On May 17, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, advises that its Chief Medical Officer and Chief Scientific Officer, Dr. Frédéric Triebel, reported it will present interim results from the three initial patient cohorts of its ongoing TACTI-mel Phase I clinical trial in a global webcast and Q&A (Press release, Immutep, MAY 17, 2018, View Source [SID1234526798]). The webcast will also include an update on the Company’s clinical immuno-oncology combination program.

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Dr. Triebel will also present a subset of these interim results at the 3rd Annual Advances in Immuno-Oncology Congress, on 25 May 2018 in London, UK. The presentation, titled "Two ACTIve Immunotherapies in melanoma (TACTI-mel): results of a phase I trial with metastatic melanoma patients treated with a soluble LAG-3 receptor (LAG-3Ig or eftilagimod alpha) as an antigen presenting (APC) activator combined with pembrolizumab" will be released to the market to coincide with the event and made available on the Company’s website.

Immutep’s current lead product is eftilagimod alpha ("efti" or "IMP321"), a potential first-in-class major histocompatibility complex class II ("MHC II") agonist and antigen presenting cell ("APC") activator. Efti is a soluble LAG-3Ig fusion protein based on the LAG-3 immune control mechanism. This mechanism plays a vital role in the regulation of the T cell immune response. Efti, unlike blocking antibodies, is unique as it uses LAG-3 itself as a tool to activate the immune system via MHC II molecules.

The TACTI-mel Phase I clinical trial is a multi-center, open-label clinical trial evaluating the combination of efti with pembrolizumab (KEYTRUDA) for unresectable or metastatic melanoma. As previously disclosed, interim results from the first three cohorts was expected in H1 2018. The trial remains ongoing, following its expansion by an additional cohort, with results from this additional cohort expected in H2 2018.

Investor Webcast Details

The webcast will be hosted by Dr. Triebel, Marc Voigt, CEO and Christian Mueller, Director of Clinical Development.

Date & Time:
Wednesday, May 30, 2018, 8:00am Australian Eastern Standard Time

Tuesday, May 29, 2018, 6:00pm US Eastern Daylight Time

Register: Interested investors can register via a link to the webcast on the Company’s website at Clinical Results of Ongoing Melanoma Study and Update on Eftilagimod Alpha Clinical Development Strategy or via the following link.

View Source

A replay of the webcast will also be available at www.immutep.com from the day after the event.

LOGO

About the TACTI-mel clinical trial

The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multi-center, open-label, dosing escalating (1, 6 or 30 mg of eftilagimod alpha or "efti") study evaluating the combination of efti with pembrolizumab for 6 months, starting at treatment cycle 5 in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869). The initial study consists of three cohorts of six patients.

In February 2018, Immutep expanded the TACTI-mel study by an additional cohort of 6 patients at 30 mg of efti in combination with pembrolizumab starting at cycle 1 and with a treatment duration of 12 months. As announced on March 22, 2018, the first patient from this additional cohort has received their first dose.

On May 17, 2018 Veru Inc. (NASDAQ: VERU), a urology and oncology biopharmaceutical company, reported the publication of data from preclinical studies of VERU-111, a novel oral alpha and beta tubulin inhibitor, showing potent activity in a highly resistant model of human prostate cancer (Press release, Veru, MAY 17, 2018, View Source [SID1234529113]). An abstract of the data was published as part of the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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Oral VERU-111 was evaluated in the 22Rv1 prostate cancer model, which represents a highly resistant and aggressive form of the disease possessing androgen receptor splice variants that are commonly found in prostate cancer resistant to hormonal approaches like abiraterone and enzalutamide. In the same model, docetaxel administered by injection did not have significant effect on tumor growth. Animals receiving docetaxel lost weight on the study, a surrogate for toxicity, whereas those on VERU-111 either maintained or gained weight while receiving the drug.

"The findings in this clinically relevant model of prostate cancer provide us with additional support and enthusiasm for evaluating VERU-111 in a Phase 1/2 clinical trial, which is scheduled to commence later this year. This is an animal model in which few drugs have been shown to be active. In addition, VERU 111 may be effective against other tumor types known to be sensitive to taxanes that are already FDA approved," said Mario Eisenberger, MD, the Dale Hughes Professor of Oncology at The Johns Hopkins University.

"Oral VERU-111 has shown positive and encouraging signs to become an important therapeutic option for a particularly challenging form of prostate cancer. We are studying VERU-111 in multiple other cancers, the data of which is also being published at ASCO (Free ASCO Whitepaper) this year. We have begun performing the required toxicity studies and our IND submission and first clinical studies are planned for later this year," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru.

About VERU-111
VERU-111 is a novel oral therapy targeting alpha and beta tubulin for the treatment of metastatic prostate, breast, endometrial, ovarian, and other cancers. In 2017, there were approximately 161,000 new cases of prostate cancer in the U.S. and about 25% of these men will die from the disease. In the U.S., 5% of men with prostate cancer will have metastatic cancer and up to 30% of men with high-risk, localized prostate cancer will develop metastatic cancer following initial therapy. The median survival of patients with metastatic prostate cancer ranges from 3.2 to 4.5 years. For these men, the 1st line therapy is androgen deprivation therapy, or medical castration. Although most will initially respond, nearly all these patients will progress to metastatic castration resistant prostate and have a poor prognosis with an average survival of 1.5 years. New 2nd line hormonal agents, like XTANDI (enzalutamide) and ZYTIGA (abiraterone/prednisone) have resulted in an additional four to five months of average survival, but nearly all men on these agents will develop progressive metastatic prostate cancer.

Drugs like VERU-111 that target tubulin, the subunits of microtubules, have been shown to be the most effective targeted cytotoxic chemotherapy for the treatment of metastatic prostate cancer. Microtubules are critical for cancer cell replication to stimulate genes for cancer cell proliferation. Docetaxel and cabazitaxel are examples of FDA-approved chemotherapy drugs that are given intravenously (IV) that target tubulin to treat metastatic prostate cancer. Although effective, the challenges for this class of chemotherapy drugs, also known as taxanes, include that they must be given intravenously (IV) and that the cancer cells develop resistance to taxanes. There are also serious safety concerns with IV taxanes which include serious hypersensitivity reactions, myelosuppression and neurotoxicity such as peripheral neuropathy and muscle weakness.

Unlike taxanes which bind to just the beta subunit of tubulin, VERU-111 binds strongly to both the alpha and beta subunits of tubulin. VERU-111 has: high oral bioavailability; less resistance as it does not interact with multiple drug resistance proteins so it cannot be pumped out of the cancer cell; minimal drug to drug interactions and high activity against many tumor types including: prostate cancer resistant to drugs like enzalutamide, AR-V7 positive and taxanes, as well as triple negative breast cancer, ovarian cancer, pancreatic cancer, lung cancer, and melanoma. In preclinical studies, VERU-111 appears to have less toxicity and less suppression of white blood cells compared to taxanes and other chemotherapy agents.

Production of the VERU-111 active pharmaceutical ingredient and preclinical safety toxicology studies required for an IND are expected to be completed in 2018. We anticipate filing an IND in 2018 and Phase 1/2 studies are planned for late 2018. Phase 1 studies of VERU-111 are planned in men who have metastatic prostate cancer that has progressed while taking androgen deprivation therapy and abiraterone or enzalutamide as well as in patients with metastatic breast, endometrial, and ovarian cancers. In the U.S., there is a $5 billion annual market for 2nd line hormone therapies for prostate cancer and a $4.8 billion annual market for IV-given taxanes and vinca alkaloids chemotherapies (docetaxel $1 billion and cabazitaxel $500 million in prostate cancer) per Decision Resources Group and Allied Market Research. Second line hormonal therapies like enzalutamide and abiraterone/prednisone have almost complete cross-resistance and should not be used in sequence for the treatment of metastatic prostate cancer. VERU-111 could be substituted for IV given docetaxel and cabazitaxel antitubulin chemotherapies. VERU-111 could also be developed as an oral dosing alternative to chemotherapies for the treatment of metastatic breast, endometrial and ovarian cancers as these tumors that responded to IV taxane chemotherapies.

On May 17, 2018 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director President and CEO: Hiroshi Nomura) reported that a total of 6 presentations including clinical study results and designs for investigational anti-cancer agents napabucasin (BBI608), DSP-7888 and TP-0903 will be made at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 1 to June 5, 2018 (Press release, Sumitomo Dainippon Pharma, MAY 17, 2018, View Source [SID1234526742]).

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【About napabucasin】
Napabucasin is an orally administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways by targeting STAT3. By inhibiting pathways involved in the maintenance of cancer stemness, it may provide a new therapeutic option against the challenges in cancer treatment such as treatment resistance, recurrence and metastasis. Napabucasin has been shown to inhibit STAT3 pathways, Nanog pathways and β-catenin pathways in pre-clinical studies.
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【About DSP-7888】
DSP-7888 is a therapeutic cancer peptide vaccine derived from Wilms’ tumor gene 1 (WT1) protein. DSP-7888 is a vaccine containing peptides that induces WT1-specific cytotoxic T lymphocytes (CTLs) and helper T cells. DSP-7888 is expected to become a treatment option for patients with various types of hematologic malignancies and solid tumors that express WT1, by inducing WT1- specific CTLs that attack WT1-expressing cancer cells. By adding a helper T cell-inducing peptide, improved efficacy over that observed with a CTL-inducing peptide alone may be achieved. DSP7888 is expected to be an option for a wide range of patients.

【About TP-0903】
TP-0903 is an AXL receptor tyrosine kinase inhibitor, which is known to be involved in acquiring resistance to conventional agents and developing metastatic capacity in cancer cells.TP-0903 may have anti-cancer activities on various cancer types through blocking transition from epithelial to mesenchymal phenotype by inhibiting AXL. TP0903 has been shown to inhibit AXL signaling and reverse the mesenchymal to epithelial phenotype in pre-clinical studies.

These agents have not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer or any other disorder.
Contact: Public & Investor Relations Group, Corporate Governance
Sumitomo Dainippon Pharma Co., Ltd.
TEL: +81-6-6203-1407 (Osaka); +81-3-5159-3300 (Tokyo)

On May 17, 2018 Alexo Therapeutics, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported it has initiated ALX148 combination dosing with targeted antibody therapies in its Phase 1 clinical program in patients with advanced solid tumors and lymphoma (Press release, Alexo Therapeutics, MAY 17, 2018, View Source [SID1234526778]). The Company will present updated data on ALX148 at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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Poster Presentation Information
Title: A Phase 1 Study of ALX148, a CD47 Blocker, Alone and in Combination with Established Anti-Cancer Antibodies in Patients with Advanced Malignancy and Non-Hodgkin Lymphoma
Session Name: Developmental Therapeutics-Immunotherapy
Session Date: June 04, 2018
Presentation Time: 8:00am – 11:30am CT
Abstract Number: 3068

"The initiation of ALX148 combination cohorts marks the next important milestone in Alexo’s development," said Sophia Randolph M.D., Ph.D., Chief Medical Officer of Alexo Therapeutics. "ALX148 is designed to enhance the efficacy of antibody-based therapies, while avoiding the dose-limiting toxicities that have been seen with other CD47-targeted approaches in the clinic. ALX148 is generally well tolerated in patients with advanced tumors and exhibits favorable pharmacokinetics and CD47 target occupancy at doses evaluated. No maximum tolerated dose of ALX148 was reached. With broad therapeutic potential across many types of cancer, we are eager to now be evaluating ALX148 in combination with select anti-cancer therapeutic antibodies."

The ALX148 Phase 1 clinical trial is a two-part study that evaluates the safety, pharmacokinetics, and pharmacodynamics of ALX148. Enrollment to the single-agent dose escalation phase is complete and the combination therapy portion in which ALX148 is administered with approved anti-cancer antibodies is ongoing. Clinical data will be presented at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting. For more information about the Phase 1 study, please visit clinicaltrials.gov, identifier number NCT03013218.

About ALX148
ALX148 is a fusion protein comprised of an engineered high affinity CD47 binding domain of SIRPα linked to an inactive Fc region of human immunoglobulin. ALX148 potently and specifically binds CD47 and blocks its interaction with SIRPα, thus inhibiting a key immune checkpoint mechanism exploited by cancer cells. In preclinical studies, ALX148 bridges innate and adaptive immunity to enhance anti-tumor response in combination with targeted anti-cancer antibodies and checkpoint inhibitors with no adverse effect on CD47-expressing normal blood cells. ALX148 is currently being investigated in a Phase 1 study in combination with checkpoint inhibitors and targeted anti-cancer antibodies (NCT03013218)

On May 17, 2018 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported that its management will be presenting at the Bank of America Merrill Lynch 2018 Health Care Conference on Thursday, May 17, 2018, at 11:20 a.m. PT in Las Vegas (Press release, NantHealth, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349532 [SID1234526743]).

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