On February 8, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the recent progress and operating results for the quarter and year ended December 31, 2018 (Press release, ImmunoGen, FEB 8, 2019, View Source [SID1234533177]).

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"We generated significant momentum in the business during 2018, led by the completion of enrollment in FORWARD I, our registration study for mirvetuximab soravtansine in platinum-resistant ovarian cancer; the publication of combination data in over 100 patients to support label expansion; and the advancement of our earlier-stage portfolio," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "On the strength of this performance, we enter 2019 poised to deliver on a number of important catalysts for the company, including top-line results from FORWARD I in the first half of the year, the potential BLA and MAA submissions for mirvetuximab monotherapy in the second half of the year, and additional combination data from our triplet in platinum-sensitive disease. Beyond our lead program, we expect to report data from expansion studies in AML and BPDCN with our programs targeting hematological malignancies and to file an IND before year-end for IMGC936, an ADAM9-targeting ADC being developed in collaboration with MacroGenics. Finally, with the benefit of the sale of the Kadcyla royalty tail, we start the year with roughly $325 million on the balance sheet to support our development and pre-commercial activities as we transition to a fully-integrated company."

RECENT PROGRESS

Mirvetuximab Soravtansine

· Validation runs were successfully completed and commercial drug product is now in inventory.

· The Premarket Approval (PMA) submission for the folate receptor alpha companion diagnostic was initiated.

·Patient enrollment completed ahead of schedule in the FORWARD II triplet combination cohort evaluating mirvetuximab plus carboplatin and Avastin (bevacizumab) in patients with recurrent platinum-sensitive ovarian cancer.

·Initial safety and preliminary anti-tumor activity from the FORWARD II expansion cohort assessing mirvetuximab in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in October. Data from this cohort confirm the activity of mirvetuximab in heavily pretreated platinum-resistant ovarian cancer, with a trend toward longer duration of response with the combination than would be expected for mirvetuximab monotherapy. Maturing data from this cohort will guide further development of this novel combination.

IGN Programs and Early-Stage Pipeline

· Both IGN programs received Orphan Drug Designation in acute myeloid leukemia (AML).

·Encouraging initial data from the Phase 1 study of IMGN632 in patients with relapsed or refractory adult AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN) were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December. IMGN632 displayed anti-leukemia activity across all dose levels tested and a tolerable safety profile at doses up to 0.3 mg/kg. Enrollment in expansion cohorts is ongoing to identify the recommended Phase 2 dose and schedule for both AML and BPDCN.

· Updated data from the IMGN779 Phase 1 dose finding study in AML patients were also presented at ASH (Free ASH Whitepaper). These data show that IMGN779 continues to display a tolerable safety profile with repeat dosing across a wide range of doses on the two schedules explored in patients with relapsed AML, with anti-leukemia activity seen in both schedules. Enrollment is ongoing to identify the recommended Phase 2 dose and schedule.

·IND-enabling activities were initiated during the quarter for IMGC936, a novel ADAM9-targeting ADC being developed in collaboration with MacroGenics.

·Multiple abstracts highlighting platform innovations were submitted for presentation at the 2019 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

Operational Updates

·Commercial planning and launch readiness activities for mirvetuximab have been initiated to support a potential launch in 2020.

·Earlier this month, ImmunoGen announced the sale of residual rights to receive royalty payments on commercial sales of Kadcyla (ado-trastuzumab emtansine) to the Ontario Municipal Employees Retirement System (OMERS), the defined benefit pension plan for municipal employees in the Province of Ontario, Canada, for $65 million.

ANTICIPATED 2019 EVENTS

·Report top-line results from Phase 3 FORWARD I trial of mirvetuximab in platinum-resistant ovarian cancer in the first half of 2019, followed by full FORWARD I data presentation at a medical meeting;

·Assuming a positive readout of FORWARD I, submit Biologics License Application (BLA) and Marketing Authorization Application (MAA) for mirvetuximab for the treatment of women with platinum-resistant ovarian cancer in 2H 2019;

·Enroll FORWARD II Avastin cohort in platinum-agnostic ovarian cancer;

·Present initial FORWARD II triplet and mature doublet expansion cohort data;

·Present updated IMGN632 data with additional AML and BPDCN patients, and establish the recommended Phase 2 dose and schedule;

·Initiate IMGN632 combination studies;

· Establish IMGN779 recommended Phase 2 dose and schedule for combination studies in AML; and

·Submit an IND for IMGC936 before the end of 2019.

FINANCIAL RESULTS

Revenues for the year ended December 31, 2018 were $53.8 million, compared with $115.4 million for the year ended December 31, 2017. License and milestone fees of $15.3 million for 2018 included $13.8 million of recognized upfront fees previously received from partners and $1.5 million in partner milestone payments. This was compared to license and milestone fees of $79.5 million for 2017, which included a $30 million paid-up license fee related to an amendment to the Company’s collaboration and license agreement with Sanofi, $29.5 million related to the sale and transfer of the Company’s IMGN529 asset to Debiopharm, $7 million in partner milestone payments, and $12.7 million in amortization of a non-cash fee related to the Company’s license agreement with CytomX. Revenues for 2018 included $32.5 million in non-cash royalty revenues, compared with $28.1 million for 2017. Revenues for 2018 also included $1.4 million of research and development (R&D) support fees and $4.6 million of clinical materials revenue, compared with $3.5 million and $4.4 million, respectively, for 2017.

Operating expenses for 2018 were $214.3 million, compared with $174.4 million for 2017. The increase was driven by R&D expenses, which were $173.9 million for 2018, compared with $139.7 million for 2017. This increase was primarily due to higher external manufacturing costs and third-party service fees in support of commercial validation for mirvetuximab soravtansine, along with higher clinical trial costs related to the FORWARD I, FORWARD II, and IMGN632 studies and, to a lesser extent, an increase in stock-based compensation. General and administrative expenses for 2018 increased to $36.7 million, compared to $33.9 million for 2017, primarily due to increased third-party service fees and stock-based compensation. Operating expenses for 2018 also included a $3.7 million restructuring charge due to the previously announced decommissioning of the Company’s Norwood facility, compared to a $0.8 million charge in 2017 related to a loss recorded on leased office space.

ImmunoGen reported a net loss of $167.9 million, or $1.20 per basic and diluted share, for 2018, compared with a net loss of $96.0 million, or $0.98 per basic and diluted share, for 2017. Weighted average shares outstanding increased to 139.9 million in 2018 from 98.1 million in 2017.

ImmunoGen had $262.3 million in cash and cash equivalents as of December 31, 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 $166.4 million for 2018, compared with cash provided from operations of $7.6 million for 2017. The prior period benefited from a $75 million upfront payment received from Jazz Pharmaceuticals, and $59.5 million of fees received from Sanofi and Debiopharm. Capital expenditures were $5.2 million and $1.1 million for 2018 and 2017, respectively.

FINANCIAL GUIDANCE

For 2019, ImmunoGen expects:

·cash and cash equivalents at December 31, 2019 to be between $135 million and $140 million;

· revenues between $40 million and $45 million; and

·operating expenses between $265 and $270 million.

ImmunoGen expects that its current cash combined with the expected cash receipts from partners and collaborators will enable the Company to fund its operations at least a year beyond the release of 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 323-794-2093; the conference ID is 6271602. 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 February 22, 2019.

On February 7, 2019 For more than three decades, American Skin Association (ASA) and its affiliates reported that have funded more than $50 million in grants to address the causes and treatments of melanoma, vitiligo, and psoriasis, as well as other skin diseases, and to search for much-needed cures (Press release, American Skin Association, FEB 7, 2019, View Source [SID1234554047]). Today, ASA continues its tradition of awarding significant research grants by funding 18 promising new grants for 2019.

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This year, the much sought-after ASA Milstein Research Scholar Award for Melanoma/Non-melanoma Skin Cancer has been awarded to Neda Nikbakht, MD, PhD, Assistant Professor of Dermatology and Cutaneous Biology at Thomas Jefferson University in Philadelphia for her research on Genomic Profiling of Early Stage Cutaneous T-cell Lymphoma.

ASA renewed its commitment to Roger Lo, MD, PhD of the David Geffen School of Medicine at UCLA. Dr. Lo is midway through his work on a three-year award of the Abby S. and Howard P. Milstein Innovation Award for Melanoma/Non-Melanoma Skin Cancer Research (MIA). The grant of $750,000 was initially funded in 2018 and focuses on the field of cancer genetics and genomics, using next generation sequencing approaches to uncover the basis of resistance to both molecularly targeted therapies and immune checkpoint inhibitors.

These grants were made possible through the generosity of the Milstein Family. Howard P. Milstein, Chairman of ASA, and his family are devoted to funding vital dermatological research in an effort to discover cures for skin cancers and diseases.

"We are proud to continue our funding of crucial research through ASA. Although the skin is our largest and perhaps most vulnerable organ, dermatological research remains one of the most underfunded areas of medicine," said Mr. Milstein. "Through these grants we improve the chances of finding cures and bring hope to those suffering from devastating skin diseases."

Dr. Roger Lo, the MIA awardee, said, "I am very grateful for the continued generosity of Howard Milstein and his family. My lab is conducting patient-oriented melanoma research, the knowledge from which we will be able to use to directly impact patient management and care. This would not be possible without the support of individuals like Mr. Milstein."

ASA’s Medical Advisory Committee (MAC) is comprised of leading physicians and scientists who oversee the annual grant review and award process. Through MAC’s leadership, ASA’s grant program has supported the work of nearly 300 investigators, ranging from talented young researchers in the early phases of their careers to recognized leaders in the field of dermatology.

ASA President and Co-Chair of its MAC, Dr. David A. Norris, added, "We have a wonderful group of grant awardees this year. ASA’s Medical Advisory Committee is excited for the future findings of these important studies."

ASA provides significant special research awards to established investigators and medical students studying melanoma, non-melanoma skin cancer and skin diseases. Through these grants, ASA has promoted the early careers of many gifted young investigators and has had a profound impact both on dermatology research and clinical care of dermatologic disease. In particular, ASA-funded researchers have had a broad impact on melanoma research, improving our understanding of its diagnosis, treatment, and prognosis. With an exclusive focus on skin disease research, ASA has helped open new frontiers in skin science, producing results that can change how we understand and treat skin disease.

On February 7, 2019 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI" or the "Company"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that the independent Data and Safety Monitoring Board (DSMB) completed its third and final safety assessment of Part A of the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent glioblastoma (GBM) patients (Press release, VBI Vaccines, FEB 7, 2019, View Source [SID1234533205]). After reviewing the complete safety data from the fully enrolled, high-dose patient cohort, the DSMB unanimously recommended the continuation of the Phase 1/2a study without modification.

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Part B of the study, which is expected to enroll a cohort of up to 10 additional patients, will be an extension of the optimal therapeutic dose level from Part A of the study. The Company will define the optimal dose following availability of expanded immunologic data and survival data from all three dose cohorts in Part A, which are expected later in the first half of 2019.

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 28 patients with recurrent GBM:

Part A: Dose-escalation phase to define the safety, tolerability, and optimal therapeutic dose level of VBI-1901 in recurrent GBM patients. This phase enrolled 18 patients across three dose cohorts.

Part B: A subsequent extension of the optimal therapeutic dose level, as defined in the dose escalation phase. This phase is expected to enroll an expanded cohort of approximately 10 additional patients.

VBI-1901 is administered intradermally and is adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), a potent adjuvant that mobilizes dendritic cell function. Patients in both phases of the study will receive vaccine every four weeks until tumor progression.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.

On February 7, 2019 HiberCell, a biotechnology company developing therapeutics focused on preventing cancer relapse and metastasis, reported with $60.75M in Series A funding led by ARCH Venture Partners (Press release, HiberCell, FEB 7, 2019, View Source [SID1234533195]). HiberCell is the first company exclusively focused on tumor dormancy detection and therapeutics.

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Most patients who succumb to cancer do so because of metastatic cancer. Accumulated evidence has demonstrated that cancer recurrence is driven by dormant disseminated tumor cells (DTCs) that persist undetected in the body for prolonged periods of time. In approaching cancer as a systemic disease, the company seeks to detect and therapeutically target the ‘Achilles heel’ of patient DTCs to prevent or delay metastasis. The company is developing first-in-class therapeutics targeting DTCs originating from solid and liquid cancers.

"HiberCell is the foundational tumor dormancy company," said Alan Rigby, Ph.D., co-founder, president and chief scientific officer. "We know that dormant disseminated tumor cells are critical drivers of cancer metastasis. In translating this biology into the clinic, our work will be focused on further defining the characteristic genetics and transcriptomics of dormant disseminated tumor cells and charting a course to leverage our dormancy therapies to improve patient outcomes and survival. We believe that this approach provides a differentiated opportunity to change the paradigm of cancer treatment."

"While we have made great strides in treating primary tumors, the unfortunate and painful truth is that relapsed or metastatic cancer still claims the lives of most people with cancer, even when their primary tumor has been successfully treated," said Julio Aguirre-Ghiso, Ph.D., HiberCell’s scientific founder and professor of Medicine (Hematology and Medical Oncology), director of Head and Neck Cancer Basic Research and Solid Tumor and Metastasis Research and co-leader of the Cancer Mechanisms Program at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. "HiberCell will build on the foundational biology that is in place by focusing on novel tools to better detect, isolate and annotate the survival mechanisms in these dormant disseminated tumor cells. By targeting these mechanisms with therapeutics, we believe it is possible to extend disease-free intervals and improve the chance of survival through lower rates of relapse and metastasis."

"We’re launching HiberCell at an exciting time for cancer treatments," said Ari Nowacek, principal at ARCH Venture Partners. "Recent advances in cancer treatment that take advantage of a patient’s immune system are providing prolonged survival advantages to patients, but cancer metastasis represents a significant unmet medical need across the cancer landscape."

In addition to backing from ARCH Venture Partners, investors include Hillhouse Capital, 6 Dimensions Capital, Celgene Corporation, the NYC Life Sciences Fund and undisclosed institutional investors, family offices and private individuals.

HiberCell represents a significant investment by the NYC Life Sciences Fund. Established by the New York City Economic Development Corporation, the Fund is at the forefront of initiatives designed to champion New York City’s early-stage life sciences ecosystem. Separately, Dr. Aguirre-Ghiso received the 2016 BioAccelerate Prize for work that has been licensed by HiberCell. The Prize is awarded by the Partnership Fund for New York City to provide funding for the commercialization of research at New York academic institutions.

"HiberCell exemplifies the high caliber innovation that New York’s life sciences ecosystem can support and foster," said James Patchett, president and CEO of NYCEDC. "The HiberCell team has the scientific and financial backing needed to advance cutting-edge science and make a meaningful difference in cancer patients’ lives. NYCEDC is proud to foster that kind of work here in New York City."

"HiberCell is slated to be one of the more prominent academic new ventures in New York City this year, and demonstrates Mount Sinai’s commitment to developing innovative therapies," said Erik Lium, Ph.D., executive vice president of Mount Sinai Innovation Partners. "This groundbreaking partnership between HiberCell’s leadership team, Mount Sinai, ARCH Venture Partners, the NYCEDC and other prominent investor groups seeks to bring novel therapies to the fight against cancer."

HiberCell will occupy state-of-the-art lab and office space in The Hudson Research Center, a partnership between Taconic Investment Partners and Silverstein Properties located at 619 West 54th Street.

Leadership Team

HiberCell’s rapidly expanding, multidisciplinary team consists of world-class cancer scientists, venture capitalists and drug developers who are leaders within their respective fields. At launch, Alan Rigby, Ph.D., will lead the company as president and chief scientific officer. Ari Nowacek, Ph.D., M.D., principal at ARCH Venture Partners, will serve as vice president of operations and business development, and Mark Mulvihill, Ph.D., will serve as vice president of chemistry and drug discovery.

Board of Directors

Steven Gillis, Ph.D., chairman of the board at HiberCell, managing director at ARCH Venture Partners
Alan Rigby, Ph.D., president and chief scientific officer at HiberCell
Ari Nowacek, M.D., Ph.D., principal at ARCH Venture Partners & vice president, operations and business development at HiberCell
Kevin Heyeck, Ph.D., venture partner at 6 Dimensions Capital
Michael Yi, Ph.D., partner at Hillhouse Capital
Scientific Advisory Board

Julio Aguirre-Ghiso, Ph.D., director of Solid Tumor and Metastasis Research, director of Head and Neck Cancer Basic Research, co-leader of the Cancer Mechanisms Program and professor of Oncological Sciences, Otolaryngology, and Medicine (Hematology and Medical Oncology) at The Tisch Cancer Institute at the Icahn School of Medicine
Christoph Klein, M.D., Ph.D., head of the Department of Experimental Medicine and Therapy Research at the University of Regensburg, head of Personalized Tumor Therapy, a division of Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)
Ruggero De Maria, M.D., professor and director of the Institute of General Pathology at the Catholic University of Rome, president of the Italian Institute for Genomic Medicine in Turin, Italy and president of the Italian Alliance Against Cancer network

On February 7, 2019 nCytokinetics, Incorporated (Nasdaq:CYTK) reported that it is scheduled to report fourth quarter results on February 21, 2019 at 4:00 PM Eastern Time (Press release, Cytokinetics, FEB 7, 2019, View Source [SID1234533184]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.

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The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 9798766.

An archived replay of the webcast will be available via Cytokinetics’ website until February 28, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 9798766 from February 21, 2019 at 7:30 PM Eastern Time until February 28, 2019.