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.

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 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;p=RssLanding&cat=news&id=2372632 [SID1234530108]). 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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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

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Tumor Response
Tumor Response

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 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:

A photo accompanying this announcement is available at View Source

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.

On October 21, 2018 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") is pleased to announce that it has closed its offering (the "Offering") of 17,144,314 units (the "Units") at a price of US$0.70 (the "Offering Price") for gross proceeds of approximately US$12 million in the United States and the Canadian provinces of Alberta, British Columbia, Manitoba, Ontario and Quebec (Press release, IntelGenx, OCT 22, 2018, View Source [SID1234530112]).

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Each Unit consists of one share of common stock (the "Offered Shares") and one half of one warrant (a "Warrant"), each whole Warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of US$1.00 per share. The Warrants are exercisable immediately and will expire on the third anniversary of the date of their issuance.

The Units were distributed under a final prospectus supplement to the U.S. registration statement on Form S-3 (File No. 333-227498) which was declared effective on October 15, 2018 (the "Registration Statement") and a final Canadian MJDS prospectus supplement to the Canadian MJDS short-form base shelf dated October 18, 2018 filed by the Company in connection with the Offering. Copies of the U.S. prospectus supplement and the Registration Statement can be obtained from the SEC’s website at www.sec.gov.

Copies of the final prospectus supplement and the Registration Statement may also be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by emailing [email protected].

The Offering was conducted, on a best efforts basis, by H.C. Wainwright & Co. ("Wainwright"), in its capacity as the exclusive placement agent for the Units offered in the United States, and Echelon Wealth Partners Inc., in its capacity as the exclusive placement agent for the Units offered in Canada ("Echelon" and collectively with Wainwright, the "Agents").

The Company has granted Echelon an over-allotment option exercisable, in whole or in part, at the sole discretion of Echelon, at any time prior to 5:00 p.m. (Montreal time) on the date that is the 30th day after the closing of the date hereof, to purchase shares of common stock of the Company and/or Warrants in an amount representing up to an additional 15% of the number of Units sold pursuant to the Offering, at the Offering Price to cover over-allocations, if any, and for market stabilization purposes.

The TSX Venture Exchange (the "TSXV") has conditionally approved the listing of the common stock that will be issued by the Company in the Offering, including the shares of common stock issuable upon the exercise of the Warrants. Listing on the TSXV will be subject to the Company fulfilling all of the listing requirements of the TSXV within 30 days of the closing of the Offering.

After the payment of the Agents’ commissions and the reimbursement of certain of the Agents’ Offering expenses and the payment of other Offering expenses, the Company expects the net proceeds from the Offering to be approximately US$10.5 million. The Company intends to use the net proceeds from the Offering for its 2a Montelukast Study, its Tadalafil 505(b)(2) submission to the U.S. Food and Drug Administration, and working capital.

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 [SID1234530095]). 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):

Outcome Parameters ITT TNBC cohort No hormone Rx cohort
N (both arms) 275 97 110*
Hazard ratio (HR) 0.62 0.26 0.23
P-value .175 .013 .008
Risk reduction at 24 mo (%) 37 75.2 75.9
24-mo DFS rate (Active) (%) 89.8 92.6 93.2
24-mo DFS rate (Control) (%) 83.8 70.2 71.7
*all patients from the TNBC cohort were included in the No Hormone Rx cohort

Log-rank (K-M) Disease-Free Survival (DFS) over the duration of the study in the TNBC cohort:
SELLAS Life Sciences Group
A chart accompanying this announcement is available at View Source

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."