On October 14, 2015 The Ontario Institute for Cancer Research ("OICR") together with Novera Therapeutics Inc., ("Novera") have reported a collaboration with Janssen Biotech, LLC ("Janssen"), a Pharmaceutical company of Johnson & Johnson, to accelerate the development of promising small molecule drug candidates for haematological cancers (Press release, FACIT, OCT 14, 2015, View Source [SID1234532038]). Novera, a new Ontario biotechnology company, will discover and develop novel therapeutic compounds identified through OICR’s drug discovery program in partnership with University Health Network’s ("UHN") enabling technology and disease area biology, and coordinate the collaboration with Janssen under a collaboration, license option, and exclusive license agreement (the "agreement").

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Under the agreement, facilitated by Johnson & Johnson Innovation, Novera will receive an upfront payment and is eligible to receive various pre-clinical, clinical, regulatory and commercialization success-based milestone payments up to a total of approximately $450 million Cdn, plus tiered royalties on potential net sales of products. Janssen has been granted an exclusive option to license, for all human uses worldwide, candidate drug(s) that have been identified and will be advanced through the collaboration. Janssen will assume responsibility for subsequent pre-clinical, clinical and commercial development once it exercises its option.

As a translational research institute OICR identifies, funds and supports oncology innovations with a goal of improving clinical practice. Leveraging the extensive and renowned research community within Ontario, OICR assembles and coordinates the intellectual resources, management and expertise needed to drive anti-cancer discoveries from bench to bedside. Novera was established by FACIT, OICR’s commercialization partner, to advance the therapeutics against molecular targets in difficult-to-treat hematological malignancies.

The announced agreement with Janssen is another important example that builds on the translational mandate and vision of OICR, FACIT and Ontario’s Ministry of Research and Innovation ("MRI").

"Janssen is an excellent partner for this exciting program and we welcome the opportunity to leverage their distinguished development expertise in haematological cancers. Patients in Ontario and worldwide will benefit from this collaborative and innovative model for translational research," said Tom Hudson, President of OICR.

"We are pleased with the remarkable achievements of OICR, UHN and FACIT and their continued efforts to translate breakthrough research from the lab to the marketplace. An expanded presence of a health industry leader like Janssen in Ontario — combined with our world-class scientific research — is essential for the province to stay at the forefront of innovation for the benefit of patients and our economy," said Reza Moridi, Minister of MRI.

"As a worldwide leader in developing breakthrough medicines, Janssen is an ideal partner and an excellent fit with our plan to bring the commercial strengths and experience of multinational pharmaceutical companies to support oncology innovations arising in the Province," remarked Jeff Courtney, FACIT’s Chief Commercial Officer. "Janssen’s commitment to this program is indicative of the calibre of innovation driving OICR’s Drug Discovery initiatives."

On October 14, 2018 Y-mAbs Therapeutics, Inc. (YmAbs) reported a collaboration with Memorial Sloan Kettering Cancer Center (MSK) through a worldwide exclusive license to commercialize two clinical stage fully humanized antibody programs, and a research collaboration agreement, to further develop protein multimerization platform, MULTI-TAG (Press release, Y-mAbs Therapeutics, OCT 14, 2015, View Source,-inc.-joins-forces-with-cancer-center-to-break-new-ground-on-immunotherapy/ [SID1234529204]).

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YmAbs is a new biotechnology company focused on novel immunotherapies for cancer. The license from MSK includes anti GD2 and anti B7-H3 antibody programs in clinical development, as well as non-exclusive access to platform technologies to create next-generation humanized, affinity matured bispecific antibodies, the protein multimerization platform, MULTI-TAG.

"Under this license, YmAbs brings together renowned scientists from MSK, exceptional drug development resources and a proven expert management team to launch and quickly scale an enterprise that will deliver cutting-edge cancer immunotherapy," said Thomas Gad, YmAbs’Founder, President, and Head of Business Development and Strategy. "This is a completely unique opportunity that holds the potential to truly save lives while transforming how we treat cancer."

YmAbs’ Chief Executive Officer, Dr. Claus Møller, said, "We are excited about the impressive clinical data these assets have produced so far by treating more than 1,000 neuroblastoma patients at MSK. We look forward to continue expanding the use of these programs in a number of new oncology indications in both pediatric and adult patients."

Nai-Kong V. Cheung, MD, PhD, who is Head of MSK’s Neuroblastoma Program, said, "Based on the significant anti-tumor activity seen with the anti GD2 and anti B7-H3 antibody programs, we are pursuing an aggressive and comprehensive clinical development plan to accelerate satisfyingregulatory requirements, and make these therapies available to cancer patients in the shortest period of time possible."

MSK expects that this collaboration will ensure the commercial development of two large research programs which have evolved at the cancer center in a very unique way. The programs build uponbasic science discoveries made in Dr. Cheung’s MSK laboratory, subsequently supported through philanthropic efforts from many parent-driven initiatives, including substantial awards from theBand of Parents, a specialized non-profit organization dedicated to funding research and new therapies to treat neuroblastoma. These gifts enabled Dr. Cheung to rapidly bring improved antibody drugs into clinical trials to treat children with very few options. Through MSK’s partnership with YmAbs, these promising immunotherapies can now be developed, sustained, and made available to patients worldwide.

Marc Winthrop, Chairman of the Board of Band of Parents stated, "This exciting new partnership promises to accelerate the critical work Band of Parents has funded at MSK. Right now, only a fraction of the children afflicted with this devastating disease have access to potentially life saving treatments; this partnership will change that. We are grateful to Dr. Cheung for his continued commitment to treating neuroblastoma and to all those who have supported our organization since its inception in 2007. It is their contributions that have made this important partnership possible and will allow us to continue on our mission of funding doctors and programs committed to finding a cure for this potentially fatal pediatric cancer."

YmAbs’ initial start-up management team consists of:

Thomas Gad, Founder, President and Head of Business Development and Strategy, business entrepreneur, and father of a neuroblastoma survivor
Dr. Claus Møller, MD, PhD, CEO of YmAbs, former Chief Operating Officer, and co-founder of Genmab
Bo Kruse, CFO of YmAbs, and former Chief Financial Officer of Genmab
Torben Lund-Hansen, PhD, SVP, Head of Technical Operations, former SVP, Head of Manufacturing at Genmab

(Filing, 10-Q, MultiCell Technologies, OCT 14, 2015, View Source [SID:1234507722])

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On October 14, 2015 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported financial results for the fourth quarter and fiscal year ended July 31, 2015 (Press release, OncoSec Medical, OCT 14, 2015, View Source [SID:1234507717]).

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"We made significant progress in fiscal year 2015, including the addition of several key employees, meeting important clinical milestones, and continued strengthening of our balance sheet," said Punit Dhillon, President and CEO of OncoSec. "Immuno-oncology continues to give rise to groundbreaking new treatments and is shifting the cancer treatment paradigm. I am very excited about the prospects for OncoSec as we develop therapies that aim to harness the immune system to fight cancer and address a great unmet medical need in oncology: anti-PD-1 non-responders. OncoSec’s talented and professional team has the experience, insight, and resources to advance our R&D and clinical efforts to capture the value in this opportunity."

FINANCIAL RESULTS
For the fourth quarter of fiscal 2015 and the fiscal year ended July 31, 2015, OncoSec reported a net loss of $6.5 million and $21.2 million, or $0.48 per share and $1.67 per share, respectively, compared to a net loss of $3.6 million and $12.0 million, or $0.30 per share and $1.26 per share, respectively, for the same period last year. The increase in net loss for the year ended July 31, 2015, compared with the same period in 2014, resulted primarily from (i) an increase in headcount as OncoSec continues to grow its discovery research and clinical teams, (ii) additional outside services costs to support its device development and clinical activities and (iii) corporate communication, financing and other administrative investments to expand investor awareness and list the Company on The Nasdaq Stock Market. There were no revenues for the fiscal years ended July 31, 2015 or July 31, 2014.

Research and development expenses were $3.8 million and $13.1 million for the fourth quarter of fiscal 2015 and the fiscal year ended July 31, 2015, respectively, compared to $1.9 million and $5.8 million for the same periods in 2014. General and administrative expenses were $2.7 million and $8.1 million for the fourth quarter of fiscal 2015 and the fiscal year ended July 31, 2015, compared to $1.7 million and $6.2 million for the same period in 2014.

At July 31, 2015, OncoSec had $32.0 million in cash and cash equivalents, as compared to $37.9 million of cash and cash equivalents at July 31, 2014. OncoSec expects these funds to be sufficient to allow it to continue to operate its business for at least the next 12 months.

On October 14, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that the results from its Phase 3 clinical study, which completed enrollment in 2009 using a previous version of the Delcath Hepatic Delivery System (Melphalan/HDS) for the treatment of melanoma patients with liver metastases, have been accepted for publication in the Annals of Surgical Oncology, a leading peer-reviewed medical journal (Press release, Delcath Systems, OCT 14, 2015, View Source;p=RssLanding&cat=news&id=2096947 [SID:1234507713]).

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The manuscript details the findings from the Company’s Phase 3 clinical study, and is titled Results of a Randomized Controlled Multi-Center Phase III Trial of Percutaneous Hepatic Perfusion Compared to Best Available Care for patients with Melanoma Liver Metastases. The manuscript was prepared and submitted by the trial’s lead investigator and senior author, James F. Pingpank, Jr., M.D., Associate Professor of Surgery at the University of Pittsburgh Medical Center, and by first author, Marybeth S. Hughes, M.D., Center for Cancer Research, National Cancer Institute, on behalf of the investigators who participated in the Phase 3 trial.

"Publication of these study results is a key milestone for Delcath and we are pleased that the manuscript has been accepted by such a prestigious journal. Publication will be an important tool that will enhance our efforts to expand reimbursement in certain European countries, and will also help increase awareness of the value of this therapy in Europe," stated Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath.