On March 14, 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 fourth quarter and full year ended December 31, 2017 and provided a corporate update (Press release, BioSpecifics Technologies, MAR 14, 2018, View Source [SID1234524755]).

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"2018 is off to a solid start with the Phase 3 cellulite trials for CCH now initiated and positive interim data recently presented for our ongoing Phase 1 uterine fibroids trial, which is advancing toward a top-line data readout this year. In 2017, we continued to be pleased with our royalty revenues from XIAFLEX net sales and look forward to the continued growth of this product and the ongoing profitability of our business," said Thomas L. Wegman, President of BioSpecifics. "In 2018, we will also continue to work with our partner Endo to ensure that XIAFLEX and CCH are able to fulfill their commercial and clinical potential."

Fourth Quarter and Full Year 2017 Financial Results

BioSpecifics reported net income of $2.6 million for the fourth quarter ended December 31, 2017, or $0.37 per basic share and $0.36 per share on a fully diluted basis, compared to net income of $2.9 million, or $0.41 per basic share and $0.40 per share on a fully diluted basis, for the same period in 2016. For the full year ended December 31, 2017, the Company reported a net income of $11.3 million, or $1.58 per basic share and $1.55 per share on a fully diluted basis, compared to net income of $11.4 million, or $1.61 per basic share and $1.56 per share on a fully diluted basis for the same period in 2016.

Total revenue for the fourth quarter ended December 31, 2017 was $6.7 million, compared to $6.6 million for the same period in 2016. For the full year ended December 31, 2017, total revenue was $27.4 million, compared to $26.3 million for the same period in 2016. The increase in total revenues for the quarterly and year-end periods was primarily due to royalty revenues related to the net sales of XIAFLEX.

Royalty and mark-up on cost of goods sold (COGS) revenues recognized under BioSpecifics’ agreement with Endo for the fourth quarter ended December 31, 2017 were $6.7 million compared to $6.6 million for the same period in 2016, an increase of $0.1 million or 2 percent. Total royalty and mark-up on COGS revenues for the year ended December 31, 2017 increased to $27.4 million as compared to $25.4 million in the same period in 2016. This increase in royalties and the mark-up on COGS in each quarterly and year end periods was primarily due to royalty revenues related to the net sales of XIAFLEX.

Licensing revenue consists of licensing fees, sublicensing fees and milestones. BioSpecifics recognized licensing revenue for the fourth quarter ended December 31, 2017 and 2016 of approximately $4,000 in each period. Licensing fees recognized for the years ended December 31, 2017 and 2016 were $18,000 and $0.8 million, respectively. In the 2017 period, licensing fees recognized were related to the cash payments received under the agreement with Endo in prior years and amortized over the expected development period. In the 2016 period, licensing fees of $0.8 million were recognized related to the exercise of an opt-in right by Endo for the human lipoma indication.

Milestone revenue recognized for the years ended December 31, 2017 and 2016 was zero and $28,500, respectively. The $28,500 milestone revenue recognized in the 2016 period related to the approval of XIAFLEX in Australia for the treatment of Peyronie’s Disease by Actelion.

Research and development (R&D) expenses for the fourth quarter ended December 31, 2017 and 2016 were $0.3 million in each period. For the year ended December 31, 2017, R&D expenses were $1.2 million, compared to $1.3 million in the same period in 2016.

General and administrative expenses for the fourth quarter ended December 31, 2017 were $1.6 million, compared to $2.0 million for the same period in 2016. For the year ended, December 31, 2017, general and administrative expenses were $8.5 million, compared to $7.9 million in the same period in 2016.

Provision for income taxes for the fourth quarter ended December 31, 2017 were $2.4 million, compared to $1.5 million for the same period in 2016. For the year ended December 31, 2017, provision for income taxes were $7.0 million as compared to $6.0 million in the same period of 2016. The increase in 2017 as compared to 2016 was primarily due to the Company’s initial analysis of the Tax Cuts and Job Act. The Company has made reasonable estimates of its 2017 impact and due to the federal corporate rate reduction, a re-measurement of deferred tax assets and liabilities resulted in the recording of a charge of approximately $1.1 million.

As of December 31, 2017, BioSpecifics had cash and cash equivalents and investments of $65.1 million, compared to $52.8 million as of December 31, 2016.

XIAFLEX Commercial Highlights

On February 27, 2018, Endo reported commercial highlights for XIAFLEX for the fourth quarter and full year of 2017 (Endo’s fourth quarter 2017 financials are reported in BioSpecifics’ first quarter 2018 financials). For the fourth quarter of 2017, net revenues were $61.3 million compared to $55.5 million for the fourth quarter of 2016, a 10 percent increase, primarily driven by a full year of direct-to-consumer initiatives intended to increase patient awareness. Full year 2017 net revenues were $213.4 million compared to $189.7 million for the full year of 2016, a 12 percent increase.

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 presented interim data from the ongoing Phase 1 study of CCH for the treatment of uterine fibroids in a poster on March 9, 2018 at the Society for Reproductive Investigation’s 65th Annual Scientific Meeting in San Diego, CA. The data show the safety and effectiveness of the injection method in five patients. Three patients were injected with CCH and underwent a hysterectomy 24-96 hours after the injection. Two patients subsequently were injected with a higher dose of collagenase, and underwent a hysterectomy 63 days after the injection. The collagenase-treated tissue samples showed not only the reduction of collagen content but also the disruption of the tissue pattern, while in control tissues the collagen remained abundant and compact. The digestion of collagen did not extend beyond the capsule of any fibroid. No adverse event occurred in these patients.
In February 2018, Endo announced the initiation of two pivotal Phase 3 RELEASE clinical trials of CCH for the treatment of cellulite. These multicenter, randomized, double-blind, placebo-controlled studies will evaluate the safety and efficacy of CCH in reducing the appearance of cellulite. These two U.S. studies are expected to enroll 840 women, 420 per trial, aged 18 years or older with moderate-to-severe buttock cellulite. Each subject will receive up to three treatments in which CCH, 0.84 mg per treatment area, or placebo will be administered. The two treatment areas include the left and right buttock. Each treatment visit will occur approximately 21 days apart. A total of 12 injections will be administered into cellulite dimples per treatment area per visit. Cellulite severity will be assessed at the beginning and conclusion of treatment. The assessments will be conducted by each patient and clinician using two validated photonumeric cellulite severity scales developed by Endo and third-party psychometric experts. The primary endpoint of the studies is a composite responder analysis demonstrating at least a 2-level composite improvement on the photonumeric cellulite severity scale, independently reported by both the patient and clinician. Key secondary endpoints include the percentage of subjects that experience at least a 1-level or 2-level improvement in patient reported assessment, percentage of subjects with a 1-level composite improvement, percentage of satisfied subjects, change from baseline in a cellulite impact scale and the percentage of subjects with at least a 1-level or 2-level improvement in the global aesthetic improvement scale (GAIS).
Top-line results for the Phase 3 trials of CCH for cellulite are expected in the first quarter of 2019.
BioSpecifics is conducting an ongoing Phase 1 clinical trial of CCH for the treatment of uterine fibroids with data expected in 2018. This Phase 1 open-label dose escalation study is being conducted at the Department of Gynecology & Obstetrics at Johns Hopkins University and is designed to enroll 15 female subjects treated prior to hysterectomy. The trial’s primary endpoint will assess the safety and tolerability of a single injection of CCH directly into the uterine fibroid under transvaginal ultrasound guidance. The secondary endpoints will assess symptoms of pain and bleeding, quality of life throughout the study in addition to size, collagen content and rate of apoptosis of CCH treated fibroids.
Endo continues its commercial review of additional licensed indications, including adhesive capsulitis (frozen shoulder) and plantar fibromatosis.

On March 14, 2018 ProMIS Neurosciences, Inc. a biotechnology company focused on the discovery and development of precision treatments for neurodegenerative diseases, reported its operational and financial results for the year ended December 31, 2017 (Press release, ProMIS Neurosciences, MAR 14, 2018, View Source [SID1234525140]).

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"Over the course of the past year, we have significantly advanced our lead product candidate for Alzheimer’s disease, PMN310, demonstrating its emerging best in class profile in direct head-to-head comparison with other amyloid beta-targeted antibody therapeutics", said Eugene Williams, ProMIS Executive Chairman.

ProMIS also initiated new programs to develop antibodies against novel therapeutic targets on TDP43 for amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD), tau protein for Alzheimer’s disease (AD), and alpha-synuclein for Parkinson’s disease (PD), representing important additional opportunities in neurodegenerative diseases.

For a narrated overview of fiscal year 2017 results and outlook for 2018, please click on the link below:

http://bit.ly/2FxBuUv

Corporate Highlights

During 2017, completed private placements providing aggregate gross proceeds of approximately $7,510,000.
Successfully completed validation of five therapeutic candidates for AD, all of which demonstrated the desired target profile of binding to soluble brain tissue extracts from AD patients without binding to plaque.
Designated PMN310 as the lead product candidate for AD and demonstrated that PMN310 displays the desired profile of selectively targeting amyloid beta oligomers in a preclinical study comparing PMN310 to other amyloid beta-directed antibodies for AD.
Successfully completed humanization of PMN310 (huPMN310) for further development as lead product candidate.
Initiated programs to identify novel therapeutic targets for AD, ALS and PD.
Filed a provisional patent application with the U. S. Patent and Trademark Office relating to a novel therapeutic target on misfolded forms of TDP43 and initiated development of antibodies selective for this target associated with toxic, aggregated forms of TDP43.
ProMIS’ sponsored research agreement with the University of British Columbia received a matching industry partnered grant from the Canadian Institute of Health Research (CIHR).
Common shares of ProMIS commenced trading on December 4, 2017 on the OTCQB Venture Market in the U. S. under the stock symbol "ARFXF".
On January 4, 2018, ProMIS announced that PMN310 shows potential for improved safety profile in direct comparison to other amyloid beta-directed antibodies. The observed lack of PMN310 binding to perivascular amyloid plaque in AD brain tissue may eliminate dose-limiting brain swelling seen with aducanumab, supporting administration of higher doses to AD patients, thereby leading to greater therapeutic potency of PMN310.
Exercises of common share warrants yield gross proceeds of $1,484,498.
Financial Results

Annual Results of Operations

The Company’s net loss for the year ended December 31, 2017 was $6,019,970, compared to a net loss of $3,454,975 year ended December 31, 2016. Included in the net loss amount for the year ended December 31, 2017 were non-cash expenses of $700,953, representing share-based compensation and amortization of an intangible asset, compared to $578,254 for the year ended December 31, 2016. The increase in the net loss for the year ended December 31, 2017 is related to the costs associated with developing the Company’s AD therapeutics program, increased contracted resources and associated costs, supporting its patent portfolio, associated general corporate expenditures and higher share-based compensation.

Research and development expenses for the year ended December 31, 2017 were $3,961,375, as compared to $1,865,507 in the year ended December 31, 2016. The increase in research and development expense for the year ended December 31, 2017 is primarily attributed to higher research program costs for the AD therapeutics program, consultants and increased contracted resources.

General and administrative expenses for the year ended December 31, 2017 were $2,061,387, as compared to $1,576,271 in the year ended December 31, 2016. The increased expenditures for 2017 reflect primarily higher share-based compensation, contracted resources and other professional fees.

Outlook

The Company’s top priority for 2018 is to focus on further differentiation of PMN310 as best in class therapy for AD and to continue to progress development of PMN310 for clinical trial initiation in 2019.

The Company will also continue to expand its program targeting TDP43 in ALS and FTD and its alpha-synuclein program for PD. ProMIS will actively seek a collaborative development partnership for both these opportunities.

On March 14, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that the Company will present new research findings from its advancing pipeline programs at the 2018 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 14-18, 2018, at the McCormick Place Convention Center, Chicago, IL (Press release, Atreca, MAR 13, 2018, View Source [SID1234524725]). The two presentations will highlight the antibody responses in patients who have achieved positive clinical outcomes following checkpoint inhibitor therapy.

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"We are excited to announce new results generated via our discovery engine, using our Immune Repertoire Capture (IRC) technology," said Tito A. Serafini, Ph.D., Atreca’s President, Chief Executive Officer, and Co­Founder. "In patients having responses to cancer immunotherapy, we demonstrate that an immune system attack on tumor tissue involving anti-tumor antibodies is indeed a hallmark of such responses across diverse cancer types. We have also discovered functional anti-tumor antibodies from these patients with potential application against a variety of tumors. We are pleased to announce these findings during AACR (Free AACR Whitepaper)."

The abstracts are available in the program section of the annual AACR (Free AACR Whitepaper) meeting website, and details for the poster presentations are as follows:

Abstract Title: Increased somatic hypermutation in the immunoglobulin sequences of melanoma patients who have durable response to checkpoint inhibitor therapy (Abstract 615 / Poster 9)

Poster Session Title: Immune Response to Therapies 1
Presentation Date & Time: Sunday, April 15, 2018, 1:00 PM – 5:00 PM CT
Location: Poster Section 27, Exhibit Hall A, McCormick Place South

Abstract Title: Mining the cancer immuno-responsome: The identification of functional antitumor antibodies from patients receiving checkpoint inhibitors (Abstract 3966 / Poster 19)

Poster Session Title: Targeting Oncogenes, Tumor Suppressors, or Gene Products
Presentation Date & Time: Tuesday, April 17, 2018; 8:00 AM – 12:00 PM CT
Location: Poster Section 40, Exhibit Hall A, McCormick Place South

On March 13, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported financial results for the fourth quarter and full year ended December 31, 2017 (Press release, Bellicum Pharmaceuticals, MAR 13, 2018, View Source [SID1234524726]).

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"In the past year, we made substantial progress toward our vision of delivering cures through controllable cell therapy," said Bellicum’s President & CEO Rick Fair. "We completed enrollment in our first registrational trial of BPX-501 and remain on track for our first filing for product approval in Europe in 2019. We moved three new projects featuring our industry-leading cellular control technology into clinical trials, including the first-ever GoCAR-T with our iMC activation switch. We also made substantial preclinical progress on our next generation ‘dual-switch’ platform containing both activation and safety switches in the same CAR-T cell, and initiated plans to move two dual-switch CAR-T projects into clinical trials in 2019."

2017 HIGHLIGHTS AND CURRENT UPDATES

Bellicum Submits Response to FDA Clinical Hold on BPX-501 Trials
Last week, the Company submitted a full response to the FDA clinical hold notification, including requested changes to study protocols to provide guidelines for comprehensive monitoring and management of neurologic adverse events associated with hematopoietic stem cell transplants. The Company expects the response to satisfy the conditions for removal of the clinical hold, which applies to BPX-501 clinical trials in the U.S.

Recruitment Complete in BPX-501 E.U. Registration Trial
The Company completed enrollment in the treatment arm of its BP-004 E.U. registration trial in pediatric patients undergoing haploidentical hematopoietic stem cell transplant (haplo-HSCT) and expects to report updated data from this trial at upcoming medical meetings. The Company remains on track to file European Marketing Authorization Applications for BPX-501 and rimiducid in 2019.

Positive BPX-501 Interim Results Reported in AML and Primary Immunodeficiencies
Earlier today, the Company announced interim survival results in pediatric patients with acute myeloid leukemia (AML) suggesting that the addition of BPX-501 T cells to a haplo-HSCT may improve the anti-leukemic effect of stem cell transplantation. The Company also reported interim data in pediatric patients with primary immunodeficiencies (PIDs) undergoing a curative haplo-HSCT with BPX-501 demonstrating favorable disease-free and overall survival rates at one year. These interim results have been submitted for presentation at an upcoming medical meeting.

Robust BPX-601 GoCAR-TCell Expansion Observed Following Rimiducid Administration
The Phase 1 study of BPX-601—the first product featuring the Company’s iMC activation switch—is enrolling patients with nonresectable pancreatic cancer who test positive for prostate stem cell antigen (PSCA). The first patient dosed with rimiducid—to activate iMC following infusion of BPX-601 cells—showed a robust expansion of circulating BPX-601 cells following a single dose of rimiducid, providing the first clinical proof of concept of iMC. The patient continues to be evaluated for safety and efficacy, and the clinical site is enrolling additional patients. Bellicum expects to report findings from the initial cohorts of pancreatic cancer patients at an upcoming medical meeting and to expand the trial to other PSCA-expressing cancers later this year.

Collaborator CD19 CAR-T Trial Initiated
The first patients have been treated in a Phase 1 pediatric ALL clinical trial of a CD19 CAR-T incorporating the CaspaCIDe safety switch, which is being conducted in collaboration with Ospedale Pediatrico Bambino Gesù (OPBG), a leading European pediatric research center and hospital. The trial is designed to assess the impact of CaspaCIDe in managing the acute toxicities of CAR-T therapy.

Completed Buildout of In-House Manufacturing and Vector Production Facility
The Company recently completed the buildout and initial launch of a 30,400 square foot state-of-the-art cell manufacturing and vector production facility at its headquarters in Houston, Texas. This facility is designed and constructed to satisfy both U.S. and European regulatory standards, and the Company expects the facility will meet U.S. clinical trial and early commercialization requirements.

Bellicum Continues to Strengthen its Management Team and Board of Directors
Since August 2017, the Company has added Gregory Naeve, Ph.D. (Chief Business Officer), William Grossman, M.D., Ph.D. (Chief Medical Officer), and several key leadership appointments to strengthen its clinical and quality functions. Additionally, Edmund P. Harrigan, M.D. was recently appointed to Bellicum’s Board of Directors, bringing 28 years of cross-functional pharmaceutical industry experience, most recently as Senior Vice President, Worldwide Safety and Regulatory at Pfizer.

ANTICIPATED 2018 MILESTONES

Report updated data from the BP-004 study of BPX-501
Initiate pivotal clinical trials of BPX-501 in adult AML and in either pediatric AML or PIDs, pending regulatory clearances
Report initial results from the BPX-601 clinical trial, and expand the trial to include additional PSCA-expressing cancers
Present initial findings from the BPX-701 clinical trial at upcoming medical meetings

Fourth Quarter and Full Year 2017 Financial Results

Cash Position and Guidance: Bellicum ended the year on December 31, 2017 with cash, restricted cash and investments totaling $106.5 million, compared to $113.4 million at December 31, 2016. In the fourth quarter of 2017, the Company paid off its Hercules Capital debt facility with a $35.0 million loan from Oxford Finance. The new loan provided approximately $2.1 million in additional liquidity, interest-only payments until February 1, 2020 and a lower interest rate. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements through the first quarter of 2019.

R&D Expenses: Research and development expenses were $14.3 million and $65.7 million for the fourth quarter and year ended December 31, 2017, respectively, compared to $15.1 million and $51.3 million during the comparable periods in 2016. The higher expenses in 2017 were primarily due to increased clinical trial costs, particularly for BPX-501, start-up costs related to Bellicum’s in-house manufacturing facility and contract manufacturers in Europe and increased personnel and consulting expenses. The higher R&D expenses in the fourth quarter of 2016 were attributable to costs associated with characterization studies of rimiducid.

G&A Expenses: General and administrative expenses were $5.1 million and $21.0 million for the fourth quarter and year ended December 31, 2017, respectively, compared to $4.2 million and $16.9 million during the comparable periods in 2016. The increased G&A expenses in 2017 were primarily due to Bellicum’s overall growth, including an increase in personnel-related costs, facility costs, and other administrative costs.

Net Loss: Bellicum reported a net loss of $21.9 million for the fourth quarter of 2017 and $91.8 million for the year ended December 31, 2017, compared to a net loss of $19.9 million and $69.2 million for the comparable periods in 2016. The results included non-cash, share-based compensation charges of $3.4 million and $13.6 million for the fourth quarter and year ended December 31, 2017, respectively, and $3.1 million and $12.3 million for the comparable periods in 2016.

Shares Outstanding:
At December 31, 2017, Bellicum had 33,285,177 shares of common stock outstanding.

Conference Call and Webcast
Bellicum management will host a webcast and conference call at 5:00 p.m. Eastern today to discuss the financial results. To access the call, participants should dial 877-407-3103 (domestic) and 201-493-6791 (international) at least 10 minutes prior to the start of the call. The event will be webcast live and can also be accessed in the Investors & Media section of bellicum.com. An archived version of the webcast will also be available for replay in the Investors & Media section of the Bellicum website for at least two weeks following the call.

About BPX-501
BPX-501 is an adjunct T cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of activator agent rimiducid) should uncontrollable GvHD or other T-cell mediated complications occur. This enables physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections and enhance Graft-versus-leukemic effect without unacceptable GvHD risk. The ongoing BP-004 clinical study of BPX-501 is being conducted at transplant centers in the U.S. and Europe.

About BPX-601
BPX-601 is a GoCAR-T product candidate containing Bellicum’s proprietary inducible MyD88/CD40, or iMC, activation switch, designed to treat solid tumors expressing prostate stem cell antigen, or PSCA. Preclinical data show enhanced T cell proliferation, persistence and in vivo anti-tumor activity compared to traditional CAR-T therapies. A Phase 1 clinical trial in patients with nonresectable pancreatic cancer is ongoing. In addition to pancreatic cancer, PSCA is expressed in several other solid tumor indications, including: gastric, esophageal, cholangiocarcinoma, glioblastoma, prostate and bladder cancers. The Company plans to expand the clinical development of BPX-601 to include additional PSCA expressing cancer types.

About BPX-701
BPX-701 is a high affinity T cell receptor product candidate designed with the CaspaCIDe safety switch. It is currently being tested in a Phase 1 study of patients with refractory or relapsed acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) who test positive for PRAME, or preferentially expressed antigen in melanoma. In preclinical studies, PRAME-specific clones showed high reactivity against a panel of PRAME positive tumor cell lines, metastatic melanoma, sarcomas and neuroblastoma tissues. In vitro study data showed that BPX-701 demonstrated strong affinity to panels of cancer cells presenting PRAME peptides and low affinity to non-tumor cells, as well as complete elimination of BPX-701 cells in response to rimiducid.

Scynexis has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Scynexis, 2018, MAR 13, 2018, View Source [SID1234524715]).

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