On January 5, 2016 ASLAN Pharmaceuticals reported that we are pleased to announce that we have signed an expanded licensing agreement for the compound ASLAN003 with our partner Almirall S.A. (Almirall), a global pharmaceutical company based in Barcelona (Press release, ASLAN Pharmaceuticals, JAN 5, 2016, View Source [SID:1234512876]).

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Under the terms of the broadened licence agreement, Almirall has granted ASLAN global rights to develop and commercialise ASLAN003 for all non-topical and non-dermatological indications including oncology.

On January 5, 2016 Millendo Therapeutics, Inc., reported that it has entered into an exclusive license agreement with AstraZeneca for the worldwide development and commercialization rights to AZD4901, a product candidate for the treatment of polycystic ovary syndrome (PCOS), the most common endocrine disease in women (Press release, Millendo Therapeutics, JAN 5, 2016, View Source [SID:1234512825]). The Company will develop the compound as MLE4901. In addition, Millendo has secured a $62 million Series B investment led by New Enterprise Associates, Inc. Previously known as Atterocor, Inc., Millendo is a biopharmaceutical company focused on developing novel approaches for the treatment of orphan and specialty endocrine diseases.

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"This acquisition of MLE4901 combined with the new funding and our current programs around ATR-101 puts us on a new trajectory to build a specialty pharmaceutical company focused on multiple diseasemodifying treatments for endocrine disorders caused by hormone dysregulation," said Julia Owens, President and CEO of Millendo. "We are committed to developing novel treatment options for patients with significant unmet medical needs and we believe that MLE4901, a first-in-class, first-in-disease, nonhormonal therapy, has tremendous potential in the treatment of PCOS, for which there are currently no approved therapies." Owens continued, "Our new company name reflects our vision to develop a robust pipeline of endocrine therapeutics."

Under the terms of the licensing agreement, Millendo acquired global rights to develop and commercialize MLE4901. In exchange, AstraZeneca will receive an upfront payment and take an equity stake in Millendo, as well as development and commercial milestone payments. In addition, AstraZeneca is eligible to receive royalties on net product sales.

The financing was led by New Enterprise Associates and included new investors Roche Venture Fund, Adams Street Partners, Altitude Life Science Ventures, Longwood Fund, and Renaissance Venture Capital Fund, along with current Millendo investors Frazier Healthcare Partners, Osage University Partners, 5AM Ventures, and the Regents of the University of Michigan under the MINTS Program (Michigan Investment in New Technology Startup). In conjunction with the financing, Tracy Saxton of the Roche Venture Fund will join Millendo’s Board of Directors and Carol Gallagher will represent New Enterprise Associates, shifting from her role as an independent board member.

"Endocrine diseases represent a tremendous unmet medical need as well as an opportunity to develop a company focused on tackling these diseases," commented Carol Gallagher, partner at New Enterprise Associates. "Millendo has assembled an exceptionally strong team of drug development experts in this field as well as a portfolio of drug candidates that will make an important impact on the lives of many patients."

MLE4901 was developed on AstraZeneca’s Open Innovation platform, an industry-leading program that allows for the clinical development of compounds that do not fall under AstraZeneca’s R&D core focus areas. Under this pioneering effort in drug repositioning, when studies yield results indicative of a breakthrough therapy for patients, AstraZeneca partners the compound, concept, and data for prompt development to market.

"This is an example of how we are pushing the boundaries of science and collaborating with industry in an open manner to expedite the delivery of novel medicines to patients," said Kumar Srinivasan, Vice President of Scientific Partnering and Alliances with AstraZeneca’s Innovative Medicines and Early Development (IMED) Biotech unit. "Millendo’s focus and expertise in specialty endocrine diseases makes them uniquely positioned to develop this compound and bring it to patients."

About Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is the most common endocrine disease in women, and is estimated to affect 5-15% of the female population. PCOS is caused by Gonadotropin Releasing Hormone (GnRH) hyperpulsatility, which leads to increased luteinizing hormone (LH) pulse frequency and downstream hormonal abnormalities including androgen excess. Clinical symptoms include androgen excess, menstrual dysfunction, metabolic syndrome, and infertility. Current treatments are used off-label and directed at managing symptoms. There are no approved therapies for PCOS on the market.

About MLE4901

MLE4901 is a Neurokinin 3 receptor (NK3R) antagonist that acts to diminish GnRH hyperpulsatility and luteinizing hormone (LH) pulse frequency. In a Phase 2a clinical trial, significant reductions in LH and testosterone were observed in PCOS patients treated with MLE4901.

About ATR-101

ATR-101 is a selective small molecule inhibitor of ACAT1, which reduces adrenal steroids and induces apoptosis of cells derived from the adrenal cortex. ATR-101 is currently in clinical development for the treatment of adrenocortical carcinoma (ACC) with additional development areas to include congenital adrenal hyperplasia (CAH) and endogenous Cushing’s syndrome (CS).

On January 5, 2016 Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapeutics for cancer patients, reported that it intends to offer and sell up to $120,000,000 of shares of its common stock in an underwritten public offering (Press release, Epizyme, JAN 5, 2016, View Source [SID:1234508671]). Epizyme intends to grant the underwriters a 30-day option to purchase up to an additional $18,000,000 of shares of its common stock. All of the shares of common stock to be sold in the offering will be offered by Epizyme.

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Epizyme intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to:

Fund the global development costs of tazemetostat, Epizyme’s novel oral EZH2 inhibitor, outside of Japan, including the costs of the following clinical trials:

the ongoing five-arm phase 2 study in patients with non-Hodgkin lymphoma;

the recently initiated phase 2 study in adult patients with INI1-negative tumors, certain SMARCA4-negative tumors or synovial sarcoma;

the recently initiated phase 1 study in pediatric patients with INI1-negative tumors, certain SMARCA4-negative tumors or synovial sarcoma;

the planned clinical trial of tazemetostat in combination with R-CHOP in front-line elderly patients with diffuse large B-cell lymphoma;

the planned clinical trial of tazemetostat in combination with a B-cell signaling agent or immuno-oncology agent in patients with B-cell non-Hodgkin lymphoma; and

the planned phase 2 study of tazemetostat in BAP1-mutated mesothelioma;

Initiate market development activities, begin building regulatory and commercial strategies to prepare for the global launch of tazemetostat, if approved, and expand the company’s clinical and regulatory capabilities;

Fund research and development to advance the company’s pipeline of preclinical product candidates and its programs that are subject to the Celgene collaboration and to expand its drug development platform; and

For working capital and other general corporate purposes.

Citigroup, Leerink Partners LLC and RBC Capital Markets, LLC are acting as joint book-running managers for the offering. JMP Securities and Wedbush PacGrow are acting as co-lead managers for the offering with Mizuho Securities USA Inc. acting as co-manager. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

A shelf registration statement relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on May 4, 2015 and declared effective by the SEC on May 29, 2015. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement related to the offering is expected to be filed with the SEC and, if and when filed, copies of the preliminary prospectus supplement relating to the offering may be obtained for free by visiting EDGAR on the SEC website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] or by phone at 800-831-9146; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by email at [email protected], or by phone at 1-800-808-7525 ext. 6142; or RBC Capital Markets, LLC, 200 Vesey Street, 8th Floor, New York, NY 10281-8098; Attention: Equity Syndicate; Phone: 877-822-4089; Email: [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 January 5, 2016 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in 2015 it enrolled 340 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, JAN 5, 2016, View Source [SID:1234508669]). In the month of December it enrolled 33 patients. Total patient enrollment for the trial is now 668 as of December 31, 2015 in the world’s largest Phase 3 study in head and neck cancer.

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The enrollment of 340 patients in the study during 2015 represents a 75% increase over total patient enrollment of 195 in 2014. It also exceeds the total number of patients enrolled in the prior four years combined from 2011 through 2014.

Geert Kersten, CEL-SCI’s CEO, stated, "2015 has been a record breaking year for us in terms of patient enrollment, a key indicator of the progress we are achieving in our Phase 3 head and neck cancer trial. We believe that doctors would likely not be enrolling new patients in the study unless they believed that the Multikine treatment regimen was benefiting their patients. We further believe that Ergomed, the Clinical Research Organization (CRO) running the Phase 3 study since 2013, would not have invested an additional $2 million, for a total of $12 million, into the Phase 3 study if did not see a good chance of success."

Mr. Kersten added, "We also believe that this strong patient enrollment will be very helpful to us in CEL-SCI’s ongoing $50 million plus arbitration claim against the former CRO that used to run our Phase 3 study."

The current study goal is to enroll 880 patients through approximately 100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

On January 5, 2016 OncoMed Pharmaceuticals Inc. (NASDAQ: OMED) reported the achievement of two milestones from Celgene Corporation and pre-announced its 2015 year-end pro-forma cash balance and key anticipated events for 2016 (Filing, 8-K, OncoMed, JAN 5, 2016, View Source [SID:1234508667]).

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OncoMed achieved the $70 million safety milestone from Celgene based on an analysis of available Phase 1b and blinded interim Phase 2 clinical trial safety data associated with the demcizumab (anti-DLL4, OMP-21M18) program. The data from the pancreatic, non-small cell lung and ovarian cancer clinical trials showed no demcizumab-related Grade 3 or higher cardio-pulmonary toxicities among 155 patients treated with truncated dosing. Of those, 68 patients have received at least two cycles of demcizumab at the Phase 2 dose or higher and have been followed for at least 100 days. OncoMed also achieved a $2.5 million milestone for clinical candidate designation of an undisclosed preclinical immuno-oncology program, "IO#2". This is OncoMed’s second immuno-oncology program to reach clinical candidate designation, and both programs are advancing in IND-enabling studies.

Including the Celgene milestones, OncoMed ended 2015 with approximately $227.2 million in pro-forma cash, representing approximately 1.5 years of cash, without taking into account future potential milestone payments from partners, and exceeding its 2015 guidance predicting a year-end cash balance of greater than $120 million. Full-year operating expenses for 2015 are anticipated to be approximately $110 million, in accordance with previous guidance. OncoMed plans to provide full-year 2016 guidance during its 2015 fourth quarter earnings call in the first quarter of 2016.

"The achievement of the demcizumab $70 million safety milestone is based on extensive Phase 1b and blinded Phase 2 data, and positions OncoMed to rapidly enroll its Phase 2 randomized YOSEMITE and DENALI clinical trials, as well as the Phase 1b demcizumab plus pembrolizumab (anti-PD1) trial, and also to explore the potential of demcizumab in ovarian cancer," said Paul J. Hastings, OncoMed’s Chairman and Chief Executive Officer. "We enter 2016 in a strong cash position to support all seven internally discovered programs through clinical trials, including four randomized Phase 2 clinical studies, and to advance two immuno-oncology candidates toward IND filings while maintaining ongoing discovery efforts. Over the course of this year, we anticipate completing and reporting on our first randomized Phase 2 clinical trial, the tarextumab ALPINE study in pancreatic cancer, presenting additional data from our ongoing clinical- and discovery-stage programs, filing at least one new IND and achieving additional milestones related to our collaborations."

2016: Anticipated Key Financial Milestones and Pipeline Progress by Program
Demcizumab (anti-DLL4, OMP-21M18)

• Present updated Phase 1b survival data for demcizumab in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in previously untreated pancreatic cancer at the Gastrointestinal Cancer Symposium (ASCO GI) being held January 21-23, 2016 in San Francisco, CA. OncoMed’s presentation, titled "A Phase 1b study of the anti-cancer stem cell agent demcizumab (DEM) and gemcitabine (GEM) +/- nab-paclitaxel in patients with pancreatic cancer (Abstract 341)," will be presented by Dr. Manuel Hidalgo during Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract on Friday, January 22, 2016.
• Initiate Phase 1b clinical trial of demcizumab plus anti-PD1 pembrolizumab in the first quarter of 2016.

• Update survival data from the demcizumab Phase 1b non-small cell lung cancer (NSCLC) clinical trial.

• At the ASCO (Free ASCO Whitepaper) meeting in June 2015, OncoMed reported Phase 1b clinical trial data in NSCLC for 23 advanced-stage patients who received continuous dosing of demcizumab plus standard-of-care chemotherapy. These data showed that 43 percent (10 of 23) of patients were alive past two years, demonstrating prolonged survival in this subset of patients. A recent update of continuous dosing data revealed one additional death with 39 percent (9 of 23) of patients alive past 2 years.

• In August, 2015, OncoMed updated survival data for 23 patients who received truncated doses of demcizumab plus chemotherapy and were showing a similar trend toward improved survival. At that time, fifty-two percent (12 of 23) of patients who received truncated doses of demcizumab plus carboplatin and pemetrexed remained alive from 8-30 months after initial dosing. A recent update of these data has revealed four additional deaths. Currently, 35 percent (8 of 23) of patients remain alive between 12 and 34 months after the initiation of treatment and median overall survival is 11.6 months. Although these data represent a Phase 1b clinical trial in small numbers of patients, they suggest that a subset of patients treated with the demcizumab truncated dosing regimen in NSCLC continues to derive long-term benefit. These data continue to support and enable the current randomized Phase 2 "DENALI" trial.

• Complete enrollment in the randomized Phase 2 "YOSEMITE" clinical trial of demcizumab in combination with Abraxane and gemcitabine in patients with first-line pancreatic cancer by year end. Data from this study are expected to be available by early 2017.

• Continue enrollment in the Phase 2 "DENALI" clinical trial of demcizumab plus carboplatin and pemetrexed in first-line non-squamous NSCLC.

• Report results from the ovarian cancer Phase 1b trial of demcizumab plus paclitaxel.
The next potential financial milestone for demcizumab is an opt-in payment from Celgene that may occur through the end of either of the Phase 2 pancreatic cancer or NSCLC trials. Following option exercise, OncoMed and Celgene will co-develop and co-commercialize demcizumab in the U.S., sharing profits 50/50, while Celgene would lead development and commercialization outside the U.S.
Tarextumab (anti-Notch 2/3, OMP-59R5)

• Present updated survival data from the Phase 1b clinical trial of tarextumab plus chemotherapy in small cell lung cancer at the time of the IASLC 16th Annual Targeted Therapies of Lung Cancer Meeting being held February 17-21, 2016.

• Report top-line results from the Phase 2 "ALPINE" clinical trial of tarextumab in combination with Abraxane plus gemcitabine in advanced pancreatic cancer during the second half of 2016.
GlaxoSmithKline (GSK) may exercise the option for tarextumab through the end of either of the randomized Phase 2 clinical trials in pancreatic or small cell lung cancers. If GSK elects to exercise its option, OncoMed is eligible to receive a $25 million payment, and GSK would lead and fully fund further development and commercialization.
Wnt programs – Vantictumab (anti-Fzd7, OMP-18R5) and Ipafricept (Fzd8-Fc, OMP-54F28)

• Advance vantictumab and ipafricept through multiple ongoing Phase 1b clinical studies.
Bayer can elect to exercise its options on vantictumab and ipafricept at any point through completion of Phase 1b trials. OncoMed and Bayer amended their agreement November 2015 to enroll up to 24 additional subjects in the ongoing Phase 1b clinical trials of vantictumab in breast cancer and ipafricept in ovarian cancer. Bayer has agreed to reimburse OncoMed for all out-of-pocket expenses to support this additional patient enrollment. OncoMed anticipates presenting opt-in packages to Bayer for both vantictumab and ipafricept in late 2016/early 2017.
Brontictuzumab (anti-Notch1, OMP-52M51)

• Initiate Phase 1b clinical trial of brontictuzumab combined with FOLFIRI in colorectal cancer patients including an expansion cohort of biomarker-selected subjects based on promising data presented in November 2015 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).
GSK may currently elect to opt in brontictuzumab at the end of Phase 1a, for a fee of $18.75 million or at the conclusion of Phase 2 for a fee of $25 million. GSK and OncoMed have agreed to share out-of-pocket costs on the Phase 1b clinical trial described above, and are currently discussing a potential extension of GSK’s Phase 1a option through the end of Phase 1b.
Anti-DLL4/VEGF bispecific (OMP-305B83)

• Aim to present data from the Phase 1a dose-escalation clinical trial of anti-DLL4/VEGF bispecific. Presentation of data will be contingent on the number of dose cohorts needed to identify a Phase 2 single-agent dose and abstract acceptance at a scientific conference.
Through the conclusion of the Phase 1a and 1b clinical trials, Celgene may exercise its option to co-develop and co-commercialize anti-DLL4/VEGF bispecific.
Anti-RSPO3 (OMP-121R10)

• Initiate enrollment of Phase 1a biomarker-selected expansion cohort

• Aim to present Phase 1a data at an upcoming medical meeting in the second half of 2016, contingent upon dose-escalation and abstract acceptance.

• Initiate enrollment of Phase 1b component in the first-in-human trial of anti-RSPO3 in combination with FOLFIRI chemotherapy in subjects with colorectal cancer including biomarker-positive subjects.
As with the anti-DLL4/VEGF bispecific, Celgene may exercise its option to co-develop and co-commercialize anti-RSPO3 through the conclusion of the Phase 1 clinical trial.
Immuno-oncology Pipeline

• Advance either the immuno-oncology product candidate that is part of OncoMed’s collaboration with Celgene (IO#2) or OncoMed’s wholly owned GITRL-Fc program to an Investigational New Drug (IND) application filing by the end of 2016. Both programs are currently advancing in IND-enabling preclinical studies.
OncoMed estimates that over the course of the next two-to-three years (2016, 2017 and 2018), the company may be eligible to receive more than $168 million in potential opt-in payments from its collaboration with Celgene, $60 million in potential opt-in and milestone payments from Bayer and $43 million in potential opt-in payments from GSK. Overall, in future years, OncoMed is eligible for more than $5 billion in total potential milestone and option payments from its partners under its collaboration agreements with Celgene, Bayer, and GSK. To date, OncoMed has received over $450 million from its existing partners.
Reminder: OncoMed Chairman and CEO Paul J. Hastings will present at the 34th Annual JP Morgan Healthcare Conference in San Francisco on Thursday, January 14, 2016 at 10:00 am Pacific Time. The presentation will be webcast live and available for replay from the OncoMed website in the Investor Relations section.