On October 16, 2018 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:30 a.m. ET (1:30 p.m. BST) on Tuesday, Oct. 23, 2018, to discuss the company’s third quarter 2018 financial results (Press release, Alkermes, OCT 16, 2018, View Source;p=irol-newsArticle&ID=2371934 [SID1234529947]). Management will also provide an update on the company.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Tuesday, Oct. 23, 2018, through 5:00 p.m. ET (9:00 p.m. GMT) on Tuesday, Oct. 30, 2018, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.

On October 16, 2018 MabVax Therapeutics Holdings, Inc. (OTC: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the development of antibody-based products to address unmet medical needs, reported that the Company’s audited financial statements for 2017 and 2016 have been re-instated and brought current in quarterly filings with the Securities and Exchange Commission (the "SEC") (Press release, MabVax, OCT 16, 2018, View Source [SID1234530126]). The re-instatement of audited financial statements was made possible through the combined efforts of the Company working with its prior auditors to bring current their procedures through last Friday, a requirement necessary to reinstate the audited financial statements. What made the re-instatement possible is that the Court of Chancery of the State of Delaware (the "Court") on September 20, 2018, granted the Company’s Verified Petition for Relief Under 8 Del. C. § 205, captioned In re: MabVax Therapeutics Holdings, Inc., C.A. No. 2018-0549-TMR (the "Delaware Petition"), as submitted, and entered an order validating (i) conversions of the Company’s preferred stock into common stock that occurred between June 30, 2014 and February 12, 2018 and (ii) corporate acts that occurred during the same time period that we believed were approved by our stockholders but that, for reasons described in the Delaware Petition, may not have been approved by the requisite percentage of stockholder voting power during the same time period.

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MabVax Therapeutics Logo (PRNewsfoto/MabVax Therapeutics Holdings, I)

David Hansen, the Company’s President and CEO, commented, "The re-instatement of audited financial statements was an important step in enabling us to file our financial reports and becoming a current reporting company, which included our filing of both our annual report and our first and second quarter 10-Qs yesterday. Our next step will be to submit our application to the OTCQB market place. We remain focused on achieving our objectives, which are to continue overcoming recent challenges faced by the Company and to build shareholder value that will attract the interest of new potential partners."

On October16, 2018 Euronext Paris: FR0010331421 – IPH) reported that updated data from ongoing clinical trials evaluating lead asset, monalizumab, partnered with AstraZeneca/MedImmune, will be presented at the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich, Germany, October 19-23, 2018 (Press release, Innate Pharma, OCT 16, 2018, View Source [SID1234530304]). Eric Vivier, Chief Scientific Officer, is invited to the ESMO (Free ESMO Whitepaper) Congress as speaker in the Early detection of cancer using minimally invasive biomarkers Special Symposium.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A KOL call will be held Monday, October 22, at 4pm CEST (10 am EDT)

Dial in numbers:

France and International: +33 (0)1 72 72 74 03 US only: +1 646 722 4916

PIN code: 69616804#

The presentation will be made available on the Company’s website 30 minutes before the conference begins.

A replay will be available on Innate Pharma’s website after the conference call.

Posters and presentation details:

Results of a Phase II study evaluating monalizumab in combination with cetuximab in previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
Date and time: October 20, 2018, 15:00
Presentation number: 1049PD
Session: Poster Discussion session – Head and neck
Presenter: Jérôme Fayette, Medical Oncologist at the Centre Léon Bérard Lyon, France
Location: Hall B3 – Room 23, ICM München, Munich, Germany

Title: Translational endpoints in patients with metastatic microsatellite-stable colorectal cancer (MSS-CRC) treated with durvalumab plus monalizumab (anti-NKG2A)
Date & time: October 20, 2018, 12:30
Presentation number: 1194P
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC – early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Presenter: Jennifer R. Diamond, Associate Professor, Division of Medical Oncology at the Colorado University, Denver, US
Location: Hall A3, Poster Area Networking Hub, ICM München, Munich, Germany

Title: Changes in the innate immune system as early events in cancer
Date & time: October 22, 2018, 15:05 – 15:25
Session: Special Symposium
Session Name: Early detection of cancer using minimally invasive biomarkers
Presenter: Eric Vivier, Chief Scientific Officer of Innate Pharma, Marseille, France
Location: Hall A1 – Room 17, ICM München, Munich, Germany

On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer (Press release, US FDA, OCT 16, 2018, View Source,advanced%20or%20metastatic%20breast%20cancer [SID1234613394]). Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.

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Approval was based on EMBRACA (NCT01945775), an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.

The primary efficacy outcome was progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by blinded independent central review. Estimated median PFS was 8.6 and 5.6 months in the talazoparib and chemotherapy arms, respectively (HR 0.54; 95% CI: 0.41, 0.71; p<0.0001).

The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity. Most common (≥20%) adverse reactions of any grade were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite.

FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) to identify patients with breast cancer with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib. The effectiveness of the BRACAnalysis CDx test was based on the EMBRACA trial population for whom deleterious or suspected deleterious gBRCAm status was confirmed with either prospective or retrospective testing with BRACAnalysis CDx.

The recommended talazoparib dose is 1 mg taken as a single oral daily dose, with or without food.

View full prescribing information for TALZENNA.

FDA granted this application priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

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Check out recent approvals at the OCE’s podcast, Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.).

On October 16, 2018 BioInvent International AB (OMXS: BINV) reported its intention to initiate three new clinical programs in solid cancer (Press release, BioInvent, OCT 16, 2018, View Source [SID1234529930]). In addition to the previously disclosed programs (BI-1206 + rituximab – projected topline results H1 2020; and the Transgene and Pfizer collaborations), and subject to successful preclinical results and sufficient financial resources, BioInvent intends to advance the following programs in solid cancer: anti FcγRllB antibody/anti-PD1 antibody – projected start phase l/lla in H1 2019; BI-1607, an anti FcγRllB antibody/check point inhibitor – projected start phase l proof of concept trial in H2 2019; BI-1808 (anti-"EmergingTNFRS" antibody) +/- anti-PD1 antibody – projected start phase l in H1 2020.

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On December 10, BioInvent has the pleasure to invite investors, financial analysts and media to attend the Company’s Capital Markets Day at the IVA Conference Center, Grev Turegatan 16 in Stockholm between 2 pm and 4 pm. BioInvent has made a concerted effort over the past months to reframe its equity story to better bring out its value drivers – the strength of its discovery platform, the scientific and clinical rationale of targeting Fc gamma receptors in cancer immunotherapy and its leadership in that space, the substantial unmet medical need of the cancer indications it is pursuing, and the associated commercial opportunity.

Speakers at the Capital Markets Day include Martin Welschof, CEO, Björn Frendéus, Chief Scientific Officer and Andres McAllister, Chief Medical Officer. The presentations will give an overview of BioInvent’s current and planned cancer immunotherapy programs, and the company’s strategy to create shareholder value. The Company looks forward to engaging with all its stakeholders.

To attend the Capital Markets Day, please register by e-mail to [email protected] or by phone +46 46 286 85 54 no later than December 6. Following the event, a video recording will be published on BioInvent’s website.

During the months of October and November, BioInvent’s management will undertake an intensive program of investor meetings across the U.S., Europe, and Israel. As part of this program, BioInvent will host a Key Opinion Leader (KOL) event in New York on November 6. Details of this event, which will be webcast live and archived on BioInvent’s website, will be announced shortly. At the KOL event, BioInvent’s management and an invited scientific key opinion leader will engage with the U.S. investor community to present the Company’s scientific and clinical value drivers.