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Stemline Therapeutics Announces Four ELZONRIS Presentations, Including an Oral Presentation, at Upcoming ASH Meeting

On November 2, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that ELZONRIS (tagraxofusp; SL-401), a novel targeted therapeutic directed to CD123, will be featured in four presentations, including an oral presentation, at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held December 1-4, 2018 in San Diego, CA (Press release, Stemline Therapeutics, NOV 2, 2018, View Source [SID1234530630]).

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Additionally, the Company is hosting an investor/analyst event on December 3, 2018 and plans to provide updates on the progress of its pre-commercial activities, disease awareness campaign, and market expansion efforts.

Details on the ASH (Free ASH Whitepaper) presentations are as follows:

BPDCN – Oral Presentation
Title: Results of Pivotal Phase 2 Trial of Tagraxofusp (SL-401) in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 765
Session: 616. Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: New Treatment Strategies
Date/Time: Monday, December 3, 2018 3:15 PM PT
Location: Manchester Grand Hyatt San Diego, Seaport Ballroom F

Chronic Myelomonocytic Leukemia (CMML)
Title: Results from Ongoing Phase 1/2 Trial of Tagraxofusp (SL-401) in Patients with Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML)
Presenter: Mrinal Patnaik, MBBS; Mayo Clinic
Abstract: 1821
Session: 637. Myelodysplastic Syndromes – Clinical Studies: Poster I
Date/Time: Saturday, December 1, 2018 6:15 PM–8:15 PM PT
Location: San Diego Convention Center, Hall GH

Myelofibrosis (MF)
Title: Results from Ongoing Phase 1/2 Trial of Tagraxofusp (SL-401) in Patients with Intermediate or High Risk Relapsed/Refractory Myelofibrosis
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 1773
Session: 634. Myeloproliferative Syndromes: Clinical: Poster I
Date/Time: Saturday, December 1, 2018 6:15 PM–8:15 PM PT
Location: San Diego Convention Center, Hall GH

Tagraxofusp + Hypomethylating Agents: Chronic Myelomonocytic Leukemia (CMML)
Title: Evaluation of Combination Tagraxofusp (SL-401) and Hypomethylating Agent (HMA) Therapy for the Treatment of Chronic Myelomonocytic Leukemia (CMML)
Presenter: Aishwarya Krishnan, Memorial Sloan Kettering Cancer Center
Abstract: 1809
Session: 636. Myelodysplastic Syndromes – Basic and Translational Studies: Poster I
Date/Time: Saturday, December 1, 2018 6:15 PM – 8:15 PM PT
Location: San Diego Convention Center, Hall GH

Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented, "We are honored that ASH (Free ASH Whitepaper) has selected the BPDCN pivotal results for oral presentation. This selection underscores the heightening awareness of the disease – BPDCN, the target – CD123, and the clinical impact of the drug candidate – ELZONRIS. In addition, our regulatory team continues to work diligently in an effort to make ELZONRIS available to patients as quickly as possible, and our commercial team continues to execute on our broad-based pre-launch initiatives. This includes the build-out of our sales, marketing and reimbursement teams as well as continuing to advance our disease awareness campaign. In parallel, we are excited to present updated clinical data from our ongoing clinical trials in patients with chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF). Based on these data, we are enthusiastic about our plans to implement pivotal trials, or cohorts, in these devastating malignancies."

About BPDCN
Please visit the BPDCN disease awareness booth at ASH (Free ASH Whitepaper) 2018 (#205) and the website: www.bpdcninfo.com.

Advaxis Provides Update on Clinical Pipeline

On November 2, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that it will be continuing its ongoing Phase 3, randomized, double-blinded, placebo-controlled, pivotal study of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer (AIM2CERV) (Press release, Advaxis, NOV 2, 2018, View Source [SID1234530629]).

The current trial design has a planned sample size of 450 subjects to maintain adequate statistical power over a broader range of survival outcomes, as well as a pre-planned interim analysis (IA) of safety and efficacy. However, the Company is evaluating the possibility of accelerating the IA timeline and establishing a more stringent futility boundary. The Company anticipates that over the next couple of months it will finalize the redesign of the trial and review it with the U.S. Food and Drug Administration (FDA). During this time, the study is continuing to enroll patients under its current design, which is being conducted under a Special Protocol Assessment with the FDA.

"Based on discussions over the past several months with a number of experts in the field regarding our AIM2CERV trial, we have become increasingly optimistic about the prospects of this study. We believe that continuing to invest in this study, along with certain other product candidates, provides us with a diversified portfolio across drug constructs, cancer types and stages of development," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We believe this approach affords the best opportunity to demonstrate the therapeutic potential of drug candidates generated from our unique and proprietary Lm platform." He concluded, "The redesign of AIM2CERV with an earlier interim analysis would allow us to alter course or, if necessary, stop the study, depending on the results. If the FDA accepts our proposed revisions, we anticipate having a recommendation based on the interim analysis from the data monitoring committee as early as the fourth quarter of 2020."

In addition to continuing its AIM2CERV trial for AXAL, the Company plans to initiate an investigator-sponsored trial with a major research center in head and neck cancer in early 2019. The Company is also continuing to follow subjects in its Phase 1/2 study of ADXS-PSA in combination with KEYTRUDA in metastatic castration-resistant prostate cancer. Intriguing early data from 37 patients in this study presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) earlier this year showed an improvement in survival in subjects with PSA declines from baseline of 50% or greater (~19% of all treated subjects). The Company expects to provide an update on survival rates along with correlative biomarker work in the first quarter of 2019.

To maximize the efficient use of clinical funding resources, the Company will not continue enrollment in its Phase 1/2 study of AXAL in combination with durvalumab for the treatment of patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer, and will not initiate its ADVANCE study for the treatment of women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix.

The Company’s Phase 1 dose-escalation study of ADXS-NEO expressing personalized tumor antigens in subjects with various solid tumors, in collaboration with Amgen, is continuing to enroll subjects and Advaxis anticipates providing safety, tolerability and immune correlative data from the first two cohorts in the first half of 2019.

The Company also continues to progress its ADXS-HOT 503 drug candidate, expressing public (shared) tumor antigens both as monotherapy and in combination with KEYTRUDA for the treatment of non-small cell lung cancer (NSCLC). The Company plans to have the first subject enrolled in this Phase 1/2 study by the end of 2018 with an anticipated readout of safety, tolerability and immune correlative data from the first cohort in the first half of 2019. The Company’s clinical testing of ADXS-HOT in prostate cancer and bladder cancer will continue as the next areas of focus. Initiation of clinical trials in each of these cancers will be delayed until early 2020 to ensure adequate funding for the Company’s other programs.

In support of these programs, Advaxis anticipates its annual cash usage to be approximately $45 million, which was reduced from an annual cash usage of approximately $80 million earlier this year.

The Company will be holding a conference call today, November 2, 2018, at 11:00 a.m. Eastern time to provide an update on its clinical programs.

Conference Call & Webcast Information
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 1538717
WEBCAST: ir.advaxis.com/events-presentations

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning today two hours after the close of the conference call. To access the recording, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the operator with the conference ID: 1538717. In addition, an audio webcast will be archived on the Company’s website for a period of time at www.advaxis.com.

Checkpoint Therapeutics Reports Third Quarter 2018 Financial Results and Recent Corporate Highlights

On November 2, 2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the third quarter ended September 30, 2018 (Press release, Checkpoint Therapeutics, NOV 2, 2018, View Source [SID1234530627]).

"In the third quarter of 2018, we announced positive interim safety and efficacy data from our ongoing Phase 1/2 clinical trial of CK-101, a third-generation EGFR inhibitor being evaluated in advanced non-small cell lung cancer (NSCLC), which was a significant milestone for the company," said James F. Oliviero, President and Chief Executive Officer of Checkpoint. "Our plans remain on-track for the rest of the year as we continue enrollment to establish the optimal dose of CK-101, after which we plan to initiate a Phase 3 trial in 2019 in treatment-naïve EGFR mutation-positive NSCLC patients. We also look forward to reporting early next year interim data from the expansion cohort phase of our Phase 1 clinical trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers."

Recent Corporate Highlights:

In September 2018, Checkpoint announced positive interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being evaluated in advanced NSCLC. The data were presented in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer in Toronto. CK-101 was well tolerated across multiple dose groups and safe. Durable anti-tumor activity was observed, particularly in treatment-naïve EGFR mutation-positive NSCLC patients.
In October 2018, Checkpoint appointed Christian Béchon to its Board of Directors.
Financial Results:

Cash Position: As of September 30, 2018, Checkpoint’s cash and cash equivalents totaled $29.6 million, compared to $19.2 million at December 31, 2017, an increase of $10.4 million year-to-date.
R&D Expenses: Research and development expenses for the third quarter of 2018 were $7.8 million, compared to $5.0 million for the third quarter of 2017, an increase of $2.8 million.
G&A Expenses: General and administrative expenses for the third quarter of 2018 were $1.5 million, compared to $1.3 million for the third quarter of 2017, an increase of $0.2 million.
Net Loss: Net loss attributable to common stockholders for the third quarter of 2018 was $9.3 million, or $0.32 per share, compared to a net loss of $5.9 million, or $0.26 per share, for the third quarter of 2017.

GlycoMimetics Reports Third Quarter 2018 Results and Highlights Recent Company Achievements

On November 2, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the third quarter ended September 30, 2018 and highlighted recent company achievements (Press release, GlycoMimetics, NOV 2, 2018, View Source [SID1234530626]). Quarter-end cash and cash equivalents at September 30, 2018 were $219.8 million.

"During the third quarter, we focused our activity on planning and initiating GlycoMimetics’ comprehensive clinical program to evaluate uproleselan across the spectrum of AML. We expect to announce enrollment of the first patient in our own Phase 3 pivotal study of "upro" in relapsed/refractory patients within a very short period of time, as initiation activity is well underway at many sites, and enrollment is now open. Support among investigators for this trial as well as for our two consortia-led trials is strong. We believe that the data contained in the abstracts selected for oral and poster presentations at the ASH (Free ASH Whitepaper) meeting reinforce the benefits already shared at prior medical meetings and bolster our confidence in upro’s potential to change the treatment paradigm in AML, whether patients have AML that is relapsed, refractory, or newly diagnosed," said Rachel King, GlycoMimetics Chief Executive Officer.

Key Operational Highlights for the Third Quarter of 2018:

The company’s strategic partner Pfizer continued to enroll individuals with sickle cell disease (SCD) in its Phase 3 clinical study of rivipansel for the treatment of vaso-occlusive crisis (VOC). Pfizer advised GlycoMimetics in August that enrollment was approximately 75% complete and is estimated to be completed in early 2019, with top-line data expected to be available in the second quarter of 2019.
The GMI-sponsored pivotal Phase 3 trial of uproleselan in relapsed/refractory AML is being initiated across multiple investigative sites in the US, and work continues to expand to clinical sites across Europe, Canada and Australia.
Planning advanced for the National Cancer Institute (NCI) collaborative study of uproleselan in newly diagnosed patients fit for chemotherapy; a protocol including an interim analysis of event-free survival was finalized and posted on clinicaltrials.gov.
Planning continued for the collaborative Haemato Oncology Foundation for Adults in the Netherlands (HOVON) European study of uproleselan in newly diagnosed patients unfit for chemo with a goal of trial initiation in 2019.
Third Quarter 2018 Financial Results:

Cash position: As of September 30, 2018, GlycoMimetics had cash and cash equivalents of $219.8 million as compared to $123.9 million as of December 31, 2017. In March 2018, GlycoMimetics completed a public offering of 8,050,000 shares of common stock, yielding net proceeds of $128.4 million.
R&D Expenses: The Company’s research and development expenses increased to $9.7 million for the quarter ended September 30, 2018 as compared to $5.8 million for the prior year quarter. The increase was primarily due to an increase in clinical trial expenses related to the start-up of the Phase 3 clinical trial of uproleselan and higher manufacturing expenditures for uproleselan clinical supplies for our planned Phase 3 clinical trial and to meet our supply obligations for clinical trials of uproleselan conducted by or in collaboration with third parties.
G&A Expenses: The Company’s general and administrative expenses increased to $2.8 million for the quarter ended September 30, 2018 as compared to $2.4 million for the prior year quarter. The increase was primarily due to higher patent and other legal expenses.
Shares Outstanding: Shares outstanding as of September 30, 2018 were 43,137,227.
The company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 9176334. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

About Uproleselan (GMI-1271)

Uproleselan (yoo’ pro le’sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects. The U.S. Food and Drug Administration (FDA) has granted uproleselan Breakthrough Therapy Designation for the treatment of adult AML patients with relapsed/refractory (R/R) disease. GlycoMimetics is currently implementing a comprehensive development program across the clinical spectrum of AML. This includes a company sponsored Phase 3 trial in R/R AML and two consortia-sponsored trials in newly diagnosed patients. One consortium trial is being sponsored by the NCI and will enroll newly diagnosed patients fit for intensive chemotherapy. The other trial is sponsored by the HOVON group in Europe and will enroll newly diagnosed patients unfit for intensive chemotherapy.

About Rivipansel

Rivipansel, the most advanced drug candidate in the GlycoMimetics pipeline, is a glycomimetic drug candidate that acts as a pan-selectin antagonist, meaning it binds to all three members of the selectin family – E-, P- and L-selectin. The first potential indication for rivipansel is VOC of SCD, one of the most severe complications of SCD which can result in acute ischemic organ injury at one or more sites. By reducing cell adhesion, activation and inflammation that are believed to contribute to reduced blood flow through the microvasculature during VOC, GlycoMimetics believes that rivipansel could be the first drug to interrupt the underlying cause of VOC, thereby potentially enabling patients to leave the hospital more quickly. Pfizer is conducting a Phase 3 clinical trial for rivipansel in SCD.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma (MM) or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GlycoMimetics has completed a Phase 1 clinical trial of GMI-1359 in healthy volunteers.

ImmunoGen Reports Recent Progress and Third Quarter 2018 Operating Results

On November 2, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported operating results for the quarter ended September 30, 2018 (Press release, ImmunoGen, NOV 2, 2018, View Source [SID1234530623]).

"With the completion of enrollment in FORWARD I, we have initiated the activities required to support a BLA filing and launch mirvetuximab soravtansine in ovarian cancer. Over the last three months, we have completed the product validation runs for drug substance, put in place operational metrics and resources to ensure timely assessment of the primary endpoint for the study, and moved ahead with pre-launch commercial planning," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "In parallel, we continued to execute across the remainder of the business, including presentation of initial data from the FORWARD II KEYTRUDA combination at ESMO (Free ESMO Whitepaper), accelerating accrual in the FORWARD II triplet cohort, and advancing our next ADC into preclinical development in collaboration with MacroGenics. Looking ahead to the fourth quarter and the coming year, with a strong cash runway, we are well-positioned to deliver on our strategic priorities and look forward to oral presentations for our novel IGN assets, IMGN779 and IMGN632, at ASH (Free ASH Whitepaper) in December and to announcing top-line results from FORWARD I during the first half of 2019."

PIPELINE PROGRESS AND PARTNER-RELATED UPDATES

Favorable tolerability and encouraging anti-tumor activity data from the FORWARD II expansion cohort of mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant ovarian cancer were presented at the 2018 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October. The goal of the combination is to prolong clinical benefit of the ADC in later-line patients through concomitant activation of the immune system.
The Food and Drug Administration (FDA) has granted orphan-drug designation to IMGN632 for the treatment of acute myeloid leukemia (AML).
ImmunoGen and MacroGenics advanced the IMGC936 (ADAM9-targeting ADC) program into IND-enabling activities. ADAM9-positive tumor types include non-small cell lung, triple-negative breast, gastric, and pancreatic cancers.
ImmunoGen presented preclinical data related to an epithelial cell adhesion molecule (EpCAM)-targeting Probody drug conjugate (PDC) at the European Antibody Congress in October. The EpCAM-targeting PDC integrates the PROBODY technology developed by CytomX, which enables the selection of targets previously thought to be incompatible with ADC development due to high normal tissue expression.
Roche announced in October that the Phase 3 KATHERINE study met its primary endpoint showing that KADCYLA (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to HERCEPTIN (trastuzumab) as an adjuvant treatment in people with HER2-positive early breast cancer who have residual disease present following neoadjuvant treatment.
ANTICIPATED UPCOMING EVENTS

Oral presentation of data from IMGN779 Phase 1 dose finding study at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting;
Oral presentation of initial data from IMGN632 Phase 1 dose finding study at the 2018 ASH (Free ASH Whitepaper) Annual Meeting and preclinical poster sessions related to IMGN632;
Complete enrollment in the FORWARD II cohort assessing a triplet combination of mirvetuximab plus carboplatin and AVASTIN (bevacizumab) in patients with recurrent platinum-sensitive ovarian before the end of 2018, and report initial data in mid-2019;
Initiate a new expansion cohort in the FORWARD II study to evaluate mirvetuximab plus AVASTIN in patients with recurrent ovarian cancer in 1Q 2019; and
Report top-line results from Phase 3 FORWARD I trial of mirvetuximab soravtansine in 1H 2019.
FINANCIAL RESULTS
Revenues for the quarter ended September 30, 2018 were $10.9 million, compared with $8.5 million for the quarter ended September 30, 2017. License and milestone fees of $0.7 million for the third quarter of 2018 included recognition of a $0.5 million milestone pursuant to a license agreement with Fusion Pharmaceuticals. Revenues in the third quarter of 2018 included $8.4 million in non-cash royalty revenues, compared with $6.5 million for the same quarter in 2017. Revenues for the third quarter of 2018 also included $0.4 million of research and development (R&D) support fees and $1.4 million of clinical materials revenue, compared with $0.7 million and $1.2 million, respectively, for the same quarter in 2017.

Operating expenses for the third quarter of 2018 were $56.5 million, compared with $39.6 million for the same quarter in 2017. The increase was driven by R&D expenses, which were $47.2 million in the third quarter of 2018, compared with $31.7 million for the third quarter of 2017. This increase was primarily due to higher antibody and cytotoxic manufacturing costs in support of commercial validation runs for mirvetuximab soravtansine, along with higher clinical trial costs related to the FORWARD II combination assessments and, to a lesser extent, expenses resulting from stock-based compensation. General and administrative expenses in the third quarter of 2018 were $8.3 million, compared to $7.9 million in the same quarter of 2017. Operating expenses for the third quarter of 2018 also included a $0.9 million restructuring charge due to the workforce reduction related to the previously announced decommissioning of the Company’s Norwood facility.

ImmunoGen reported a net loss of $46.8 million, or $0.32 per basic and diluted share, for the third quarter of 2018, compared with a net loss of $56.7 million, or $0.61 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 147.2 million from 93 million in those quarters.

ImmunoGen had $303.2 million in cash and cash equivalents as of September 30, 2018, compared with $267.1 million as of December 31, 2017, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $125.1 million for the first nine months of 2018, compared with cash provided from operations of $37.1 million for the same period in 2017. The prior period benefited from a $30 million paid-up license fee received from Sanofi, a $75 million upfront payment received from Jazz Pharmaceuticals, and a $25 million upfront payment received from Debiopharm. Capital expenditures were $4.2 million and $0.8 million for the nine months ended September 30, 2018 and 2017, respectively.

FINANCIAL GUIDANCE
ImmunoGen has updated its cash and revenue guidance for 2018. ImmunoGen now expects:

cash and cash equivalents at December 31, 2018 to be between $250 million and $255 million; and
revenues between $50 million and $55 million.
Guidance for operating expenses remains unchanged:

operating expenses between $215 and $220 million.
ImmunoGen expects that its current cash combined with the expected cash revenues from partners and collaborators will enable the Company to fund its operations at least a year beyond the top-line results from the Phase 3 FORWARD I trial, which are expected in the first half of 2019.

CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 323-794-2423; the conference ID is 8582527. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through November 16, 2018.