On October 19, 2017 Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported that it plans to release its third quarter 2017 financial results on Thursday, October 26, 2017 after the U.S. stock markets close (Press release, Apollo Endosurgery, OCT 19, 2017, View Source [SID1234521164]).

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Apollo will hold a conference call on Thursday, October 26, 2017 at 4:00 p.m. CT / 5:00 p.m. ET to discuss the results. The dial-in numbers are (888) 576-4387 for domestic callers and (719) 457-6931 for international callers. The conference ID number is 3769341. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at apolloendo.com.

A replay of the webcast will remain available on Apollo’s website, apolloendo.com, until Apollo releases its fourth quarter 2017 financial results. In addition, a telephonic replay of the call will be available until November 2, 2017. The replay dial-in numbers are (844) 512-2921 for domestic callers and (412) 317-6671 for international callers. Please use the replay conference ID number 3769341.

About Apollo Endosurgery, Inc.

On October 19, 2017 Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported that it plans to release its third quarter 2017 financial results on Thursday, October 26, 2017 after the U.S. stock markets close.

Apollo will hold a conference call on Thursday, October 26, 2017 at 4:00 p.m. CT / 5:00 p.m. ET to discuss the results. The dial-in numbers are (888) 576-4387 for domestic callers and (719) 457-6931 for international callers. The conference ID number is 3769341. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at apolloendo.com.

A replay of the webcast will remain available on Apollo’s website, apolloendo.com, until Apollo releases its fourth quarter 2017 financial results. In addition, a telephonic replay of the call will be available until November 2, 2017. The replay dial-in numbers are (844) 512-2921 for domestic callers and (412) 317-6671 for international callers. Please use the replay conference ID number 3769341.

About Apollo Endosurgery, Inc.

On October 19, 2017 Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops viral-based immunotherapies, reported its business update for the quarter ending September 30, 2017 (Press release, Transgene, OCT 19, 2017, View Source [SID1234521053]).

During the quarter, Transgene continued implementing its development plan. Two clinical trials have started, combining Pexa-Vec with nivolumab (liver cancer), and combining TG4001 with avelumab (HPV-positive head and neck cancers). In the United States, the Food and Drug Administration has granted the clearance to launching the trial evaluating TG4010 in lung cancer. To date, seven clinical trials evaluating Transgene immunotherapies are underway. They will enable our 5 products to deliver clinical results by 2018.

In parallel, Transgene has published scientific results in peer-reviewed journals that consolidate the mechanism of action of TG4010.

Finally, with Invir.IOTM, Transgene confirmed its ambition and its pioneering vision in the field of oncolytic viruses. This platform will enable the Company to design a new generation of multifunctional oncolytic viruses. A first research agreement was signed with Randox.

“We are delighted with the progress made in clinical development and research since early 2017. We are in line with the objectives announced at the beginning of the year and we will continue to deliver a very dense news flow over the coming months. Our cash position allows us to confirm our financial visibility until the end of 2018,” said Philippe Archinard, Chairman and Chief Executive Officer of Transgene.

Operating revenue:

The following table summarizes the third quarter operating revenue for 2017 compared to the same period in 2016:

Q3
First Nine
Months
In millions of euros 2017 2016 2017 2016

Revenue from collaborative and licensing agreements 0.3 0.1 0.7 2.0
Government financing for research expenditures 1.1 1.4 4.2 4.4

Operating revenue 1.4 1.5 4.9 6.4

During the third quarter of 2017, revenue from collaborative and licensing agreements was mainly composed of research services, including the collaboration service agreement with Servier started in June 2017, and royalties.

As of September 30, 2017, government financing for research expenditures mainly consisted in the research tax credit, and amounted to 75% of amount expected for 2017. During the third quarter of 2017, this research tax credit amounted to €4.2 million versus €4.4 million over the same period in 2016).

Cash, cash equivalents, available-for-sale financial assets and other financial assets:

Cash, cash equivalents, available-for-sale financial assets and other financial assets stood at €40.0 million as of September 30, 2017, compared to €56.2 million as of December 31, 2016.

In the first nine months of 2017, Transgene’s cash burn was €16.2 million, compared to €16.3 million for the same period in 2016 (excluding EIB loan and rights issue).

Cash burn was €3.9 million in the third quarter of 2017. During this period, the Company notably received €2.5 million of grants and conditional advances from bpifrance as final balance of the ADNA program. As a reminder, cash burn was €12.3 million in the first half of 2017, including a milestone payment of $4 million to SillaJen, Inc. and a revenue of €5.4 million of research tax credit.

Outlook:

Transgene confirms that it expects 2017 cash burn to be around €30 million based on the current development plan.

Key achievements of the period:

TG4010:
FDA approval to begin the clinical trial with TG4010 + nivolumab + chemotherapy in the first-line treatment of lung cancer (NSCLC), in collaboration with Bristol-Myers Squibb (press release distributed on September 11, 2017);
Publication of two peer-reviewed scientific articles supporting the efficacy and mechanism of action of TG4010 and the synergistic effects in combination with ICIs (press release distributed on October 12, 2017).
Pexa-Vec:
First patient treated in the Phase 1/2 trial evaluating the combination of Pexa-Vec and nivolumab (ICI) for the first-line treatment of advanced liver cancer (press release distributed on July 31, 2017);
Poster presentation at the ESMO (Free ESMO Whitepaper) 2017 congress on the results of the Phase 1 part of METROmaJX trial (Pexa-Vec + metronomic cyclophosphamide) (press release distributed on September 7, 2017).
TG4001:
First patient treated in the Phase 1b/2 trial combining TG4001 and avelumab (ICI) in HPV-positive head and neck cancers, in collaboration with the alliance Merck KGaA and Pfizer (press release distributed on September 19, 2017).
TG1050:
Poster presentation at the AASLD Liver meeting 2017 on first data of TG1050 indicating the induction of a robust and specific immune response in patients with chronic hepatitis B (press release distributed on October 17, 2017).
New oncolytic viruses – Invir.IOTM Platform:
New data published in Cancer Research, confirming the potential of Transgene’s next generation armed oncolytic virus (press release distributed on July 24, 2017);
Launch of Invir.IOTM, an integrated platform dedicated to the next generation of multifunctional oncolytic viruses (press release distributed on September 21, 2017);
Signing of a collaboration agreement with Randox to develop next generation of oncolytic virus expressing Randox’ Single-domain Antibodies (SdAb), based on the Invir.IOTM Platform (press release distributed on October 2, 2017).

On October 19, 2017 Propanc Biopharma Inc. (OTCQB: PPCB) (“Propanc Biopharma” or “the Company”), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that key scientific data has been published in a peer reviewed journal, Scientific Reports, demonstrating a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen provide potent anti-tumor efficacy in pancreatic and ovarian cancers (Press release, Propanc, OCT 19, 2017, View Source [SID1234521051]). From the publishers of Nature, it is an online, open access journal, which publishes primary research from all areas of the natural and clinical sciences.

Published data from the Company’s R&D program were conducted with Universities of Jaén and Granada and University Hospital, Spain, vivoPharm Pty Ltd, Australia, and the Dove Clinic for Integrated Medicine, UK. Highlights include the anti-angiogenic effect of PRP by using fibrous capsule formation assays, as well as cell invasion and wound healing assays, along with the analysis of epithelial to mesenchymal transition (EMT) markers performed on human cancer cells treated with PRP.

Of particular note in the publication is the evaluation of clinical efficacy of a suppository formulation of pancreatic proenzymes in the context of a UK Pharmaceutical Specials Scheme, led by Dr Kenyon, where 19 from 46 patients (41.3%) with late stage cancers, most suffering from metastases, had a survival time significantly longer than the expected life span. For the whole set of cancer types, a mean survival of 9.0 months was significantly higher than their mean life expectancy, 5.6 months, in a one way ANOVA test (alpha = 0.05, P less than 0.05).

“We are delighted that our latest scientific paper shows the synergistic effects of our PRP formulation, which is proven to inhibit in vitro angiogenesis, tumour growth, cancer cell migration and invasiveness, and to be an effective and well tolerated in vivo anti-tumor treatment,” said Dr Julian Kenyon, Propanc Biopharma’s Chief Executive Officer. “Furthermore, the clinical efficacy of a suppository formulation containing both pancreatic proenzymes administered to late stage cancer patients during a compassionate use program in the UK and Australia confirms a mean survival significantly higher than mean life expectancy. Therefore, I believe PRP could have relevant oncological applications for the treatment of advanced or metastatic pancreatic cancer and advanced epithelial ovarian cancer, which are our initial target patient populations in our planned clinical development program.”

PRP is a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 Billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing a combined market segment of $14 Billion predicted in 2020, by GBI Research.

To view Propanc Biopharma’s “Mechanism of Action” video on anti-cancer product candidate, PRP, please click on the following link: View Source

To be added to Propanc Biopharma’s email distribution list, please click on the following link: View Source and submit the online request form.

On October 19, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported that the European Medicines Agency (EMA) has granted Orphan Drug Designation for G100, Immune Design’s investigational intratumoral therapy, for the treatment of follicular non-Hodgkin’s lymphoma (Press release, Immune Design, OCT 19, 2017, View Source [SID1234521040]).

The EMA orphan drug designation is assigned to products targeting the treatment of rare diseases, which are defined as having a prevalence of not more than 5 in 10,000 people in the European Union (EU). This designation provides the sponsor with certain benefits, including protocol assistance, reduced fees for regulatory activities and up to 10 years of market exclusivity in the EU upon marketing approval for the designated indication.

G100 has also been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of follicular non-Hodgkin’s lymphoma.

G100 is a product candidate from Immune Design’s GLAAS discovery platform. It contains a potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist, Glucopyranosyl Lipid A (GLA), and is the lead product candidate in Immune Design’s Antigen Agnostic approach. G100 activates innate and adaptive immunity in the tumor microenvironment to generate an immune response against the tumor’s preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate tumor-infiltrating lymphocytes, macrophages and dendritic cells, and promote antigen-presentation and the recruitment of T cells to the tumor. The induction of local and systemic immune responses has been shown in preclinical studies to result in local and abscopal (shrinking of tumors outside the scope of the localized treatment) tumor control. Currently, G100 is being evaluated as both a monotherapy (with local radiation) and in combination with Merck’s anti-PD-1 agent, pembrolizumab, pursuant to a clinical collaboration with Merck, in a randomized Phase 1/2 clinical trial in patients with follicular non-Hodgkin’s lymphoma.