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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

On June 25, 2019 TILT Biotherapeutics Ltd, the leading company globally working in the area of enabling tumor T-cell therapies and checkpoint inhibiting antibodies with oncolytic viruses, reported that it has entered into an agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate its armed oncolytic virus, TILT-123, with avelumab in patients with solid tumors refractory to routine modalities (Press release, TILT Biotherapeutics, JUN 25, 2019, View Source [SID1234537255]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased to initiate a collaboration with Merck KGaA, Darmstadt, Germany and Pfizer to translate our findings into patients. Preclinical results with TILT-technology and anti-PD(L)1 agents suggest immune activation and efficacy in certain animal models", explains Akseli Hemminki (MD, PhD, eMBA), CEO and Founder of TILT Biotherapeutics.

*Avelumab is under clinical investigation in combination with TILT-123 for treatment of solid tumors and has not been demonstrated to be safe and effective for this use. There is no guarantee that avelumab in combination with TILT-123 will be approved by any health authority worldwide.

About Avelumab

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in more than 45 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, major adverse cardiovascular events (MACE), and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Additional common adverse reactions reported in patients receiving BAVENCIO in combination with axitinib include hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. Clinical chemistry and hematology laboratory value abnormalities have been reported including but not limited to grade 3-4 lymphopenia, anemia, elevated cholesterol and liver enzymes.

For full Prescribing Information and Medication Guide for BAVENCIO, please see www.BAVENCIO.com.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

1
GlobalData PharmaPoint: HER2-Negative/HR+ and Triple Negative Breast Cancer – Global Drug Forecast and Market Analysis to 2025, December 2016

LOGO

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).

On June 25, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported that it has commenced an underwritten public offering of approximately $100 million of shares of its common stock (Press release, Odonate Therapeutics, JUN 25, 2019, View Source [SID1234537256]). In addition, Odonate has granted the underwriters a 30-day option to purchase up to an additional $15 million of shares of its common stock. All of the shares of common stock to be sold in the underwritten public offering are being offered by Odonate.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Odonate intends to use the proceeds from the proposed underwritten public offering of its shares of common stock for development and regulatory activities relating to tesetaxel, as well as for working capital and general corporate purposes.

Jefferies and Cowen are acting as joint book-running managers. LifeSci Capital is acting as lead manager for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission (SEC) and became effective on February 28, 2019.

A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering can be made only by means of a prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]) or Cowen and Company, LLC (c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717; telephone: 631-274-2806; email: [email protected]).

On June 25, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will report its second quarter 2019 financial results after the market close on Monday, July 29, 2019 (Press release, Medpace, JUN 25, 2019, View Source [SID1234537258]). The Company will host a conference call the following morning, Tuesday, July 30, 2019, at 9:00 a.m. ET to discuss these results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 6197355.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at investor.medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available from 12:00 p.m. ET on Tuesday, July 30, 2019 until 12:00 p.m. ET on Tuesday, August 13, 2019. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 6197355.