On October 28, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported an update on the ongoing development of its product candidates (Press release, Immutep, OCT 28, 2019, View Source [SID1234549973]).

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!

Eftilagimod alpha ("efti" or "IMP321") Clinical Update

AIPAC – Phase IIb clinical trial

The Company is fully on track to report progression-free survival data and overall response rate data in Q1 of calendar year 2020. AIPAC is potentially a pivotal clinical trial, meaning it could serve as the basis to pursue appropriate regulatory approval pathways for efti, subject to sufficient and clinically meaningful data from the trial and regulatory interactions. Importantly AIPAC would be the first successful randomised trial in solid tumors for an antigen presenting cell activator and would be a very significant step in validating this new class of products.

TACTI-002 – Phase II clinical trial

Immutep presented initial encouraging data of the first cohort of 17 patients for Part A (patients with first line non-small cell lung cancer) of its TACTI-002 Phase II study, which is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada), in June. Part A has been expanded by the data monitoring committee in September to include 19 additional patients.

Recruitment is ongoing for Part B (second line non-small cell lung cancer) and Part C (second line head and neck squamous cell carcinoma), where 6 and 12 patients have been recruited, respectively. There is also potential to expand Parts B and C, subject to the required number of predefined patient responses being observed in these groups. Hence, in total 35 patients have been recruited across all three groups in TACTI-002.

Immutep will report data updates from the open label TACTI-002 study at SITC (Free SITC Whitepaper) on 8 November, at 7.00am EST, as well as in Q1 2020.

TACTI-mel – Phase I clinical trial

Immutep’s CSO and CMO presented final efficacy data at the World Immunotherapy Congress in Basel on 15 October 2019. The key findings were efti has a favourable safety profile in combination with pembrolizumab with no dose-limiting toxicities and the recommended dosage level for a Phase II trial is 30 mg of efti (this is the dosage level currently being evaluated in the ongoing TACTI-002 Phase II trial).

In addition, final efficacy data has been reported, confirming deep durable responses have been observed, with 12 patients (50%) having a decrease of ³ 75% in the target lesions and 9 patients (38%) being treated for ³ 12 months with pembrolizumab plus efti.

Final safety data is expected to be presented in H1 2020.

INSIGHT-004 – Phase I clinical trial

In June 2019, the first patient was enrolled in Germany and has received the first dose of treatment in INSIGHT-004, the fourth arm of the INSIGHT trial (INSIGHT-004 is also known as Stratum D of INSIGHT) which is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. The first cohort (6 mg of efti) is now fully recruited with six patients in total. The second cohort (30 mg of efti) will recruit six patients, bringing the total participants in the study to 12 patients.

Initial safety data from the study is expected to be reported in Q4 2019.

Efti Manufacturing

The company is also working on upscaling the manufacturing process from 200L to 2,000L single-use bioreactors at the WuXi Biologics manufacturing plant (Wuxi, China) in order to be better prepared for potential commercial manufacturing and additional registration trials in multiple indications.

IMP761 Update

IMP761

Immutep is continuing cell line development and the associated manufacturing steps of its IMP761 product candidate following encouraging preclinical results that demonstrated the immunosuppressive activity of IMP761.

Update on Programs Fully Funded by Immutep’s Licensing Partners

GlaxoSmithKline (GSK) – Phase I and II clinical trials

In September, Immutep announced that it will receive a milestone payment from GSK of £4 million (~A$7.39 million) related to the first patient being dosed in GSK’s Phase II clinical trial evaluating GSK2831781 in ulcerative colitis. This milestone payment was received by Immutep from GSK in October.

Novartis – Phase I and II clinical trials

Immutep’s partner Novartis, is conducting five trials of LAG525, derived from IMP701, which is licensed from Immutep. Earlier this year, it commenced the recruitment of 220 patients for its combinatory Phase Ib clinical trial in triple negative breast cancer.

Recruitment is also ongoing for its Phase II study in advanced triple negative breast cancer and its Phase II study in melanoma. A further two trials are active, namely a Phase I/II trial in advanced solid tumors and a Phase II trial in a range of advanced malignancies.

Eddingpharm (EOC Pharma) – Phase I clinical trial

The Phase I clinical study is ongoing with efti for the treatment of metastatic breast cancer.

On October 28, 2019 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that it will host a conference call and live audio webcast on Tuesday, November 5, 2019 at 4:30 p.m. Eastern Time to discuss financial results for the third quarter and nine months ended September 30, 2019 and to provide a business update (Press release, CymaBay Therapeutics, OCT 28, 2019, View Source [SID1234549905]).

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!

Conference Call Details
To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13694084. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On October 28, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported that it has entered into a $10.9 million common stock purchase agreement, including a $1.0 million initial common stock purchase, with Aspire Capital Fund, LLC, a Chicago-based institutional investor (Press release, Salarius Pharmaceuticals, OCT 28, 2019, View Source [SID1234549922]).

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!

With the investment by Aspire plus non-dilutive funding from the Cancer Prevention Research Institute of Texas (CPRIT) and ongoing financial support from the National Pediatric Cancer Foundation, Salarius believes it is well-capitalized to advance its current clinical programs through a number of near-term, value creating milestones, including early safety and efficacy data readouts from the ongoing Phase 1/2 clinical trial of Seclidemstat, Salarius’ lead drug candidate, in Ewing sarcoma and the Phase 1 clinical trial of Seclidemstat in advanced solid tumors.

Under the agreement, Aspire Capital is committed to purchase up to $10.9 million of Salarius’ common stock over a 30-month span extending into 2022, subject to certain terms and conditions. Immediately upon execution of the agreement, Aspire Capital made an initial purchase of 210,526 shares for $1.0 million, a per share purchase price of $4.75, which is equal to the closing sale price of Salarius’ shares on October 24, 2019, the date of the agreement. Any additional sales to Aspire Capital under the agreement will occur at the sole discretion of Salarius and at prices based on the market price of Salarius’ common stock at the time of each sale.

"This common stock purchase agreement with Aspire Capital provides Salarius with additional access to capital and financing flexibility allowing Salarius to further advance its lead drug candidate, Seclidemstat," commented David Arthur, Chief Executive Officer of Salarius. "We believe our non-dilutive financial support from both CPRIT and the National Pediatric Cancer Foundation, now combined with funding from Aspire Capital, puts Salarius in a good financial position as we continue our work targeting the epigenetic causes of cancer."

Steven G. Martin, the Managing Member of Aspire Capital, commented, "We are very pleased to announce this investment in Salarius as we recognize LSD1 as a novel and exciting target with ever increasing clinical validation in a broad range of cancers, including Ewing sarcoma and other advanced solid tumors, as well as hematologic cancers such as AML. Seclidemstat has demonstrated promising and potentially best-in-class characteristics driven by its differentiated reversible binding profile and inhibition of both the enzymatic and scaffolding functions of LSD1. Furthermore, we’re intrigued by recent evidence showing that the inhibition of LSD1 stimulates interferon production highlighting Seclidemstat’s potential as an important new immuno-oncology agent. Aspire Capital is confident that Salarius offers a good opportunity for near and long-term value creation."

Under the terms of the agreement with Aspire Capital, Salarius retains full control over the timing of any stock sales made under the agreement and the amount of stock sold to Aspire Capital. There are no warrants, options, financing swaps, derivatives or other securities associated with the agreement. The agreement contains no restrictions on the use of proceeds, financial covenants or restrictions on future financings and no rights of first refusal, participation rights, penalties or liquidated damages. Lastly, Salarius maintains the right to terminate the agreement at any time, at its discretion, without any additional cost or penalty. The proceeds from this agreement will be used for working capital and general corporate purposes.

In addition to the Common Stock Purchase Agreement, Salarius also entered into a Registration Rights Agreement with Aspire Capital. Additional details regarding the transaction, including the issuance of commitment fee shares, the Common Stock Purchase Agreement and related Registration Rights Agreement is available in Salarius’ Current Report on Form 8-K, filed today with the SEC. Salarius has filed a prospectus supplement to its Form S-3 shelf registration statement (File No. 333-231010), which was declared effective on May 17, 2019 by the U.S. Securities and Exchange Commission, qualifying the offer and sale of common shares to Aspire Capital. A copy of the Prospectus Supplement is available on EDGAR at www.sec.gov or may be obtained upon request to Salarius. 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 jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On October 28, 2019 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported plans to support a phase II randomized trial for lung cancer patients (Press release, NCCN, OCT 28, 2019, View Source [SID1234549938]). The study is titled TH-138: Phase II randomized trial of carboplatin + pemetrexed + bevacizumab, with or without atezolizumab in stage IV non-squamous NSCLC patients who harbor a sensitizing EGFR mutation or have never smoked. Joseph Treat, MD, Professor, Department of Hematology/Oncology, Fox Chase Cancer Center, will serve as principal investigator, with Hossein Borghaei, DO, and J. Nicholas Bodor, MD, PhD, also from Fox Chase Cancer Center, as co-investigators, along with Jyoti Patel, MD, incoming Assistant Director for Clinical Research at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. The study is made possible through collaboration with Genentech, who provided funding and study drugs.

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!

"Lung cancer is the leading cause of cancer-related death in the United States and worldwide," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "As advances are made in the development of targeted therapies and immunotherapies, there is opportunity for greatly needed improvement in outcomes."

Cigarette smoking remains the primary cause of most lung cancer cases, but nearly 20 percent occur in people who have never smoked1. Those non-smoking related cancers generally have a different molecular profile than those in smokers, including mutations in the epidermal growth factor receptor (EGFR), and may have variable response to checkpoint inhibitors.2

This study will focus on patients whose tumors include an EGFR mutation or who are never smokers (defined as fewer than 100 cigarettes in their lifetime). It will examine whether the anti-PD-L1 inhibitor atezolizumab plus carboplatin, pemetrexed, and bevacizumab will improve progression-free survival and overall survival in this population, as compared to carboplatin, pemetrexed, and bevacizumab.

The study is projected to take 31 months, and include more than 100 patients from across 15-20 cancer centers. It is open to people 18 and older who have not been previously treated with any systemic therapy other than tyrosine kinase inhibitors (TKIs).

The NCCN ORP fosters innovation and knowledge discovery that improve the lives of patients with cancer. Visit NCCN.org/ORP to learn more about past and current clinical investigations.

On October 28, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that it will report its third quarter 2019 financial results on Monday, November 4, 2019 (Press release, Deciphera Pharmaceuticals, OCT 28, 2019, View Source [SID1234549906]).

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!

In connection with the earnings release, Deciphera’s management team will host a live conference call and webcast at 4:30 PM ET on Monday, November 4, 2019, to discuss the Company’s financial results and provide a general corporate update.

The conference call may be accessed by dialing (866) 930-5479 (domestic) or (409) 216-0603 (international) and referring to conference ID 1181263. A webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source The archived webcast will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.