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Heat Biologics CSO to Present Interim Results From the Monotherapy Arm in Its Ongoing HS-410 Phase 2 Bladder Cancer Trial at the Phacilitate Immunotherapy World Conference

On January 26, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported that Taylor Schreiber, M.D. Ph.D., Heat’s Chief Scientific Officer, will discuss three-month interim data from the unblinded, monotherapy cohort of the company’s ongoing Phase 2 trial of HS-410 (vesigenurtacel-L) for the treatment of high risk, non-muscle invasive bladder cancer (NMIBC) at the Phacilitate Immunotherapy World Conference in Washington, D.C. on January 25-27, 2016 (Press release, Heat Biologics, JAN 26, 2016, View Source [SID:1234508862]). In the monotherapy arm of Heat’s Phase 2 trial, a series of weekly intradermal injections of HS-410 is being dosed as an alternative to intravesical standard of care, Bacillus Calmette-Guérin (BCG).

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Dr. Schreiber will report that to-date HS-410 has been well-tolerated, with no serious adverse events. Six out of seven patients in the 25-patient arm, who have reached the 3-month timepoint after treatment with HS-410 alone, remain recurrence free. One of those patients had carcinoma in situ (CIS) – the patient population believed to be least responsive to BCG – and that patient experienced complete response. Images of the bladder taken from treated patients showed changes that resemble lymphoid (T cell rich) structures that we have observed in biopsy samples, indicating that HS-410 is generating an immune response as expected.

"These interim data are consistent with previous results from our Phase 1 trial, demonstrating that intradermal injections of HS-410 lead to a localized immune response within the urinary bladder," said Dr. Schreiber. "The fact that these localized immune responses are now being seen in the absence of standard of care, BCG, indicates that the response is due to HS-410. If the monotherapy arm of the trial demonstrates a trend toward low recurrence rates in the absence of BCG, that may extend options for subsequent pivotal study designs, and may potentially provide bladder cancer patients with an alternative to repeated BCG catheterization procedures. We look forward to presenting additional data from this trial in the future."

Heat continues to enroll the anticipated 25 patients who will receive HS-410 monotherapy and expects to complete enrollment in the first half of 2016. The three other blinded, randomized, placebo-controlled arms in the Phase 2 trial evaluating HS-410 in combination with BCG are fully enrolled with a total of 75 patients. Heat anticipates reporting topline efficacy, immune-response and safety data from those arms in the fourth quarter of 2016.

About HS-410 (vesigenurtacel-L)

HS-410 is an investigational product candidate for NMIBC based on Heat’s proprietary ImPACT immunotherapy platform, designed to generate CD8+ "killer" T cells that attack cancer cells. HS-410 is currently being evaluated in an ongoing Phase 2, placebo-controlled, 100-patient NMIBC trial at multiple centers and has been granted U.S. FDA Fast Track Designation for the treatment of NMIBC.

About Bladder Cancer

According to the American Cancer Society, bladder cancer is the fifth most common cancer in the U.S., with approximately 75,000 new cases and 16,000 deaths in 2015. About 75% of the newly diagnosed patients have NMIBC. A key issue for bladder cancer is the high rate of recurrence, for which limited treatment options are available beyond complete bladder removal.

Athenex Announces US FDA Allowance of the Investigational New Drug Application of Oradoxel, the Proprietary Oral Form of Docetaxel

On January 25, 2016 Athenex reported that it has received United States Food and Drug Administration (US FDA) allowance to proceed in the clinic with its proprietary oral form of Docetaxel (Press release, Athenex, JAN 25, 2016, View Source [SID1234517498]). This allowance to proceed represents Athenex’s sixth successful oncology investigational new drug (IND) application by the US FDA (5 oral anticancer drugs, one ointment) and the third such clinical drug candidate in Athenex’s oral absorption platform. Docetaxel is an established and effective high potency anti-cancer drug. Athenex has developed an oral form, called Oradoxel. The Athenex oncology oral absorption technology is based on a proprietary P-glycoprotein (Pgp) pump inhibitor ("Orascovery" platform) licensed exclusively from our business partner, Hanmi Pharmaceuticals, in 2011 for all major worldwide territories except Korea and Japan that were retained by Hanmi Pharmaceuticals. Athenex currently has the oral forms of paclitaxel and irinotecan in later stage clinical studies, which showed promising profiles in earlier clinical evaluations.

Douglas Kramer, MD, Athenex Vice President of Clinical Development and Regulatory Affairs stated "Our team submitted to the FDA a comprehensive IND package for Oradoxel of over 35,000 pages, including information on our oral absorption platform. Our Pgp pump inhibitor has been demonstrated to enhance the oral absorption of well-known oncology drugs that today are only available to patients as intravenous medicines. We are excited for the possibilities to make a difference in helping more cancer patients."

Gerald Fetterly, PhD, Athenex Vice President of Clinical Pharmacology added "We have learned in the clinic that converting existing intravenous high potency oncology drugs into oral forms opens the door to optimizing a wide array of patient dosing regimens which cannot be achieved with IV. Oral forms of dosing allow the patients to be exposed over a longer period of time to the potent active pharmaceutical ingredients and clinical studies have shown expected pharmacokinetic blood levels of exposure; leading to good clinical efficacy with less adverse side effects compared with the intravenous counterparts."

Athenex Chairman and CEO Johnson YN Lau, MBBS, MD, FRCP, commented, "I want to congratulate both our Athenex Hong Kong team and the Athenex US team, and thank our collaborators on this project on achieving this important successful regulatory milestone. The Oradoxel project was initially developed by the Athenex Hong Kong team in the Henry Cheng Research Laboratory for Drug Development, Department of Applied Biology and Chemical Technology (ABCT), The Hong Kong Polytechnic University and this project was also partially supported by a SERAP matching grant from the Hong Kong Innovation and Technology Commission. Hong Kong should be congratulated as an innovator of important drug development science for cancer patients globally. This accomplishment also reinforces the successful execution of our business strategy creating a medical technology bridge between China and the United States."

In addition to its primary territories, Athenex is also developing Oraxol and Oratecan with Hanmi Pharmaceuticals, the originator of the Orascovery platform, in Korea and Japan, with PharmaEssentia in Taiwan and Singapore, and with ZenRx in New Zealand and Australia.

Affimed Enters into Collaboration with Merck to Evaluate AFM13 in Combination with KEYTRUDA® (pembrolizumab) for Patients with Hodgkin Lymphoma

On January 25, 2016 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that it has entered into a clinical research collaboration in immunooncology with Merck (NYSE: M RK), known as MSD outside the United States and Canada (Press release, Affimed Therapeutics, JAN 25, 2016, View Source [SID:SID1234515606]). Under the terms of the agreement, Affimed will fund and conduct a Phase 1b clinical trial to investigate the combination of Merck’s anti - PD - 1 therapy, KEYTRUDA (pembrolizumab), with Affimed’s proprietary drug candidate AFM13 for the treatment of patients with Hodgkin lymphoma whose disease has relapsed or is refractory to chemotherapy, including treatment with the marketed antibody - drug - conjugate Adcetris TM (brentuximab vedotin). Merck will supply Affimed with KEYTRUDA for the clinical trial. The purpose of the study is to establish a dosing regimen for this combination therapy and assess its safety and efficacy. Affimed is on track to initiate the study in the first half of 2016.

AFM13 is a bispecific antibody targeting CD30, an antigen specifically expressed in a variety of T - and B - cell lymphomas and targeting CD16A, an antigen expressed on natural killer (NK - ) cells, which are important for the activation of the innate immune system and the subsequent killing of tumor cells. KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD - 1 and its ligands, PD - L1 a nd PD - L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.
In patient - derived xenograft models, AFM13, in combination with an antiPD1 antibody, demonstrated impressive synergy, with up to 90 percent of the tumor eradicated. In this preclinical work, conducted at Stanford University, it was also shown that both NK and Tcells infiltrated the tumors and that cytokine levels, including notably interferongamma, were elevated.
"Our development strategy is to combine our NKcell engagers with other immunotherapies that could enhance their efficacy through the uptake of both NK - cells and Tcells, and the collaboration with Merck is an important step in executing this strategy," said Dr. Adi Hoess, CEO of Affimed.

"AFM13, a firstinclass NKcell engager, has shown an acceptable safety profile and preliminary antitumor activity in the firstinhuman Phase 1 study . Additionally, preclinical studies indicate that a combination with an anti PD1 therapy could act synergistically and rep resent an additional future treatment option for patients." "Evaluating the potential for innovative combination therapies through strategic collaborations in difficulttotreat tumor types continues to be an important part of our clinical development program for KEYTRUDA," said Dr. Eric Rubin, vice president and therapeutic area head, oncology early - stage development, Merck Research Laboratories . "In partnering with companies such as Affimed, we continue our efforts to bring forward new scientific breakthroughs for patients with Hodgkin lymphoma and the field of immuno-oncology overall."

The agreement is between Affimed and Merck, through a subsidiary. The collaboration agreement includes a provision for the potential expansion of the collaboration to include a subsequent Phase 3 clinical trial. Additional details were not disclosed.

OncoMed Provides Update on Tarextumab Phase 2 Pancreatic Cancer ALPINE Trial

On January 25, 2016 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics,reported an update on the Phase 2 ALPINE clinical trial following a pre-planned January 23 interim efficacy assessment of the clinical trial by an independent data safety monitoring board (DSMB) (Press release, OncoMed, JAN 25, 2016, View Source [SID:1234508857]). The DSMB assessed data from 172 patients treated as of a January 6, 2016 data cutoff date.

From a safety standpoint, the DSMB recommended that the study proceed to completion without modification. No unexpected safety findings emerged from its review.

However, the DSMB informed OncoMed of several findings regarding futility of the trial, notably:

A statistically significant worsening of response rate and progression-free survival (PFS) in the treatment arm in the overall intent-to-treat population, as well as a negative trend in each Notch biomarker subgroup
A strong trend to lack of benefit in the treatment arm for overall survival (OS), regardless of Notch biomarker levels, suggesting a low probability of achieving a statistically significant OS benefit based on analyses reviewed by the DSMB

Based on this information, OncoMed is in the process of unblinding the trial to carefully assess the current results and determine appropriate next steps for this fully enrolled trial. Eighteen patients remain on study drug treatment (tarextumab or placebo) between 172 and 527 days.

"The findings communicated by the DSMB suggest a low likelihood of a statistically significant benefit in overall survival in the tarextumab ALPINE pancreatic cancer trial," said Paul J. Hastings, Chairman and CEO. "Our aim is to quickly unblind the trial and work with our clinical sites and investigators to verify, analyze, interpret, and fully understand the data, including Notch biomarker subgroup trends, and determine next steps."

The Phase 2 ALPINE trial is a randomized, double-blinded, multicenter clinical trial designed to evaluate the efficacy of tarextumab in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated Stage IV pancreatic cancer. The ALPINE study completed enrollment of 177 patients in August 2015. The trial was designed to compare the overall survival of patients receiving tarextumab 15 mg/kg every two weeks versus placebo in combination with Abraxane plus gemcitabine. Secondary and exploratory endpoints, including progression-free survival and overall response rate, pharmacokinetics, safety and other biomarkers, are to be evaluated. Overall survival, progression-free survival and overall response rates will be assessed using a predictive biomarker for high tumor Notch3 expression. Increased Notch3 expression is estimated to occur in approximately 70 percent of pancreatic tumors and is associated with poor patient outcomes.

Conference Call Today

OncoMed management will host a conference call today beginning at 8:30 a.m. ET/5:30 a.m. PT to answer investor and analysts questions regarding the ALPINE Phase 2 program.

Analysts and investors can participate in the conference call by dialing 1-855-420-0692 (domestic) and 1-484-756-4194 (international) using the conference ID# 37742080. The web broadcast of the conference call will be available for replay through February 15, 2016 via a link in the Investor Relations section of the OncoMed website.

About Tarextumab (anti-Notch2/3, OMP-59R5)
Tarextumab (anti-Notch2/3, OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies have suggested that tarextumab exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, tarextumab appears to have anti-cancer stem cell effects, and (2) tarextumab affects pericytes, impacting stromal and tumor microenvironment. Tarextumab is currently being studied in two randomized Phase 2 clinical trials. The "ALPINE" study (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) is assessing tarextumab with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in first-line advanced pancreatic cancer patients. The "PINNACLE" study (A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Platinum Therapy in Subjects with Untreated Extensive Stage Small Cell Lung Cancer) is testing tarextumab in combination with etoposide and cisplatin and etoposide and carboplatin in first-line extensive-stage small cell lung cancer patients. Tarextumab is part of OncoMed’s collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to tarextumab during certain time periods through completion of the proof-of-concept Phase 2 trials.

Immunocore’s IMCgp100 Granted Orphan Drug Designation by US FDA for the Treatment of Uveal Melanoma

On January 25, 2016 Immunocore, a world-leading biotechnology company developing novel T cell receptor (TCR) based biological drugs to treat cancer, infectious diseases and autoimmune disease, reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead programme, IMCgp100, for the treatment of uveal melanoma (Press release, Immunocore, JAN 25, 2016, View Source [SID1234518904]). The Orphan Drug status qualifies Immunocore for a number of development incentives and will enable Immunocore to receive fast track registration for IMCgp100, its lead ImmTAC (Immune mobilising mTCR Against Cancer) therapeutic.

Uveal melanoma, a rare disease in which cancer cells form in the tissues of the eye, comprises approximately 3% of all melanomas, and is the primary intraocular malignancy of the adult eye. There are currently no effective treatments on the market for this debilitating disease.

For a drug to qualify for orphan drug designation both the drug and the disease must meet certain criteria specified in the Orphan Drug Act (ODA) and FDA’s implementing regulations at 21 CFR Part 316.

IMCgp100 is Immunocore’s wholly-owned and most advanced ImmTAC, currently in Phase IIa clinical trials for the treatment of late stage cutaneous and uveal melanoma. To date, more than 85 patients have been treated with IMCgp100.

IMCgp100 was also accepted last year to participate in the European Medicines Agency’s (EMA) Adaptive Pathways Pilot Programme, part of the EMA’s strategy of providing timely access for patients to new medicines to treat serious conditions with high unmet medical need.

Eliot Forster, Chief Executive Officer of Immunocore, commented: "Immunocore now has the opportunity to fast-track this important programme, which we believe has the scope to offer a treatment option to people who currently have none. We look forward to accelerating the ongoing clinical programme with IMCgp100."