On October 2, 2018 Kite, a Gilead Company (Nasdaq: GILD), and HiFiBiO Therapeutics, a biotechnology company focused on the discovery of therapeutic antibodies through single B cell screening and analysis, reported the companies have entered into a research collaboration and license agreement to develop technology supporting the discovery of neoantigen-reactive T cell receptors (TCRs) for the potential treatment of various cancers, including solid tumors (Press release, Kite Pharma, OCT 2, 2018, View Source [SID1234537506]).

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Kite and HiFiBiO intend to adapt HiFiBiO’s proprietary single cell technology platform to create a high throughput approach that will potentially allow for the in-depth screening of TCR repertoires from patient samples to identify shared antigen and neoantigen TCRs for use in adoptive cellular therapies. Neoantigens arise from tumor-specific mutations that are unique to each patient’s cancer, offering the potential for more targeted antitumor activity.

Under the terms of the agreement, HiFiBiO will receive a $10 million upfront payment and will be eligible for additional payments based on the achievement of certain research milestones. Kite will have an exclusive option to license HiFiBiO’s platform to screen T cell repertoires and to identify TCRs for use in TCR engineered T cell therapies with a corresponding payment to HiFiBiO.

"Neoantigen-based cell therapy is a very exciting, yet complex, area of research that has the potential to transform the way we treat many solid tumors," said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. "We are excited about this collaboration with HiFiBiO, which will build upon our existing capabilities focused on discovering cell therapies which target patient-specific tumor neoantigens."

"Kite is a recognized leader in the cell therapy field," said Liang Schweizer, PhD, President and Chief Executive Officer, HiFiBiO Therapeutics. "We are proud that our proprietary single cell technology platform, which is utilized to support the rapid progression of our novel antibody therapeutics pipeline, will now also be implemented by Kite for the development of novel cell therapies targeting neoantigens."

On October, 2018 Pandion Therapeutics reported that it has been named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Pandion Therapeutics, OCT 2, 2018, View Source [SID1234529780]).

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Pandion is developing a new class of drugs to treat diseases with high unmet medical need, including inflammatory bowel disease, autoimmune liver disease, kidney diseases, type 1 diabetes, and autoimmune skin conditions. Pandion’s approach is shifting the paradigm from systemic immunosuppression to therapies that act locally at the site of disease to restore immune homeostasis.

"We are delighted to be recognized by FierceBiotech as one of their Fierce 15," said Dr Anthony Coyle, CEO and President of Pandion. "We are building an exciting, energetic and bold company with a dynamic and diverse team, and we are privileged to be making new drugs that we believe will meaningfully impact the lives of many patients."

The Fierce 15 celebrates the spirit of being "fierce"—championing innovation and creativity, even in the face of intense competition. This is FierceBiotech’s 16th annual Fierce 15 selection.

An internationally recognized daily report reaching a network of over 285,000 biotech and pharma industry professionals, FierceBiotech provides subscribers with an authoritative analysis of the day’s top stories. Every year FierceBiotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.

On October 2, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that Dr. Alain Algazi, Associate Professor of Medicine at UCSF, will present data from OncoSec’s OMS-100 study of TAVO (intratumoral tavokinogene telseplasmid) as a monotherapy treatment for metastatic melanoma in an oral presentation during the Melanoma Bridge Conference being held on November 29 – December 1 in Naples, Italy (Press release, OncoSec Medical, OCT 2, 2018, View Source [SID1234529888]).

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Dr. Algazi’s recently accepted presentation, entitled Intratumoral tavokinogene telseplasmid induces abscopal clinical responses in metastatic melanoma patients, will describe the OMS-100 Phase 2 multicenter, single-group study which evaluated the efficacy and safety observed after repeat dosing and different intervals between TAVO cycles. The primary endpoint was overall response rate (ORR) by modified "skin" Response Evaluation Criteria In Solid Tumors (mRECIST). Dr. Algazi, the primary investigator, is a leading expert in oncology research as well as a Clinical Strategic Advisor and a Clinical Advisory Board member for OncoSec.

The new data will demonstrate that local treatment with TAVO alone led to whole-body immune responses associated with regression of untreated lesions in half of the 50 patients treated on the study.

"We were grateful to Dr. Algazi and the Melanoma Bridge Conference for the opportunity to share this important TAVO monotherapy data demonstrating abscopal clinical responses with the clinicians, biotechnology executives, and industry opinion leaders in attendance," said Daniel J. O’Connor, OncoSec President and Chief Executive Officer. "Having Dr. Algazi present data from our OMS-100 study at the Melanoma Bridge Conference is an exciting opportunity for OncoSec as it serves to highlight our clinical work investigating TAVO as a monotherapy in the treatment of metastatic melanoma, as well as bring added visibility to our Phase 2b PISCES/KEYNOTE-695 clinical trial combining TAVO with pembrolizumab in metastatic melanoma for patients that have failed all available treatment options, including anti-PD-1 immunotherapy."

Details of the presentation are as follows:

Session Title: Mechanisms of resistance and drivers of response
Presentation Title: Intratumoral tavokinogene telseplasmid induces abscopal clinical responses in metastatic melanoma patients will address
Date and Time: Friday, November 30, 2018; 4:50 PM – 5:05 PM CEST (10:50 AM – 11:05 AM ET)
Location: Naples, Italy

On October 2, 2018 Nordic Nanovector ASA (OSE: NANO) reported that an abstract reporting data from the Phase 1/2a LYMRIT 37-01 study investigating Betalutin (177Lu-lilotomab satetraxetan) in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma (iNHL) has been accepted for a poster presentation at the 60th Annual Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (1-4 December 2018, San Diego, CA) (Press release, Nordic Nanovector, OCT 2, 2018, View Source [SID1234553494]).

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Title: LYMRIT 37-01: A phase I/II study of 177Lu-lilotomab satetraxetan (Betalutin) antibody-radionuclide-conjugate (ARC) for the treatment of relapsed non-Hodgkin’s lymphoma (NHL) – Analysis with 6-month follow-up

Authors: A. Kolstad, et al.

The Company will also have two non-clinical posters: one presenting Betalutin and one presenting the investigational anti-CD37 radioimmunoconjugate 212Pb-NNV003, which is under evaluation in a research collaboration between Nordic Nanovector and Orano Med (formerly AREVA Med).

Cell Cycle Kinase Inhibitors Potentiate the Effect of 177Lu-lilotomab Satetraxetan in Treatment of Aggressive Diffuse Large B-Cell Lymphoma

Authors: G.R. Rødland et al.

Targeted Alpha Therapy with 212Pb-NNV-003 for the Treatment of CD37 Positive B-Cell Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin Lymphoma (NHL)

Authors: A. Saidi et al.

The abstracts will be published on 1 November 2018 at 09:00am Eastern time at View Source

On October 2, 2018 Compass Therapeutics, a biotechnology company committed to the ambitious goal of comprehensively drugging the human immune system, reported that it has been named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotech companies in the industry (Press release, Compass Therapeutics, OCT 2, 2018, View Source [SID1234529744]).

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Compass, which completed its $132 million Series A financing this year, is forging a new approach to identifying antibody drug candidates that engage all targets in the biologically complex human immune synapse. The company’s antibody discovery platform enables the rapid identification of therapeutic candidates that engage with a broad range of epitopes and its StitchMabs bispecific screening platform enables the empirical, high-throughput identification of novel synergistic combinations and bispecifics. To date, the company’s integrated R&D approach has generated therapeutic candidates for more than 30 targets in cancer, inflammation and autoimmune disease. More than 15 of them are now advancing through preclinical development.

"We’re honored that the editors of FierceBiotech have recognized Compass for our pioneering approach to antibody-based therapeutics," said Thomas Schuetz, M.D., Ph.D., the company’s co-founder and chief executive officer. "We believe our empirical, unbiased approach to drug discovery will lead to therapeutics with new mechanisms to modulate the human immune system."

The Fierce 15 celebrates the spirit of being "fierce"— championing innovation and creativity, even in the face of intense competition. Selection to the list is based on factors including the strength of a company’s technology, partnerships and venture backers and its competitive market position.