On March 23, 2018 Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of ABP 980, a biosimilar to Herceptin (trastuzumab) (Press release, Amgen, MAR 23, 2018, View Source;p=RssLanding&cat=news&id=2339486 [SID1234525391]). ABP 980 has been recommended for approval for the treatment of the same three types of cancer as Herceptin is approved for in the European Union (EU), including HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.

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"The positive opinion issued by the CHMP for ABP 980 marks an important step for our biosimilar portfolio, as it’s our second oncology biosimilar to reach this important milestone, and further underscores our commitment to providing the oncology community access to high-quality cancer therapies," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to continuing our work with Allergan and European regulatory authorities to bring additional options to patients with cancer."

The Marketing Authorization Application for ABP 980 was supported by analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase 3 comparative efficacy, safety and immunogenicity study was conducted in adult female patients with HER2-positive early breast cancer.

"We are committed to providing patients with important medicines to help them fight cancer," said David Nicholson, chief research and development officer at Allergan. "The CHMP’s positive opinion for the marketing authorization of ABP 980 reinforces its potential to increase physician choice and patient access to an important biologic."
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the EU. If approved, a centralized marketing authorization will be granted that will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the EC’s decision.

Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by the EC.
About ABP 980

ABP 980 is being developed as a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody approved in many regions for the treatment of HER2-overexpressing early breast cancer, adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer. The active ingredient of ABP 980 is a humanized monoclonal antibody that has the same amino acid sequence as trastuzumab. ABP 980 has the same pharmaceutical dosage form and same strength after reconstitution as trastuzumab. Amgen and Allergan also submitted a Biologics License Application to the U.S. Food and Drug Administration (FDA) for ABP 980 in 2017.

On March 23, 2018 Euronext Paris: FR0010331421 – IPH) reported that its partner MedImmune, AstraZeneca’s global biologics research and development arm, has amended the clinical trial protocol of the ongoing Phase I trial investigating the safety and efficacy of monalizumab, Innate’s investigational first-in-class anti-NKG2A monoclonal antibody, in combination with AstraZeneca’s approved anti-PD-L1 immune checkpoint inhibitor, durvalumab, in patients with advanced solid tumors (Press release, Innate Pharma, MAR 23, 2018, http://www.innate-pharma.com/en/news-events/press-releases/partner-medimmune-expands-colorectal-cancer-patient-cohort-ongoing-phase-i-trial-evaluating-monalizumab-combination-imfinzir-durvalumab [SID1234525390]). The trial protocol has been expanded to add new expansion cohorts aiming at testing monalizumab in combination with durvalumab and standard of care in patients with 1st- and 2nd-line, metastatic colorectal cancer (CRC).

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The dose-escalating part of the study has been completed, while the expansion cohorts in selected advanced solid tumors are ongoing.
The primary objective of the new study arms will be safety, with Overall Response Rate (ORR) and Duration of Response (DOR), amongst others, as secondary outcome measures.
Pierre Dodion, Chief Medical Officer of Innate Pharma, commented: "We are delighted that our partner MedImmune has decided to further expand the colorectal patient population to evaluate the safety and efficacy of monalizumab in combination with durvalumab and the current standard of care in 1st- and 2nd-line therapy. In addition, we look forward to the first clinical data read-outs from the Phase I study and initial expansion cohort program during 2018."
An update to study D419NC00001 including the new additional study arms has been published on clinicaltrials.gov.

On March 23, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), or the "Company", reported its financial results (according to IFRS) for the year ended December 31, 2017 (Press release, Epigenomics, MAR 23, 2018, View Source [SID1234525127]).

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KEY HIGHLIGHTS

Financial

Total revenue of EUR 1.9 million
EBITDA (before share-based payment expenses) loss of EUR 9.4 million
Liquidity of EUR 13.7 million (incl. marketable securities) at year-end following successful capital raises in 2017
Corporate

Voluntary takeover offer by Summit Hero Holding GmbH in 2017 highlighted inherent value of the Company’s products and technologies
Epigenomics AG gets CE-IVD mark for lung cancer test Epi proLung
First quarter 2018

U.S. Senators Capito and Heinrich introduce Bi-Partisan Colorectal Cancer Detection Bill aiming to provide coverage under the Medicare program for FDA-approved qualifying blood-based colorectal cancer screening tests
Greg Hamilton, Chief Executive Officer of Epigenomics, commented: "In 2017, we remained focused on our key priorities medical guideline inclusion and initial payor coverage for our innovative blood-based colon cancer test, Epi proColon, while maintaining high cost discipline in all company areas. In 2018, we expect to reach significant milestones with regard to Medicare payment and coverage for Epi proColon. The recent bipartisan legislative initiative by U.S. Senators Capito and Heinrich addresses payment as the last remaining barrier for Medicare patients associated with colon cancer screening. The passing of this bill provides to millions of underscreened rural Americans access to colon cancer screening and has the potential to ultimately save thousands of lives."

Financial results

In 2017, Epigenomics’ total revenue decreased to EUR 1.9 million (2016: EUR 4.2 million). In the previous year, our U.S. commercialization partner had initially stocked up on inventories of Epi proColon following the product’s FDA approval. Revenue of about EUR 1.3 million was generated through licensing income, product sales were at EUR 0.5 million.
Total operating costs decreased to EUR 13.2 million (2016: EUR 17.3 million). Research and development costs decreased to EUR 4.3 million (2016: EUR 5.1 million). Selling, general and administrative costs decreased to EUR 8.0 million (2016: EUR 10.2 million).
Operating loss (EBIT) in 2017 decreased to EUR -10.3 million (2016: EUR -12.3 million). Net loss for the year decreased to EUR 10.2 million (2016: EUR 11.2 million) and loss per share decreased to EUR 0.44 (2016: EUR 0.55).
Cash consumption in 2017 decreased to EUR 10.1 million (2016: EUR 13.7 million). Net cash inflows from financing activities reached EUR 11.5 million in 2017 (2016: EUR 17.4 million), net cash flow was at EUR 1.4 million (2016: EUR 3.8 million).
The Company’s liquidity (incl. marketable securities) at year-end 2017 was EUR 13.7 million (Dec 31, 2016: EUR 12.3 million).
Outlook 2018

Revenue

Our business projections for 2018 are based mainly on the commercialization of Epi proColon in the U.S.A. The commercialization of this product depends primarily on securing reimbursement from public and private health insurers. Prior to the entry into force of a reimbursement decision we expect only a slight increase in product revenue in 2018.
Overall, we expect that revenue will increase but will remain on low levels, ranging between EUR 2.0 million and EUR 4.0 million.
EBITDA

We anticipate that EBITDA before share-based payment expenses will be in a range EUR -11.5 million and EUR -14.0 million in 2018.
Cash consumption

Based on our business plans for 2018, we expect cash consumption in line with our EBITDA before share-based payment expenses guidance.
We ended the 2017 fiscal year with EUR 13.7 million in cash and marketable securities. While current financial resources are sufficient at our projected cash consumption to support the Company’s operations beyond 2018, we will raise additional capital if necessary in 2018.
The forecast cash consumption is based on our assumption that the convertible notes maturing as of December 31, 2018 will be converted with no adverse effect on liquidity, or will be extended.
Further Information

The annual report 2017 can be downloaded from Epigenomics’ website at:
View Source

Conference call for analysts and investors

The Company will host a conference call and webcast at 2.30 pm CET / 9.30 am EDT, today. The webcast can be accessed on the Company’s website: View Source

The dial-in numbers for the conference call are:

Dial-in number within Germany: +49 30 233225798

Dial-in number within the UK: +44 20 3872 0880

Dial-in number within the U.S.A.: +1 516-269-8974

Participants are kindly requested to dial in 10 minutes prior to the start of the call.

An audio replay of the conference call will be provided on Epigenomics’ website subsequently.

On March 23, 2018 -Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported that it has completed enrollment of the interim analysis cohort of 20 patients in its Phase 2 clinical trial of AG013 for the treatment of oral mucositis (OM) (Press release, , 23 23, 2018, View Source [SID1234524965]).

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"We are very excited to complete this enrollment milestone for our Phase 2 trial of AG013 for oral mucositis, one of the most common and debilitating complications of chemo-radiation therapies. With no approved convenient preventative treatment, oral mucositis represents a serious unmet need for cancer patients receiving treatment on an outpatient basis," said Alan Joslyn, Oragenics’ President and Chief Executive Officer. "After we complete this treatment phase and evaluate the safety of the initial 20 patients enrolled in the trial, we intend on expanding the trial in the United States and Europe to complete study enrollment. We expect to report preliminary data on the initial 20 enrolled patients during the second quarter of 2018 with top-line results of the trial expected in 2019."

The purpose of the Phase II study (NCT03234465) is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time to development, and overall incidence of OM (WHO scale used) during the active treatment phase, beginning from the start of chemoradiation therapy (CRT) until 2 weeks following its completion.

The Phase II trial is a double-blind, placebo-controlled, 2-arm, multi-center trial in which subjects will be randomized in a 1:1 ratio to receive either placebo or AG013. AG013 is a mouth rinse formulation of Lactococcus lactis strain sAGX0085, deficient in the gene coding for thymidylate synthase and producing human TFF1 (Trefoil Factor 1). Approximately 200 subjects will be enrolled in the study. An initial cohort of 10 patients that received AG013 is included in the 20 patients enrolled to date.

Safety will be evaluated on the basis of treatment-emergent AEs (TEAEs), vital signs, weight, physical examinations, clinical laboratory assessments and the presence of AG013-sAGX0085 in whole blood. Tolerability (taste, consistency and smell) will be collected from the patient diary.

In a Phase 1B study the efficacy analysis suggested a 35% reduction in percentage of days with UOM in AG013-subjects versus placebo. All placebo subjects experienced 2 days of UOM, whereas 29% of AG013 subjects had UOM for 0 or 1 day. AG013 use resulted in fewer unscheduled office and emergency room visits. No differences were noted in mouth and throat soreness, opioid use, or gastrostomy tube placement.

In terms of safety and dosing, Oral live AG013 bacterial and hTFF1 levels in saliva and oral mucosa were equivalent among treatment groups. The most frequently occurring adverse events were nausea, oral pain, fatigue, diarrhea, and mucosal inflammation. Only 12% (3 of 25 adverse events), mainly nausea, were attributed to the investigational medicinal product: AG013 or placebo. Importantly, AG013 bacteria were not detected in blood.

AG013 is an ActoBiotics therapeutic candidate formulated as a convenient oral rinsing solution and designed by our strategic collaboration partner ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation (NYSE: XON) to deliver the therapeutic molecule Trefoil Factor 1 to the mucosal tissues in the oral cavity. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in subsequent repair. AG013 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in November 2016.

Under an Exclusive Channel Collaboration Agreement with ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation , Oragenics has an exclusive worldwide license to develop and commercialize AG013 to treat OM in cancer patients.

On March 23, 2018 IntelGenx Technologies Corp. (TSX VENTURE:IGX) (OTCQX:IGXT) reported that it will release its fourth quarter and full year 2017 financial results after market close on March 29, 2018 (Press release, IntelGenx, MAR 23, 2018, View Source;Conference-Call-to-Follow/default.aspx [SID1234524964]).

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An accompanying conference call will be hosted by Dr. Horst G. Zerbe, President and Chief Executive Officer, and Mr. Andre Godin, Executive Vice-President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Date: Thursday, March 29, 2018

Time: 4:30 p.m. EDT

Conference dial-in: (833) 211-3233

International dial-in: (647) 689-3955

Conference ID: 6786519

Webcast Registration: Click here

Following the live call, a replay will be available on the Company’s website, www.intelgenx.com, under "Investor Relations."