On December 13, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that Dr. Gregory Adams, Chief Scientific Officer, will chair a session focused on antibody drug conjugates and fusion proteins at the Antibody Engineering and Therapeutics Meeting in San Diego, CA (Press release, Eleven Biotherapeutics, DEC 13, 2017, View Source [SID1234522620]). As part of the session, Dr. Adams will give a talk on the potential for tumor-targeted payloads to prime the immune system to facilitate more effective therapy in combination with immuno-oncology agents, including checkpoint inhibitors.

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"Checkpoint inhibitors are a significant step forward in the quest to engage the patient’s immune system in the fight against cancer. Checkpoint inhibitors function by blocking the signals that cancers use to inhibit the immune system. However, for checkpoint inhibitors to be effective, they require the presence of an active immune response against the cancer. There is broad recognition of the potential for tumor-targeted payloads, such as Eleven’s Targeted Protein Therapeutics (TPTs), to provide this spark to the immune system and act synergistically with checkpoint inhibitors," said Dr. Gregory Adams, Chief Scientific Officer of Eleven Biotherapeutics. "Earlier this year at the American Association of Cancer Research Conference, we presented data which supports this potential, demonstrating that TPTs induce immunogenic cell death as evidenced by the presence of damage-associated molecular patterns. Our collaboration with the National Cancer Institute and AstraZeneca aims to build on this evidence."

Session Details

Title: Antibody-Drug Conjugates & Fusion Proteins
Date: Wednesday, December 13, 2017
Time: 8:10 am – 12:00 pm PT
Location: Manchester Grand Hyatt; San Diego, CA

About Vicinium

Vicinium is manufactured as a single protein anti-epithelial cell adhesion molecule (anti-EpCAM) fusion protein fused with Pseudomonas Exotoxin A (ETA) designed to specifically target and deliver a potent anti-cancer payload directly into tumor cells. It is constructed with a stable, genetically-engineered linker to ensure its potent protein payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues thereby improving the compound’s safety. Vicinium’s one-step manufacturing process offers significant cost advantages and results in the production of a homogenous product, with less batch-to-batch variability than most antibody drug conjugates. Vicinium is currently in a Phase 3 registration clinical trial for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) in patients who have previously received two courses of Bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Eleven Biotherapeutics intends to enroll 134 subjects in the trial, including 77 subjects with carcinoma in situ (CIS), at over 70 centers in the United States and Canada. Primary and secondary endpoints include complete response (CR) in CIS subjects, time to disease recurrence and event free survival. The Company expects to complete patient enrollment in the first quarter of 2018 and to report topline three-month data in mid-2018.

On December 12, 2017 Palleon Pharmaceuticals, a company focused on developing Glycoimmune Checkpoint Inhibitors to treat cancer, reported an agreement with King’s College London to license intellectual property developed in the laboratory of Joy Burchell, Ph.D., Professor of Glyco-Oncology at the university. This agreement gives Palleon the exclusive rights to a patent portfolio that will facilitate the development of drugs that target Glycoimmune Checkpoints, a novel approach to overcoming resistance to first-generation immuno-oncology drugs.

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Professor Burchell has been a leader in the field of aberrant glycosylation in breast cancer for over 25 years. Earlier in her career she developed tools that demonstrated that more than 90% of breast cancers, and many other carcinomas, carry glycans that are different from those carried by proteins on normal cells. She was the first to show that a mucin known as MUC1 is present in the sera of breast cancer patients. This discovery enabled the development of the CA15.3 test, a serum assay used to measure the response to breast cancer treatment and to monitor recurrence of breast cancer. More recently, Professor Burchell has been investigating how aberrant glycosylation of MUC1 plays a significant role in immunosuppression and allows the cancer to thrive.

Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon, commented, "Professor Burchell’s research is at the forefront of understanding how tumors use glycans to evade the immune system. We now know that tumor cells down-regulate a wide spectrum of immune cell types by cloaking themselves in certain glycan patterns, and that this mechanism of immunosuppression can be targeted by a new class of drugs. This licensing agreement strengthens Palleon’s position as the leader in this new approach to defeating cancer’s suppression of the human immune system."

Dr. Burchell added, "We have known about the alteration of glycans on the surface of malignant cells for decades. However, recent discoveries in the field of glycoscience have demonstrated the role of glycans in immunosuppression. Glycobiology is now emerging as a major axis of immunosuppression in cancer. We expect these findings to provide the foundation for developing immuno-oncology drugs that will have a significant impact on the lives of patients."

On December 12, 2017 Repros Therapeutics Inc. (NASDAQ: RPRX) ("Repros" or the "Company") reported that it has entered into a definitive agreement under which Allergan plc ("Allergan"), through a subsidiary, will acquire Repros for a cash payment of $0.67 per share (Press release, Repros Therapeutics, DEC 12, 2017, View Source [SID1234522585]). The Company’s Board of Directors has unanimously approved the transaction.

Under the terms of the merger agreement, a subsidiary of Allergan will commence a cash tender offer to purchase all of the outstanding shares of Repros common stock for $0.67 per share. The closing of the tender offer is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Repros common stock. The merger agreement contemplates that Allergan, through its subsidiary, will acquire any shares of Repros that are not tendered into the offer through a second-step merger, which will be completed as soon as practicable following the closing of the tender offer. Pending approvals, Repros anticipates the transaction will close during the first quarter of 2018.

Stifel, Nicolaus & Company, Incorporated is serving as exclusive financial advisor to Repros, and Morgan, Lewis & Bockius LLP is serving as Repros’ legal counsel. Covington & Burling LLP is serving as Allergan’s legal counsel.

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On December 12, 2017 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing tumor-targeted and immuno-oncology therapies based on its pioneering research in cancer epigenetics, reported that the first patient has been dosed in its Phase 1b/2 PROSTAR study of CPI-1205, a small-molecule inhibitor of EZH2, combined with enzalutamide or abiraterone/prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Constellation Pharmaceuticals, DEC 12, 2017, View Source [SID1234522670]).

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"The initiation of this combination study marks a significant milestone for the company as we execute on our goal to rapidly advance our pipeline of epigenetic therapeutics that have the potential to address difficult-to-treat cancers," said Adrian Senderowicz, M.D., senior vice president and chief medical officer of Constellation Pharmaceuticals. "Today’s announcement marks the first evaluation of CPI-1205 in solid tumors. We anticipate advancing CPI-1205 and other therapies from our EZH2 portfolio in additional solid tumor clinical trials in the future."

CPI-1205 is a potent, highly selective, first-generation small-molecule inhibitor of EZH2, a clinically-validated target in cancer. In multiple types of cancer, including mCRPC, EZH2 contributes to drug resistance over time by enhancing pro-tumor pathways, such as androgen receptor signaling. CPI-1205 has shown single-agent activity and synergistic activity with small-molecule androgen inhibitors in preclinical studies. CPI-1205 has also demonstrated single-agent clinical activity and a dose-dependent increase in exposure correlated to pharmacodynamic biomarkers during a clinical trial of CPI-1205 in selected lymphoma patients.

"There is a tremendous need for new, safe and effective medicines for advanced prostate cancer, especially for men with progressive mCRPC," said Mary-Ellen Taplin, M.D., Dana-Farber Cancer Institute and an investigator in the trial. "We look forward to learning how CPI-1205 may help overcome resistance mechanisms in mCRPC and extend response to therapy."

The Phase 1b portion of the PROSTAR study is designed to assess safety, pharmacokinetics, pharmacodynamics, as well as a recommended Phase 2 dose (RP2D) of CPI-1205 in combination with either enzalutamide (marketed as Xtandi by Astellas and Pfizer) or abiraterone acetate (marketed as Zytiga by Janssen), which are FDA-approved second-generation androgen inhibitors. The Phase 2 portion of the PROSTAR study will assess clinical activity and potential biomarkers to identify patient populations with higher clinical anti-tumor activity to CPI-1205.

About mCRPC

mCRPC is an advanced form of prostate cancer and is defined by disease progression despite treatment with androgen depletion therapy (ADT). mCRPC may present as one, or any combination of, a continuous rise in serum levels of prostate-specific antigen (PSA), progression of known metastases, or appearance of new metastases. Prognosis is associated with several factors, including the ability to perform certain daily activities and the presence of bone pain. Additional symptoms commonly include anemia (low healthy red blood cell levels), weight loss, fatigue, hypercoagulability (abnormal blood coagulation) and increased susceptibility to infection. mCRPC presents as a spectrum of disease ranging from patients without symptoms but rising PSA levels despite ADT, to patients with metastases and significant debilitation.

About CPI-1205

CPI-1205 is a therapeutic candidate from Constellation Pharmaceuticals’ EZH2 portfolio and is an inhibitor of Enhancer of Zeste Homolog 2 (EZH2). The function of EZH2 is to selectively suppress gene expression of several pro-cancer pathways that contribute to drug resistance.

On December 12, 2017 CEL-SCI Corporation (NYSE American: CVM) reported that no further patient enrollment is required in the pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). The accrual and treatment phases of this Phase 3 study are complete (Press release, Cel-Sci, DEC 12, 2017, View Source [SID1234522593]). All of the 928 enrolled patients in the study are being followed-up as required by the study protocol.

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CEL-SCI recently announced that the study’s Independent Data Monitoring Committee (IDMC) completed its most recent review of the data from all 928 patients enrolled in the study, and recommended continuing the study as there was no evidence of any significant safety questions.

The primary endpoint of the study, a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. Standard of Care alone, will be determined after a total of 298 deaths have occurred in these two main comparator arms of the study and have been recorded in the study database. The last patient was enrolled in the study in September 2016. Approximately 135 patients were enrolled in the study from 2011 to 2013, about 195 were enrolled in 2014, about 340 in 2015, and about 260 in 2016. The study protocol assumed an overall survival rate of about 55% at 3 years for the SOC treatment group alone.

IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials, especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time.