On November 5, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the third quarter ended September 30, 2019 (Press release, Curis, NOV 5, 2019, View Source [SID1234550291]).

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"This past quarter, we made significant progress in advancing our clinical programs for fimepinostat and CA-4948, with continued enrollment across both Phase 1 trials and data readouts on-track for both programs in the fourth quarter of this year. We are particularly encouraged by the early indications of anti-cancer activity with CA-4948." said James Dentzer, President and Chief Executive Officer of Curis. "We are pleased by the safety and tolerability profile of CA-170 in our Phase 1 study and continue to believe VISTA is an important and scientifically-validated target. However, initial data suggest that CA-170 may not be an effective monotherapy agent for addressing VISTA in mesothelioma patients. We plan to further evaluate the translational science and clinical pharmacodynamics of CA-170, as well as the patient data from our Phase 1 study, to determine the optimal future clinical strategy for CA-170."

Third Quarter 2019 and Recent Operational Highlights

Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

Curis is evaluating fimepinostat (a MYC suppressor) with venetoclax (a BCL-2 inhibitor) combination regimen in an ongoing Phase 1 study in diffuse large B-cell lymphoma (DLBCL), including patients with double-hit/double-expressor (DH/DE) lymphoma. DLBCL is often driven by specific alterations in both MYC and BCL2. In the clinic, fimepinostat and venetoclax have each demonstrated single-agent activity. In preclinical models, fimepinostat administered in combination with venetoclax resulted in an enhanced benefit relative to each agent alone.
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

Curis is evaluating CA-4948 in an ongoing Phase 1 dose escalation study in patients with non-Hodgkin lymphoma (NHL), including those with oncogenic MYD88 mutations and toll-like receptor (TLR) pathway activation. Curis plans to continue dose escalation in the study to determine the optimal dose for clinical development.
Curis plans to initiate a separate Phase 1 trial of CA-4948 in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), a focus on those with spliceosome mutations that encode oncogenic IRAK4-L.
Immuno-oncology, CA-170 (VISTA / PDL1 antagonist; Aurigene collaboration):

Curis released initial efficacy data from its Phase 1 study of CA-170 in malignant plural mesothelioma (MPM) patients (high VISTA expressors) in conjunction with the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. The Phase 1 study was designed to evaluate the safety, recommended Phase 2 dose, and maximum tolerated dose of CA-170. Secondary endpoints included pharmacokinetic (PK) and anti-cancer activity, and exploratory endpoints included biomarkers and pharmacodynamic (PD) effects. The study enrolled 12 patients with MPM across 6 study sites within the U.S. and U.K., randomizing patients into two cohorts. The high-dose cohort received 1,200 mg twice-daily (BID) of CA-170, while the low-dose cohort received 200 mg BID of CA-170. Patients who did not respond or experienced disease progression at the 200 mg BID dose were crossed over to the high-dose cohort.
Of 12 patients enrolled, 11 patients have discontinued study treatment, with no partial or complete responses observed, per Response Evaluation Criteria In Solid Tumors (RECIST), Immune-related Response Criteria (irRC) or modified RECIST 1.1 for mesothelioma.
Of 11 patients on treatment for at least one post-baseline disease assessment, 7 had a best response of stable disease:
2 of 3 (66%) patients at the 200 mg BID dose (mean duration of 64 days)
5 of 8 (63%) patients assigned or escalated to the 1,200 mg BID dose (mean duration of 115 days)
CA-170 was generally safe and well-tolerated, with low rates of drug-related, immune-related or serious adverse events, and showed dose-proportional clinical PK.
Based on these data, Curis does not intend to enroll additional patients in this study. The Company plans to further evaluate the translational science and clinical pharmacodynamics of CA-170, in addition to patient data from the Phase 1 study, to assess the potential of future clinical studies of CA-170.
The Company is presenting the results from the Phase 1 study at the SITC (Free SITC Whitepaper) 2019 Annual Meeting in National Harbor, Maryland:

Date/Time:

Saturday, November 9, 2019, 4:45 p.m. EST

Location:

Prince George’s Exhibition Hall C

Poster Number:

O28

Title:

First-in-Class Small Molecule CA-170 Targeting VISTA: A Report on Efficacy Outcomes from a Cohort of 12 Malignant Pleural Mesothelioma (MPM) Patients in Study CA-170-101

Corporate:

In August 2019, Curis announced the appointments of Reinhard von Roemeling, M.D., as Senior Vice President, Clinical Development, and Christine Guertin as Vice President, Regulatory Affairs & Quality Assurance.
In September 2019, Curis announced the promotion of Bill Steinkrauss to Chief Financial Officer.
Upcoming 2019 Milestones

The company will be presenting at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting held December 7-10, 2019 in Orlando, FL, and will provide an update on:
Initial safety data from the Phase 1 study of the combination of fimepinostat and venetoclax in patients with R/R DLBCL, including patients with DH/DE lymphoma; and
Updated safety and efficacy data from the Phase 1 dose escalation study of CA-4948 in patients with NHL.
Third Quarter 2019 Financial Results

Curis reported a net loss of $6.4 million, or $0.19 per share on both a basic and diluted basis for the third quarter of 2019, as compared to a net loss of $7.2 million, or $0.22 per share on both a basic and diluted basis for the same period in 2018.

Revenues for the third quarter of 2019 were $2.9 million, as compared to $2.8 million for the same period in 2018. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses were $8.2 million for the third quarter of 2019, as compared to $9.3 million for the same period in 2018, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for the third quarter of 2019, as compared to $0.2 million for the same period in 2018.

Research and Development Expenses (R&D). R&D expenses were $5.1 million for the third quarter of 2019, as compared to $5.0 million for the same period in 2018. The increase was primarily driven by increased costs related to clinical activities for CA-4948.

General and Administrative Expenses (G&A). G&A expenses were $2.9 million for the third quarter of 2019 as compared to $4.1 million for the same period in 2018. The decrease was primarily driven by lower personnel, legal and consulting services during the period.

Other Expenses. Net other expense for the third quarter 2019 was $1.1 million, as compared to $0.8 million for the same period in 2018. Net other expense for the third quarter 2019 primarily consisted of imputed interest expense related to future royalty payments, whereas in 2018 the expense related to interest accrued on Curis Royalty’s debt obligations.

As of September 30, 2019, Curis’s cash, cash equivalents, marketable securities and investments totaled $28.0 million and there were approximately 33.2 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into the second half of 2020.

Conference Call Information

Curis management will host a conference call today, November 5, 2019, at 8:30 a.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On November 5, 2019 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol-Myers Squibb") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "Celgene Notes") issued by Celgene Corporation (NASDAQ:CELG) ("Celgene") for up to $19,850,000,000 aggregate principal amount of new notes to be issued by Bristol-Myers Squibb Company (the "Bristol-Myers Squibb Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Bristol-Myers Squibb on behalf of Celgene to adopt certain proposed amendments (the "Amendments") to the indentures governing the Celgene Notes (Press release, Bristol-Myers Squibb, NOV 5, 2019, View Source;5 [SID1234550290]). Bristol-Myers Squibb hereby extends such expiration date from 5:00 p.m., New York City time, on November 6, 2019, to 5:00 p.m., New York City time, on November 8, 2019 (as the same may be further extended, the "Expiration Date").

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On the early participation date of May 1, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the Celgene Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal hereby, each as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019, October 30, 2019, November 1, 2019 and as amended hereby, and are conditioned upon the closing of Bristol-Myers Squibb’s acquisition of Celgene (the "Merger"), which condition may not be waived by Bristol-Myers Squibb, and certain other conditions that may be waived by Bristol-Myers Squibb.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and on or about the closing date of the Merger. The closing of the Merger is expected to occur by the end of 2019. As a result, the Expiration Date may be further extended one or more times. Bristol-Myers Squibb will provide notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on November 4, 2019, the principal amounts of Celgene Notes set forth in the table below had been validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Celgene Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019, October 30, 2019, November 1, 2019 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470 3900 (U.S. toll-free) or (212) 430 3774 (banks and brokers). The eligibility form is available electronically at: View Source

On November 5, 2019 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel cancer vaccines, reported strong preliminary data from the ongoing VB N-01 phase I/IIa clinical trial of the VB10.NEO neoantigen cancer vaccine. The data is from the first 16 patients assessed for safety after treatment with a VB10.NEO, and the first 14 patients assessed for clinical responses.

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Key highlights include:

• Clinical responses were observed after treatment start with VB10.NEO in 50% of all analysed patients across tumour types o Lesion size reductions of 10-100% or stabilization of prior progressing lesions.

o All four head and neck cancer (SCCHN) patients, the melanoma patient, the nonsmall cell lung cancer (NSCLC) patient and one of eight renal cancer (RCC) patients show a clinical response after starting VB10.NEO vaccinations.

• Clinical responses correlate with high quality neoepitopes and strong de novo CD8 positive neoepitope-specific T cell responses induced by VB10.NEO. 2

Prof. Dr. med. Jürgen Krauss, of the Department of Medical Oncology, National Center for Tumor Diseases, University Hospital Heidelberg, Germany, and coordinating investigator of the study, said: "I am very pleased with the progress of this clinical phase I/IIa for Vaccibody’s neoantigen cancer vaccine. The data indicate that VB10.NEO induces best in class neoepitope-specific immune responses and the clinical responses observed in the first patients are highly intriguing. Since we have not observed any safety concerns with this treatment so far, there is a very high interest to broaden the patient population exposed to this innovative treatment. We are highly committed to continue this exciting program and we hope this clinical trial will help pave the way for a novel class of new efficacious and safe treatment for cancer patients."

Agnete Fredriksen President and CSO of Vaccibody, commented:

"We are very excited to see a clinical response with a clear effect on both the size and the growth of the lesions in a high number of the first patients treated with VB10.NEO as early as 9 weeks after the first dose of VB10.NEO.

Since we enrolled patients that had been treated with checkpoint inhibitor therapies for at least 5 months before the first dose of VB10.NEO, we are confident that in the cases of actual reductions of lesion sizes this effect can be attributed to the vaccine since most responses to checkpoint inhibitors happens within the first 3-5 months. After this period, further reductions in lesions size are unexpected and lesions that progress usually continue to grow without further interventions. Also, the observation of a strong correlation between high quality neoepitopes in the vaccine and the strength of de novo CD8 neoepitope-specific immune responses that translate into clinical responses is very encouraging.

Importantly, this confirms the ability of Vaccibody’s vaccine delivery platform to generate strong CD8 T cell responses, critical for tumour killing. Importantly, responses were also observed in patients with low tumour mutational burden that progressed after long-term checkpoint inhibitor therapy."

Michael Engsig, CEO of Vaccibody, continued: "To our knowledge, this is the first time that a neoepitope cancer vaccine shows the ability to actually shrink tumours, even in heavily pre-treated patients with advanced or metastatic disease. Taken together, we are very encouraged to build on these findings and continue development of our neoantigen cancer vaccine program."

Results Before VB10.NEO vaccination, most patients had received multiple lines of prior anti-cancer therapy and had been treated with a checkpoint inhibitor (CPI) (nivolumab or pembrolizumab) for 5-32 months. All had stable disease or mixed progressive disease when enrolled into the study. Five patients were progressing between enrolment and first dose of VB10.NEO and one had a partial response, while the remaining patients were stable. Twelve of the 14 patients 3 continued treatment with a CPI during VB10.NEO treatment. A clinical response, defined as either >10% reduction in the target lesions (as identified at screening) or converting progressive lesions into stable lesions (<20% increase, up to 37 weeks follow-up) after starting VB10.NEO treatment, was observed in seven of the 14 patients (4 SCCHN, 1 melanoma, 1 NSCLC and 1 RCC). The strongest clinical responses were most often seen in the lesions that were used to select the neoepitopes. Eleven patients had low tumour mutational burden (TMB), two patients had medium TMB and one patient had high TMB. The top 20 neoepitopes predicted by Vaccibody’s proprietary NeoSELECTTM algorithm were selected for each of the fully personalized VB10.NEO neoantigen vaccines. Vaccibody’s proprietary DNA vaccine manufacturing process has so far yielded 100% manufacturing success with the top 20 selected neoepitopes for all patients.

One RCC patient who discontinued CPI and started immunosuppressive treatment prior to first dose of VB10.NEO was not included in the immunogenicity analyses. Immunogenicity to each individual neoepitope was assessed in eight patients after six vaccinations by in vitro prestimulated IFN-γ ELISpot. The breadth and the strength of neoepitope-specific T cell responses were increased with number of vaccinations. Patients showing a clinical response also had the strongest immune responses and the highest frequency of high quality neoepitopes. The safety data for the 16 patients who has received at least one dose of VB10.NEO shows that VB10.NEO is well tolerated. Most common adverse events attributable to the VB10.NEO treatment were injection-related hypertensive episodes and injection site reactions. Four patients with SCCHN were assessed, three with low TMB and one with medium TMB. Two patients had progressive disease, one had stable disease and one had partial response at start of VB10.NEO vaccination. The patients had been on CPI for 12-32 months before starting VB10.NEO treatment. Strong neoantigen-specific T cell responses were seen in the vast majority (60-90%) of the selected neoepitopes after VB10.NEO vaccination with up to 1000-fold increase. A clinical response was observed in all four SCCHN patients: In the patients who had progressed on CPI before starting VB10.NEO a stabilisation or reduction in the size of the target lesions were observed after starting VB10.NEO treatment. In patients with stable disease or partial response on CPI, a reduction in lesion size was observed after starting VB10.NEO treatment. If the patients had multiple target lesions, the strongest response was observed in the lesions used to select neoantigens for the vaccine. Eradication of tumour cells containing the mutations targeted by the vaccine was observed in a follow-up biopsy from one of the patients. One melanoma patient was assessed. The patient had high TMB and stable disease at start of VB10.NEO vaccination and the patient had been on CPI for 10 months before treatment with VB10.NEO vaccination. An increased neoantigen-specific T cell response was seen to 50% of the selected neoepitopes after VB10.NEO vaccination with the majority being de novo responses. A clinical response with lesion size reduction was observed in the patient. 4

One NSCLC patient was assessed. The patient had medium TMB and stable disease as best response during nine months of CPI treatment before start of vaccination. Disease progression was observed during vaccine manufacturing with the occurrence of a new lesion. A clinical response in the form of rapid reduction in the target lesion was observed nine weeks after the first VB10.NEO vaccination.

Eight patients with RCC were assessed for clinical response, all with low TMB. Two patients had progressive disease and six had stable disease at start of VB10.NEO vaccination. One patient was taken off CPI and started immunosuppressive therapy prior to the first dose of VB10.NEO. Limited clinical responses have been observed until data-cut off (up to 37 weeks after first VB10.NEO vaccination). Interestingly, only one of the RCC patients has had an increase of >20% in the sum of target lesions and none of the lesions used to select neoantigens for the vaccine has progressed (defined as >20% increase in size.) Correlating with the limited clinical responses, fewer high-quality epitopes and neoepitope-specific immune responses were observed.

The Poster The Poster (ID: P424) will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting Saturday, 9 November, 7:00 am-8:30 pm local time in National Harbor, Maryland. Vaccibody staff will be available during the poster session at SITC (Free SITC Whitepaper).

On November 5, 2019 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported positive preclinical results further elucidating the mechanism of action of BL-8040 in combination with an anti PD-1 and chemotherapy (Press release, BioLineRx, NOV 5, 2019, View Source [SID1234550288]). The results, summarized in a poster entitled, "Combination of BL-8040, anti PD-1 and chemotherapy significantly reduced pancreatic tumor growth and changed the balance between CD4+/FOXP3+ cells and CD8+ cells in the tumor," will be presented on November 8, 2019 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, Maryland.

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"The results seen in this preclinical pancreatic cancer study support our hypothesis that the triple combination of BL-8040, anti-PD-1 and chemotherapy helps combat this difficult to treat cancer," said Philip Serlin, Chief Executive Officer of BioLineRx. "These preclinical data from the triple combination study support the mechanism of action of BL-8040 demonstrated in earlier clinical data from the dual combination of BL-8040 and pembrolizumab, showing a reduction in immuno-suppressive cells, accompanied by an increase in activated effector CD8+ T cells. We believe the ability of BL-8040 to modulate the tumor microenvironment allows for better activation of immune effector cells when combined with chemotherapy and immunotherapy. We are very hopeful that this anti-tumor activity will be confirmed in humans as we eagerly await results from the triple combination arm of our COMBAT/KEYNOTE-202 Phase 2 study of BL-8040, KEYTRUDA and chemotherapy in metastatic pancreatic cancer, which we expect to report by year end."

About the Pre-Clinical Study
The pre-clinical study assessed the effects of BL-8040, anti-PD-1 and chemotherapy (Irinotecan, Fluorouracil and Leucovorin), both alone and in various combinations, on tumor growth and immune cell constitution in a mouse model for pancreatic cancer.

Key findings include:

•The triple combination of BL-8040+anti-PD-1+chemotherapy had a significantly better effect on tumor growth compared to chemotherapy alone or any dual combination with chemotherapy.

The triple combination of BL-8040+anti-PD-1+chemotherapy showed the best effect in modulation of the tumor microenvironment, resulting in reduction in immunosuppressive cells, and accompanied by increase of activated T effector cells.

About BL-8040
BL-8040 is a short synthetic peptide that functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor over-expressed in many human cancers. CXCR4 has been shown to be correlated with poor prognosis, and plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance. CXCR4 is also directly involved in the homing and retention of hematopoietic stem cells (HSCs) and various hematological malignant cells in the bone marrow.

In a number of clinical and preclinical studies, BL-8040 has shown a critical role in immune cell trafficking, tumor infiltration by immune effector T cells and reduction in immunosuppressive cells within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" tumors (i.e., sensitizing them to immune check point inhibitors). BL-8040-mediated inhibition of the CXCR4-CXCL12 (SDF-1) axis has also shown robust mobilization of HSCs for transplantation in hematological malignancies.

BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On November 5, 2019 Heat Biologics, Inc. (NASDAQ:HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported that an abstract has been posted on The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) website in connection with the Company’s planned poster presentation at SITC (Free SITC Whitepaper)’s 34th Annual Meeting on November 8, 2019 (Press release, Heat Biologics, NOV 5, 2019, View Source [SID1234550287]).

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The abstract summarizes the latest interim top line data from Cohort B of the Company’s Phase 2 trial of the Company’s "off-the-shelf" cell-based therapy, HS-110, in combination with Opdivo (Nivolumab) in advanced non-small cell lung cancer (NSCLC), which completed enrollment in July 2019. This cohort enrolled patients who had previously received a checkpoint inhibitor (CPI) and whose disease had subsequently progressed. The data suggests that re-challenging the immune system with nivolumab and HS-110 after checkpoint inhibitor treatment failure may restore responsiveness and clinical benefit. Additionally, the combination of HS-110 and nivolumab is well-tolerated, and no increase in the incidence of immune-related adverse events was observed to date, as compared to CPI monotherapy. The full abstract is available at: View Source

Jeff Wolf, Heat Biologics’ CEO, commented, "NSCLC patients who progressed after checkpoint inhibitor treatment have limited therapeutic options. The latest results are encouraging and suggest that HS-110 in combination with nivolumab may address this key unmet medical need. As of this data cut, the median overall survival (OS) is estimated to be 11.8 months, with 70% of the patients still alive. I am unaware of any published checkpoint combination studies that offered superior OS in patients that had experienced previous checkpoint inhibitor treatment failure in NSCLC. This data also compares favorably to reported studies using chemotherapy following checkpoint inhibitor progression 1, 2 ".

Signals of clinical efficacy were observed in the reported objective response rate (ORR), disease control rate (DCR) and progression free survival (PFS). Importantly, patients experiencing dermal injection site reactions (ISR) had statistically significant improvement in PFS and OS compared to those without ISR (Hazard Ratio = 0.40, p=0.0068 and Hazard Ratio = 0.16, p=0.0005, respectively). Additional data will be presented at SITC (Free SITC Whitepaper) on November 8 ,2019.

Details of Heat Biologics’ poster presentation:

Abstract Title: Treating advanced non-small lung cancer (NSCLC) patients after checkpoint inhibitor treatment failure with a novel combination of Viagenpumatucel-L (HS-110) plus nivolumab

Poster #: P411
Date: Friday, November 8, 2019, 7am – 8pm (Eastern Time)
Location: Gaylord National Hotel & Convention Center, Washington DC

References:

1 Costantini A, Corny J, Fallet V et al. Efficacy of next treatment received after nivolumab progression in patients with advanced nonsmall cell lung cancer. ERJ Open Res. 2018 Apr 20;4(2).

2 Schvartsman G, Peng SA, Bis G, et al. Response rates to single-agent chemotherapy after exposure to immune checkpoint inhibitors in advanced non-small cell lung cancer. Lung Cancer. 2017 Oct;112:90-95.