On October 11, 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 clinical data on the Company’s lead product candidate eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3Ig fusion protein based on the LAG-3 immune control mechanism, will be presented at two industry conferences in October and November 2019 (Press release, Immutep, OCT 11, 2019, View Source [SID1234540969]).

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Conference:

World Immunotherapy Congress as part of Festival of Biologics 2019

Dates:

October 15-17, 2019 (Tuesday, 15th October/ 2.50 p.m. CET)

Venue:

Basel Congress Centre, Basel, Switzerland

Presentation Title:

A soluble LAG-3 protein (eftilagimod alpha) with an anti-PD-1 antibody (pembrolizumab): a new combination in immuno-oncology – mature results of TACTI-mel

Presenter:

Frédéric Triebel, CSO & CMO of Immutep

Conference:

34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)

Dates:

November 6-10, 2019 (Friday, November 8th, 7.00am – 8.00pm EST)

Venue:

Gaylord National Hotel & Convention Center in National Harbor, 201 Waterfront St, Forest Heights, MD 20745, USA

Title:

Initial results from a Phase II study (TACTI-002) in non-small cell lung cancer, or head and neck cancer patients receiving eftilagimod alpha (LAG-3 fusion protein) and pembrolizumab

Poster Number:

343

Authors:

J. Peguero, E. Felip, B. Doger, M. Marjem, E. Carcereny, T. Clay, P. Bajaj, M. Krebs, F. Triebel
All presentations will be made available on the Company’s website at View Source

On October 11, 2019 NicOx presented the Corporate Presentation (Press release, NicOx, OCT 11, 2019, View Source [SID1234540970]).

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On October 11, 2019 Kangpu Biopharmaceuticals reported that it has successfully completed a first-in-human phase I single ascending dose (SAD) clinical study of KPG-818 conducted in the United States (Press release, Kangpu Biopharmaceuticals, OCT 11, 2019, View Source [SID1234540934]).

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This randomized, double-blind, placebo-controlled study evaluated the safety, tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants following oral administration. A total of 40 subjects were randomized to receive active drug or placebo in a double-blind fashion (8 subjects in each dose cohort, 6 subjects randomized to receive active drug and 2 subjects randomized to receive placebo). Five dose levels (2, 5, 10, 20 and 30 mg) were investigated.

In the completed phase I study, there were no safety or tolerability concerns. No serious adverse events (SAE) were reported at any dose level studied. No stopping criteria were met. KPG-818 was well tolerated at all tested dose levels. KPG-818 also demonstrated a favorable pharmacokinetic profile supporting once-daily oral dosing. The phase I results also revealed that dosing under fed conditions does not have significant influence on the exposure of KPG-818 as compared to fasted conditions.

The study results will assist Kangpu Biopharmaceuticals in identifying appropriate doses of KPG-818 that can be administered in subsequent clinical trials in patients with systemic lupus erythematosus (SLE) or hematological malignancies.

About KPG-818

KPG-818 is a novel small molecule modulator of the CRBN E3 ubiquitin ligase complex CRL4-CRBN. In preclinical studies, KPG-818 demonstrated outstanding in vitro anti-inflammatory and anti-proliferative properties as well as remarkable in vivo efficacy in myeloma and lymphoma animal models. KPG-818 is currently being developed by Kangpu Biopharmaceuticals for the treatment of SLE and hematological malignancies.

On October 11, 2019 Universal Health Services, Inc. (NYSE: UHS) reported that it will report results for its third quarter ended September 30, 2019 after the market closes on Thursday, October 24, 2019 (Press release, Universal Health Services, OCT 11, 2019, View Source [SID1234540972]). There will be a conference call for investors and analysts at 9:00 a.m. Eastern Time on Friday, October 25, 2019. The dial-in number is 1-877-648-7971.

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A live broadcast of the conference call will be available on the company’s website at www.uhsinc.com. Also, a replay of the call will be available following the conclusion of the live call for one full year.

On October 11, 2019 SHINE Medical Technologies, LLC reported the creation of a new division of the company — SHINE Therapeutics. The establishment of the division enhances the company’s ability to focus on filling critical future needs in the rapidly growing therapeutic isotope market, while continuing to leverage its radioisotope production expertise.

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The company’s Therapeutics division will initially focus on the development and commercialization of lutetium‑177, or Lu‑177, a therapeutic isotope that is combined with a disease-specific targeting molecule to treat cancer. Targeting molecules deliver Lu‑177 atoms to cancer sites throughout the body, where they directly irradiate cancer cells.

The first Lu‑177-based targeted radiotherapy (for neuroendocrine tumors) reached the market in 2018. Many high-potential targeted molecules for the treatment of a range of other cancers with Lu-177 are currently under investigation. SHINE is also evaluating additional medical isotopes with therapeutic properties for future development.

Katrina Pitas, a 10-year veteran of SHINE who served most recently as the company’s vice president of business development, has been appointed vice president and general manager of SHINE Therapeutics.

"Targeted radiotherapy has the potential to fundamentally change the way cancer patients are treated," Ms. Pitas said. "But a robust, reliable supply of therapeutic isotopes will be crucial as both the discipline and associated market continue to grow. Our Lu‑177 development program is well underway, and we look forward to bringing high-purity Lu‑177 to market."

In May, the company entered an agreement with the Institute of Organic Chemistry and Biochemistry of the Czech Academy of Sciences (IOCB Prague) that provides SHINE with a global, exclusive license to a novel separation technology that it will use to separate lutetium from enriched ytterbium targets. The technology will enable SHINE to produce non-carrier-added, high-specific-activity Lu‑177.

"We are excited to bring our core competencies and technology to serve the rapidly emerging therapeutic market," said Greg Piefer, SHINE’s founder and CEO. "This market is particularly exciting, as it offers very promising therapies for patients who before now had difficult or impossible to treat late stage cancers. The focus of our new division is to ensure cancer patients have a reliable supply chain of isotopes as new drugs are approved."

SHINE is continuing its efforts to bring molybdenum-99, or Mo‑99, to a global market experiencing shortages that directly affect patient care. Construction of the company’s first-of-its-kind isotope production facility in Janesville, Wis., where it will produce Mo‑99 using the company’s patented technology, is underway and progressing well.

European Association of Nuclear Medicine Annual Congress

SHINE will be exhibiting at the European Association of Nuclear Medicine (EANM) Annual Congress in Barcelona, Spain. The exhibit hall will be open Oct. 13-15. You can find SHINE at booth no. 23 near the center entrance to the exhibit hall