On October 30, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will host a conference call on Tuesday, November 7, 2017, at 8:30 a.m. ET to review its third quarter 2017 financial results and provide an update on the company (Press release, Infinity Pharmaceuticals, OCT 30, 2017, View Source [SID1234521299]).

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A live webcast of the conference call can be accessed in the Investors/Media section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 97100725. An archived version of the webcast will be available on Infinity’s website for 30 days.

On October 30, 2017 Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) reported that it will host a webcast and conference call to discuss the company’s financial results for the quarter ended September 30, 2017, and provide a general business overview on Monday, November 6, 2017, at 4:30 p.m. ET (1:30 p.m. PT) (Press release, Portola Pharmaceuticals, OCT 30, 2017, View Source [SID1234521302]).

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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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Conference Call Details
The live conference call on Monday, November 6, 2017, at 4:30 p.m. Eastern Time, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or (765) 507-2588 internationally and using the passcode 7269839. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

On October 30, 2017 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) reported that management plans to report its third quarter 2017 financial results on Monday, November 6, 2017, after the close of the U.S. financial markets (Press release, CTI BioPharma, OCT 30, 2017, View Source [SID1234521285]). Following the announcement, members of the management team will host a webcast conference call to discuss the results and provide a general corporate update at 4:30 p.m. ET (1:30 p.m. PT). Access to the event can be obtained as follows:

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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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Monday, November 6
1:30 p.m. PT/4:30 p.m. ET/10:30 p.m. CET
1-888-461-2021 (domestic)
+1 719-325-2359 (international)

To access the live audio webcast or the subsequent archived recording, visit CTI BioPharma’s website, www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available at approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 1048572. The telephone replay will be available until Monday, November 13, 2017.

On October 29, 2017 Esanex, Inc., a clinical stage company developing Heat Shock Protein inhibitors for the treatment of cancer, reported that it is presenting preclinical data from its Heat Shock Protein 90 (Hsp90) inhibitor SNX-5422 program, showing promising anti-tumor effects both alone and in combination with checkpoint inhibitors, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, Esanex, OCT 29, 2017, View Source [SID1234521339]).

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"Results from these two studies reaffirm our belief in the potential of SNX-5422 both as a monotherapy and in combination with immuno-oncology drugs," said Everardus (Eric) Orlemans, Ph.D, Chief Scientific Officer and Senior Vice President, Development, Esanex. "We are conducting further research to explore the potential of SNX-5422 in other indications as well as through our ongoing Phase 1b trial in chronic lymphocytic leukemia. The results from the combination research support further development of SNX-5422 in combination with checkpoint inhibitors for the potential treatment of a number of cancer types."

The two posters will be presented October 29th at 12:30 – 4:00 pm EST, in Hall E, Pennsylvania Convention Center.

Poster B139: "Promising antitumor effects of SNX-5422 in combination with checkpoint inhibitors in an MC38 murine model", presented at the session PO.B20 – Therapeutic Agents: Other Topics.
SNX-5422 is an orally active prodrug of SNX-2112, a potent, highly selective inhibitor of Hsp90. The results described in the poster show that SNX-5422 at either 25 mg/kg or 40 mg/kg, in combination with the immune checkpoint inhibitors anti-PD1, PD-L1 or CTLA4, demonstrated significant antitumor activity in the MC38 murine colon cancer model.

Poster B026: "SNX-2112 interferes with mitochondrial metabolism in TP53 mutant tumors", presented at the session PO.B05 – Metabolism.
In vitro work with SNX-2112, the active derivative of SNX-5422, demonstrated significant antitumor activity in TP53 null tumors and in rearranged MYC hematologic and selected solid tumors (e.g., hepatocellular carcinoma, mesothelioma). This activity appears to be, in part, the result of interference with cancer related metabolic pathways.

About SNX-5422
SNX-5422 is a chemically unique, orally active Hsp90 inhibitor that has provided durable clinical responses in open label trials in non-small cell lung cancer (NSCLC) and neuroendocrine tumors (NET). The potential of SNX-5422 in hematologic cancers is currently being explored in a chronic lymphocytic leukemia (CLL) open label clinical trial (clinicaltrials.gov ID#NCT02973399). With approximately 200 patients treated to date, SNX-5422 has a well-established safety profile that supports studying it in combination with existing approved drugs in a variety of clinical settings.

On October 29, 2017 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody can, cer therapeutics, reported preliminary data from an ongoing Phase 1a/b clinical trial with its lead oral investigational agent, RGX-104 (Press release, Rgenix, OCT 29, 2017, View Source [SID1234521283]). These data demonstrate immune-stimulatory activity in solid tumor patients with highly-refractory malignancies, including patients who have failed prior checkpoint inhibitors. Also presented were pre-clinical data establishing the immune-modulatory and anti-tumor effects of RGX-104. The company presented the data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Philadelphia.

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RGX-104 is a liver X receptor (LXR) agonist that upregulates the expression of the target gene, Apolipoprotein E (ApoE), triggering several downstream effects via ApoE receptors. In pre-clinical data presented today, treatment with RGX-104 in mouse models resulted in dual effects on myeloid-derived suppressor cells (MDSCs) and dendritic cells (DCs), both innate immune cells that play a central role in regulating anti-tumor immunity and response to checkpoint inhibitors. Innate immune activation with RGX-104, coupled with a reduction in tumor blood vessels, resulted in anti-tumor activity as a monotherapy as well as synergy with checkpoint inhibitors (CPI) in several drug-resistant mouse models. These data provide rationale for Rgenix’s ongoing Phase 1a/b trial of RGX-104 in advanced cancer patients and support evaluation of RGX-104 as both a monotherapy as well as in combination with CPIs.

As part of the ongoing Phase 1a/b clinical trial, 15 patients with a variety of solid tumors have been treated with escalating doses of RGX-104 monotherapy. Patients treated with RGX-104 had a median of six prior therapies with a range of 1-12, highlighting a population of patients with profoundly resistant disease.

Activation of the LXR-ApoE pathway with oral administration of RGX-104 was associated with immune-stimulatory activity in 9 of 10 evaluable patients. This was demonstrated by an increase (up to 11-fold) in activated circulating PD-1+CD8+ T cells during treatment. T cell activation was observed in patients who experienced modulation of the innate immune system during treatment. The effect of RGX-104 on the innate immune system consisted of both MDSC depletion (up to 95% decrease) as well as DC activation as indicated by induction of PD-L1 expression (up to 100% increase). In most cases these effects were observed within two weeks of treatment initiation and generally preceded the onset of T cell activation.

Safety data demonstrate good tolerability with on-target safety findings in the first three dosing cohorts. One patient experienced a DLT of grade 4 reversible neutropenia – a known potential effect of LXR agonism – that reversed within one week, allowing the patient to subsequently tolerate a 50% dose reduction. No MTD has been reached to date. Stable disease has been observed in 4 of 12 evaluable patients, including three who have failed prior checkpoint inhibitor therapy, for periods of at least 8 weeks.

“We are very pleased to see robust evidence of immune stimulation in such highly-pretreated patients,” said Roger Waltzman, MD, MBA, and Chief Medical Officer of Rgenix. “CPI therapy is now commonplace but only a minority of patients derive clinical benefit. We hope the effects of RGX-104 on modulating barriers to innate and adaptive immune function will enable a larger number of patients to benefit from this therapy. These preliminary results also highlight the potential for development of RGX-104 as a monotherapy.”

Rgenix plans to enroll subsequent dose-escalation cohorts of the RGX-104 monotherapy trial in Q4 2017. Additionally, Rgenix is planning to initiate the Phase 1b expansion component of the study, comprised of disease directed cohorts receiving RGX-104 monotherapy as well as cohorts receiving RGX-104 combined with a CPI, projected to begin in 1H 2018.

“These preliminary data establish RGX-104 as a potential first-in-class oral immunotherapy agent with broad immune-stimulatory activity and a unique dual mechanism targeting innate immunity,” said Masoud Tavazoie, MD, PhD, and Chief Executive Officer of Rgenix. “These results also further validate our discovery platform at Rgenix, as well as our pipeline of other drug candidates slated to begin entering clinical-stage development in 2018.”

The LXR-ApoE pathway was discovered as a cancer target using a microRNA (miRNA) based target discovery approach originally developed at The Rockefeller University and now exclusively licensed to Rgenix.