On October 3, 2018 FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target drivers of cancer and other immune-related disorders, reported that it has been named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, recognizing it as one of the most promising private biotechnology companies in the industry (Press release, FLX Bio, OCT 3, 2018, View Source [SID1234529772]).

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"We are honored to be selected as a Fierce 15 company, which we feel highlights the incredibly hard work by our team and our unique approach to targeting the immune system," said Brian Wong, M.D., Ph.D., Chief Executive Officer of FLX Bio. "We believe that our big-data and cutting-edge drug discovery capabilities permit selective control of key immuno-modulatory cells such as regulatory T cells to effectively treat cancers and other immune disorders."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. Every year FierceBiotech evaluates hundreds of private companies from around the world for inclusion on its annual Fierce 15 list. Selection is based on a variety of factors including the strength of a company’s technology, partnerships, venture backers, and competitive market position.

On October 3, 2018 Coordination Pharmaceuticals, Inc. (CPI), a privately held and clinical-stage biopharmaceutical company focused on nanotechnology-based cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application to initiate a first-in-human Phase 1 clinical study of CPI-100 in patients with advanced tumors (Press release, Coordination Pharmaceuticals, OCT 3, 2018, View Source [SID1234532212]).

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CPI-100 is a structurally optimal core-shell nanoparticles based on CPI’s proprietary nanoscale coordination polymer (NCP) platform technology to selectively deliver immunostimulatory chemotherapeutic combinations to tumors, providing a new approach to initiate and stimulate immune-mediated eradication of cancer cells using synergistic nanomedicines. "FDA’s timely acceptance and approval of CPI-100 IND is an important milestone for the company. We are excited about the opportunity to study the first NCP-based product in clinical trials." said Wenbin Lin, Ph.D., founder and chairman of CPI and also the James Franck Professor of Chemistry, Radiation & Cellular Oncology, and the Ludwig Center for Metastasis Research at the University of Chicago. "We expect this study will generate important insights into the safety of CPI-100 and its preliminary therapeutic efficacy in cancer patients."

On October 3, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that clinical data on the company’s lead product candidate eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3Ig fusion protein based on the LAG-3 immune control mechanism, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting being held November 7-11, 2018, in Washington, D.C (Press release, Immutep, OCT 3, 2018, View Source [SID1234529718]).

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Abstract titles and authors are:

Title: Results from a Phase I dose escalation trial (TACTI-mel) with the soluble LAG-3 protein (IMP321, eftilagimod alpha) together with pembrolizumab in unresectable or metastatic melanoma

Authors: Victoria Atkinson; Frederic Triebel; Christian Mueller; Chrystelle Brignone; Melissa Eastgate; Amitesh Roy; Adnan Khattak; Andrew Haydon

Title: A multicenter, phase II study in patients with first line NSCLC, or recurrent PD-X refractory NSCLC or with recurrent HNSCC receiving Eftilagimod Alpha in combination with Pembrolizumab (TACTI-002)

Authors: Martin Forster; Frederic Triebel; Christian Mueller; Chrystelle Brignone; Tatsiana Skrahina

The exact time of Immutep’s presentation and further details will be available closer to the conference date.

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