On November 9, 2018 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported a business update and financial results for the third quarter ended September 30, 2018 (Press release, Leap Therapeutics, NOV 9, 2018, View Source [SID1234531197]).

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"Our team has executed extremely well over the past quarter, rapidly enrolling multiple clinical trials and presenting impressive clinical and preclinical data for both of our programs. We are excited about the potential for our DKN-01 antibody in patients with esophagogastric cancer, both in combination with KEYTRUDA (pembrolizumab) and with paclitaxel. We believe that the emerging response and disease control rates, and now the progression-free survival and overall survival data, reflect outcomes that are clinically meaningful to patients with very difficult to treat cancer and are greater than what has previously been demonstrated with approved single agents," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "In addition, we look forward to presenting data from the studies of our TRX518 antibody in combination with KEYTRUDA, OPDIVO (nivolumab) or gemcitabine at the European Society for Molecular Oncology 2018 Immuno-Oncology Congress in December."

Recent Developments

Since the end of the second quarter, the Company has continued to make strong progress with the development of their product candidates.

DKN-01/KEYTRUDA: At the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) 2018 Annual Congress, Leap presented clinical data from a study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer. As of the cut-off date for the poster, DKN-01 and pembrolizumab had a 23.5% overall response rate and 58.8% disease control rate in evaluable gastric or gastroesophageal junction cancer patients who have been heavily pre-treated and not received any prior anti-PD-1/PD-L1 therapy. All four of the responding patients had tumors that were microsatellite stable, which is a subgroup of patients who have historically experienced a less than ten percent response rate to KEYTRUDA monotherapy.

DKN-01/PACLITAXEL: At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, Leap presented an update on a clinical study evaluating DKN-01 in combination with paclitaxel in patients with advanced esophagogastric cancer. The combination of DKN-01 and paclitaxel generated a 46.7% overall response rate, 19.6 weeks median progression free survival, and 61.1 weeks median overall survival in fifteen evaluable patients as a second line therapy. In the benchmark RAINBOW study, paclitaxel monotherapy in second line gastroesophageal junction or gastric cancer patients generated a 16.1% overall response rate, 2.9 months median progression free survival, and 7.4 months median overall survival. Additionally, in our study in the subgroup of twelve evaluable patients with heavily pre-treated esophageal squamous cell carcinoma, the combination of DKN-01 and paclitaxel produced a 33.3% overall response rate, 13.7 weeks median progression free survival, and 31.0 weeks median overall survival.

DKN-01 in HCC: The first patient has been enrolled in Leap’s investigator-initiated study of DKN-01 as a monotherapy and in combination with NEXAVAR (sorafenib) in hepatocellular carcinoma patients with Wnt pathway activation.

TRX518/BAVENCIO: In July, Leap announced a collaboration agreement with Pfizer and Merck KGaA, Darmstadt, Germany to evaluate TRX518 in combination with BAVENCIO (avelumab) and cyclophosphamide chemotherapy. Under the terms of the collaboration, Leap will be conducting a Phase I/II clinical trial in advanced solid tumors including expansion populations in patients with relapsed/refractory ovarian, breast, and prostate cancers.

· TRX518/KEYTRUDA or OPDIVO or GEMCITABINE: During the third quarter, Leap presented initial data from a clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab). Three patients treated with TRX518 in combination with anti-PD1 antibodies have experienced clinical benefit. An esophageal squamous cell carcinoma patient treated with TRX518 and KEYTRUDA demonstrated a partial response with a 77% reduction in tumor volume, and an ocular melanoma patient experienced stable disease with a 23% reduction in tumor volume. An urothelial carcinoma patient who had progressed while on KEYTRUDA has had a partial response with TRX518 and OPDIVO with a 39% reduction in tumor volume. We have also fully enrolled the TRX518 and gemcitabine expansion cohort. We plan to present additional data from this trial at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress in December 2018.

Selected Third Quarter 2018 Financial Results

Net loss was $6.6 million for the third quarter of 2018, compared to $6.8 million for the same period in 2017.

Research and development expenses were $6.5 million for the third quarter 2018, compared to $6.8 million for the same period in 2017. The decrease of $0.3 million was primarily due to a decrease of $1.3 million in manufacturing costs related to clinical trial material. This decrease was partially offset by an increase of $0.7 million in clinical trial costs, an increase of $0.2 million in payroll and other related costs and an increase of $0.1 million in stock based compensation expense.

General and administrative expenses were $2.1 million for the third quarter 2018, compared to $1.8 million for the same period in 2017. The increase of $0.3 million in general and administrative expenses was primarily due to a $0.2 million increase in stock based compensation expense and an increase of $0.1 million in legal, audit and consulting fees associated with corporate and business development activities.

Cash, cash equivalents and marketable securities totaled $23.2 million at September 30, 2018. Research and development incentive receivables totaled $2.1 million. In October 2018, we received $0.8 million of research and development tax incentive payments from the Commonwealth of Australia. We anticipate that our current cash resources will extend until late in the third quarter of 2019.

On November 9, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company that develops antibody-based drug candidates for tumor-directed immunotherapy and Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company that develops new treatments in immunology and hematology, reported that new preclinical data for ALG.APV-527 will be presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Scientific Conference, held in Washington, DC, USA, November 9-11, 2018 (Press release, Alligator Bioscience, NOV 9, 2018, View Source [SID1234531196]).

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ALG.APV-527 is a drug candidate for immunotherapeutic treatment of 5T4 positive solid cancer tumors. It is designed to activate the immune system via the co-stimulating receptor 4-1BB (CD137) on activated cytotoxic T cells and NK (Natural Killer) cells. ALG. APV-527 is designed to induce a powerful and tumor-directed immunoreactivation in the presence of 5T4 positive tumor cells. 5T4 is a tumor antigen found in a variety of malignant tumor types.

Preclinical data show that ALG.APV-527 is located in 5T4 positive tumors and selectively stimulates and enhances tumor-responsive immune responses of T cells and NKs, providing powerful anti-tumor effects. In brief, the preclinical data shows that ALG.APV-527 in the presence of 5T4 positive cells:

Increases the ability of CD8 positive T cells to secrete pro-inflammatory cytokines such as IFN gamma
Strengthens NK cell’s cell killability
In addition, the new data confirm that the 5T4 antigen is found in a variety of tumor types. 5T4 positive tumor cells were detected in non-small cell lung cancer (NSCLC) tumor, head and neck cancer, mesothelioma, pancreatic, bladder, kidney and ovarian cancer, but not in normal tissue samples such as liver and heart.

"Recent preclinical results further enhance ALG.APV-527’s potential for targeting 5T4 positive tumors and selectively activating the immune system via tumor-specific activation of T cells and NK cells. Overall, this gives potential for better anti-tumor effect with less side effects. We are now compiling a preclinical data packet with the goal of submitting a clinical trial (CTA) clinical trial in the second half of 2019, "said Christina Furebring, Senior Vice President Research at Alligator.

"Our new bispecific drug candidate ALG.APV-527 continues to show promising results in preclinical in vitro and in vivo studies. It exhibits properties such as goal-directed T-cell activation, optimized stability, an antibody-like half-life of 9 days, and good production characteristics. Aptevo and Alligator believe that this gives ALG.APV-527 a potential to become a unique anti-cancer drug for the treatment of several 5T4 expressive solid tumors, where there is today a major medical need. We are looking forward to submitting a CTA next year and then commencing clinical studies, "said Jane Gross, Chief Scientific Officer at Aptevo.

Alligator / Aptevos poster presentation titled "Potent Tumor-Directed T Cell Activation and Tumor Inhibition Induced by a 4-1BB x 5T4 ADAPTIR Bispecific Antibody " will be presented today November 9th from 18.45 to 14.45 (12.45-14.45 local) time) and from kl.30.30 to 2.30 (18.30-20.30 local time).

For more information, see View Source .

For further information please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Telephone: 046-286 44 95
Email: [email protected]

This information is the information that Alligator Bioscience AB (publ) is obliged to disclose under the EU Market Abuse Regulation and the Securities Market Act. The information was provided, through the contact of the above contact person, for publication on November 9, 2018, at 06:00.

About ALG.APV-527
ALG.APV-527 is a bispecific antibody (4-1BB x 5T4) intended for tumor directed treatment of solid cancer tumors. ALG.APV-527 was constructed by combining Alligator’s antibody library ALLIGATOR-GOLD and Aptevo’s bispecific technology ADAPTIR . The antibody ALG.APV-527 consists of two parts, one activating tumor-specific T cells via the co-stimulating receptor 4-1BB (CD137) and the other binding to the protein 5T4 on the surface of tumor cells. This controls the immune activating effect of ALG.APV-527 to the tumor and not to normal tissue.

On November 9, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported data from a preplanned secondary efficacy analysis across human leukocyte antigen (HLA) allele subgroups from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of the combination of nelipepimut-S (NeuVax, NPS) +/- trastuzumab (Herceptin) targeting HER2 low-expressing breast cancer patient cohorts (Press release, Sellas Life Sciences, NOV 9, 2018, View Source [SID1234531195]). The data are being presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held November 7 -11, 2018.

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The data presented confirm the therapeutic potential of NPS for patients with early-stage TNBC in the adjuvant setting across HLA types A-02, -03, -24 and -26 which cover approximately 80-85% of the North American/European populations and 86-90% of Asian/Pacific basin populations. In the subgroup of triple negative breast cancer (TNBC) patients with the HLA-A24+ allele type, which is highly prevalent in the Asian population, treated with the combination of NPS and trastuzumab (n=47), the p-value is 0.003 with a 90.6% relative reduction in risk of relapse or death at 24 months and a hazard ratio of 0.08 in favor of the active (combination) arm.

"These data not only confirm the clinical effect of the NPS plus trastuzumab combination in TNBC, which we recently announced at ESMO (Free ESMO Whitepaper) with a p-value of 0.013 and a 75% relative reduction in the risk of relapse or death, but also positions NPS biologically as an agent that could potentially be used globally, considering the high prevalence of the HLA-A24 allele in populations across the Pacific basin and Asia. We are scheduled to meet with the U.S. regulatory authorities in December 2018 on the most optimal and expeditious development path for NPS in TNBC, and continue to advance ongoing interactions with potential partners," said Dr. Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

"In this preplanned secondary efficacy analysis, consistent positive clinical benefit was seen in the TNBC cohort, irrespective of patients’ HLA allele types in favor of the NPS plus trastuzumab combination arm. Specifically, the HLA-A24+ TNBC patients had a significant improvement in disease-free survival both by log-rank and landmark (24 month) analysis despite the lowest predicted binding potential between the E75 (NPS) antigen and this HLA-type," commented Elizabeth A. Mittendorf, MD, PhD, Rob and Karen Hale Distinguished Chair in Surgical Oncology, Director of Research, Breast Surgical Oncology Brigham and Women’s Hospital, Director, Breast Immuno-Oncology Program Dana-Farber/Brigham and Women’s Cancer Center, and the Principal Investigator of the Phase 2b study.

"This suggests that NPS, which is able to bind to the lower-affinity MHC-I conformations (A24) in addition to the high-affinity ones, i.e., A02 and A03, may generate an optimally favorable immunologic response, possibly due to decreased exposure and tolerance to the E75 epitope. This is important, as other peptide vaccines can be tolerogenic and lead to progressively diminishing immunogenicity over time, something we do not expect to see with NPS," continued Dr. Mittendorf.

Herceptin is a registered trademark of Genentech, Inc. and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

SITC Presentation Information

Date: Friday, November 9th, 2018
Time: 12:45 p.m. to 2:15 p.m. and 6:30 p.m. to 8:30 p.m. ET.
Venue: SITC (Free SITC Whitepaper) 2018 Annual Meeting, Walter E. Washington Convention Center, Washington, DC
Location: Poster Hall E
Poster number: P159
Title: "Correlation between response and HLA type in a randomized phase IIb trial of NeuVax + trastuzumab in HER2 low-expressing breast cancer patients to prevent recurrence."

About SITC (Free SITC Whitepaper)

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy and serves scientists, clinicians, academicians, patients, patient advocates, government representatives and industry leaders from around the world. Currently, SITC (Free SITC Whitepaper) has more than 2,000 members who represent 22 medical specialties in 42 countries around the world and brings together all aspects of the cancer immunology and immunotherapy community in its annual meeting.

On November 9, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today presented initial data from the Phase 1 AMBER trial of TSR-022 (anti-TIM-3 antibody) in combination with TSR-042 (anti-PD-1 antibody) in patients who have progressed following anti-PD-1 therapy treatment, in an oral session during the 2018 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference in Washington, D.C (Press release, TESARO, NOV 9, 2018, View Source [SID1234531194]). Additionally, Phase 1 GARNET data of TSR-042 in patients with previously treated recurrent/advanced non-small cell lung cancer (NSCLC) and Phase 1 monotherapy dose-escalation data for TSR-033 (anti-LAG-3 antibody) in a broad range of solid tumors were also highlighted in poster presentations.

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"The initial AMBER data featured at this year’s SITC (Free SITC Whitepaper) conference are the first clinical data to be presented for an anti-TIM-3 antibody in combination with an anti-PD-1 antibody and demonstrated that the combination of TSR-022 and TSR-042 is active and generally well tolerated in NSCLC and melanoma patients who have progressed following anti-PD-1 treatment," stated Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Additionally, updated results from the GARNET trial demonstrated robust clinical activity of TSR-042 in previously treated, anti-PD-1 naive patients with recurrent or advanced NSCLC, the vast majority of which had TPS <50%. We look forward to presenting additional data from these studies in 2019."

A Phase 1 study of TSR-022, an anti-TIM-3 monoclonal antibody, in combination with TSR-042, an anti-PD-1 antibody (AMBER) [Oral presentation; Abstract: 10877; Poster: O21]

AMBER is an ongoing, open-label, Phase 1 study of TSR-022, an anti-TIM-3 antibody, in monotherapy or in combination with TSR-042, an anti-PD-1 antibody. The TSR-022 and TSR-042 combination portion of the study consists of dose-escalation and expansion cohorts. Data presented at SITC (Free SITC Whitepaper) included safety and efficacy data from the combination dose-escalation and two expansion cohorts: NSCLC patients that had progressed following anti-PD-1 treatment and melanoma patients that had progressed following anti-PD-1 treatment. Patients were treated with 100 milligrams or 300 milligrams of TSR-022 in combination with a fixed dose of TSR-042 (500 milligrams) every 3 weeks. A dose response trend was observed in both the NSCLC and melanoma cohorts based on greater clinical activity observed in patients treated with a 300 milligram dose of TSR-022 as compared to a 100 milligram dose.

At the time of data cutoff, 39 patients with NSCLC who had progressed following anti-PD-1 treatment had received treatment with the TSR-022 and TSR-042 combination, including 14 patients at the 100 milligram dose and 25 patients at the 300 milligram dose of TSR-022. Among the 11 evaluable patients treated with the 100 milligram dose of TSR-022, 1 had a confirmed partial response by immune related RECIST (irRECIST) criteria and 3 had stable disease. Among the 20 evaluable patients treated with the 300 milligram dose of TSR-022, 3 had confirmed partial responses and 8 had stable disease. All objective responses were in PD-L1 positive (TPS ≥ 1%) patients, indicating potential for biomarker enrichment. Sixteen patients had known PD-L1 positive tumors. Among the 12 evaluable patients with PD-L1 positive tumors treated with either the 100 or 300 milligram dose of TSR-022, 4 patients had confirmed partial responses (3 responses ongoing) and 6 had stable disease.

Preliminary safety findings indicate that the combination of TSR-022 and TSR-042 was generally well-tolerated. Pharmacokinetic analysis showed that a 300 mg dose is not sufficient to maintain maximal pharmacodynamic effect and suggests that a 900 milligram dose of TSR-022 should maintain a maximal effect in the vast majority of patients for the duration of the Q3W dosing interval. Patients with NSCLC who have progressed following anti-PD-1 treatment are currently being enrolled in the NSCLC expansion cohort at the 900 milligram dose of TSR-022 in combination with TSR-042. Additional data from this cohort (900 milligram dose) and the melanoma cohort (100 and 300 milligram doses) are expected in 2019.

GARNET: Preliminary safety, efficacy, pharmacokinetic, and biomarker characterization from a Phase 1 clinical trial of TSR-042 (anti-PD-1 monoclonal antibody) in patients with previously treated recurrent/advanced NSCLC [Poster: P326; Abstract: 10853]

GARNET is an ongoing Phase 1 study evaluating TSR-042 as a monotherapy in patients with advanced solid tumors. The ongoing cohort expansion portion of GARNET is evaluating TSR-042 at a dose of 500 milligrams every 3 weeks for the first 4 cycles and 1,000 milligrams every 6 weeks thereafter in four cohorts: MSI (microsatellite instability)-high endometrial cancer, MSI-high non-endometrial cancer, MSS (microsatellite-stable) endometrial cancer and previously treated recurrent / advanced anti-PD-1 naïve NSCLC. Data presented at SITC (Free SITC Whitepaper) included safety and efficacy data from the cohort of patients with NSCLC, which is fully enrolled.

At the time of data cutoff, 67 patients with previously treated recurrent / advanced anti-PD-1 naive NSCLC had received treatment with TSR-042, and 47 patients had at least one post-baseline tumor assessment or had discontinued treatment prior to first baseline assessment. Among these 47 patients, 15 had partial responses (including 2 unconfirmed responses that have not yet progressed) by irRECIST criteria for an overall response rate (ORR) of 31.9%; 14 additional patients (29.8%) had stable disease. Responses were durable and nine of the 15 responses are ongoing (60%).

The majority of patients (32 of 34; 94%) with available PD-L1 status had TPS <50% and clinical activity of TSR-042 was observed across all PD-L1 TPS categories. Among the 32 patients with low PD-L1 expression, 13 patients had TPS 1-49%, of which 5 had partial responses (ORR of 38.5%; including one unconfirmed response), and 19 patients had TPS <1%, of which 3 had partial responses (ORR of 15.8%).

Preliminary safety findings indicate TSR-042 was generally well-tolerated, with a safety profile characteristic of approved anti-PD-1 inhibitors for NSCLC.

The GARNET study is intended to support a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in 2019 for patients with recurrent endometrial cancer.

A Phase 1 dose escalation study of TSR-033, an anti-LAG-3 monoclonal antibody, in patients with advanced solid tumors (CITRINO) [Poster Number: P325; Abstract: 10332]

Data from the monotherapy dose-escalation portion of the CITRINO study were presented and included 30 patients treated with different doses of TSR-033. There were no Grade ≥3 treatment-related treatment emergent adverse events reported. Exposure and peripheral receptor occupancy increased in a dose proportional manner from 20 milligrams to 720 milligrams.These preliminary findings indicate that TSR-033 was generally well tolerated across multiple dose levels, with a safety profile consistent to those of other immune checkpoint inhibitors.

Enrollment is ongoing for patients treated with TSR-033 in combination with 500 milligrams of TSR-042.

Investor Briefing and Webcast
TESARO will host an investor and analyst briefing in New York City on Monday, November 12 at 8:15AM local time. A reception will begin at 8:00AM ET, preceding the presentation. During the briefing, TESARO management will provide an overview of the Company’s immuno-oncology pipeline, followed by a detailed review of recent data presentations. The presentation will be followed by Q&A. This event will be webcast live and archived for 30 days, and may be accessed from the TESARO Investor Events and Presentations webpage at www.tesarobio.com.

About the AMBER Study
AMBER is an ongoing Phase 1 study of TSR-022, an anti-TIM-3 antibody, alone and in combination with TSR-042, an anti-PD-1 antibody. The study consists of two parts: dose escalation and cohort expansion. The monotherapy and combination dose-escalation parts of the study are complete. In the combination dose-escalation, patients were treated with 100 milligrams, 300 milligrams, or 900 milligrams of TSR-022 in combination with a fixed dose of TSR-042 (500 milligrams) every 3 weeks. The three expansion cohorts include NSCLC patients with progression following anti-PD-1 treatment, melanoma patients with progression following anti-PD-1 treatment, and colorectal cancer patients.

About the GARNET Study
GARNET is an ongoing multicenter, open-label, Phase 1 study of TSR-042 as a monotherapy in patients with advanced solid tumors. GARNET included a weight-based dose escalation study (Part 1) and a fixed-dose safety study (Part 2A), both of which have been completed. Results of these studies were used to determine the recommended Phase 2 dose (RP2D; 500 mg Q3W for the first 4 cycles then 1000 mg Q6W). The ongoing cohort expansion portion of GARNET is evaluating TSR-042 in four cohorts: MSI (microsatellite instability)-high endometrial cancer, MSI-high non-endometrial cancer, MSS (microsatellite-stable) endometrial cancer and previously treated recurrent / advanced anti-PD-1 naïve NSCLC.

About the CITRINO Study
CITRINO is an ongoing multicenter, open-label Phase 1 study evaluating TSR-033, an anti-LAG-3 antibody, alone or in combination with an TSR-042 in patients with advanced solid tumors in a broad range of solid tumors.

About TSR-042, TSR-022, and TSR-033
TSR-042 is an investigational humanized anti-programmed death (PD)-1 monoclonal antibody that binds with high affinity to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2. TSR-042 is the only anti-PD-1 therapy being studied as monotherapy every 3 weeks for 4 doses then every 6 weeks thereafter. TSR-042 was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3 (TSR-075).

On November 9, 2018 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first in class collagenase-based product marketed as XIAFLEX in the U.S. and Xiapex in Europe, reported its financial results for the third quarter ended September 30, 2018 and provided a corporate update (Press release, BioSpecifics Technologies, NOV 9, 2018, View Source [SID1234531193]).

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"We are encouraged by the positive data recently reported for CCH in two new potential indications. We announced positive topline results from our Phase 1 clinical trial of CCH for the treatment of uterine fibroids in October and our partner Endo announced positive data from the Phase 3 clinical trials of CCH for the treatment of cellulite in November. The preliminary safety and efficacy data from our uterine fibroids trial demonstrates the promising potential for CCH injection for the treatment of this highly prevalent women’s health disease for which very limited non-surgical options are available," said Thomas L. Wegman, President of BioSpecifics. "With regard to our commercial pipeline and revenues, we were pleased to see continued growth for our two marketed indications for XIAFLEX, Peyronie’s Disease and Dupuytren’s Contracture with 22 percent year-over-year revenue growth for the quarter."

Third Quarter 2018 Financial Results
BioSpecifics reported net income of $5.0 million for the third quarter ended September 30, 2018, or $0.69 per basic share and $0.69 per share on a fully diluted basis, compared to net income of $2.7 million, or $0.38 per basic share and $0.37 per share on a fully diluted basis, for the same period in 2017.

Total revenue for the third quarter ended September 30, 2018 was $8.2 million, compared to $6.5 million for the same period in 2017. The increase in total revenues for the quarterly period was primarily due to royalties associated with higher net sales of XIAFLEX in Dupuytren’s contracture and Peyronie’s disease partially offset by lower mark-up on cost of goods sold revenue in prepaid foreign mark-up on cost of goods sold revenue recognized under new revenue standard ASC 606, as of January 1, 2018.

Licensing revenue consists of licensing fees, sublicensing fees and milestones. BioSpecifics recognized licensing revenue for the third quarter ended September 30, 2018 of zero and $4,408 for the same period in 2017.

Research and development (R&D) expenses for the third quarter ended September 30, 2018 were $0.2 million compared to $0.4 million for the same period in 2017. The decrease in the 2018 period, as compared to the 2017 period, was mainly due to lower consulting fees associated with clinical costs and other R&D programs.

General and administrative expenses for the third quarter ended September 30, 2018 and 2017 were $2.2 million in each period.

Provision for income taxes for the third quarter ended September 30, 2018 were $1.1 million, compared to $1.5 million for the same period in 2017.

As of September 30, 2018, BioSpecifics had cash and cash equivalents and investments of $77.0 million, compared to $65.1 million as of December 31, 2017.

As of September 30, 2018, BioSpecifics had 7,283,528 shares of common stock outstanding.

XIAFLEX/CCH Pipeline Updates and Anticipated Upcoming Milestones

BioSpecifics manages the development of collagenase clostridium histolyticum (CCH) for the treatment of uterine fibroids and has the right to initiate the development of any new potential indication not licensed by Endo. Endo’s licensed indications include Dupuytren’s Contracture and Peyronie’s Disease, both approved and marketed; in addition to cellulite, adhesive capsulitis, human and canine lipoma, lateral hip fat and plantar fibromatosis. BioSpecifics has entered into different in-licensing and royalty agreements in respect of indications currently marketed and under development. It is company policy not to announce publicly royalty rates for potential future indications under development before commercialization. It is important to emphasize that in-licensing royalty rates vary from indication to indication and it should not be assumed that the in-licensing royalty rates for potential future indications will be the same as those for currently marketed indications.

Positive Topline Phase 1 Uterine Fibroid Data Reported in October: BioSpecifics announced positive topline results from the Phase 1 clinical trial of CCH for the treatment of uterine fibroids. The study met the primary endpoint of safety and tolerability with no observed clinically significant adverse reactions. Pharmacodynamic changes were noted in all secondary endpoints with the exception of apoptosis. Statistically significant reductions in collagen content were observed as compared to control fibroids with a median reduction of 39 percent (p<0.05), as well as statistically significant reductions in collagen distribution as compared to control fibroids with an average reduction in density of collagen bundles of 21 percent.
Positive Phase 3 RELEASE-1 and RELEASE-2 Cellulite Data Reported in November: Endo announced positive results from two Phase 3 studies, RELEASE-1 and RELEASE-2, of CCH for the treatment of cellulite with highly statistically significant levels of improvement in the appearance in the target buttock at Day 71 reported. The study achieved the primary endpoint (RELEASE-1, p=0.006 & RELEASE-2, p=0.002) of composite responder analysis demonstrating at least a 2-level composite improvement independently reported by patient and clinician on the photonumeric scales of cellulite severity. Secondary endpoints included both investigator and patient assessments of cellulite appearance as measured by CR-PCSS (Clinician Reported- Photonumeric Cellulite Severity Scale) and PR-PCSS (Patient Reported- Photonumeric Cellulite Severity Scale) scores, SRSS (Subject Self Rating Scale) and the Subject-Global Aesthetic Improvement Scale. Eight out of eight key secondary endpoints were achieved for RELEASE-1 and seven out of eight secondary endpoints were achieved for RELEASE-2. CCH was well-tolerated in actively treated subjects with most adverse events being mild to moderate in severity and primarily limited to the local injection area.
XIAFLEX Expected to Continue to Grow in the Low 20 Percent Range: XIAFLEX future growth initiatives continue to support the increase in disease state awareness for both Peyronie’s Disease and Dupuytren’s Contracture through direct to consumer campaigns.