FogPharma Secures $66 Million Series B Financing

On May 16, 2018 FogPharma reported the closing of a $66 million Series B financing (Press release, FogPharma, MAY 16, 2018, View Source [SID1234552458]). The round was led by 6 Dimensions Capital, with participation by additional new investors, including GV (formerly Google Ventures), Blue Pool Capital, Horizons Ventures, Nan Fung Group, and Leerink Partners. All existing investors participated in the round including Deerfield Management, Boyu Capital, WuXi AppTec Corporate Ventures, and a prominent international group of non-institutional investors.

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FogPharma was founded by renowned scientist-entrepreneur Dr. Gregory Verdine, whose Harvard lab invented cell-penetrating miniproteins and who coined the term "drugging the undruggable" to describe his life’s mission. FogPharma’s research and development strategy is unique in that it pairs a broadly-enabling new drug class, designed to access the cell interior, with a massively parallelized engine to discover – rapidly and on-demand – drugs that engage the most intractable of disease targets. FogPharma’s drug discovery engine has been configured to deliver multiple new medicines in rapid succession, with clinical entry for the first product, a first-in-class beta-catenin antagonist, by the end of 2019, followed by a steady stream of first-in-class clinical product candidates addressing other intractable targets.

While FogPharma’s approach has many therapeutic applications, the company’s early focus is on drugging the major, intractable drivers of cancer and on pharmacological management of the immune response.

"One of the most important challenges of our time is making actionable the enormous, inactionable trove of biological data on human disease targets. FogPharma is addressing this challenge by bringing forward a new class of medicines that combine the cell-penetrating ability of small molecules with the broad, target power of biologics, and by learning how to discover these medicines better, faster and smarter," said Verdine, chief executive officer and chief scientific officer, FogPharma.

Added Verdine, "We are thrilled to have such an incredible group of investors who share our vision of fundamentally advancing the treatment of cancer and other serious diseases with few if any current treatment options. We are excited at the opportunity provided by this financing to propel our programs and drug discovery engine forward."

Proceeds from the Series B raise will enable the company to advance its first-in-class beta-catenin inhibitor (iCat) program into Phase 2 development for cancer indications involving Wnt pathway activation. The financing will also be used to advance clinical development of its first-in-class Cbl-b inhibitor program and a third as-yet-undisclosed program through IND-enabling studies, and FogPharma’s drug discovery platform for three additional, distinct and differentiated forms of cell-penetrating miniproteins.

In association with the Series B financing, FogPharma has appointed to its board of directors: Dr. Leon Chen, chief executive officer, 6 Dimensions Capital; Dr. Krishna Yeshwant, general partner, GV; and Dr. Rick Klausner, founder and director, Juno Therapeutics, GRAIL and Mindstrong.

"There is substantial and persistent interest in tackling targets like beta-catenin and Cbl-b, which are clearly important biologically and medically, but untouchable by conventional therapeutics. I was captivated by the FogPharma team’s unprecedented ability to go after these and other intractable targets," said Klausner, formerly director of the National Cancer Institute and executive director of the Bill and Melinda Gates Foundation.

"The opportunity in the near term to bring cell-penetrating miniproteins to the 20-25 percent of cancer patients whose disease is driven by the Wnt pathway is tremendous, and the opportunity beyond that to be the first to drug Cbl-b for immuno-oncology indications, is extraordinary. On behalf of 6 Dimensions Capital, I am thrilled to have led this exceptional investor syndicate and foster FogPharma’s mission," said Chen, chief executive officer, 6 Dimensons Capital, and member of the FogPharma board of directors.

Through seed and Series A financing, FogPharma previously secured $11 million bringing the company’s total funding to-date to $77 million.

In addition to FogPharma, Verdine founded and leads LifeMine Therapeutics, which has buit a first-of-its-kind, genomically-enabled drug discovery platform that can rapidly develop new drugs from fungi. Both LifeMine Therapeutics and FogPharma are headquartered in Cambridge, Mass. and were established operationally in 2016. Verdine is highly regarded for having moved seamlessly between successful roles as life scientist, entrepreneur, investor, and chief executive throughout his career. He is Erving Professor at Harvard University and Harvard Medical School and has founded multiple NASDAQ-listed biotech companies including Wave Life Sciences, Enanta, Eleven Bio, Variagenics, Tokai, Aileron, and a private company, Gloucester Pharmaceuticals, acquired by Celgene in 2010.

GT BIOPHARMA ANNOUNCES UPDATE TO OXS-3550 IND FILING, ITS MOST ADVANCED TRI-SPECIFIC KILLER ENGAGER

On May 16, 2018 GT Biopharma Inc. (OTCQB: GTBP and Euronext Paris "GTBP.PA" or the "Company")), an immuno-oncology biotechnology company focused on innovative treatments based on the Company’s proprietary platforms, has reported that it expects to file the Investigational New Drug Application ("IND") for OXS-3550, the Company’s most advanced Tri-specific Killer Engager ("TriKE") product candidate, in mid-2018 (Press release, GT Biopharma , MAY 16, 2018, View Source [SID1234539530]).

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GT Biopharma is working in collaboration with the Masonic Cancer Center at the University of Minnesota under a program led by Dr. Jeffrey Miller, Deputy Director. Dr. Miller is a recognized leader in the field of Natural Killer ("NK") cell and IL-15 biology and their therapeutic potential.

"The expected filing of the IND for our first TriKE product candidate in mid-2018 is representative of the overall progress we are making as a company," said Shawn M. Cross, Chairman and Chief Executive Officer of GT Biopharma. "We look forward to updating our shareholders on our progress throughout 2018 as we continue to execute on our objectives."

The IND for OXS-3550 was filed in June 2017 by the University of Minnesota. Before the IND was transferred to the Company in October 2017, the FDA requested that additional preclinical toxicology be conducted prior to initiating clinical trials. The FDA also requested additional information and clarifications on the manufacturing (CMC) and clinical packages. The Company has reported that the requested additional information and clarifications have been completed and are being incorporated into the IND in eCTD format and that it expects to file the IND in mid-2018.

Genosco/Yuhan Announce Results from Phase 1/2 Study of YH25448(GNS-1480), a 3rd-Generation EGFR-TKI, in Advanced NSCLC to be Presented at ASCO 2018

On May 16, 2018 Genosco, a clinical-stage biotechnology company focused in immunology and oncology, reported that the abstract from a Phase 1/2 study evaluating YH25448 (GNS-1480) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) is now available on the website of the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. YH25448 (GNS-1480), Genosco’s 3rd-generation EGFR-TKI candidate partnered for clinical development and commercialization with Yuhan Corporation, is an oral, potent, irreversible EGFR-TKI that is highly selective for activating (EGFRm) and T790M resistance mutations.

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"We are encouraged by the safety and efficacy results shown in these data and look forward to the presentation of the full data set which will inform the future clinical trials," said Jong Sung (John) Koh, Ph.D., Genosco CEO.

Results from an open-label, multi-center Phase 1/2 study of YH25448 (GNS-1480) for patients with advanced NSCLC with or without CNS metastases will be presented in a poster session (Abstract 9033) by Byoung Chul Cho, M.D., Ph.D., Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea, at ASCO (Free ASCO Whitepaper) in Chicago. The poster (#356) is titled YH25448, a 3rd-generation EGFR-TKI, in patients with EGFR-TKI-resistant NSCLC: Phase I/II study results and will be presented in the Lung Cancer—Non-Small Cell Metastatic session on Sunday, June 3, 2018, 8:00 AM – 11:30 AM CT.

A total of 105 patients with EGFRm advanced NSCLC with acquired resistance to EGFR-TKIs with or without brain metastasis were enrolled in a Phase 1/2 study with dose-escalation and expansion cohorts.

Updated data will be presented at ASCO (Free ASCO Whitepaper).

About YH25448
YH25448 (GNS-1480) is an oral, potent, highly mutant-selective and irreversible, investigational 3rd-generation EGFR-TKI that penetrates the blood-brain barrier (BBB). It targets the activating EGFR mutations Del19 and L858R, as well as the T790M mutation, while sparing wild type. EGFR mutations are present in approximately 10-15% of NSCLCs. YH25448 (GNS-1480) is being evaluated in advanced NSCLC as both first- and second-line treatments.

Oncolytics Biotech® Announces Publication of REOLYSIN® Abstract
for the ASCO 2018 Annual Meeting

On May 16, 2018 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported publication of an abstract on pelareorep for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting (Press release, Oncolytics Biotech, MAY 16, 2018, View Source [SID1234527101]). The meeting will take place from June 1 – 5, 2018 at McCormick Place, Chicago, IL.

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The abstract, authored by Wilkinson et al., "Pelareorep to promote the expression of a IFN-gamma-related gene signature that predicts response to checkpoint blockade therapy", outlines results of a study assessing whether pelareorep promotes a predictive inflamed tumor phenotype that correlates with a response to immunotherapy in breast cancer (BC), colorectal cancer (CRC), hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC). The results suggest that all cell lines are susceptible to pelareorep’s induced cytopathic effect. In particular, BC and HCC cells lines had a significantly inflamed phenotype and also upregulated key chemokines known to promote response to immunotherapy.

"These results clearly demonstrate that viral priming in both BC and HCC tumors can activate interferon gamma-related gene expression which both upregulates checkpoint ligands on tumor cells and promotes activation and infiltration of lymphocytes into the tumor," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "They also support the hypothesis that the virus is engaging a dramatic immune response against the tumor in our recent mBC trial but also suggests that the virus may very well act as a backbone for checkpoint blockage by promoting an inflamed phenotype in the tumor microenvironment."

The complete Abstract can be found online at View Source Full details from the poster presentation will be announced when it is being presented on Monday, June 4 from 8:00 – 11:30 in Hall A, poster board #303.

About REOLYSIN/Pelareorep

REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

CytomX Therapeutics Announces Presentations at 2018 ASCO Annual Meeting

On May 16, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX) a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that preliminary clinical results from PROCLAIM-072, an ongoing Phase 1/2 trial evaluating CX-072, a Probody therapeutic targeting PD-L1, will be presented at the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, CytomX Therapeutics, MAY 16, 2018, View Source [SID1234527068]). The conference will take place from June 1-5 in Chicago, Illinois.

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Two posters will detail initial results from two ongoing dose escalation arms of the PROCLAIM-CX-072 trial as monotherapy and in combination with Yervoy (ipilimumab) in patients with advanced unresectable solid tumors.

"Our goal at CytomX is to reinvent therapeutic antibodies for the treatment of cancer and these first-in-human data represent a key milestone for the Probody platform," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "We look forward to expounding on our initial findings, published today in abstract form, at ASCO (Free ASCO Whitepaper). The preliminary data in these abstracts are encouraging as we are observing initial signs of antitumor activity for both CX-072 monotherapy and the ipilimumab combination, in this difficult-to-treat, late-stage patient population for whom approved PD-agents are not available. Furthermore, these data suggest that CX-072 is well tolerated and shows an encouraging, emerging safety profile as a monotherapy and in combination with ipilimumab. Taken together, our preliminary findings are consistent with the Probody hypothesis and align with our vision of transforming lives with safer, more effective therapies."

CytomX’s ASCO (Free ASCO Whitepaper) poster presentations will include longer follow-up periods in both the monotherapy and combination arms, as well as data from additional patients treated in combination with ipilimumab and will reflect a data cutoff approximately five months after the abstract data cutoff. Additional data from the PROCLAIM-072 trial is expected during the second half of 2018 and in 2019.

Abstract 3071/Poster #285 – Preliminary Results of the First-In-Human, Dose-Finding PROCLAIM-072 Trial of the PD-L1 Probody Therapeutic CX-072 as Monotherapy in Patients with Advanced Solid Tumors

Presenter: Karen A. Autio, M.D., MSc., Memorial Sloan Kettering Cancer Center
Session: Developmental Therapeutics—Immunotherapy
Date/Time: Monday, June 4, 8:00 – 11:30 a.m.
Location: Hall A

Abstract 3072/Poster #286 – Preliminary Interim Results of the First-In-Human, Dose-Finding PROCLAIM-072 Trial of the PD-L1 Probody Therapeutic CX-072 in Combination with Ipilimumab in Patients with Advanced Solid Tumors

Presenter: Rachel E. Sanborn, M.D., Earle A. Chiles Research Institute, Providence Cancer Center
Session: Developmental Therapeutics—Immunotherapy
Date/Time: Monday, June 4, 8:00 – 11:30 a.m.
Location: Hall A

Abstract Book – Preliminary Single-Dose Clinical Pharmacokinetics of an Anti–PD-L1 Probody Therapeutic (Pb-Tx) in Cancer Patients

Pharmacokinetic data published in the conference abstract book suggests that CX-072 is behaving as designed in circulation and that CX-072 circulates predominately in the intact, masked form with low or no binding to the target in the periphery.

CytomX’s posters will be available online under the Events and Presentations section of the CytomX website at the time of presentation at www.CytomX.com.

CytomX will be hosting a conference call and webcast on Monday, June 4, 2018 to discuss the ASCO (Free ASCO Whitepaper) poster presentations with specific event details to be announced closer to the start of the conference.

About PROCLAIM

PROCLAIM (Probody Clinical Assessment In Man) is an international umbrella program designed to evaluate CytomX Probody therapeutics. The first module is the PROCLAIM-072 clinical program, an open-label, dose-finding Phase 1/2 trial evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with metastatic or locally advanced unresectable solid tumors or lymphomas. CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Tolerability: Demonstrate that CX-072 is well tolerated in patients, and potentially improves safety, particularly in the combination setting.

Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.

Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical models.