On October 22, 2018 GTx, Inc. (Nasdaq: GTXI) reported financial results for the third quarter ended September 30, 2018, and provided a corporate update (Press release, GTx, OCT 22, 2018, View Source [SID1234530034]).

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"During the quarter, we turned our focus to the ongoing selective androgen receptor degrader program and the potential of our novel selective androgen receptor degrader to treat castration-resistant prostate cancer. We expect to select the most appropriate development compounds by year-end, which we plan to take into IND-enabling studies next year," said Robert J. Wills, Ph.D., Executive Chairman of GTx. "Additionally, we are exploring other strategic options for the company with the goal of optimizing the full potential of our development pipeline."

Corporate Development Update

Selective Androgen Receptor Degrader (SARD): Prostate Cancer

The Company has an ongoing preclinical program to evaluate its novel selective androgen receptor degrader (SARD) technology in castration-resistant prostate cancer (CRPC). In some men with CRPC, current prostate cancer therapy is not effective or subject to emerging resistance. The Company believes that its SARDs may be first-in-class dual-interacting androgen receptor (AR) antagonists and degraders, and may therefore potentially treat CRPC in men who are non-responsive to current androgen targeted therapies. Going forward, the Company plans to:

Complete ongoing mechanistic preclinical studies by year-end or early in the first quarter of 2019;
Select the most appropriate SARD compounds to move forward with IND-enabling studies in 2019; and
Potentially advance one of its SARD compounds into a first-in-human clinical trial in 2020
Selective Androgen Receptor Modulator (SARM): Stress Urinary Incontinence (SUI), Breast Cancer

SUI: Enobosarm, a SARM, was evaluated in post-menopausal women with SUI compared to placebo. During the quarter, the Company announced that the ASTRID Trial, a Phase 2 double-blind, placebo-controlled clinical trial of orally-administered enobosarm (3 mg or 1 mg) in post-menopausal women with SUI, did not achieve statistical significance on the primary endpoint for the trial. Enobosarm was generally safe and well tolerated, and reported adverse events were minimal and similar across all treatment groups. The Company is conducting a comprehensive review of all the ASTRID data and is consulting with key experts to fully understand the study outcomes.

Advanced Breast Cancer: Enobosarm was also evaluated as a hormonal therapy for women with estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer in a Phase 2 clinical trial. The trial met the primary efficacy endpoint in the trial; there are three women in the study who continue to respond to treatment after almost two years on enobosarm (two have stable disease, one now has a partial response). Approximately one year ago, the Company determined that treatment paradigms had shifted to immunotherapies and/or combination therapies, and that it was no longer feasible for GTx to conduct further development of enobosarm in breast cancer.

Enobosarm has been evaluated in more than two dozen clinical trials enrolling over 2,200 subjects, in which approximately 1,500 subjects were treated with enobosarm at doses ranging from 0.1 mg to 100 mg. At all evaluated dose levels, enobosarm was observed to be generally safe and well tolerated.

Third Quarter 2018 Financial Results

As of September 30, 2018, cash and short-term investments were $38.1 million compared to $43.9 million at December 31, 2017.
Research and development expenses for the quarter ended September 30, 2018 were $7.5 million compared to $5.9 million for the same period of 2017.
General and administrative expenses for the quarter ended September 30, 2018 were $2.2 million compared to $2.6 million for the same period of 2017.
The net loss for the quarter ended September 30, 2018 was $9.4 million compared to a net loss of $8.5 million for the same period in 2017.
Net loss for the nine months ended September 30, 2018 was $33.0 million compared to a net loss of $21.2 million for the same period in 2017.
GTx had approximately 24.1 million shares of common stock outstanding as of September 30, 2018. Additionally, there are warrants outstanding to purchase approximately 5.3 million shares of GTx common stock at an exercise price of $8.50 per share and approximately 3.3 million shares of GTx common stock at an exercise price of $9.02.

On October 22, 2018 Anaeropharma Science Inc. headquartered in Tokyo (hereinafter "Anaeropharma") reported that Anaeropharma Science and Chugai Pharmaceutical Co., Ltd. headquartered in Tokyo (hereinafter "Chugai") have concluded a collaborative research agreement concerning the creation of novel oncology drugs utilizing characteristic features of Bifidobacterium longum through Anaeropharma’s proprietary platform technology, "in situ Delivery and Production System" (hereinafter "i-DPS") (Press release, Anaeropharma Science, OCT 22, 2018, View Source [SID1234530116]). An overview of the contract follows.

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A collaborative research agreement concerning the creation of novel oncology drugs utilizing i-DPS technology

Under the agreement, Anaeropharma and Chugai conduct joint research regarding specific oncology substances by use of Anaeropharma’s i-DPS technology and Chugai’s technology. The scope of the agreement is limited to the specific substances predetermined by both companies, and the i-DPS technology will be applied only to those substances.

About i-DPS and its development programs

Bifidobacterium is obligatory anaerobe which exists as enteroflora in the human body, and known as nonpathogenic bacteria. Solid cancers have immature vascular constructs and their interstitial tumors are in the state of hypoxia. The company aims to leverage the recombinant Bifidobacterium technology to create a new class of anti-cancer drugs. The technology offers broad potential of being more effective to solid tumors and generates oncology drugs with less risks of adverse events than conventional anti-cancer drugs.

The leading product developed using i-DPS technology, APS001F, a recombinant Bifidobacterium to express Cytosine Deaminase which converts a prodrug, 5-FC, to an anti-cancer drug, 5-FU, is under a phase 1 clinical trial in the U.S.

On October 22, 2018 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that it will host a conference call and webinar to provide key updates on the advancement of its CD33 program on Friday, October 26, 2018 at 11:00 AM ET (Press release, Actinium Pharmaceuticals, OCT 22, 2018, View Source [SID1234530262]). Actinium’s CD33 program utilizes the Antibody Radio-Conjugate (ARC), lintuzumab-Ac-225 for hematologic indications including Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Multiple Myeloma (MM). Actinium recently completed its Phase 2 Actimab-A trial in patients newly diagnosed with AML who are over the age of 60 and unfit for intensive chemotherapy. Dr. Gary Schiller Professor Medicine, Hematology-Oncology at UCLA Medical Center and Dr. Tapan Kadia, Assistant Professor of Medicine, Department of Leukemia at the MD Anderson Cancer Center will highlight Actinium’s post Phase 2 trial development plans for Actimab-A in AML.

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Actinium is also developing Actimab-MDS, which is intended to be a single dose, chemotherapy-sparing targeted conditioning agent for patients with high-risk MDS. Currently, this patient population either cannot undergo a bone marrow transplant or have poor outcomes. Management will provide an update on the regulatory pathway for Actimab-MDS following positive interactions with the U.S. Food and Drug Administration (FDA).

Dr. Mark Berger, Actinium’s Chief Medical Officer said, "Our CD33 program has progressed significantly in 2018 resulting in a highly valuable body of data that we are using to inform our ongoing development strategy. Our Antibody Radio-Conjugate approach, given its differentiated mechanism of action, has allowed us to expand this program beyond a traditional AML directed approach which is where other CD33 programs in the industry are focused. The unique ability of our ARC’s enable cell killing to occur not just via internalization of the antigen but also from the cell surface and by crossfire. In addition, our ARCs labeled with radioactive actinium are characterized by the high linear energy transfer of alpha radiation which is able to cause double stranded DNA breaks via a single alpha particle hit. This potent cell killing power of alpha radiation when used in an efficiently targeted manner as in our Actimab program enables us to expand into other radio-sensitive CD33 expressing malignancies such as multiple myeloma and now for targeted conditioning for MDS, both of which are indications where Actinium is developing the only CD33 targeting agent. In addition, we have moved into a novel combination trial for patients with significant unmet need with our Actimab-A CLAG-M study. We are pleased to have made this progress, but we believe the next evolution of our CD33 program will be even more exciting. As such, we look forward to highlighting our post Phase 2 trial development plans for Actimab-A with Dr. Schiller and Dr. Kadia."

Sandesh Seth, Actinium’s Chairman and Chief Executive Officer said, "We are excited to introduce these latest initiatives as they clearly establish Actinium’s Antibody Radio-Conjugate based CD33 program as the industry leader. Further, we are about to enter a period that will showcase data from several of the CD33 program initiatives that this team has advanced. Given the inherent nature of our technology, the expertise of our team and strong relationships with thought leaders, we have been able to craft a development strategy that leverages the strengths of our drug candidates and Antibody Warhead Enabling technology platform into indications with high unmet medical needs. The webinar will showcase the attractiveness of using our Antibody Radiation-Conjugate approach in meeting these needs. In addition, it will establish the strategic importance of Actimab-MDS in enabling our company to develop a multi-asset pipeline of targeted conditioning agents which have the potential to improve access and outcomes for patients undergoing bone marrow transplant and cellular therapy in a chemotherapy-free or chemotherapy-sparing manner."

Conference call and webcast Participation Information
Date: Friday, October 26, 2018
Time: 11:00 AM ET
Webcast Registration: View Source
U.S. Participant Dial-in: (718) 865-8336
U.S./Canada Toll Free Dial-in: (855) 427-0225
Conference ID: 4831

On October 22, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported data from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of the combination of nelipepimut-S (NeuVax, NPS) +/- trastuzumab (Herceptin) targeting HER2 low-expressing breast cancer patient cohorts (Press release, Sellas Life Sciences, OCT 22, 2018, View Source [SID1234530035]). The data were presented in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Annual Meeting, being held in Munich, Germany.

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"These data presented at ESMO (Free ESMO Whitepaper) today highlight the therapeutic potential of NPS for patients with early-stage triple negative breast cancer (TNBC), who currently face limited and ineffective treatment options in the adjuvant setting," said Dr. Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "The combination of NPS and trastuzumab demonstrated a clinically meaningful and statistically significant difference in the cohort of patients with TNBC with a 75.2% reduction in risk of relapse or death at 26 months. Importantly, following review of the final data that were also assessed by the independent Data Safety Monitoring Board (DSMB) on October 15, 2018, there was an incremental further improvement of clinical benefit to patients now observed in comparison with the data from the interim analysis completed more than six months ago."

The key data from today’s presentation, based on the final analysis, are shown below, including the summary table and the Kaplan-Meier (K-M) survival curve showing specifically the TNBC cohort:

Safety: Most treatment-emergent adverse events (TEAEs) were of mild or moderate (G1/2) severity (local: 98%; systemic: 93%). The majority of G3 systemic TEAEs were unrelated to NPS. Treatment-related adverse events consisted of manageable local injection site reactions, skin induration, pruritus, and fatigue.

Efficacy:
Outcomes Summary (comparison between the 2-arms of the study, i.e., Active: NPS + TZ, and Control: TZ alone):

Notably, the patient demographics and baseline disease characteristics were well balanced between the two arms, both in the intention-to-treat (ITT) and TNBC populations.

Elizabeth A. Mittendorf, M.D., Ph.D., Rob and Karen Hale Distinguished Chair in Surgical Oncology, Director of Research, Breast Surgical Oncology Brigham and Women’s Hospital, Director, Breast Immuno-Oncology Program Dana-Farber/Brigham and Women’s Cancer Center, and the Principal Investigator of the Phase 2b study commented: "It is encouraging to see that the final analysis of the NPS +/- trastuzumab Phase 2b trial for the TNBC cohort not only confirms the previously reported positive data, presented in full today, but also provides evidence for a significant clinically positive outcome with the combination. In many early stage TNBC patients, the benefit of initial treatment with neoadjuvant chemotherapy is incomplete, leaving room for improvement, especially in the adjuvant or maintenance setting. To date, targeted therapies have not proven effective for TNBC. Putting HER2 in the crosshairs of an immunotherapeutic combination, in this case NPS plus trastuzumab in triple-negative (HER2 IHC 1+/2+; hormone receptor negative) breast cancer patients, makes sense biologically considering preexisting activated cellular immunity in most patients with these tumors and the pharmacodynamic synergy between these two agents."

Dr. Stergiou further stated, "We look forward to continuing our discussions with U.S. and European regulatory agencies on the most optimal and expeditious development path for NPS in TNBC. To that end, we will be meeting with the FDA in December. We are also engaging in ongoing discussions with potential partners. I would like to thank all patients who participated in this NPS study, and their families and outstanding physicians, as well as our team at SELLAS and our supportive stockholders. As October is breast cancer awareness month, one could not have thought of a better timing to present this data, consistent with our mission to develop potentially life-saving drugs for patients in need."

Herceptin is a registered trademark of Genentech, Inc. and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

Conference Call

SELLAS will host a conference call on Monday, October 22, 2018 at 8:00 a.m. ET to discuss these data. To participate in the conference call, please dial (866) 416-7995 (domestic) or +1 (409) 217-8225 (international) and refer to conference ID 5571389. A live webcast of the call can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.sellaslifesciences.com.

An archived webcast recording will be available on the SELLAS website beginning approximately two hours after the call.

About ESMO (Free ESMO Whitepaper)

The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) is Europe’s leading non-profit medical oncology organization. ESMO (Free ESMO Whitepaper) is a membership-based society, comprising of 500 expert committee members and 18,000 oncology professionals. ESMO (Free ESMO Whitepaper) organizes a large number of meetings to provide its members and the community with the resources they need and also plays a major role in public policy and European affairs. The ESMO (Free ESMO Whitepaper) 2018 Annual Meeting represents a multi-professional platform for oncology education and exchange, and for immense international visibility for scientific research, and will be held under the tagline "Securing access to optimal cancer care."

On October 22, 2018 Athenex (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported the presentation of encouraging efficacy and safety data of Oraxol in the treatment of metastatic breast cancer patients who failed previous chemotherapies in a pharmacokinetics (PK) and phase II clinical trial conducted in Taiwan (Press release, Athenex, OCT 22, 2018, View Source [SID1234530117]). The data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on October 21, 2018 in Munich, Germany. Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy, combined with HM30181A (a novel gastrointestinal tract specific P-glycoprotein pump inhibitor).

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Results from twenty four patients with metastatic breast cancer were reported. Common metastatic sites included bone (n=12), liver (n=9), lungs (n=9), lymph nodes (n=9) and 6 patients had ³ 3 metastasis. These patients failed a median of two previous chemotherapies.

Eleven patients (45.8%) achieved partial remission (PR), 10 patients (41.7%) had stable disease (SD) (two patients with SD will have their last CT scans conducted in early November and therefore, the overall PR rate may be higher), and 3 patients had progressive disease (PD), as shown in the waterfall plot of tumor responses below:

Note that two patients with PD showed small tumor size changes of <30% but were classified as PD because new metastatic lesions were identified by CT scans (* indicates the two patients). Two SD patients are expected to complete their last CT scans in early November and the overall PR rate may be higher in the final analysis.

Drug-related serious adverse events consisting of Grade 4 neutropenia were observed in 3 patients and all recovered completely. There was no dose-limiting neuropathy observed. The Oraxol pharmacokinetic profiles at week 1 were reproducible at week 4, and the plasma AUC exposure is similar to those reported for intravenous paclitaxel at 80mg/kg weekly.

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, stated, "The encouraging pharmacokinetic profile and the positive Phase II clinical efficacy and safety data showed the excellent potential of Oraxol. We are advancing our Phase III program rapidly."

Dr. Ko-Chung Lin, Chief Executive Officer of PharmaEssentia, the licensee of Oraxol for Taiwan, Singapore and Vietnam, commented, "Athenex has been an excellent partner to PharmaEssentia. We have been working closely together on the clinical studies and on our discussions with the regulatory authorities. We are delighted to see such a wonderful set of encouraging results and we are fully committed to support the development of Oraxol in the territory we have licensed from Athenex."

The Orascovery program was initially discovered by Hanmi Pharmaceuticals and licensed to Athenex. PharmaEssentia Corporation (Taiwan Stock Exchange: 6446), licensed the Taiwan, Singapore and Vietnam commercialization rights of Oraxol from Athenex and is a close partner, particularly in the clinical developments of Oraxol in Taiwan.