1/L1 monotherapy (n=7)

2 of 12 evaluable patients with progressive disease on prior anti-PD-1/L1 monotherapy achieved a partial or stable disease response for at least 10.5 months

Medianprogression-free survival (PFS), duration of response, and median overall survival have not been reached

Treatment was well tolerated with no Grade 3 or higher treatment-related AEs in longer term follow up

Details for the poster presentation are as follows:

Durability of responses to the combination of SD-101 and pembrolizumab in advanced metastatic melanoma: Results of a phase Ib, multicenter study

Session Title: Phase I Trials in Progress

Abstract: CT139

Poster Board Number: 22

Date/Time: Tuesday Apr 17, 2018 8:00 AM – 12:00 PM CDT

Location: McCormick Place South, Hall A, Poster Section 42

SD-101 in combination with KEYTRUDA generally was well tolerated. The most common treatment-emergent adverse events were injection site reactions and transient grade 1 to 2 flu-like symptoms, including fever, chills and myalgia.

About MEL-01 (KEYNOTE-184)
The dose-escalation and expansion study of SD-101 in combination with KEYTRUDA includes patients with histologically or cytologically confirmed unresectable Stage IIIc/IV melanoma. The primary endpoints of the trial are MTD and evaluation of the safety of intratumoral SD-101 in combination with KEYTRUDA. In addition, the trial is investigating response as assessed by the investigator according to RECIST v1.1, biomarker assessments and duration of response. Patients previously treated with anti-PD-1 and other immunotherapies are included.

About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with metastatic melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.