On May 20, 2016 TG Therapeutics, Inc. (Nasdaq:TGTX), reported that updated data has been selected for presentation at the upcoming 21st European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, to be held from June 9 – 12, 2016 in Copenhagen, Denmark (Press release, TG Therapeutics, MAY 20, 2016, View Source [SID:1234512627]).

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Presentations Include:

Title: Long-term follow-up of the next generation PI3K-delta inhibitor TGR-1202 demonstrates safety and high response rates in CLL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P207
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Anthony Mato, MD, University of Pennsylvania, Philadelphia, PA

Title: Long-term follow-up of the next generation PI3Kδ inhibitor TGR-1202 demonstrates safety and high response rates in NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P315
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Owen A. O’Connor, MD, PhD, Columbia University Medical Center, NY, NY

Title: Preliminary results of a Phase I/Ib study of ibrutinib in combination with TGR-1202 in patients with relapsed/refractory CLL or MCL
Abstract Number: E1053
E-poster Presentation
Presenter: Matthew S. Davids MD, Dana-Farber Cancer Institute, Boston, MA

A copy of the EHA (Free EHA Whitepaper) abstracts were made available yesterday, May 19, 2016 through the EHA (Free EHA Whitepaper) meeting website at www.ehaweb.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.

On May 19, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported the publication of three abstracts which were accepted for the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from June 3 to June 7 in Chicago, Illinois, USA (Press release, MorphoSys, MAY 19, 2016, View Source [SID:1234512586]). The abstracts include updated clinical data on the Company’s proprietary drug candidate MOR202 from a phase 1/2a study in patients with multiple myeloma as well as a patient subgroup analysis from the phase 2 study of MOR208 in non-Hodgkin’s lymphoma (NHL). The MOR202 abstract has also been selected by the conference organizers for discussion in a separate session. In addition, partners of MorphoSys will present data on several HuCAL antibodies that are currently in clinical development.

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"We are delighted to publish a new package of clinical data at the preeminent conference on clinical oncology. The data set provides additional insight into the progress of our lead cancer compounds MOR208 and MOR202," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "For MOR202, we are in particular looking forward to presenting additional efficacy data from the dose escalation Phase 1/2a study in multiple myeloma in combination with lenalidomide and with pomalidomide."

List of abstracts relating to MorphoSys’s proprietary programs

Abstract #8012

MOR202 alone and in combination with pomalidomide or lenalidomide in relapsed or refractory multiple myeloma: Data from clinically relevant cohorts from a phase 1/2a study.

The poster presentation will include safety results and, in particular, efficacy from additional patient cohorts receiving the anti CD38 antibody MOR202 alone and in combination with pomalidomide or lenalidomide from the ongoing trial. The poster presentation will take place on Monday, June 6, 8:00 am – 11:30 am CDT, as part of the Hematologic Malignancies – Plasma Cell Dyscrasia track. The findings will be discussed at the poster discussion session on Monday, June 6, 2016, 3:00 PM – 4:15 PM CDT, at E354b.

Abstract #7545

Subgroup analyses of diffuse large B-cell lymphoma (DLBCL) and indolent lymphoma cohorts from a phase 2a study of single-agent MOR208 in patients with relapsed or refractory non-Hodgkin’s lymphoma (R-R NHL).

The poster presentation will include a subgroup analysis of an open-label, multicenter, phase 2a study of the anti-CD19 antibody MOR208 in R-R NHL patients progressing after at least one prior rituximab-containing therapy, as described in the abstract. The poster presentation will take place on June 6, 8:00 am – 11:30 am CDT, as part of the Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia track.

Abstract #TPS7572

A phase 2 study of MOR208 plus idelalisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously treated with a Bruton’s tyrosine kinase inhibitor

The poster presentation will include the trial design of an intended phase 2 study (COSMOS), which was originally planned to evaluate MOR208 in combination with idelalisib in CLL and SLL, in particular ibrutinib-refractory CLL, as described in the abstract. After the discontinuation of several combination trials of idelalisib with other compounds and clinical holds by the regulatory authorities in Europe and the U.S., this planned trial is currently under review and discussions with regulatory authorities are ongoing. The poster presentation will take place on June 6, 8:00 am – 11:30 am CDT, as part of the Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia track.

List of abstracts for programs from MorphoSys’s partnered discovery business

Additionally, MorphoSys’s partners will present data for several HuCAL antibodies, which are currently in clinical development:

Abstract #TPS8576

A pivotal randomized phase 2 study of anetumab ravtansine or vinorelbine in patients with advanced or metastatic pleural mesothelioma after progression on platinum/pemetrexed-based chemotherapy (NCT02610140).

Abstract #8564

Updated results of phase 1b study of tarextumab (TRXT, anti-Notch2/3) in combination with etoposide and platinum (EP) in patients (pts) with untreated extensive-stage small-cell lung cancer (ED-SCLC).

Abstract #530

Phase 1b/2 trial of BI 836845, an insulin-like growth factor (IGF) ligand-neutralizing antibody, combined with exemestane (Ex) and everolimus (Ev) in hormone receptor-positive (HR+) locally advanced or metastatic breast cancer (BC): primary phase 1b results.

Abstract #3002

Phase 1b study of PF-05082566 in combination with pembrolizumab in patients with advanced solid tumors.

Abstract #2516

Phase 1b study of WNT inhibitor vantictumab (VAN, human monoclonal antibody) with Paclitaxel (P) in patients (pts) with 1st- to 3rd-line metastatic HER2-negative breast cancer (BC).

Abstract #2509

Phase I study of anti-mesothelin antibody drug conjugate anetumab ravtansine (AR).

The full abstracts can be accessed online at View Source

On May 19, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "the Company"), reported the availability of an abstract titled "A phase 2 study of intralesional PV-10 followed by radiotherapy for localized in transit or recurrent metastatic melanoma" that has been published in conjunction with the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") being held in Chicago June 3-7, 2016.

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To see this abstract, visit: View Source

The abstract, ID: e21072, was published May 18, 2016, and is authored by Matthew Foote and colleagues at the Princess Alexandra Hospital and University of Queensland, in Brisbane, Australia.

Eric Wachter, Ph.D., Chief Technology Officer of Provectus, noted, "This abstract describes initial analysis of data from an investigator-initiated study of PV-10 followed by regional radiotherapy for refractory melanoma. Patients received a single course of PV-10, and if not immediately achieving a complete response they received a modest dose of radiation 6-10 weeks later. This combination yielded an 87% response rate with a third of patients achieving complete response. The response was durable (12.2 months mean duration of complete response), however, the protocol did not allow for subsequent retreatment, and the authors report that 80% of patients eventually had recurrence. Nonetheless, the melanoma specific survival of almost 5 and a half years is encouraging, and I agree with the authors’ conclusion that these results justify expanded evaluation in a randomized trial."

Wachter continued, "This work arose from observations by these same researchers several years ago that, as they stated at the time, melanoma patients treated with PV-10 followed by external beam radiotherapy ‘had an impressive response.’ Also as observed in those early cases, the data reported in this ASCO (Free ASCO Whitepaper) abstract show that there appears to be minimal potential for increased side effects when PV-10 is used in combination with radiotherapy."

Wachter concluded, "The primary purpose of presenting research data at international meetings such as ASCO (Free ASCO Whitepaper) is to share knowledge within the medical community. An important implication of this is fostering dialog within the community regarding appropriate use of such data. In this case, I hope this initial report will help foster relationships that facilitate advancement of these findings into advanced studies, as suggested by the authors."

On April 16, 2018 Abpro, an integrated life science company at the forefront of synthetic biology, reported co-development agreements with Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital (BWH), two of the country’s leading academic medical centers (Press release, abpro therapeutics, MAY 19, 2016, View Source [SID1234525613]). By leveraging Abpro’s DiversImmune platform, Abpro will co-develop multiple monoclonal antibodies with MGH for use in its oncology and inflammation and autoimmunity research programs and with BWH for its fibrosis research, according to these independent and separate agreements.

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With MGH, Abpro will collaborate with John H. Stone, MD, MPH, Director of Clinical Rheumatology and Professor of Medicine, Harvard Medical School, and Shiv Pillai, MD, PhD, Associate Geneticist, Center for Cancer Research and Professor of Medicine, Harvard Medical School, for both fibrosis and oncology. Dr. Stone’s work focuses on vasculitis, a group of inflammatory diseases that target blood vessels. His team has identified a novel T lymphocyte that may drive the intractable condition of fibrosis across an array of human diseases. At the Pillai Lab, one of the pathways being studied suggests new approaches for the treatment of autoimmune disorders. Dr. Pillai and his colleagues have discovered novel ways to strengthen immune responses and enhance helper T cell memory that provides hope for developing more effective personalized immune-system based treatments for cancer.

"I look forward to leveraging Abpro’s platform to develop antibodies for targets that traditionally, have been difficult to target," said Dr. Shiv Pillai, who also is a member of Abpro’s Scientific Advisory Board. "I have been familiar with Abpro’s unique approach, and we are looking forward to working with it in our lab."

With BWH, Abpro will work with Michael B. Brenner, MD, Theodore B. Bayles Professor of Medicine Chief, Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital, in the areas of inflammation and autoimmunity. In addition to the full development of basic research in areas relevant to rheumatic and allergic diseases, translational research and clinical research at the population level and patient therapeutics, the division has also organized and integrated much of its research to provide interdisciplinary progress in several key human diseases.

According to these co-development agreements, MGH and BWH will work with Abpro towards the development of new therapeutic antibodies using Abpro’s Diversimmune platform, which is designed to generate antibodies with high sensitivity and specificity for advancing human health.

Abpro’s products and discovery services are used by leading academic labs and companies around the world for life science research purposes, such as therapeutics, diagnostics and research products. Abpro has formed multiple partnerships around novel biomolecules with leading biotechnology and international pharmaceutical companies including Amgen, Eli Lilly, Genzyme, MedImmune, Merck, Novartis, Pfizer, and others. In addition, Abpro has collaborated with several academic research centers, including Harvard University, Massachusetts Institute of Technology and Stanford University.

On May 19, 2016 Guided Therapeutics, Inc. (OTCQB:GTHP) reported its operating results for the first quarter ended March 31, 2016 (Press release, Guided Therapeutics, MAY 19, 2016, View Source [SID:1234512610]).

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Sales Revenue, Cost of Sales and Gross Profit (Loss) from Devices and Disposables: Sales revenue from the sale of LuViva devices and disposables for the three months ended March 31, 2016, was $262,000, a 106% increase compared to the same period in 2015. Related costs of sales and net realizable value expenses were approximately $68,000, which resulted in a gross profit of approximately $194,000 for the first quarter of 2016. For the same period in 2015, approximately $127,000 in sales revenue was offset by approximately $107,000 in related costs of sales, resulting in a gross loss on devices and disposables of approximately $20,000. The increase from gross loss to gross profit was due to increased sales of disposables with the Company’s primary distributor, which carry a higher profit margin than device sales.

Research and Development Expenses: Research and development expenses decreased to approximately $290,000 for the three months ended March 31, 2016, compared to $373,000 for the same period in 2015. The decrease, of approximately $83,000, was primarily due to a slight decrease in payroll expenses.

Sales and Marketing Expenses: Sales and marketing expenses were approximately $117,000 during the three months ended March 31, 2016, compared to $172,000 for the same period in 2015. The decrease was primarily due to Company-wide expense reduction and cost savings efforts.

General and Administrative Expenses: General and administrative expenses decreased to approximately $917,000 during the three months ended March 31, 2016, compared to approximately $963,000 for the same period in 2015. The decrease of approximately $46,000, or 5.0%, was primarily related to lower compensation and option expenses incurred during the same period.

Other Income: Other income for the three months ended March 31, 2016, was approximately $23,000, compared to other income of approximately $21,000 for the three months ended March 31, 2015.

Interest Expense: Interest expense decreased to approximately $158,000 for the three months ended March 31, 2016, as compared to approximately $492,000 for the same period in 2015, primarily due to amortization of debt discount and debt issuance costs that were higher for the same period in 2015.

Fair Value of Warrants Expense: Fair value of warrants expense recovery was approximately $1,395,000 for the three months ended March 31, 2016, as compared to approximately $714,000 for the same period in 2015.

Net income was approximately $130,000 during the three months ended March 31, 2016, compared to a net loss of $1,245,000 for the same period in 2015, for the reasons outlined above. Preferred stock dividends was approximately $470,000 during the three months ended March 31, 2016, compared to $31,000 for the same period in 2015. Basic Net loss per share, was $0.11 for the three months ended March 31, 2016, and $1.31 for the same period in 2015. Diluted Net loss per share, was $0.00 for the three months ended March 31, 2016, and $1.31 for the same period in 2015.

Cash on hand at March 31, 2016, was approximately $56,000, as compared to approximately $35,000 at December 31, 2015. Net inventory on hand at the end of the quarter was approximately $1.3 million. The Company continues to manage cash and liquidity with austerity.

"The first quarter was a record for shipping single-use disposable LuViva cervical guides with almost 24,000 going to our Turkish distributor," said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. "We also shipped LuViva devices to Saudi Arabia and Indonesia during the quarter, bringing to 10 the number of units in the Middle East and 15 in Southeast Asia. As of the end of the first quarter, we shipped a total of 97 LuViva devices and approximately 60,000 disposable cervical guides, worldwide."

"During the first quarter, we received notification that the Health Services Sector of Nairobi County, Kenya, has agreed to purchase an additional five LuViva units for use in the agency’s cervical cancer screening program. The planned purchase brings to six the number of LuVivas ordered by Nairobi County, which is the largest population center in East Africa with approximately 900,000 screening-aged women," Mr. Cartwright said.

"Finally, we expanded our distribution in Latin America to include the Dominican Republic in the first quarter and subsequently shipped our first unit there," Mr. Cartwright said. "We continue to negotiate with potential partners for distribution and manufacturing rights in China, and are in late stage discussions with a partner for India."