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Immutep Completes Patient Enrolment of the AIPAC Phase IIb Clinical Trial in Metastatic Breast Cancer

On June 25, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that it has completed patient enrolment of the Phase IIb Active Immunotherapy PAClitaxel (AIPAC) clinical trial in HER2-negative/ Hormone Receptor positive (HR+) metastatic breast cancer (MBC) (Press release, Immutep, JUN 25, 2019, View Source [SID1234537271]).

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The AIPAC study has enrolled 226 patients at more than 30 clinical trial sites across Germany, the UK, France, Hungary, Belgium, Poland and the Netherlands. The trial is evaluating Immutep’s lead product candidate, eftilagimod alpha (efti or IMP321), in combination with paclitaxel, a standard of care chemotherapy, as a chemo-immunotherapy combination in patients with HR+ MBC not eligible for human epidermal receptor 2 (HER2) therapies. This combination is designed to boost the immune response against tumour cells compared to chemotherapy plus placebo. Apoptotic tumour cells induced by chemotherapy release antigenic tumour debris which are then captured by APCs. Boosting the APC network with efti increases cytotoxic T-cell responses which complements the direct cytotoxic effect of the chemotherapy.

The primary endpoint of the AIPAC study is PFS according to RECIST as evaluated by blinded independent central readers. Additional efficacy endpoints include PFS by local read, overall response rate (ORR) and overall survival (OS). The Company expects to report PFS data, together with ORR data, in Q1 of calendar year 2020.

AIPAC is a potentially pivotal clinical trial, meaning it could serve as a basis to pursue appropriate regulatory approval pathways for efti with, for example, the European Medicines Agency (EMA) or the U.S. Food and Drug Agency (FDA), subject to sufficient and clinically meaningful data from the trial and regulatory interactions. Before AIPAC started, the Company received scientific advice from the EMA and is currently exploring ways to bridge its research efforts in HR+ MBC to the United States.

Metastatic breast cancer, also called stage IV breast cancer, is the most advanced stage of breast cancer where it has spread beyond the breast to other organs in the body, most often the bones, lungs, liver or brain. It is estimated that each year there are over 800,000 new cases worldwide of MBC that are HER2 negative and HR positive1. Paclitaxel is a taxane-based standard of care chemotherapy that is widely used for patients in the EU and United States with this cancer.

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GlobalData PharmaPoint: HER2-Negative/HR+ and Triple Negative Breast Cancer – Global Drug Forecast and Market Analysis to 2025, December 2016

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Immutep CEO Marc Voigt commented: "The completion of recruitment for our Phase IIb AIPAC study is an important milestone for Immutep as this is our largest and most advanced clinical trial. As the first PFS data read-out is event-driven, the timeline for reporting remains on track for early in 2020. We sincerely thank our principal investigators, the patients and their families for being part of this study.

MBC is a serious medical condition where patients have a median life expectancy of approximately two years from the start of first line chemotherapy. This means there is a clear high unmet medical need for new therapies that may deliver improved outcomes compared to current standard of care therapies."

AIPAC Principal Investigator Dr Hans Wildiers added: "By combining efti with chemotherapy, we hope to boost the body’s immune response against tumour cells and improve treatment outcomes compared to giving chemotherapy alone. Most studies in metastatic breast cancer, including immune therapy, are focusing on blocking the PD-1/PD-L1 checkpoint pathway, but results have been disappointing in this type of hormone sensitive metastatic breast cancer. With efti, we hope to activate the immune system more efficiently in hormone sensitive metastatic breast cancer, the most frequent breast cancer subtype. Through the AIPAC study, we are leading the search for effective immune therapy in this subtype."

Immutep CSO and CMO, Dr Frederic Triebel said: "APC activators are a new class of drug products that could nicely complement the action of standard of care, either chemotherapy or immune checkpoint inhibitors. Despite recent positive announcements including preliminary anti-CD40 agonist mAb data in a difficult-to-treat "cold tumor" indication such as advanced pancreatic carcinoma, this new class of IO drug products has not yet been validated in a pivotal trial in terms of efficacy. We hope that the results of the AIPAC trial will unequivocally demonstrate the value of APC activators in combined advanced cancer therapies."

About AIPAC

Active Immunotherapy PAClitaxel (AIPAC) is a Phase IIb clinical trial in HER2-negative/ HR positive metastatic breast cancer. Based on Immutep’s LAG-3 technology, the study evaluates the combination of the Company’s lead product candidate, eftilagimod alpha (efti, LAG-3Ig or IMP321), and a taxane-based chemotherapy, called paclitaxel, as an immunotherapy. This combination is aimed at boosting the immune response against tumour cells compared to chemotherapy alone. In AIPAC, 226 hormone receptor positive metastatic breast cancer patients are randomised 1:1 to treatment A (paclitaxel chemotherapy plus placebo) or treatment B (paclitaxel chemotherapy plus eftilagimod alpha) for six months. Thereafter, patients will pass over to the maintenance phase with efti alone.

The primary endpoint of the study is progression-free survival (PFS). The Company expects to report first PFS data in Q1 of calendar year 2020.

For more information regarding the AIPAC trial, visit clinicaltrials.gov (identifier NCT02614833) and View Source).

LabCorp to Announce Second Quarter Financial Results on July 25, 2019

On June 25, 2019 LabCorp (NYSE: LH) reported that it will release its second quarter of 2019 financial results before the market opens on Thursday, July 25, 2019, followed by a conference call and webcast beginning at 9:00 a.m. EDT to discuss the results (Press release, LabCorp, JUN 25, 2019, View Source;p=RssLanding&cat=news&id=2402266 [SID1234537268]). Interested parties can access the conference call by dialing 844-634-1444 within the U.S. and Canada, or 1-615-247-0253 internationally, using the passcode 9679477.

An audio replay of the conference call will be available from 1:00 p.m. EDT on July 25, 2019, until 11:30 a.m. EDT on August 8, 2019, by dialing 855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the passcode 9679477.

The earnings release, accompanying financial information, and a real-time webcast of the conference call will be available on the LabCorp Investor Relations website. The webcast will be archived and accessible through July 24, 2020.

Intensity Therapeutics Announces Clinical Collaboration with Merck

On June 25, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based approach to treat solid tumor cancers through direct injection of its proprietary therapeutic agents, reported that it has entered into an agreement with Merck (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of Intensity’s lead product candidate INT230-6 and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced solid malignancies including pancreatic, bile duct, squamous cell and non-MSI high colon cancers (Press release, Intensity Therapeutics, JUN 25, 2019, View Source [SID1234537266]).
"Our research suggests our product, INT230-6, which enables improved recognition of cancer by the immune system, may exhibit additional effect when combined with anti-PD-1 antibodies," said Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "We are excited to be working with Merck, one of the world’s leading cancer immuno-oncology companies, on our current Phase 1/2 clinical trial to explore the combination of INT230-6 and KEYTRUDA in cancers with high unmet medical need. We are looking forward to initiating the combination portion of our program in the second half of this year."

Ian. B. Walters, M.D., Intensity’s Chief Medical Officer, added, "We will be able to test the combination in a variety of difficult to treat tumors that historically have been non-responsive to checkpoint inhibitors. INT230-6 has demonstrated monotherapy activity, as well as a favorable safety profile, in patients with advanced cancers."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.

Medtronic Announces the Upsizing of its Maximum Tender Offer to up to $4.35 billion for Certain Outstanding Debt Securities Issued by Medtronic, Inc., Medtronic Global Holdings S.C.A. and Covidien International Finance S.A.

On June 25, 2019 Medtronic plc (the "Company") (NYSE:MDT) reported the upsizing of the previously announced cash tender offer (the "Maximum Tender Offer") by its wholly-owned indirect subsidiaries, Medtronic, Inc., Medtronic Global Holdings S.C.A. ("MGH") and Covidien International Finance S.A. ("CIFSA" and, together with Medtronic, Inc. and MGH, the "Offerors") for up to $3.0 billion combined aggregate purchase price (excluding accrued and unpaid interest to, but not including, the applicable settlement date and excluding fees and expenses related to the tender offers) of certain series of outstanding senior notes that are subject to the Maximum Tender Offer (collectively, the "Maximum Tender Offer Notes") as set forth in the Offer to Purchase, dated June 24, 2019 (the "Offer to Purchase") (Press release, Medtronic, JUN 25, 2019, View Source;p=RssLanding&cat=news&id=2402330 [SID1234537265]). The Offerors are increasing the aggregate maximum purchase price from $3.0 billion to $4.35 billion (the "Aggregate Maximum Purchase Price"). The other terms of the tender offers (the "Any and All Tender Offer" and, together with the Maximum Tender Offer, the "Tender Offers") for any and all of the approximately $1.175 billion in aggregate principal amount of the other two series of notes of the Offerors described in the Offer to Purchase (the "Any and All Notes" and, collectively with the Maximum Tender Offer Notes, the "Notes") remain unchanged. The Offerors reserve the right, subject to applicable law, to further increase or waive the Aggregate Maximum Purchase Price or the Series Tender Caps.

The Offerors’ acceptance of the Notes is subject to a financing condition that the Offerors shall have closed one or more debt financings resulting in net proceeds to the Offerors in an amount not less than the amount required, upon the terms and subject to the conditions of the applicable Tender Offer, to purchase all the Notes validly tendered and accepted for purchase in the Tender Offers and to pay accrued interest thereon and fees and expenses associated therewith. The Company separately announced today that it had priced a registered public offering of €5.0 billion of senior notes, which is expected to close, subject to customary closing conditions, on July 2, 2019, the proceeds of which would be used to purchase Notes in the Tender Offers.

Information Relating to the Tender Offers

Barclays Capital Inc., BofA Merrill Lynch and Goldman Sachs & Co. LLC are acting as the dealer managers (the "Dealer Managers") for the Tender Offers. The information agent and tender agent is Global Bondholder Services Corporation ("Global Bondholder"). Copies of the Offer to Purchase and related offering materials are available by contacting Global Bondholder at +1-866-470-4200 (U.S. toll-free) or +1-212-430-3774 (banks and brokers). Questions regarding the Tender Offers should be directed to Barclays Capital Inc., Liability Management Group at +1-212-528-7581 (collect) or +1-800-438-3242 (toll free), BofA Merrill Lynch, Liability Management Group, at +1-980-387-3907 (collect) or +1-888-292-0070 (toll-free) or Goldman Sachs & Co. LLC at +1-212-357-0215 or +1-800-828-3182 (toll free).

None of the Offerors, the Company or their affiliates, their respective boards of directors or managing members, the Dealer Managers, Global Bondholder or the trustee with respect to any series of Notes is making any recommendation as to whether holders of Notes should tender any Notes in response to any of the Tender Offers, and neither the Offerors nor any such other person has authorized any person to make any such recommendation. Holders of Notes must make their own decision as to whether to tender any of their Notes, and, if so, the principal amount of Notes to tender.

This press release shall not constitute an offer to sell, a solicitation to buy or an offer to purchase or sell any securities. The Tender Offers are being made only pursuant to the Offer to Purchase and only in such jurisdictions as is permitted under applicable law.

The full details of the Tender Offers, including complete instruction on how to tender Notes, are included in the Offer to Purchase. The Offer to Purchase contains important information that should be read by holders of Notes before making a decision to tender any Notes. The Offer to Purchase may be downloaded from Global Bondholder’s website at View Source or obtained from Global Bondholder, free of charge, by calling toll-free at +1-866-470-4200 (bankers and brokers can call collect at +1-212-430-3774).

Medtronic Announces Pricing of €5 Billion of Senior Notes

On June 25, 2019 Medtronic plc (NYSE:MDT) reported that its wholly-owned subsidiary, Medtronic Global Holdings S.C.A. ("Medtronic Luxco"), has priced an offering (the "Offering") of €250,000,000 principal amount of floating rate senior notes due 2021, €750,000,000 principal amount of 0.00% senior notes due 2022, €1,000,000,000 principal amount of 0.25% senior notes due 2025, €1,000,000,000 principal amount of 1.00% senior notes due 2031, €1,000,000,000 principal amount of 1.50% senior notes due 2039, and €1,000,000,000 principal amount of 1.75% senior notes due 2049(collectively, the "Notes") (Press release, Medtronic, JUN 25, 2019, View Source;p=RssLanding&cat=news&id=2402331 [SID1234537264]).The floating rate senior notes due 2021 are further issuances of, fully fungible with, rank equally in right of payment with and form a single series with the €500,000,000 principal amount of floating rate senior notes due 2021 initially issued by Medtronic Luxco on March 7, 2019. All of Medtronic Luxco’s obligations under the Notes will be fully and unconditionally guaranteed by Medtronic plc (the "Company") and Medtronic, Inc., a wholly-owned indirect subsidiary of Medtronic Luxco, on a senior unsecured basis.

The net proceeds of the Offering will be used to fund the previously announced cash tender offers (the "Tender Offers") for several series of outstanding notes issued by Medtronic, Inc., Medtronic Luxco and Covidien International Finance S.A., a wholly-owned indirect subsidiary of the Company, and to pay accrued and unpaid interest, premiums, fees and expenses in connection with the Tenders Offers. Any remaining net proceeds of the Offering will be used for repayment of other indebtedness and general corporate purposes. The Offering is expected to close on July 2, 2019, subject to customary closing conditions. The joint book-running managers for the Offering are Barclays Bank PLC, Goldman Sachs & Co. LLC and Merrill Lynch International.

The Offering is being made only by means of a prospectus dated February 3, 2017 and prospectus supplement (together, the "Prospectus"). You may get these documents for free by visiting EDGAR on the Securities and Exchange Commission website at www.sec.gov. Alternatively, copies of the Prospectus for the Offering may be obtained by contacting Barclays Bank PLC, toll free at +1-888-603-5847, Goldman Sachs & Co. LLC, toll-free at +1-866-471-2526 and Merrill Lynch International, toll-free at +1-800-294-1322.