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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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."

On October 22, 2018 Aclaris Therapeutics, Inc. (Nasdaq: ACRS), a dermatologist-led, biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet patient needs in aesthetic and medical dermatology and immunology, reported the closing of its underwritten public offering of 9,941,750 shares of its common stock at a price to the public of $10.75 per share, which includes the full exercise of the underwriters’ option to purchase 1,296,750 additional shares, for total gross proceeds of approximately $106.9 million, before deducting underwriting discounts and commissions and offering expenses (Press release, Aclaris Therapeutics, OCT 22, 2018, View Source [SID1234530061]). All of the common stock in the offering was sold by Aclaris.

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Leerink Partners and Evercore ISI acted as joint book-running managers for the offering. Cantor acted as lead manager for the offering. Guggenheim Securities acted as co-manager for the offering.

A shelf registration statement relating to this offering was filed with the Securities and Exchange Commission (SEC) on November 2, 2016 and declared effective by the SEC on November 14, 2016. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: (800) 808-7525, ext. 6132, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, by telephone at 888-474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On October 22, 2018 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported updated preliminary results from a Phase 2 clinical trial of its lead product candidate, tipifarnib, in squamous cell carcinomas with HRAS mutations (Press release, Kura Oncology, OCT 22, 2018, View Source [SID1234530048]). The results are being presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich. A copy of the presentation is available online at www.kuraoncology.com.

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As of the September 7, 2018 clinical data cutoff date, 17 patients with HRAS mutant head and neck squamous cell carcinomas (HNSCC) were enrolled in the ongoing Phase 2 trial. Tumor size reductions were observed in nine of 11 evaluable patients, with five confirmed partial responses (PRs) as defined by standard RECIST criteria, including three patients with durable responses lasting more than 17 months. A sixth patient achieved a confirmed PR after the data cutoff. Four patients had stable disease, including two patients who experienced prolonged disease stabilization lasting more than six months. Only one patient experienced progressive disease as best response.

Another patient with HRAS mutant HNSCC, who is currently being treated off-protocol, has been reported as an unconfirmed PR with a 40% tumor size reduction.

In addition, the ongoing Phase 2 trial enrolled six patients in an additional cohort of other HRAS mutant squamous cell carcinomas (SCCs). One of the two evaluable patients in this cohort achieved a confirmed PR. Four patients were not evaluable as of the data cutoff date, including two patients who were pending initial efficacy assessments.

An analysis of available tumor biopsy samples (n=20) indicated a significant association between the allele frequency of HRAS mutations and a patient’s best response to tipifarnib. Patients with HRAS mutant allele frequencies as low as 1% were treated with tipifarnib. Of the 13 HNSCC/SCC patients with a tumor HRAS mutant allele frequency greater than 20%, six achieved PRs, one achieved an unconfirmed PR and is ongoing, and two experienced disease stabilization greater than six months. No meaningful clinical benefit was observed in the seven patients with an allele frequency less than 20%. Data from The Cancer Genome Atlas (TCGA HNSCC, provisional) indicate that patients with an HRAS mutant allele frequency greater than 20% represent approximately 5% of the overall HNSCC population.

"The results from this study indicate that tipifarnib is active in this difficult-to-treat population, with rapid and durable responses independent of prior therapy," said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and principal investigator of the study. "These data are particularly encouraging when we consider the high unmet need for patients with recurrent, metastatic head and neck squamous cell carcinomas, despite the introduction of immunotherapy into the treatment paradigm."

Response rates for the three therapies approved for treatment of HNSCC in the second line, Keytruda (pembrolizumab), Opdivo (nivolumab) and Erbitux (cetuximab), range from 13-16%, with progression-free survival of approximately two months.

Patients in the Phase 2 trial of tipifarnib in HRAS mutant HNSCC had a median of two prior lines of therapy (range 1-5), with confirmed responses observed in patients who had progressed on cetuximab regimens, immunotherapy or both.

Dose-limiting, treatment-emergent adverse events in the trial included hematological events and gastrointestinal disturbances, which were managed by dose interruption and/or dose reduction. When dose interruption/delay is taken into account, the median dose received by trial patients across all three cohorts was determined to be 600 mg twice daily by Cycle 2. Four of the responses in the trial were achieved at the 600 mg dose, including one patient who started dosing at 600 mg due to frailty and experienced a PR, and three patients who were dose-reduced to 600 mg and experienced a confirmed PR. Two additional patients achieved disease stabilization greater than six months.

Based on the observations from this Phase 2 trial, Kura intends to introduce a minimum tumor HRAS mutant allele frequency, anticipated to be no lower than 20%, as an entry criterion and use 600 mg orally twice daily as the starting dose in its upcoming AIM-HN registration-directed study of tipifarnib in HRAS mutant HNSCC. Kura also intends to implement these modifications in its ongoing Phase 2 trial and anticipates being able to provide additional data in 2019.

"We are very encouraged by the progress reported today in the treatment of patients with HRAS mutant squamous cell carcinomas," said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. "These data provide

preliminary clinical evidence of successful targeting of RAS-driven tumors. Notably, we observed a significant association between HRAS mutant allele frequency and objective response. We believe this finding represents a meaningful advancement in the field of precision medicine that will help our efforts to deliver on the promise of tipifarnib as a therapy for the treatment of HNSCC. We are applying these learnings to our upcoming registration-directed trial, which remains on track to initiate by year end."

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 17:00 CET / 11:00 a.m. ET today, October 22, 2018, following the conclusion of Dr. Ho’s presentation at the ESMO (Free ESMO Whitepaper) 2018 Congress. The live call may be accessed by dialing (877) 516-3514 for domestic callers or (281) 973-6129 for international callers and using conference ID #6045389. A live webcast of the call will be available from the Investors and Media section of the company website at www.kuraoncology.com, and will be archived there for 30 days.

About Tipifarnib

Kura Oncology’s lead candidate, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown compelling and durable anti-cancer activity in certain patient subsets. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, the company is seeking to identify those patients most likely to benefit from tipifarnib. In addition to its development program in solid tumors with HRAS mutations, Kura has identified the CXCL12 pathway and bone marrow homing of myeloid cells as potential biomarkers of activity for tipifarnib in certain hematologic malignancies. The company expects to present biomarker-enriched data from peripheral T-cell lymphomas (PTCL) at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018.