On May 19, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage immuno-oncology drug development company, reported that Paul Maffuid, PhD, Executive Vice President of Research and Development, will discuss MabVax’s unique approach to the discovery of fully human antibodies to cancer antigens and the resulting lead HuMab-5B1 clinical projects in a presentation at America’s Antibody Congress in San Diego on May 19-20, 2016 (Press release, MabVax, MAY 19, 2016, View Source [SID:1234512575]).

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Dr. Maffuid will outline the unique approach that MabVax has taken to the discovery of novel fully human antibodies from cancer patients vaccinated against their cancers. The discovery platform surveys the immune response of many patients by interrogating single B-cells from these patients who are producing antibodies against the intended target. These antibodies are then cloned, retaining the natively paired heavy and light chains of the antibody, and produced recombinantly. To date, MabVax has identified multiple antibodies with the selectivity, affinity, and cytotoxicity necessary to make them clinical development candidates. MVT-5873 is the company’s lead clinical development product and currently in a Phase I clinical trial in patients with metastatic pancreatic cancer. MVT-5873 (HuMab-5B1) is currently being evaluated at three centers in an open-label, multicenter, dose-escalation Phase I clinical trial as a single agent and in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer. MVT-2163 (89Zr-DFO-HuMab-5B) is the company’s lead immuno-PET imaging agent that utilizes the targeting specificity of MVT-5873. MVT-2163 will open as an open-label, multicenter, dose-escalation Phase I clinical trial early in June. MVT-1075 (177Lu-DTPA-HuMab-5B) is the company’s radioimmunotherapy agent and third clinical program from this platform. The radioimmunotherapy product is planned for introduction into the clinic early in 2017.

The MVT-5873 Phase I trial is designed to evaluate the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first cohort of patients is being enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient cohort will establish the safety and optimized dose of the antibody when administered with standard of care chemotherapy and a third patient cohort will be administered the optimized dose of antibody as a single agent for the treatment of patients with advanced cancer.

Dr. Maffuid will also present information regarding a second Phase I trial scheduled to begin in the next few weeks. This trial will evaluate MVT-2163, also based on HuMab-5B1 antibody, as a next-generation PET imaging agent for the diagnosis and management of patients with pancreatic cancer. When the antibody is combined with a radio-label as a novel PET imaging agent, the 89Zr-HuMab-5B1 product has demonstrated high-image resolution of tumors in established xenograft animal models, making it attractive diagnostic agent for detection of metastatic pancreatic cancer and for use in combination with the HuMab-5B1 therapeutic product.

The company is currently completing preclinical development activities to support filing an Investigative New Drug Application (IND) for MVT-1075 with the FDA later this year. A summary of preclinical data will be presented which demonstrated effectiveness in established xenograft animal models demonstrating potential as an therapeutic agent.

MabVax anticipates discussing preliminary results from both Phase I trials during the third quarter of this year.

On May 19, 2016 Celator Pharmaceuticals, Inc. (Nasdaq:CPXX) reported that Phase 3 clinical trial data for VYXEOS (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351), its lead product candidate, will be presented at upcoming medical conferences (Press release, Celator Pharmaceuticals, MAY 19, 2016, View Source [SID:1234512619]).

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Presentation at ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, June 3-7, 2016:

Date & Track Time:
Saturday, June 4, 2016 – 3:00pm to 6:00pm CT

Track:
Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Presentation Title:

Final results of a phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML

Presenter:
Jeffrey E. Lancet, M.D., H. Lee Moffitt Cancer Center & Research Institute

Abstract #:
7000

Presentation Time:
3:00pm to 3:12pm CT

Location:
Arie Crown Theatre

Presentation at EHA (Free EHA Whitepaper) Annual Congress in Copenhagen, June 9-12, 2016:

Date:
Saturday, June 11, 2016

Topic:
Acute Myeloid Leukemia – Clinical Session

Title:
New Compounds in AML Treatment

Presentation Title:
CPX-351 treatment of previously untreated older AML patients with high-risk AML markedly increases the response rate over 7+3 in patients with FLT3 mutations

Presenter:
Bruno C. Medeiros, M.D., Stanford University

Abstract Code:
S502

Presentation Time:
4:15pm to 4:30pm CET

Location:
Hall A3

The ASCO (Free ASCO Whitepaper) abstracts became available at 5:00pm ET on May 18th (abstracts.asco.org) and the EHA (Free EHA Whitepaper) abstracts at 12:00pm CET on May 19th (EHA Learning Center – Official eLearning Portal of the European Hematology Association (EHA) (Free EHA Whitepaper)).

Analyst and Investor Meeting on VYXEOS

Celator will host an Analyst and Investor meeting on Saturday, June 4, 2016 at the Chicago Marriott Downtown Magnificent Mile starting at 7:00pm CT. The meeting will discuss data from the Phase 3 clinical trial in high-risk AML patients. Seating is limited, please contact the Trout Group, Brooks Rahmer ([email protected]), regarding attendance. The meeting will be webcast and available on Celator’s website (www.celatorpharma.com).

About VYXEOS

VYXEOS (cytarabine:daunorubicin) Liposome for Injection, also known as CPX-351, is a nano-scale co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ration. VYXEOS represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nano-scale liposome in order to maintain the desired ratio following administration. The FDA granted Breakthrough Therapy designation to VYXEOS for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC. VYXEOS was granted orphan drug status for the treatment of AML by the FDA and the European Commission. VYXEOS was also granted Fast Track designation for the treatment of elderly patients with secondary AML by the FDA.

In a Phase 3 trial in patients with high-risk (secondary) AML, the median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving the standard of care regimen of cytarabine and daunorubicin known as 7+3, representing a 3.61-month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3. The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.

Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS. No substantial difference in Grade 3 or higher adverse events was observed between VYXEOS and 7+3. In the intent-to-treat population, Grade 3-5, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events. In the intent-to-treat population, Grade 3-5, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.

Celator published results from two randomized, controlled, Phase 2 trials with VYXEOS. The first trial was conducted in newly diagnosed elderly AML patients and the second trial was conducted in patients with AML in first relapse

On May 18, 2016 Merck KGaA, Darmstadt, Germany, and Pfizer reported that avelumab* presentations across seven different tumor types, including two oral presentations, will be featured at the 52nd American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3–7, 2016, in Chicago, IL (Press release, Merck KGaA, MAY 18, 2016, View Source;newsType=1 [SID:1234512553]). The avelumab presentations, from the rapidly accelerating JAVELIN clinical development program, include new study results from a number of difficult-to-treat cancers, including data from the pivotal Phase II trial of avelumab being investigated as second-line treatment for metastatic Merkel cell carcinoma (MCC). Additional data include highlights from mesothelioma, adrenocortical carcinoma, non-small cell lung cancer, and urothelial bladder, gastric and ovarian cancers, as well as updated safety data.

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"One of our key highlights for ASCO (Free ASCO Whitepaper) will be the new avelumab data in second-line metastatic Merkel cell carcinoma," said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. "As there are currently no approved treatments for this rare and aggressive cancer, these clinically meaningful data represent a breakthrough for this difficult-to-treat tumor type."

Since ASCO (Free ASCO Whitepaper) 2015, the collaboration between Merck KGaA, Darmstadt, Germany, and Pfizer has made significant progress. The JAVELIN development program for avelumab now includes 30 ongoing clinical programs and nine pivotal studies. As of May 2016, JAVELIN now includes approximately 2,200 patients, being treated across more than 15 tumor types.

"These data add to the growing body of evidence for avelumab, indicating efficacy and a favorable safety profile in multiple cancers, which supports ongoing development," said Chris Boshoff, M.D., PhD., Vice President and Head of Early Development, Translational and Immuno-Oncology at Pfizer Oncology. "Through our comprehensive JAVELIN clinical development program for avelumab, we are making meaningful advances for a broad range of patients with cancer."

Avelumab is an investigational, fully human antibody specific for a protein found on tumor cells called PD-L1, or programmed death ligand. As a checkpoint inhibitor, avelumab is thought to have a dual mechanism of action which is believed to enable the immune system to find and attack cancer cells. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells such as T-cells, exposing them to anti-tumor responses. Avelumab is also thought to help white blood cells such as natural killer (NK) cells find and attack tumors in a process known as ADCC, or antibody-dependent cell-mediated cytotoxicity.

A list of accepted avelumab abstracts is included below. The abstracts are also available on the ASCO (Free ASCO Whitepaper) website.

Title Lead Author
Abstract
ID /
Poster
No.

Presentation
Date / Time
Session
Oral Presentations
Mesothelioma
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced unresectable mesothelioma from the JAVELIN Solid Tumor Phase Ib trial: safety, clinical activity, and PD-L1 expression
Hassan R
Abstract
ID: 8503

Sunday, June 5
8:00 a.m. CDT
Arie Crown Theater

Lung Cancer –
Metastatic
Disease
Merkel Cell Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic Merkel cell carcinoma previously treated with chemotherapy: results of the Phase II JAVELIN Merkel 200 trial
Kaufman H
Abstract
ID: 9508

Monday, June 6
1:15 p.m. CDT
Arie Crown Theater

Melanoma/Skin
Cancers
Poster Discussions
Gastric/Gastro-esophageal
Junction Cancer
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced gastric or gastroesophageal junction cancer from the JAVELIN Solid Tumor Phase Ib trial: analysis of safety, clinical activity
Chung HC
Abstract
ID: 4009
Poster No.: 1

Saturday, June 4
8:00 a.m. CDT
Hall A

Gastrointestinal
(Noncolorectal)
Cancer
Urothelial Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic urothelial carcinoma from the JAVELIN Solid Tumor Phase Ib trial: analysis of safety, clinical activity, and PD-L1 expression
Apolo A
Abstract ID:
4514
Poster
No.: 137

Monday, June 6
1:00 p.m. CDT
Hall A

Genitourinary
(Nonprostate)
Cancer
Adrenocortical Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced adrenocortical carcinoma from the JAVELIN Solid Tumor Phase Ib trial: safety and clinical activity
Le Tourneau C
Abstract
ID: 4516
Poster
No.: 138

Monday, June 6
1:00 p.m. CDT
Hall A

Genitourinary
(Nonprostate)
Cancer
Poster Presentations
NSCLC
Avelumab (MSB0010718C; anti-PD-L1) as a first-line treatment for patients with advanced NSCLC from the JAVELIN Solid Tumor Phase Ib trial: safety, clinical activity, and PD-L1 expression
Verschraegen C
Abstract
ID: 9036
Poster
No.: 359

Saturday, June 4
8:00 a.m. CDT
Hall A

Lung Cancer –
Non-Small Cell
Metastatic
Gastric Cancer
Maintenance therapy with avelumab (MSB0010718C; anti-PD-L1) vs continuation of first-line chemotherapy in patients with unresectable, locally advanced or metastatic gastric cancer: the Phase III JAVELIN Gastric 100 trial
Moehler M
Abstract ID:
TPS4134
Poster No.:
124b

Saturday, June 4
8:00 a.m. CDT
Hall A

Gastrointestinal
(Noncolorectal)
Cancer
Gastric Cancer
Avelumab (MSB0010718C; anti-PD-L1) + best supportive care (BSC) vs BSC ± chemotherapy as third-line treatment for patients with unresectable, recurrent, or metastatic gastric cancer: the Phase III JAVELIN Gastric 300 trial
Bang Y-J
Abstract ID:
TPS4135
Poster No.:
125a

Saturday, June 4
8:00 a.m. CDT
Hall A

Gastrointestinal
(Noncolorectal)
Cancer
NSCLC
Avelumab (MSB0010718C; anti-PD-L1) vs platinum-based doublet as first-line treatment for metastatic or recurrent PD-L1–positive non-small-cell lung cancer: the Phase III JAVELIN Lung 100 trial
Reck M
Abstract ID:
TPS9105
Poster No.:
425a

Saturday, June 4
8:00 a.m. CDT
Hall A

Lung Cancer—
Non‐Small Cell
Metastatic
Advanced Cancer
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced cancer: safety data from 1300 patients enrolled in the Phase Ib JAVELIN Solid Tumor trial
Kelly K
Abstract ID:
3055
Poster No.:
377

Sunday, June 5
8:00 a.m. CDT
Hall A

Developmental
Therapeutics—
Immunotherapy
Advanced Malignancies
Avelumab (MSB0010718C; anti-PD-L1) in combination with other cancer immunotherapies in patients with advanced malignancies: the Phase Ib/II JAVELIN Medley study
Ribas A
Abstract ID:
TPS3106
Poster No.:
422b

Sunday, June 5
8:00 a.m. CDT
Hall A

Developmental
Therapeutics—
Immunotherapy
Ovarian Cancer
Avelumab (MSB0010718C; anti-PD-L1) in patients with recurrent/refractory ovarian cancer from the JAVELIN Solid Tumor Phase Ib trial: safety and clinical activity
Disis ML
Abstract ID:
5533
Poster No.:
356

Monday, June 6
1:00 p.m. CDT
Hall A

Gynecologic
Cancer
Ovarian Cancer
Avelumab (MSB0010718C; anti-PD-L1) ± pegylated liposomal doxorubicin vs pegylated liposomal doxorubicin alone in patients with platinum-resistant/refractory ovarian cancer: the Phase III JAVELIN Ovarian 200 trial
Pujade Lauraine E
Abstract ID:
TPS5600
Poster No.:
421b

Monday, June 6
1:00 p.m. CDT
Hall A

Gynecologic
Cancer
Renal Cell Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in combination with axitinib as first-line treatment for patients with advanced renal cell carcinoma
Larkin J
Abstract ID:
TPS4580
Poster No.:
199a

Monday, June 6
1:00 p.m. CDT
Hall A

Genitourinary
(Nonprostate)
Cancer

*Avelumab is the proposed nonproprietary name for the anti-PD-L1 monoclonal antibody (MSB0010718C). Avelumab is under clinical investigation and has not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.

About Avelumab

Avelumab (also known as MSB0010718C) is an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought to enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to potentially engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC). In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

On May 19, 2016 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada; hereinafter called "Sumitomo Dainippon Pharma") reported that clinical data of napabucasin (BBI608) and amcasertib (BBI503) will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 3 to June 7, 2016 (Press release, Dainippon Sumitomo Pharma, MAY 18, 2016, View Source [SID:1234512577]).

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Napabucasin: 6 presentations
1. ABSTRACT #3564, Poster #261: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-246: NCT02024607: Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) administered in combination with FOLFIRI +/- Bevacizumab (Bev) in patients (pts) with advanced colorectal cancer (CRC). The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

2. ABSTRACT #4128, Poster #120: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-118: NCT02231723: A Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) in combination with Gemcitabine and nab-Paclitaxel (nab-PTX) in patients (pts) with metastatic pancreatic cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

3. ABSTRACT #9093, Poster #416: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-201: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Non-Small Cell Lung Cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

4. ABSTRACT #1094, Poster #199: Sunday, June 5 from 8:00 a.m. – 11:30 a.m.:BBI608-201: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Triple Negative Breast Cancer. 2 The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

5. ABSTRACT #5578, Poster #401: Monday, June 6 from 1:00 p.m. – 4:30 p.m.:BBI608-118: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Platinum Resistant Ovarian Cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

6. ABSTRACT #TPS4144, Poster #129b: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.:BBI608-336: NCT02178956: The BRIGHTER trial: A phase III randomized double-blind study of BBI-608 + weekly paclitaxel versus placebo (PBO) + weekly paclitaxel in patients (pts) with pretreated advanced gastric and gastro-esophageal junction (GEJ) adenocarcinoma.
The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

Amcasertib: 1 presentation
1. ABSTRACT #6018, Poster #340: Saturday, June 4 from 1:00 p.m. – 4:30 p.m. (Poster Session) Saturday, June 4 from 4:45 p.m. – 6:00 p.m. (Poster Discussion Session):BBI503-101: NCT01781455: Phase I Extension Clinical Study of BB503, a First-in-Class Cancer Stemness Kinase Inhibitor, in Adult Patients with Advanced Head and Neck Cancer.
The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

On May 18, 2016 TG Therapeutics, Inc. (Nasdaq:TGTX), reported that updated data has been selected for presentation at the upcoming 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 3 – 7, 2016, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, MAY 18, 2016, View Source [SID:1234512600]).

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Poster Presentation & Discussion Session:

Title: Long-term follow-up of the PI3Kδ inhibitor TGR-1202 to demonstrate a differentiated safety profile and high response rates in CLL and NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: 7512 (Poster Board # 68)
Presentation Date & Time: Monday, June 6, 2016 8:00 AM – 11:30 AM CT
Track: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Howard A. Burris MD, Sarah Cannon Research Institute/Tennessee Oncology
Discussion Session:
1:15 PM – 2:45 PM CT, at Room E354b
A copy of the ASCO (Free ASCO Whitepaper) abstracts were made available today, May 18, 2016 at 5:00pm ET through the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.