On September 20, 2018 Exicure, Inc. (OTCQB:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional spherical nucleic acid (SNA) constructs, reported Phase 1 results for AST-008, an SNA consisting of toll-like receptor 9 (TLR9) agonists designed for immuno-oncology applications (Press release, Exicure, SEP 20, 2018, View Source;p=RssLanding&cat=news&id=2368198 [SID1234529613]).

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"Phase 1 results for AST-008 demonstrated our desired highly potent immune system activation without serious adverse events or dose limiting toxicity. We believe this molecule could lead to better combination therapies for patients with cancer and, to that end, we expect to initiate a Phase 1b/2 trial in patients before year end," said Dr. David Giljohann, Chief Executive Officer of Exicure. "These data support the potential of our SNA platform for immuno-oncology and set the stage for ongoing development of the SNA platform into indications well beyond cancer."

Exicure’s Phase 1 Trial Results

The Phase 1 trial of AST-008 was a single ascending subcutaneous dose trial comprised of 16 healthy volunteers. AST-008 was shown to be safe and tolerable in all subjects, with no serious adverse events and no dose limiting toxicity. AST-008 was well tolerated and all AST-008-related adverse events were of short duration, reversible and consistent with TLR9 activation.

In addition to the principle safety and tolerability endpoint, the trial screened for levels of select cytokines and markers of immune cell activation. AST-008 was shown to elicit high levels of certain cytokines as well as activate important effector cells of the immune system including T cells and natural killer cells, the main drivers of anti-tumor response.

For the four subjects receiving the trial’s top dose of about 20 µg/kg of AST-008, initial analyses suggest that the average fold-increase above baseline for these cytokines is approximately as follows: IFN-gamma: 3 fold; IL-6: 57 fold; IL-12: 2 fold; IP-10: 32 fold; and MCP-1: 4 fold. At this dose, AST-008 also elicited 9.5 fold and 3.5 fold increases in the fraction of activated T cells and natural killer cells, respectively, compared to baseline.

Exicure’s Planned Phase 1b/2 Patient Trial

Exicure intends to begin an open-label Phase 1b/2 trial of intra-tumorally dosed AST-008 in combination with a checkpoint inhibitor before year end. The trial will begin with an AST-008 dose finding Phase 1b stage, followed by a Phase 2 expansion stage. In the Phase 1b, Exicure will enroll patients with superficial injectable tumors and will prioritize those with Merkel cell carcinoma, cutaneous squamous cell carcinoma, melanoma, and squamous cell carcinoma of the head and neck. Preliminary data from the Phase 1b stage are expected in late 2019.

Historical TLR9 Agonist Healthy Volunteer Data

In 2015, Mologen AG published results (European Journal of Cancer, 2015, volume 51, supplement 1, page S12) from a healthy volunteer trial. In a single cohort, 13 subjects each received one 60 mg dose (equivalent to 923 µg/kg for a 65 kg subject) of lefitolimod subcutaneously. On average, across the cohort, there was a 7 fold-increase in IP-10 expression above baseline. No cell activation data were reported. Lefitolimod is currently in a Phase 3 clinical trial.

In 2004, Coley Pharmaceutical Group (now Pfizer, Inc.) published results (Journal of Immunotherapy, 2004, Volume 27, pages 460–471) from a single ascending dose healthy volunteer trial. In that trial, their TLR9 agonist, PF-03512676, was administered subcutaneously to six subjects per dose level. For the 20 µg/kg dose level, the average fold-increase above baseline for these cytokines is as follows: IFN-gamma: no change from baseline; IL-6: 8 fold; IL-12: no change from baseline; IP-10: 9 fold; and MCP-1: 3 fold.

Upcoming Presentations

Exicure management expects to be presenting and available for meetings at a number of fall investor conferences including:

October 2 – Ladenburg Thalmann 2018 Healthcare Conference at the Sofitel Hotel New York, NY;
October 3 – Leerink Partners Roundtable Series: Rare Disease & Oncology at the Lotte New York Palace, New York, NY;
October 9 – Chardan’s 2nd Annual Genetic Medicines Conference at the Westin Grand Central, New York, NY;
October 25 – BTIG Biotech Conference at the Langham Hotel, New York, NY.

On september 20, 2018 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, reported that Mr. Dror Ben-Asher, chief executive officer of RedHill, will present a corporate overview at the Ladenburg Thalmann 2018 Healthcare Conference, on Tuesday, Oct. 2, 2018, at 10:30 a.m. ET, at the Sofitel Hotel in New York City (Press release, RedHill Biopharma, SEP 20, 2018, View Source [SID1234529589]).

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The presentation will be broadcast live and available for replay on the Company’s website, View Source, for 30 days. Please access the website at least 15 minutes ahead of the presentation to register, download, and install any necessary audio software.

On September 20, 2018 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported that it was informed that Bayer AG dosed the first patient in the Phase 1 clinical trial of BAY 1905254, a first-in-class immuno-oncology therapeutic antibody targeting the ILDR2 protein, in patients with advanced solid tumors (Press release, Compugen, SEP 20, 2018, View Source [SID1234529531]). Under the terms of the collaboration and license agreement, Compugen is entitled to a milestone payment of $7.8 million at first patient dosing. ILDR2 is a new immune checkpoint protein identified by Compugen using its predictive target discovery platform.

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"ILDR2 was one of the first immune checkpoint targets discovered through our discovery platforms and the first to enter into a R&D collaboration and license agreement with a pharma partner," stated Anat Cohen-Dayag, PhD, President and CEO of Compugen. "Bayer has been an outstanding partner and we greatly appreciate their excellent R&D team and commitment to advancing this program to the clinic."

"BAY 1905254 and our internally-developed COM701 are the first drug candidates to enter Phase 1 trials addressing new drug targets discovered computationally by Compugen. This represents a breakthrough achievement for Compugen and proof-of-concept of the power of our computational discovery capabilities. We hope that each of these drug candidates will become a life changing treatment option for patients unresponsive to existing cancer immunotherapies," Dr. Cohen-Dayag added.

About ILDR2 and BAY 1905254
ILDR2 is a novel B7/CD28-like immune checkpoint target discovered computationally by Compugen. Preclinical studies demonstrated inhibitory effects of ILDR2 on T cells, consistent with it being an immune checkpoint ligand. Additional expression and functional studies suggest that ILDR2 acts as an inhibitor of the priming step of T cell activation, thereby muting T cell response to cancer.

BAY 1905254 is a fully human antibody that blocks the immunosuppressive activity of ILDR2. BAY 1905254 exhibits anti-tumor activity as a monotherapy in various mouse models, and also demonstrates additive anti-tumor effects in combination with other cancer therapy approaches in those models, indicating the possibility for multiple combination uses in cancer immunotherapy.

On September 20, 2018 Array BioPharma Inc. (NASDAQ: ARRY) reported that the European Commission (EC) has approved BRAFTOVI in combination with MEKTOVI for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation, as detected by a validated test (Press release, Array BioPharma, SEP 20, 2018, View Source [SID1234529528]). This approval is applicable to all 28 European Union (EU) member states, as well as Liechtenstein, Iceland and Norway.

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"With an even greater number of patients with advanced BRAF-mutant melanoma in Europe than in the U.S., we are delighted BRAFTOVI + MEKTOVI will be available to these patients who are in critical need of additional options that delay disease progression and improve overall survival," said Ron Squarer, Chief Executive Officer. "Our European partner, Pierre Fabre, has a strong legacy in oncology, and with over a thousand employees dedicated to this therapeutic area, we are very pleased they have made BRAFTOVI + MEKTOVI a top priority for their team."

The EC approval is based on results from the Phase 3 COLUMBUS trial, of which the primary endpoint was median progression-free survival (mPFS). BRAFTOVI + MEKTOVI achieved an mPFS of nearly 15 months [14.9 months versus vemurafenib monotherapy at 7.3 months; hazard ratio (HR) 0.54 (95% CI, 0.41–0.71), p<0.0001].

BRAFTOVI + MEKTOVI is the first targeted treatment to achieve over 30 months median overall survival (OS). As published in The Lancet Oncology in September 2018, BRAFTOVI + MEKTOVI reduced the risk of death compared to vemurafenib [HR (0.61), (95% CI 0.47,0.79), p <0.0001]. Median OS was 33.6 months for patients treated with the combination, compared to 16.9 months for patients treated with vemurafenib.

Detailed recommendations for the use of these products in the EU are described in the summary of product characteristics (SmPC), which are published in the European public assessment report (EPAR) and made available in all official EU languages at View Source

Array has exclusive rights to BRAFTOVI and MEKTOVI in the U.S. and Canada. Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea, Medison exclusive rights to commercialize both products in Israel and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Latin America and Asia (excluding Japan and South Korea).

In June 2018, the U.S. Food and Drug Administration (FDA) approved BRAFTOVI + MEKTOVI for the treatment of unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma.

Only 5% of patients who received BRAFTOVI + MEKTOVI discontinued treatment due to adverse reactions. The most common adverse reactions (≥25%) in patients receiving BRAFTOVI + MEKTOVI were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia.

About BRAF-mutant Metastatic Melanoma
Melanoma develops when unrepaired DNA damage to skin cells triggers mutations that may lead them to multiply and form malignant tumors. Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates. [1,2] There are a variety of gene mutations that can lead to metastatic melanoma. The most common genetic mutation in metastatic melanoma is BRAF. There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma. [1-5]

About BRAFTOVI + MEKTOVI
BRAFTOVI is an oral small molecule BRAF kinase inhibitor and MEKTOVI is an oral small molecule MEK inhibitor which target key enzymes in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma, colorectal cancer, non-small cell lung cancer and others. In the U.S., BRAFTOVI + MEKTOVI are approved for the treatment of unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma. In Europe, the combination is approved for adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation, as detected by a validated test.

The Swiss Medicines Agency (Swissmedic) and the Australian Therapeutic Goods Administration (TGA) are currently reviewing the Marketing Authorization Applications for BRAFTOVI and MEKTOVI submitted by Pierre Fabre, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is currently reviewing the Manufacturing and Marketing Approval applications submitted by Ono Pharmaceutical Co, Ltd.

About COLUMBUS
The COLUMBUS trial (NCT01909453) is a two-part, international, randomized, open label Phase 3 trial evaluating the efficacy and safety of BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) compared to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAFV600 mutation. The primary endpoint of the trial was mPFS; all secondary efficacy analyses, including the prospectively planned analysis overall survival, are descriptive in nature. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the trial.

BRAFTOVI + MEKTOVI Indications and Usage
BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are kinase inhibitors indicated for use in combination for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600E mutation.
Limitations of Use: BRAFTOVI is not indicated for the treatment of patients with wild-type BRAF melanoma.

BRAFTOVI + MEKTOVI Important Safety Information
The information below applies to the safety of the combination of BRAFTOVI and MEKTOVI unless otherwise noted.

Warnings and Precautions
New Primary Malignancies: New primary malignancies, cutaneous and non-cutaneous malignancies can occur. In the COLUMBUS trial, cutaneous squamous cell carcinoma, including keratoacanthoma, occurred in 2.6% and basal cell carcinoma occurred in 1.6% of patients. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Discontinue BRAFTOVI for RAS mutation-positive non-cutaneous malignancies.

Tumor Promotion in BRAF Wild-Type Tumors: Confirm evidence of BRAFV600E or BRAFV600Kmutation prior to initiating BRAFTOVI.

Cardiomyopathy: In the COLUMBUS trial, cardiomyopathy occurred in 7% and Grade 3 left ventricular dysfunction occurred in 1.6% of patients. Cardiomyopathy resolved in 87% of patients. Assess left ventricular ejection fraction by echocardiogram or MUGA scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. The safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal.

Venous Thromboembolism (VTE): In the COLUMBUS trial, VTE occurred in 6% of patients, including 3.1% of patients who developed pulmonary embolism.

Hemorrhage: In the COLUMBUS trial, hemorrhage occurred in 19% of patients and ≥Grade 3 hemorrhage occurred in 3.2% of patients. Fatal intracranial hemorrhage in the setting of new or progressive brain metastases occurred in 1.6% of patients.

Ocular Toxicities: In the COLUMBUS trial, serous retinopathy occurred in 20% of patients; 8% were retinal detachment and 6% were macular edema. Symptomatic serous retinopathy occurred in 8% of patients with no cases of blindness. In patients with BRAF mutation-positive melanoma across multiple clinical trials, 0.1% of patients experienced retinal vein occlusion (RVO). Permanently discontinue MEKTOVI in patients with documented RVO. In COLUMBUS, uveitis, including iritis and iridocyclitis, was reported in 4% of patients. Assess for visual symptoms at each visit. Perform ophthalmic evaluation at regular intervals and for any visual disturbances.

Interstitial Lung Disease (ILD): ILD, including pneumonitis, occurred in 0.3% of patients with BRAF mutation-positive melanoma across multiple clinical trials. Assess new or progressive unexplained pulmonary symptoms or findings for possible ILD.

Hepatotoxicity: In the COLUMBUS trial, the incidence of Grade 3 or 4 increases in liver function laboratory tests was 6% for alanine aminotransferase (ALT) and 2.6% for aspartate aminotransferase (AST). Monitor liver laboratory tests before and during treatment and as clinically indicated.

Rhabdomyolysis: In the COLUMBUS trial, elevation of laboratory values of serum creatine phosphokinase (CPK) occurred in 58% of patients. Rhabdomyolysis was reported in 0.1% of patients with BRAF mutation-positive melanoma across multiple clinical trials. Monitor CPK periodically and as clinically indicated.

QTc Prolongation: In the COLUMBUS trial, an increase in QTcF to >500 ms was measured in 0.5% (1/192) of patients. Monitor patients who already have or who are at significant risk of developing QTc prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms.

Embryo-Fetal Toxicity: BRAFTOVI or MEKTOVI can cause fetal harm when administered to pregnant women. Nonhormonal contraceptives should be used during treatment and for at least 30 days after the final dose for patients taking BRAFTOVI + MEKTOVI.

Adverse Reactions
The most common adverse reactions (≥20%, all Grades, in the COLUMBUS trial) were: fatigue, nausea, diarrhea, vomiting, abdominal pain, arthralgia, myopathy, hyperkeratosis, rash, headache, constipation, visual impairment, serous retinopathy.

In the COLUMBUS trial, the most common laboratory abnormalities (≥20%, all Grades) included: increased creatinine, increased CPK, increased gamma glutamyl transferase, anemia, increased ALT, hyperglycemia, increased AST, and increased alkaline phosphatase.

Drug interactions
Avoid concomitant use of strong or moderate CYP3A4 inhibitors or inducers and sensitive CYP3A4 substrates with BRAFTOVI. Modify BRAFTOVI dose if concomitant use of strong or moderate CYP3A4 inhibitors cannot be avoided.

Please see full Prescribing Information for BRAFTOVI and full Prescribing Information for MEKTOVI for additional information [6,7]. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Array at 1-844-Rx-Array (1-844-792-7729).

On September 20, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported its clinical data on tislelizumab, an investigational anti-PD-1 antibody, in Chinese patients with lung cancers, in two oral presentations at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) in Xiamen, China (Press release, BeiGene, SEP 20, 2018, View Source;p=RssLanding&cat=news&id=2368376 [SID1234529526]).

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"Advanced lung cancer is one of our focus areas for development of tislelizumab, where we hope to have an impact on the way patients are treated both in China and worldwide. This complex and difficult-to-treat disease has proven to be susceptible to treatment with immunotherapies," commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. "The preliminary data presented today demonstrate that tislelizumab is generally well tolerated and has antitumor activity both as monotherapy and in combination with several chemotherapy regimens used in small cell and non-small cell lung cancer patients. We are hopeful that further study of tislelizumab may lead to a new treatment option for a broad array of patients with lung cancers."

Summary of Preliminary Results of Phase 2 Trial in China of Tislelizumab Combined with Chemotherapy as First-Line Treatment in Advanced Lung Cancer Setting

The multi-center, open-label Phase 2 trial in China (CTR20170361) of tislelizumab in combination with chemotherapy enrolled 54 patients with previously untreated locally advanced or metastatic lung cancer. All patients received tislelizumab at 200 mg every three weeks, plus platinum doublet until disease progression. Patients with non-squamous non-small cell lung cancer (NSCLC) (n=16) received pemetrexed plus platinum; patients with squamous NSCLC received either paclitaxel plus platinum (cohort A, n=15) or gemcitabine plus platinum (cohort B, n=6); and patients with small cell lung cancer (SCLC) received etoposide plus platinum (n=17).

As of the June 5, 2018 data cutoff, 35 patients remain on treatment. Treatment discontinuation due to adverse events (AEs) occurred in three patients. Fifty-one patients had at least one post-baseline tumor assessment and were evaluable for efficacy. Objective responses (including confirmed and unconfirmed partial responses) were observed in 56 percent (31 percent confirmed; all patients with an unconfirmed partial response remained on treatment) of 16 evaluable patients with non-squamous NSCLC; 80 percent (all confirmed) in 15 evaluable patients with squamous NSCLC, cohort A; 67 percent (all confirmed) in six patients with squamous NSCLC, cohort B; and 82 percent (47 percent confirmed; all patients with an unconfirmed partial response remained on treatment) in 17 evaluable patients with SCLC. Data continue to mature with follow-up.

AEs were considered manageable and reversible, with chemotherapy dose modifications or tislelizumab dose holds, except for one fatal event of myocarditis/myositis. Five patients (9.3%) experienced at least one grade ≥3 AE (polymyositis, dyspnea, rhabdomyolysis, myocarditis/myositis, and myasthenia gravis) that were considered to be possibly related to tislelizumab. Immune-related AEs (irAEs) occurred in 13 patients (24%) and included hypothyroidism (n=3), decreased tri-iodothyronine (n=2), hyperthyroidism (n=2), pneumonitis (n=2), pyrexia (n=2), and rash (n=2).

"We are excited by the preliminary data of tislelizumab combined with chemotherapy in patients with advanced lung cancer. The safety and tolerability appear consistent with previous data, and high response rates of up to 80 percent in a squamous NSCLC cohort along with low discontinuation rates support continued investigation of tislelizumab in patients with advance lung cancer. We are hopeful that this combination therapy will offer improved outcomes in this advanced disease setting," said Professor Jie Wang, M.D., from the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College in Beijing, China, and lead author of the presentation.

Summary of Preliminary Results of Tislelizumab in Chinese Patients with NSCLC from Phase 1/2 Trial

The multi-center, open-label Phase 1/2 trial in China (CTR20160872) of tislelizumab enrolled 46 patients with NSCLC in the Phase 2 indication expansion portion of the trial, with 21 patients having expression of PD-L1 in 10 percent or more of their tumor cells (PD-L1+); the remaining 25 patients were considered PD-L1 negative (PD-L1-).

As of the May 11, 2018 data cutoff, 15 patients (33%) remained on treatment with the median treatment duration of 4.1 months (0.2–11.3 months) and a median follow-up of 8.4 months (0.2–11.8 months). Treatment discontinuation due to adverse events (AEs) occurred only in one patient. The median duration of treatment was 3.5 months (0.2-11.2 months) and 4.4 months (0.7–11.3 months) in PD-L1+ and PD-L1- cohorts, respectively. A total of 42 patients had at least 1 post-baseline tumor assessment and were evaluable for antitumor activity. Confirmed partial responses were observed in 17 percent of the evaluable patients, including 12 percent and 20 percent in PD-L1+ and PD-L1- patients, respectively.

Across the two arms, the most common treatment-related AEs (TRAEs) (occurring in ≥ 10% of patients) were increased transaminases (26%), rash (11%) and hypothyroidism (11%). A total of 14 patients had serious AEs and three of these patients experienced serious TRAEs, including nausea and vomiting (n=1), increased aspartate aminotransferase (AST) (n=1) and hyperglycemia (n=1). Three patients experienced a serious AE with a fatal outcome (multiple organ dysfunction syndrome [n=1], central nervous system metastases [n=1], hypotension [n=1]); none were determined to be related to treatment. Immune-related AEs occurred in 26 patients (57%) and many were overlapping with the TRAE cases.

"The prognosis for patients with late stage non-small cell lung cancer remains particularly poor. We are pleased that this trial demonstrated that treatment with tislelizumab was generally well tolerated. We are excited to see that Phase 3 trials evaluating tislelizumab, either as monotherapy or in combination with chemotherapy, in patients with advanced NSCLC are underway and look forward to the results," said Yi-Long Wu, M.D., President of Chinese Thoracic Oncology Group (CTONG) and lead author of the presentation.

Trial data with the same cut off time will be presented at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC), which takes place September 23-26 in Toronto.

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).