1stOncology™: Cancer Intelligence Service – Page 12949 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

LEO Pharma Exercises Option with HitGen to License Compounds for Development of Novel Class of Drugs in Dermatology

On November 12, 2019 LEO Pharma A/S and HitGen Inc. are reported that HitGen and LEO Pharma expands their collaboration with a license to develop a novel class of drugs for a dermatology indication (Press release, Leo, NOV 12, 2019, View Source [SID1234550956]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The licensed compounds were identified using HitGen’s leading technology platform, which involved screening DNA encoded libraries (DEL), containing over 400 billion small molecules with drug-like properties, synthesized on a broad range of structurally diverse scaffolds. A number of novel small molecule leads for an undisclosed target nominated by LEO Pharma are subject of this license.

Under the terms of the collaboration agreement, HitGen will grant exclusive rights to LEO Pharma to develop and commercialize the licensed compounds. HitGen will be eligible for preclinical and clinical milestone payments from LEO Pharma as the project progresses, in addition to an option exercise fee.

Today’s announcement marks a significant milestone in the long lasting partnership between LEO Pharma and HitGen originally initiated in 2015.

"We are delighted to announce this license with LEO Pharma. The success of delivery of these licensed compounds has further demonstrated the power of our DEL platform to discover novel small molecules against a variety of targets, including those previously deemed challenging for small molecule modalities. In this case that target may be characterized as a "protein-protein interaction", a class that has proved "hard-to-drug" for small molecule discovery. The current achievement marks the continued progress and success of the discovery collaboration between the companies, spanning a range of discovery programs. We look forward to announcing future milestones as the programs progress." said Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen.

To date HitGen has initiated screening efforts on multiple LEO Pharma discovery programs related to dermatology. These programs are at various stages of screening, selection, synthesis and validation.

"It is with great pleasure that we expand our collaboration with HitGen to further accelerate LEO Pharma’s ambition to discover promising lead compounds against challenging drug targets in dermatology. This license marks a successful discovery of a promising compound series targeting a novel "protein-protein interaction" and is yet another important milestone in our dedicated efforts to discover and develop oral first-in-class drugs. LEO Pharma is committed to making pioneering advances in dermatology research and to bringing new treatments to patients faster," said Dr. Thorsten Thormann, Vice President of Global Research at LEO Pharma.

AIVITA Biomedical Announces New Positive Phase 2 Glioblastoma Data at SITC Annual Meeting Podium Presentation

On November 12, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that data from its ongoing Phase 2 clinical trial in GBM was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting by Principal Investigator Dr. Daniela Bota (Press release, AIVITA Biomedical, NOV 12, 2019, View Source [SID1234550953]). The oral presentation was titled "Phase II trial of therapeutic vaccine consisting of autologous dendritic cells loaded with autologous tumor cell antigens from self-renewing cancer cells in patients with newly diagnosed glioblastoma."

Dr. Bota presented interim results from the Phase 2 trial testing AIVITA’s patient-specific immunotherapy AV-GBM-1 in patients with glioblastoma multiforme (GBM). At this time survival is 96% at six months and 91% at twelve months with three patients followed for more than a year. Furthermore, a vast majority of patients displayed an appropriate immune response and a decrease of tumor biomarkers.

AIVITA’s immunotherapy targets tumor-initiating cells. Treatment involves a series of subcutaneous injections. As of the end of October 2019, cell lines had been successfully established for 46/48 patients and dendritic cells produced for 41/42 patients; 38 of the planned 55 patients had been enrolled, 31 had started therapy, and 12 had completed all 8 doses and 184 doses had been injected. Blood tests on the first 16 patients showed induction of a new immune responses that were associated with a decrease in tumor markers.

AIVITA Chief Scientific Officer Gabriel I. Nistor, M.D. acknowledged that the immune response data is highly encouraging. "Once the trial is complete, we’re looking forward to determining the correlation between immune responses and clinical outcome as we previously did in patients with metastatic melanoma treated with a similar patient-specific vaccine," said Dr. Nistor.

"The results are very encouraging," said AIVITA Chief Medical Officer Robert O. Dillman, M.D. "The trial is still in progress and will continue to enroll patients for a few more months with follow up for at least another year. Final analysis likely will occur in early 2021."

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous cancer stem cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the cancer stem cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA’s AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298

Agenus to Host R&D Day November 15, 2019

On November 12, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1 and cancer vaccines, reported that it will host an R&D Day on November 15, 2019 (Press release, Agenus, NOV 12, 2019, View Source [SID1234550952]).

Date: Friday, November 15, 2019

Time: 11:00AM – 2:00PM

Live webcast: View Source

Location: New York, NY (by invitation only)

Agenus has delivered more I-O discoveries to the clinic in the last three years than any large pharma and is on track to file a BLA in 2020 for accelerated approval of its lead candidates Zalifrelimab (anti-CTLA-4) and Balstilimab (anti-PD-1) while also advancing AGEN1181, a potential best-in-class next generation anti-CTLA-4 antibody, and a pipeline of additional antibodies, cell therapies, and vaccines.

The event will be moderated by Dr. Garo Armen, Chairman and Chief Executive Officer, and Dr. Jennifer Buell, Chief Operating Officer, and will include presentations by world experts in I-O, Dr. Steven O’Day, Executive Director of the John Wayne Cancer Institute, and Dr. Manuel Hidalgo, Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center.

The event will be webcast live and may be accessed by visiting the "Events & Presentations" page within the Investors section of the Agenus website www.agenusbio.com or by using the link below. A replay of the webcast will be available on the Agenus website following the event.

IGM Biosciences to Present at Three Upcoming Investor Conferences

On November 12, 2019 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies for the treatment of cancer patients, reported that Fred Schwarzer, Chief Executive Officer, will present at three upcoming investor conferences (Press release, IGM Biosciences, NOV 12, 2019, View Source [SID1234550951]):

Stifel 2019 Healthcare Conference on Tuesday, November 19 at 4:45 p.m. ET in New York.
Jefferies 2019 London Healthcare Conference on Thursday, November 21 at 11:20 a.m. GMT in London.
Piper Jaffray 31st Annual Healthcare Conference on Wednesday, December 4 at 3:00 p.m. ET in New York.
A live webcast of the events will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 90 days following the presentation.

FENNEC PROVIDES BUSINESS UPDATE AND ANNOUNCES THIRD QUARTER 2019 FINANCIAL RESULTS

On November 12, 2019 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, reported its business update and financial results for the third quarter ended September 30, 2019 (Press release, Fennec Pharmaceuticals, NOV 12, 2019, View Source [SID1234550950]).

"We are nearing completion of the NDA for PEDMARK and expect to complete the rolling submission to the FDA in early 2020" said Rosty Raykov, chief executive officer of Fennec. "With the addition of a chief commercial officer during the quarter, we are focused on building the necessary team and infrastructure to support a rapid commercial launch of PEDMARK, if approved, in the second half of 2020."

Financial Results for the Third Quarter 2019

·Cash Position – Cash and cash equivalents were $15.2 million as of September 30, 2019. The reduction in cash balance over the quarter is the result of cash used for operating activities including the manufacturing and regulatory expenses associated with the regulatory submissions of PEDMARKTM.
·R&D Expenses – Research and development (R&D) expenses were $0.8 million for the three months ended September 30, 2019, compared to $1.8 million for the same period in 2018 as the Company completed a significant part of the activities needed for regulatory approval of PEDMARKTM during the first six months of 2019.
·G&A Expenses – General and administrative (G&A) expenses were $1.1 million for the three months ended September 30, 2019, and $1.1 million for the same period in 2018.
·Net Loss – Net loss was $1.8 million and $2.7 million for the three months ended September 30, 2019 and 2018, respectively.
·Financial Guidance – The Company believes its cash and cash equivalents on hand as of September 30, 2019 will be sufficient to fund the Company’s planned commercial launch of PEDMARKTM in the second half of 2020.

Financial Update

The selected financial data presented below is derived from our audited condensed consolidated financial statements which were prepared in accordance with U.S. generally accepted accounting principles. The complete interim unaudited consolidated financial statements for the period ended September 30, 2019 and management’s discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

About PEDMARK (Sodium Thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe there is estimated that over 10,000 children may receive platinum-based chemotherapy. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.