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 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 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, reported the publication of a study highlighting the ability of the DecisionDx-Melanoma test to accurately determine risk of metastasis in patients with melanoma of the head and neck (Press release, Castle Biosciences, FEB 7, 2019, View Source [SID1234533121]). Results from the study demonstrated that the DecisionDx-Melanoma test can provide independent information about recurrence risk in patients with tumors of the head and neck region, and can improve the evaluation of prognosis when used in combination with sentinel lymph node (SLN) status, especially in patients with a negative SLN biopsy. The study was published in the journal Head and Neck.

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Melanoma tumors in the head and neck region are associated with lower SLN positivity rates compared to tumors located on the trunk or extremities. There is also a higher rate of recurrence among SLN-negative patients with melanoma of the head and neck. Thus, improved methods for determining prognosis in patients with head or neck melanoma are needed.

"Tumors of the head and neck region can pose clinical challenges for traditional prognostic methods such as the SLN biopsy procedure," said lead author Brian Gastman, M.D., Cleveland Clinic Lerner Research Institute, Cleveland, Ohio. "In this study, the DecisionDx-Melanoma test accurately and independently determined prognosis for patients with melanoma of the head and neck. Importantly, the test can complement traditional AJCC staging methods and SLN status to identify high-risk patients who could potentially benefit from more aggressive surveillance and earlier therapeutic intervention at a time when these treatments can be more effective."

Study Details and Key Findings:

157 patients with Stage I, II or III melanoma of the head or neck had a median age of 65 years and median Breslow thickness of 1.6 mm. The median time to recurrence was 1.4 years and the median follow-up time was 7.1 years for patients who did not experience recurrence.
The DecisionDx-Melanoma test was performed to determine molecular class for each patient, with a Class 1A result indicating the lowest 5-year risk of metastasis and a Class 2B result indicating the highest risk.
Patients who were identified as Class 1A (lowest risk) by the DecisionDx-Melanoma test had higher recurrence-free (RFS), distant metastasis-free (DMFS) and melanoma-specific survival (MSS) rates compared to those in the SLN-negative group (80%, 83% and 98% compared to 65%, 69% and 89%, respectively).
Patients identified as Class 2B (highest risk) by the DecisionDx-Melanoma test had 5-year RFS, DMFS and MSS rates of 25%, 33% and 61%, respectively, which closely aligned with those of the SLN-positive group (20% RFS, 28% DMFS and 61% MSS, respectively).
The DecisionDx-Melanoma test demonstrated better sensitivity for identifying recurrence (74%), distant metastasis (74%) and melanoma-specific mortality (88%) than SLN biopsy alone (41%, 40% and 52%, respectively).
Similarly, the negative predictive values (NPV) for identifying recurrence (76%), distant metastasis (78%) and melanoma-specific mortality (96%) were superior to those for node positivity (64%, 67% and 90%, respectively).
When results from the DecisionDx-Melanoma test were combined with nodal status, the combination showed a sensitivity for RFS of 81%, DMFS 80% and MSS 88%, similar to those for the DecisionDx-Melanoma test alone but substantially improved over sensitivity for SLN biopsy alone.
Cox multivariate analysis comparing the DecisionDx-Melanoma Class 2 result to American Joint Committee on Cancer (AJCC) Stage IIB and above showed that both classifications were significant predictors of recurrence and distant metastasis (p≤0.006 for both endpoints), but only the Class 2 result was significant for melanoma-specific death (p=0.005).
The full published study results can be accessed at the Head and Neck website.

About DecisionDx-Melanoma

The DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of traditional factors and has been studied in over 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in five prospective studies including over 780 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,470 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter cohorts that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multi-center and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

On February 7, 2019 Harpoon Therapeutics, Inc. ("Harpoon"), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported the pricing of its initial public offering of 5,400,000 shares of its common stock at a price to the public of $14.00 per share (Press release, Harpoon Therapeutics, FEB 7, 2019, View Source [SID1234533138]). The gross proceeds to Harpoon from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by Harpoon, are expected to be $75.6 million. The shares are expected to begin trading on the Nasdaq Global Select Market on February 8, 2019 under the symbol "HARP." The offering is expected to close on February 12, 2019, subject to customary closing conditions. In addition, Harpoon has granted the underwriters a 30-day option to purchase up to an additional 810,000 shares of common stock.

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Citigroup and SVB Leerink are acting as joint book-running managers for the offering. Canaccord Genuity and Wedbush PacGrow are acting as co-managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and was declared effective on February 7, 2019. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, from: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

On February 7, 2019 Advaxis presented the Corporate Overview Presentation (Presentation, Advaxis, FEB 7, 2019, View Source [SID1234533176]).

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