On April 30, 2019 ALENTIS Therapeutics ("ALENTIS"), a Swiss-French biotech company developing novel therapeutics in advanced liver disease and cancer, reported the completion of a Series A financing of CHF 12.5million (Euro 11.1m; USD 12.5m) (Press release, Alentis Therapeutics, APR 30, 2019, View Source [SID1234556137]). The Swiss venture capital firms BioMedPartners and BB Pureos Bioventures co-led the round and were joined by Bpifrance, Schroder Adveq and the German High-Tech Gründerfonds (HTGF).

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Markus L.E. Ewert, PhD, MBA has joined the company as Chief Executive Officer. Markus was previously CBO at Ablynx, contributing to both its US IPO and highly successful sale to Sanofi. Before, he led global corporate development at GE Healthcare, had leadership positions at Novartis, and has a track record of building businesses based on innovations.

ALENTIS’ lead program is a humanized monoclonal antibody against a target that plays a key role in the pathology of liver fibrosis and hepatocellular carcinoma (HCC). Advanced liver disease and cancer are major clinical challenges world-wide and characterized by a poor outcome and limited therapeutic options.

ALENTIS’ research is powered by its proprietary drug discovery platform, which is based on a prognostic liver disease signature holding promise for the discovery and development of further drug candidates to treat advanced liver diseases and cancer.

ALENTIS is founded on ground-breaking research of the laboratory of Prof. Thomas Baumert, MD at the University of Strasbourg, the Inserm Institute for Viral and Liver Disease, the Laboratory of Excellence HepSYS and the Institut Hospitalo-Universitaire Strasbourg as well as other collaborators, including Prof. Yujin Hoshida, MD at the University of Texas Southwestern in Dallas. SATT Conectus, the organization for accelerating technology transfer in the Alsace territory (France) has been essential in providing, building and securing the IP portfolio that has been licensed to ALENTIS. BaseLaunch, a healthcare accelerator operated by BaselArea.swiss, has been instrumental as an early stage financial and operational supporter in the formation of the company. As a result of this tri-national collaboration, ALENTIS’ headquarters have been incorporated in Basel (Switzerland) with a subsidiary in Strasbourg (France) and a branch in Germany.

Thomas F. Baumert, MD, principal founder of ALENTIS and Professor of Medicine, Head Inserm Research Institute for Viral and Liver Diseases, University of Strasbourg and Strasbourg University Hospitals said: "Together with my colleagues we are excited to be translating our novel approaches and therapeutic compounds with a unique mechanism of action into clinical drug candidates, with the aim of improving the very poor outcomes of patients with advanced liver disease."

Andreas Wallnöfer, former Head of Clinical Research & Exploratory Development at F. Hoffmann-La Roche Ltd and General Partner at BioMedPartners added: "The pre-clinical data set of the ALENTIS lead molecule are most comprehensive and convincing: they support the therapeutic potential in advanced liver disease of different origins. Prof. Baumert’s research is truly translational and links pre-clinic and clinic through a prognostic gene expression signature, which is most valuable to optimally characterize the lead project and fuel further programs."

ALENTIS’ Board of Directors will comprise Neil Goldsmith, a co-founder and Chairman; Andreas Wallnöfer, General Partner at BioMedPartners; Martin Münchbach, Managing Partner at BB Pureos Bioventures; Benoit Barteau, Senior Investment Manager at BPI France, and Prof. Thomas F. Baumert, the principal founder.

On April 30, 2019 Helix BioPharma Corp. (TSX: HBP), ("Helix" or the "Company"), an immunooncology company developing innovative drug candidates for the prevention and treatment of cancer, has reported that the Trial Steering Committee ("TSC") reviewed safety data from the first dosing cohort of the Company’s LDOS003 study. No serious adverse events or dose limiting toxicities were observed (Press release, Helix BioPharma, APR 30, 2019, View Source [SID1234536460]). TSC recommended that Helix begin enrollment of patients into the second dosing cohort.

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LDOS003 is a Phase II, open-label, randomized study of immunoconjugate L-DOS47 in combination with vinorelbine and cisplatin as compared to vinorelbine and cisplatin alone in patients with lung adenocarcinoma. The study is divided into two parts. In part I, the maximum tolerated dose of L-DOS47, when given in combination with vinorelbine/cisplatin, will be determined. Cohorts of 3 patients will be recruited into three dosing cohorts (6, 9 and 12 µg/kg). All patients at a given dose level must complete the first treatment cycle (3-week period) before escalation in subsequent patients can proceed. In part II, after the maximum tolerated dose of L-DOS47 in combination with vinorelbine/cisplatin has been determined, a further 118 patients will be randomized (1:1) to receive L-DOS47 in combination with vinorelbine/cisplatin, or vinorelbine/cisplatin alone.

"We are very encouraged that the first dosing cohort of this L-DOS47 phase II study in combination with chemotherapy has been completed" said Heman Chao, Helix’s Chief Executive Officer. "We look forward to receiving more data as we advance the L-DOS47 development program."

About L-DOS47 clinical development
L-DOS47 is currently being clinically evaluated in three clinical studies, in the United States, Poland and Ukraine as a treatment for certain patients with non-small cell lung cancer ("NSCLC").

LDOS001 is a Phase I, open-label, dose escalation study being conducted in the United States at the University Hospitals Case Medical Center. The primary objective of the study is to determine the safety and tolerability of L-DOS47 in combination treatment with pemetrexed/carboplatin. The study will also evaluate the potential clinical benefit of L-DOS47 with this combination. Patient enrollment is active for this study.

LDOS002 is an open-label Phase I/II clinical study being conducted in Poland to evaluate the safety, tolerability and preliminary efficacy of ascending doses of L-DOS47, initially as a monotherapy, in patients with inoperable, locally advanced, recurrent or metastatic, non-squamous, stage IIIb/IV NSCLC. Patient enrollment has completed for this study.

LDOS003 is a phase II, open-Label, randomized study of L-DOS47 in combination with vinorelbine/cisplatin as compared to vinorelbine/cisplatin alone in patients with Lung adenocarcinoma. The 2 primary objectives of the study include safety, tolerability and efficacy of L-DOS47 in this combination treatment. Patient enrollment is about to commence for this study.

On April 30, 2019 Vividion Therapeutics, a biotechnology company with a revolutionary platform to discover small molecule therapeutics against biologically compelling but previously intractable targets, reported the completion of an oversubscribed $82 Million Series B financing (Press release, Vividion Therapeutics, APR 30, 2019, View Source [SID1234535882]). The financing was led by Nextech Invest, an oncology-focused investment firm, and included participation from additional new investors BVF Partners, Casdin Capital, Mubadala Ventures, Trinitas Capital, Mirae Asset Capital, Altitude Life Science Ventures, and Alexandria Venture Investments. Existing investors ARCH Venture Partners, Versant Ventures, Cardinal Partners and Celgene Corporation also participated in the round.

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In connection with the financing, Jakob Loven, Ph.D., Partner at Nextech Invest, will join the Vividion Board of Directors.

"Vividion’s unique approach has allowed us to discover and advance exquisitely selective small molecules against high value targets that have been extremely challenging to drug historically," said Dr. Diego Miralles, Chief Executive Officer of Vividion Therapeutics. "With over $165 million in cash and a remarkable team, we are well positioned with substantial runway to maximize the multiple opportunities provided by our unique platform, bringing therapeutics to many patients in need."

Vividion Therapeutics has pioneered an approach, based on the work of Professor Benjamin Cravatt at The Scripps Research Institute, that enablesscreening of small molecules against every protein in native biological systems. This unique platform identifies highly selective binders to previously intractable targets, agnostic to protein class and function. These can be developed into drugs utilizing a range of approaches, including direct and allosteric modulation of protein function, and targeted protein degradation. The company’s immediate focus is in oncology and immunology.

"We are witnessing a renaissance in the field of synthetic and medicinal chemistry and the numerous possibilities small molecule drug discovery brings to previously challenging target classes," said Loven. He added: "Vividion has successfully pioneered its platform to reveal druggable opportunities at an unprecedented scale and resolution to open a large range of therapeutic possibilities. We look forward to working with Vividion’s highly experienced team as they continue to build the platform and pipeline toward first-in-class medicines for underserved patients."

On April 30, 2019 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205 – the "Company"), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenue for the first quarter of 2019 (Press release, Nanobiotix, APR 30, 2019, View Source [SID1234535677]).

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Activity and results during the first quarter 2019

Revenue for the first quarter of 2019 amounted to €5K, generated by the crossed-charged to our partners of shared external contract research organization costs pursuant to our license and collaboration agreement.

The Company’s cash availability as of March 31, 2019 amounted to €40.9M. Additionally, during April 2019 the Company has raised approximately €30.5 in a placement of new shares as well as through the exercise of founders’ warrants (Bon de souscription de parts de créateur d’entreprise or BSPCE) by Laurent Levy.

Regarding clinical development, Nanobiotix and The University of Texas MD Anderson Cancer Center announced, in January 2019, a large-scale comprehensive clinical collaboration for first-in-class radioenhancer NBTXR3. The collaboration will initially support nine new Phase I/II clinical trials using NBTXR3 in treating six cancer types and will involve around 340 patients. A majority of the trials are expected to launch in 2019.

At the end of March, Nanobiotix also announced its clinical registration plan in Head and Neck cancers for the United States following US Food and Drug Administration (FDA) feedback. The Company plans to design an Overall Survival (OS)-based, randomized, event-driven Phase II/III clinical trial. 50% of patients will receive standard of care radiotherapy combined with NBTXR3 while the other 50% will receive radiotherapy in combination with cetuximab. The Company plans to initiate its global clinical trial authorization process with the US FDA in 2H2019.

Nanobiotix also received €14M in March 2019 through the second tranche disbursement of loan financing from the European Investment Bank (EIB). Nanobiotix’s financing arrangement with the EIB will enable Nanobiotix to accelerate both the development of NBTXR3’s clinical trial in Head and Neck cancers and support its European go-tomarket strategy

On April 30, 2019 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, reported its operating and financial results for the first quarter ended March 31, 2019 (Press release, Genocea Biosciences, APR 30, 2019, View Source [SID1234535659]).

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"As we say at Genocea, "targets matter," and we are advancing two programs to demonstrate that target – or antigen – selection plays a large, and underappreciated, role in driving immunotherapy efficacy," said Chip Clark, Genocea president & CEO. "We expect to present the first immunogenicity data from our ongoing GEN-009 neoantigen vaccine clinical trial at this year’s ASCO (Free ASCO Whitepaper) meeting in early June, and, assuming positive results, plan to explore the safety and efficacy of GEN-009 in combination with checkpoint inhibitors in patients with a variety of solid tumor cancers. Meanwhile, we are rapidly advancing our GEN-011 neoantigen adoptive T cell therapy, for which we intend to file an Investigational New Drug Application in the first half of 2020."

Recent Operational Highlights

Announced a clinical milestone in early January, dosing the first patients and completing enrollment in Part A of the Phase 1/2a clinical trial for GEN-009. The first immunogenicity data from this study are expected to be presented at this year’s meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2019) in early June.

Completed a private placement financing in mid-February, the first closing of which resulted in gross proceeds of $15.0 million (before deal-related expenses).

Strengthened senior management team, appointing Diantha Duvall as Chief Financial Officer in early March.
Presented additional ATLAS data at the 2019 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2019) in early April. The poster highlighted the potential use of ATLAS as a tool to predict the advanced melanoma patients for whom checkpoint therapy might prove successful.

First-Quarter 2019 Financial Results

Cash position: As of March 31, 2019, cash and cash equivalents were $29.0 million versus $26.4 million as of December 31, 2018.

Research and Development (R&D) expenses: R&D expenses were $6.5 million for the quarter ended March 31, 2019, compared to $7.3 million for the same period in 2018.

General and Administrative (G&A) expenses: G&A expenses were $3.0 million for the quarter ended March 31, 2019, compared to $3.1 million for the same period in 2018.

Net loss: Net loss was $15.6 million for the quarter ended March 31, 2019, compared to a net loss of $15.9 million for the quarter ended March 31, 2018.

Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2020.

Conference Call
Genocea will host a conference call and webcast today at 9:00 am ET. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 4864999. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.