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Y-mAbs Therapeutics, Inc. Joins Forces with Cancer Center to Break New Ground on Immunotherapy

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

10-Q – Quarterly report [Sections 13 or 15(d)]

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

OncoSec Announces Fourth Quarter and YTD Results for Fiscal Year End 2015

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]).

"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.

Delcath Phase 3 Trial Results To Be Published In Annals Of Surgical Oncology

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]).

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.

Isarna Therapeutics and Autotelic Sign ed Asset Sale and Purchase Agreement for Trabedersen

On October 14, 2015 – Isarna Therapeutics, the leader in transforming growth factor beta (TGF-β) isoform targeted antisense therapeutics, and Autotelic Inc., a specialist in therapeutic drug monitoring and development, reported an asset sale and purchase agreement for trabedersen, Isarna’s TGF-β 2 antisense oligonucleotide (Press release, Isarna Therapeutics, OCT 14, 2015, View Source [SID1234520366]).

Autotelic acquires full and world wide rights to develop trabedersen, which had previously reached Phase 3 clinical evaluation to treat recurrent high-grade glioma. No financial details of the agreement have been disclosed. " Autotelic Inc. has a unique expertise and resources that enables them to effectively advance trabedersen. The agreement, made possible by our partners at Egamid Ltd, recognizes our leadership in TGF-β and our efforts to bring trabedersen to patients while allowing us remain focused on our new generation of antisense oligonucleotides," said Dr. Philippe Calais, President and Chief Executive Officer of Isarna Therapeutics. Autotelic utilizes therapeutic drug monitoring to achieve consistent drug levels benefiting both efficacy and toxicity in multiple indications. The company’s leadership has long-standing experience in the development of cancer therapies as part of the team that led the early development of Abraxane, a protein-bound paclitaxel compound approved by the FDA and EMA for the treatment of solid tumors, which was acquired by Celgene in 2010 when it merged with Abraxis BioScience Inc. Subsequent to Abraxis, the team formed Igdrasol Inc. to develop next generation Abraxane. Igdrasol recently was acquired by NantPharma in a deal that could be worth as much as $1.3 billion. " Trabedersen is an excellent fit for our therapeutic drug monitoring program and prov ides an exciting opportunity to enhance the development of a truly novel treatment. We are looking forward to advancing this promising antisense oligonucleotide further, " commented Dr. Vuong Trieu, C hief E xecutive Officer of Autotelic.

About Trabedersen
Trabedersen, developed to target the human TGF-β2 mRNA, is believed to reverse TGF-β’s immunosuppressive effects, rendering the tumor visible to a patient’s immune system and resulting in priming and specific activation of the patient’s anti-tumor immune response. Trabedersen was developed by Isarna’s predecessor company at the Biopark in Regensburg. Trabedersen has been granted orphan designation f or three tumor indications: high grade glioma (US, EU), pancreatic cancer (US, EU) and malignant melanoma (US).

About Isarna
Therapeutics Isarna Therapeutics has an unmatched commitment to developing selective TGF-β inhibitors to effectively treat ophthalmic and fibrotic diseases and fight cancer. We are advancing a unique pipeline of novel oligonucleotides and combination modalities to transcend clinical response and improve patient outcomes. Isarna is established in the Netherlands, Germany, and t he United S tates. www.isarna-therapeutics.com.

About Autotelic Inc.
Autotelic Inc. develops novel treatments using therapeutic drug monitoring. The company was incorporated in 201 1 and is headquartered in Fountain Valley, California, United States.