On November 10, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported updated overall survival (OS) results from its Phase 1/2 study evaluating GRANITE, an individualized vaccine-based immunotherapy, for the treatment of advanced solid tumors (Press release, Gritstone Oncology, NOV 10, 2022, View Source [SID1234623670]). These results, along with results from a clinicopathologic analysis of metastatic MSS-CRC patients with and without a molecular response, will be presented via a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting.

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"The follow-up data from our Phase 1/2 study in patients with MSS-CRC who have received at least two prior lines of therapy continue to demonstrate an association between molecular response and overall survival," said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. "The median overall survival (MOS) in patients with MSS-CRC that had a molecular response has still not been reached and will now exceed 22 months; an additional four months since our last update in May 2022. This is a notable difference compared to the 6–7-month MOS typically observed in third-line MSS-CRC and the 7.8 month MOS in patients without a molecular response within our study. The clinicopathologic analysis shows MSS-CRC patients who achieve a molecular response do not have high tumor mutation burden, PD-L1 expression or high expression of IFNg-related genes. We are also observing molecular responses in patients with liver metastases, a subset that typically receives little benefit from immunotherapy. The recent publication of GRANITE Phase 1/2 results in Nature Medicine detail the program’s novel approach, and the data to date demonstrate its promise in hard-to-treat, late-line settings. The randomized Phase 2/3 GRANITE study in first-line CRC, where patients generally have more time to mount an immune response, is ongoing and preliminary data are expected in 4Q2023."

The Phase 1/2 study is evaluating the safety, immunogenicity, and clinical activity of GRANITE in combination with PD-1 checkpoint inhibitor, nivolumab and subcutaneous anti-CTLA-4 antibody ipilimumab in advanced solid tumors. This study enrolled and treated 29 patients with previously treated, metastatic solid tumors including patients with colorectal cancer, gastroesophageal adenocarcinoma, and non-small cell lung cancer. Of 13 patients with MSS-CRC, 6 experienced a molecular response defined as ≥30% reduction in circulating tumor DNA (ctDNA) and continue to have an overall survival advantage compared to those patients without a molecular response.

Updated OS data from GRANITE Phase 1/2:

6 of 13 treated patients with MSS-CRC had a molecular response and the observed median overall survival in this group will now exceed 22 months (median OS not yet reached versus 7.8 months in those without a molecular response). This compares to a median overall survival not yet reached and exceeding 18 months as reported in May 2022.
Clinicopathologic characteristics from GRANITE Phase 1/2:

4 of 6 patients with molecular response had liver metastasis.
All patients had PD-L1 expression <1% and low levels of IFNg-related gene expression.
Median tumor mutational burden was 2.9 and 3.6 mutations/MB in those with and without molecular response, respectively.
SITC presentation details are as follows:
Abstract 660: Clinicopathologic Characteristics of Patients with Metastatic Colorectal Cancer with Molecular Responses Following Treatment with an Individualized Neoantigen Vaccine Regimen
Date/Time: Friday, Nov. 11, 2022: 9:00am – 8:30pm EST
Session: Clinical Trials In Progress
Location: Boston Convention & Exhibition Center: Hall C

About GRANITE
Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens (TSNA). Gritstone identifies these TSNA using its proprietary artificial intelligence platform, EDGE. GRANITE is an individualized neoantigen-based immunotherapy program that uses adenoviral ("prime") and self-amplifying mRNA ("boost") vectors to deliver personalized immunotherapy containing the relevant neoantigens. GRANITE was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS-CRC.

On November 10, 2022 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, reported financial results for the three and nine months ended September 30, 2022 and provided a business update (Press release, Salarius Pharmaceuticals, NOV 10, 2022, View Source [SID1234623669]). Highlights of the third quarter of 2022 and recent weeks include:

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Financial Highlights

•Cash and cash equivalents were $16.8 million as of September 30, 2022, compared with $29.2 million as of December 31, 2021
•Net loss for the third quarter of 2022 was $14.4 million, or $6.41 per share, which included a loss on goodwill impairment of $8.9 million, or an impairment of $3.94 per share, compared with net loss for the third quarter of 2021 of $3.7 million, or $2.09 per share
•Higher operating expenses reflect initial SP-3164 costs as the company makes progress toward important near-term milestones
•Regained compliance with Nasdaq’s minimum-bid requirement following a reverse stock split

SP-3164 (Targeted Protein Degrader) Highlights

•Advanced plans for filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first half of 2023 after completing the pre-IND meeting process
•Presented favorable preclinical results at the 5th Annual Targeted Protein Degrader Summit showing:
oPotent cereblon binding, efficient degradation of select proteins and induction of cell death in both lymphoma and multiple myeloma cell lines
oSignificant increase in tumor growth inhibition compared with lenalidomide (Revlimid) and pomalidomide (Pomalyst) in multiple myeloma animal models
•Announced acceptance of an abstract for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showing SP-3164 has:
oAttractive therapeutic properties compared with avadomide and lenalidomide (Revlimid)
oPotential to be administered at lower doses in clinic and provide a more flexible dosing regimen compared with avadomide
oIncreased and rapid protein (IKZF1) degradation compared with lenalidomide (Revlimid) and avadomide
oSignificantly increased tumor growth inhibition as a monotherapy compared with lenalidomide (Revlimid) in an established lymphoma mouse model

"The third quarter and recent weeks were productive yet challenging for Salarius. SP-3164, our promising targeted protein degrader or molecular glue, has been generating exciting preclinical data and commensurate interest within the scientific community. Next month at the 64th ASH (Free ASH Whitepaper) annual meeting, one of blood cancer’s most prestigious events of the year, Dr. Daniela Santiesteban, our director of targeted protein degradation development, will deliver a poster presentation providing an update on additional SP-3164 research data that we believe continue to support our excitement surrounding SP-3164. We remain focused on SP-3164 IND-enabling studies and are on track to submit the IND in the first half of 2023 and to begin clinical trials shortly thereafter," said David Arthur, CEO of Salarius.

Seclidemstat (Targeted Protein Inhibitor) Highlights

•Announced acceptance of an abstract for a presentation at ASH (Free ASH Whitepaper) by collaborators at the University of Texas MD Anderson Cancer Center showing that in six patients with myelodysplastic syndrome or chronic myelomonocytic leukemia, the combination of

seclidemstat with azacitidine appeared safe at current dose levels and showed initial signs of potential activity
oResponse to therapy was observed in two patients including one patient with a complete marrow response and another patient with a complete marrow response plus hematologic improvement who transitioned to allogeneic stem-cell transplantation, which is generally considered as a potential curative treatment
•On October 18, 2022, enrollment of new patients in the Salarius-sponsored seclidemstat sarcoma clinical trial and the MD Anderson investigator-initiated hematologic clinical trial was voluntarily paused due to a suspected unexpected serious adverse reaction (SUSAR); patients currently enrolled in both studies are able to continue treatment after consulting with their physician
oThe U.S. Food and Drug Administration (FDA) subsequently agreed with Salarius’ approach and placed the sarcoma trial on partial clinical hold; Salarius is working with the FDA to further analyze the available data with the goal of understanding how best to proceed and restart enrollment
•Salarius plans to report interim results from the Phase 1/2 study of seclidemstat in Ewing sarcoma and FET-rearranged sarcomas before the end of the year

Mr. Arthur continued, "Independent investigators at MD Anderson also had an abstract accepted for presentation at the upcoming ASH (Free ASH Whitepaper) meeting and exhibition, focused on seclidemstat. The abstract concludes that in the six hematologic or blood cancer patients for whom data was available, the combination of seclidemstat with azacitidine seems safe at the current dose levels and shows signs of potential activity. Further enrollment and follow-up will continue to explore this combination. We believe this interim data is an encouraging development for these patients in need of new treatment options and we are looking forward to an additional data update next month."

Mr. Arthur concluded, "Although recent months were punctuated by highs and lows, we remain optimistic about the company’s prospects. We are delighted to be part of the protein degradation sector of drug development, an exciting opportunity driven by the commercial success of first-generation molecular glues that together had 2021 global sales of more than $16 billion. We also remain excited about seclidemstat and look forward to reporting interim clinical data that could signal the potential for new treatment options. We are looking forward to the additional updates on both programs later this year."

Third Quarter Financial Results

Net loss for the third quarter of 2022 was $14.4 million, or $6.41 per share, compared with a net loss of $3.7 million, or $2.09 per share, for the third quarter of 2021. The increase in net loss was due to higher operating expenses, including development spending on SP-3164, which was acquired in January 2022. Net loss for the third quarter of 2022 included a non-cash charge of $8.9 million for impairment of goodwill related to the 2019 reverse merger with Flex Pharma, Inc.

Net cash used for operating activities during the third quarter of 2022 was $5.7 million, compared with $1.6 million during the same quarter last year.

Nine Month Financial Results

Net loss for the first nine months of 2022 was $25.2 million, or $12.13 per share, compared with a net loss of $8.7 million, or $5.41 per share, for the first nine months of 2021. The increase in net loss was primarily due to a $8.9 million one-time nonrecurring non-cash charge for impairment of goodwill, higher research and development expenses primarily resulting from the acquisition and development of SP-3164, higher seclidemstat development costs and higher general and administrative expenses. The 2021 period included grant revenue of $1.8 million, with no such revenue in 2022.

Net cash used in operating activities for the first nine months of 2022 was $12.9 million, compared with $7.5 million for the prior-year period. The increase was primarily due to higher research and development expenses.

As of September 30, 2022, Salarius had cash, cash equivalents and restricted cash of $16.8 million, compared with $29.2 million as of December 31, 2021. Current cash and cash equivalents are expected to fund the company’s planned operations into the second half of 2023.

On November 10, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, reported financial results for the third quarter and nine months ended September 30, 2022 and provided an update on recent business events (Press release, CorMedix, NOV 10, 2022, View Source [SID1234623668]).

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Recent Corporate Highlights:

Earlier this week, CorMedix announced that the Center for Medicare & Medicaid Services (CMS) has published in the Federal Register a correction to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals New Technology Add on Payment (NTAP) reimbursement of DefenCath, increasing the maximum reimbursement per average hospital visit from $4,387.50 to $14,259.38.
CorMedix also announced the recent submission of a duplicate NTAP application to CMS, intended to take effect should the potential final approval of the DefenCath New Drug Application (NDA) by FDA occur after July 1st of 2023.
The Contract Manufacturing Organization (CMO) for the manufacture of DefenCath has informed the Company that it has implemented more than 95% of the corrective actions that resulted from a June FDA inspection, and that the CMO believes it is on track to close out remaining items during December.
As CorMedix executes on its plan to create alternative supply chain options for resubmission of the NDA for DefenCath, the Company is in the process of validating manufacturing at the CMO with heparin sourced from an alternative API supplier, as well as validating manufacturing at Alcami, an additional CMO, with heparin sourced from an alternative API supplier.
The Company’s target is to resubmit the DefenCath NDA by the end of the first quarter of 2023.
Cash and short-term investments, excluding restricted cash, at September 30, 2022 amounted to $59.0 million.
Joe Todisco, CorMedix CEO, commented, "the CorMedix team has made excellent progress on all fronts, working diligently in support of the CMO as it implements corrective actions to address deficiencies the CMO received from FDA during a June inspection of the manufacturing facility, as well as undertaking multiple steps to build out the team, processes and systems to be ready for commercialization as quickly as possible following a potential FDA approval. We have created parallel pathways to mitigate risk, with the goal of securing FDA approval of DefenCath in 2023. We look forward to providing additional updates as we aim to deliver on our commitment to patients receiving hemodialysis via central venous catheters."

Third Quarter and Nine Month 2022 Financial Highlights

For the third quarter of 2022, CorMedix recorded a net loss of $6.9 million, or $0.17 per share, compared with a net loss of $8.6 million, or $0.22 per share, in the third quarter of 2021. The lower net loss recognized during the third quarter of 2022 compared with 2021 was due to the net decrease in operating expenses.

Operating expenses in the third quarter of 2022 decreased approximately 19% to $7.0 million, compared with $8.6 million in the third quarter of 2021. R&D expense decreased approximately 51% to $2.3 million compared to $4.7 million in the third quarter of 2021, mainly due to a net decrease in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expense increased approximately 21% to $4.6 million compared with $3.8 million in the third quarter of 2021. This increase was driven primarily by an increase in costs related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefenCath.

For the nine months ended September 30, 2022, CorMedix recorded a net loss of $21.5 million, or $0.54 per share, compared with a net loss of $20.4 million, or $0.54 per share, in the first nine months of 2021. The increase in net loss in the first nine months of 2022 was driven primarily by a lower tax benefit from the NJ NOL program and an increase in operating expenses.

Operating expenses in the first nine months of 2022 were $22.3 million compared with $21.7 million during the comparable period in 2021, an increase of $0.6 million, or 3%. This increase was primarily due to higher SG&A expenses throughout the organization, partially offset by lower costs related to the manufacturing of DefenCath prior to its potential marketing approval during the nine-month period of 2022.

Total cash on hand and short-term investments as of September 30, 2022 was $59.0 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at September 30, 2022, it has sufficient resources to fund operations at least through 2023.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, November 10, 2022, at 8:30 AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

On November 10, 2022 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on helping patients fight cancer with viral immunotherapies, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Candel Therapeutics, NOV 10, 2022, View Source [SID1234623667]).

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"Candel made important progress across multiple facets of the organization this quarter," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "We have bolstered the Company’s capabilities and future potential with the appointment of three new board members and two new leadership executives, an orphan drug designation from the European Commission for CAN-2409 in glioma, and most recently a discovery partnership with the University of Pennsylvania’s Center for Cellular Immunotherapies, led by Dr. Carl June, the Richard W. Vague Professor for Immunotherapy, to study the combination of our enLIGHTEN Discovery Platform and their CAR-T cells in solid tumors. We will close the year with new clinical results coming from our pipeline being presented at R&D Day and we look ahead with confidence to deliver our world-class viral immunotherapy candidates to patients battling cancer."

Jason A. Amello, Chief Financial Officer, added, "The third quarter of 2022 was marked by significant momentum as the Company broadened its viral immunotherapy footprint and continued to execute across all of its programs in an efficient and cost-effective manner."

Third Quarter 2022 and Recent Highlights

In August, the Company enhanced its Board of Directors with the appointments of three new Board members. (View Release)

Joseph Papa, Chief Executive Officer of Bausch + Lomb Corporation

Gary Nabel, MD, PhD, Chief Innovation Officer of OPKO and Chief Executive Officer, ModeX Therapeutics, Inc., an OPKO Health company

Renee Gaeta, Chief Financial Officer of Eko Devices

In September, the Company strengthened its executive leadership team with appointments of Jason A. Amello as Chief Financial Officer and Garrett Nichols, MD, MS, as Chief Medical Officer. (View Release)

Separately in September, the Company submitted the protocol for a phase 3 clinical trial evaluating CAN-2409 in patients living with high-grade glioma (HGG) to a central institutional review board.

Also in September, the European Medicines Agency (EMA) issued a positive opinion for orphan drug designation for CAN-2409 in glioma. (View Release)

In October, the European Commission adopted the EMA’s decision to grant CAN-2409 orphan drug designation for the treatment of glioma.

Also in October, the Company formed a partnership with Neil Sheppard, DPhil, Director of the T Cell Engineering Lab at the University of Pennsylvania’s Center for Cellular Immunotherapies, led by Carl. H June, MD, the Richard W. Vague Professor of Immunotherapy, to study combinations of novel viral immunotherapy and CAR-T cell therapy candidates in solid tumors. (View Release)

In early November, Dr. Tak participated in separate fireside chats with Credit Suisse and BMO Capital Markets. (View Webcasts)
Key Upcoming Milestones and Events

37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (View Release)

On November 11, Anne R. Diers, PhD, Director of Early Research at Candel, will lead an in-person poster session on pre-clinical CAN-2409 data.

Also on November 11, Patrick Y. Wen, MD, Principal Investigator from Dana-Farber Cancer Institute, will present new data in an in-person oral session on

CAN-2409 in combination with nivolumab and standard of care from the Company’s phase 1b clinical trial in newly diagnosed HGG.

On November 16, Dr. Tak will take part in an in-person fireside chat at Jefferies London Healthcare Conference. (Register Here)

27th Annual Meeting of the Society for Neuro-Oncology (SNO) (View Release)

On November 18, new clinical data from the Company’s phase 1 trial of CAN-3110 in recurrent HGG will be presented in an in-person oral session by Alexander Ling, PhD, a Postdoctoral Research Fellow from Brigham and Women’s Hospital.

On December 6, the Company will hold its virtual R&D Day with leadership and renowned oncology experts to present an in-depth overview of the Company’s viral immunotherapy platforms and clinical pipeline including additional data from its phase 2 clinical trial of CAN-2409 in combination with anti-PD-1 or PD-L1 agents in patients with stage III/IV non-small cell lung cancer.

Financial Results for the Quarter Ended September 30, 2022

Research and Development Service Revenue, related party: Research and Development Service Revenue, related party, for the third quarters ended September 30, 2022 and 2021 was $31,000.

Research and Development Expenses: Research and development expenses were $5.4 million for the quarter ended September 30, 2022 compared to $5.3 million for the comparable period in 2021. The increase was primarily due to personnel-related costs for additional headcount, as well as operating expenses related to the conduct of five ongoing clinical studies. Research and development expenses includes non-cash stock compensation expense of $343,000 and $1.5 million for the third quarter of 2022 and 2021, respectively.

General and Administrative Expenses: General and administrative expenses were $3.5 million for the third quarter of 2022 compared to $2.8 million for the third quarter of 2021. The increase was primarily due to higher recruiting costs, personnel-related costs, and professional and consulting fees associated with operating as a public company. General and administrative expenses includes non-cash stock compensation expense of $400,000 and $390,000 for the third quarter of 2022 and 2021, respectively.

Net Loss: Net loss for the third quarter of 2022 was $8.7 million compared to $16.2 million for the comparable period of 2021. The net loss for the third quarter of 2022 includes non-operating interest, dividend and investment expense of $176,000 and a non-cash credit of $369,000 for the change in the fair value of the Company’s warrant liability. The net loss for the third quarter

of 2021 includes net non-operating income of $117,000 and a non-cash charge of $8.3 million for the change in the fair value of the Company’s warrant liability.

Cash Position: Cash and cash equivalents as of September 30, 2022 were $77.2 million compared to $82.6 million as of December 31, 2021, and reflects the receipt of $20.0 million from the term loan with Silicon Valley Bank in February 2022. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the first quarter of 2024.

On November 10, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported confirmatory top-line clinical data from the final analysis of results from its Phase 1/2 clinical trial of galinpepimut-S (GPS), the Company’s Wilms Tumor-1 (WT1)-targeting peptide immunotherapeutic, in combination with Merck’s anti-PD-1 therapy, pembrolizumab (KEYTRUDA), in patients diagnosed with WT1(+) relapsed or refractory platinum-resistant advanced metastatic ovarian cancer (Press release, Sellas Life Sciences, NOV 10, 2022, View Source [SID1234623666]).

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Data from 17 patients enrolled in the study, conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., Inc., Rahway, N.J., USA (known as MSD outside the United States and Canada), have undergone final analysis for safety and efficacy. All enrolled patients were resistant to standard of care platinum-based therapy and 76.5 percent (13/17) of the patients were refractory to or had failed their first- or second-line therapies, with 23.5 percent (4/17) having failed three or more lines of therapy, including one patient (5.9 percent) who failed five previous lines of therapy. Of the 17 patients, 16 received at least three doses of GPS and had follow-up cross-sectional imaging (CT/MRI) to determine tumor status.

Summary of Top-Line Overall Survival and Progression-Free Survival Data:

Median Overall Survival (OS) was 18.4 months compared to 13.8 months in a checkpoint inhibitor single agent study in a similar patient population treated with checkpoint inhibitor alone
Median Progression-Free Survival (PFS) was 12 weeks compared to eight weeks in a checkpoint inhibitor single agent study in a similar patient population treated with checkpoint inhibitor alone
The overall response rate (ORR) of the trial is 6.3 percent with a disease control rate (DCR), which is the sum of overall response rate and rate of stable disease, of 50.1 percent at a median follow-up of 14.4 months. In a checkpoint inhibitor single agent study in a similar platinum-resistant ovarian cancer patient population treated with a checkpoint inhibitor alone, the observed DCR was 37.2 percent, consistent with a DCR rate increase of approximately 45 percent in the GPS combination with Keytruda over that seen for checkpoint inhibitors alone.
Importantly, survival and disease control benefits were observed in patients harboring tumors with any level of detectable PD-L1 expression, i.e., those with Combined Positive Score (CPS) of one or higher. The DCR is 63.6 percent in patients with a CPS of one or higher in this study.

In the Phase 1/2 study, patients with a CPS score of less than one showed a median OS of 3.2 months vs. patients with a CPS greater than or equal to one who had a median OS of 18.4 months and, as it relates to time to progression, patients with a CPS score of less than one had a median PFS of 1.9 months and patients with a CPS score of greater than or equal than one showed a median PFS of 3.8 months.

In 16 evaluable patients in whom serial peripheral blood samples were available, a correlation was observed between PFS and OS and WT1-specific immune response after GPS vaccination across more than one channel with intracellular cytokine flow-cytometry assays in peripheral blood lymphocytes assaying reactivity against the four pooled WT1 antigens comprising GPS. The data were consistent with those seen in previous studies of GPS.

The safety profile of GPS in combination with pembrolizumab was similar to pembrolizumab alone, with the only addition of low-grade, rapidly resolving local reactions at the GPS injection site, consistent with observations from other GPS clinical studies.

"GPS has been primarily studied as maintenance therapy to provide an overall survival benefit after patients reach a state of minimal residual disease or complete remission. In contrast, in this very difficult to treat patient population with relapsed or refractory measurable advanced platinum-resistant ovarian cancer, who underwent intensive chemotherapy with no apparent enduring clinical benefit, the data suggests that the combination of GPS plus pembrolizumab may be effective in stabilizing active disease. We are excited that both the disease control rate and overall survival results support our belief that GPS has the potential to become an important therapeutic addition to a backbone of checkpoint blockade for WT1(+) ovarian cancer patients, as well as other WT1-expressing tumor types," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "SELLAS plans to submit the full dataset at a major medical conference by mid-next year. I would like to extend my sincere gratitude to all patients who have participated in this clinical trial, as well as the collective study teams at SELLAS and Merck," concluded Dr. Stergiou.

"What I find particularly important for patients with advanced platinum-resistant ovarian cancer is that GPS appears to enhance efficacy of checkpoint inhibitors in patients with tumors with detectable PD-L1 expression, whilst demonstrating a low adverse event burden. Until now, in immunotherapy-recalcitrant tumor types, like ovarian cancer, the impression by many experts has been that patients with CPS scores equal to or higher than 10 may be the most probable candidates to derive clinically meaningful benefit from checkpoint inhibitor therapy, either alone or in combination," stated Bruno Bastos, MD, Medical Oncologist and Study Investigator at the Miami Cancer Institute, Physician Lead of the Multiple Tumors/Phase 1 Clinic, and Assistant Professor at the Herbert Wertheim College of Medicine. "Based on these results, it appears that any ovarian cancer patient whose tumor expresses any level of PD-L1, as long as this biomarker is detected, may benefit from the addition of GPS to a checkpoint inhibitor regimen. If these data are confirmed in larger studies in PD-L1+, WT1+ advanced ovarian cancer, it could enable us to bring the benefits of immunotherapy drugs to a broader patient population in a very difficult setting. This is indeed exciting for the ovarian cancer field, as well as patients suffering from other types of WT1+ malignancies," concluded Dr. Bastos.

About Ovarian Cancer
Ovarian cancer is one of the most common gynecologic malignancies and the fifth most frequent cause of cancer death in women in the United States. Over 22,000 cases are diagnosed annually, and there are an estimated 15,500 deaths per year. The majority of patients have widespread disease at presentation. The 5-year survival for advanced-stage disease remains less than 30 percent. Combining GPS with the checkpoint inhibitor pembrolizumab, which beneficially and profoundly alters the tumor microenvironment (TME) is hypothesized to increase the proportion of patients who develop an immune response against their cancer and potentially improve their clinical outcome over checkpoint inhibitors monotherapy, without the burden of additional toxicities in macroscopically measurable malignancies.