TG Therapeutics, Inc. Announces Issuance of Composition of Matter Patent for TG-1101 in the United States

On April 13, 2016 (TG Therapeutics, Inc. (Nasdaq:TGTX) reported that the United States Patent and Trademark Office (USPTO) has issued a patent for the composition of matter of TG-1101, the Company’s novel, glycoengineered monoclonal antibody (Press release, TG Therapeutics, APR 13, 2016, View Source [SID:1234510746]). The patent, U.S. Patent No. 9,234,045 specifically covers the composition of TG-1101, and its use for treating various forms of CD20 expressing leukemia and lymphoma, including chronic lymphocytic leukemia (CLL) and various types of non-Hodgkin’s lymphoma, including follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

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The patent was issued to LFB SA and is exclusively licensed to TG Therapeutics pursuant to the Company’s existing license agreement with LFB SA. The issuance affords patent protection for TG-1101 in the US through July of 2029, exclusive of additional patent term extensions also available. TG-1101 is currently being studied in two Phase 3 clinical trials in patients with CLL, with additional registration directed trials in NHL expected to commence in 2016.

"We are excited to announce the issuance of the first U.S. patent for TG-1101 which affords protection through 2029. With composition of matter patents now in place for both TG-1101 and TGR-1202, and an additional later-filed patent application on the combination of TG-1101 and TGR-1202, we believe we have established a very strong intellectual property position for the two components of our proprietary ‘TG-1303′ regimen that provides a very attractive exclusivity period without the risk of generic competition for many years to come," stated Michael S. Weiss, the Company’s Executive Chairman and Interim CEO. Mr. Weiss continued, "We remain focused on continuing to strengthen our intellectual property position through the issuance of additional patents for both TG-1101 and TGR-1202 individually as well as in combination here in the US and abroad."

Tokai Announces Presentations on Galeterone at the AACR Annual Meeting 2016

On April 13, 2016 Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported that two presentations on galeterone will be made during poster sessions held at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 in New Orleans (Press release, Tokai Pharmaceuticals, APR 13, 2016, View Source;p=RssLanding&cat=news&id=2156705 [SID:1234510747]). Galeterone, Tokai’s lead product candidate, is being developed for the treatment of men with metastatic castration-resistance prostate cancer.

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Title: Galeterone-induced degradation of the androgen receptor involves inhibition of deubiquitinating enzymes
Date/time: Monday, April 18, 2016, 8 a.m. – 12 p.m. CDT
Location: Section 16
Abstract: 1234
Title: The effect of novel CYP17 inhibitor galeterone on gonadal and tumor progestogen and androgen levels in SCID mice bearing LNCaP prostate cancer xenografts
Date/time: Tuesday, April 19, 2016, 1 – 5 p.m. CDT
Location: Section 1
Abstract: 3490
Additional information, including the presentation schedule and full abstracts, may be found at www.aacr.org. A copy of each presentation will be available on the "Publications & Presentations" page of Tokai’s website, www.tokaipharma.com.

About Galeterone
Galeterone is an oral small molecule that utilizes the established pathways, including CYP17 enzyme and androgen receptor inhibition, of the current second-generation hormonal therapies abiraterone and enzalutamide. Galeterone also introduces a distinct third mechanism – androgen receptor degradation – that decreases the sensitivity of androgen receptors to androgen activity, thus leading to reductions in tumor growth. Tokai is developing galeterone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). ARMOR3-SV, the company’s pivotal Phase 3 study of galeterone in treatment-naive mCRPC patients whose prostate tumors express the AR-V7 splice variant, is evaluating whether administration of galeterone results in a statistically significant increase in radiographic progression-free survival as compared to enzalutamide. Tokai is also evaluating galeterone in mCRPC patients who have shown resistance following treatment with second-generation hormonal agents. Tokai has worldwide development and commercialization rights to galeterone.

OncoSec to Host Webcast and Panel Discussion on New Melanoma Clinical Data

On April 13, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that it will host a webcast to provide an overview and panel discussion regarding new clinical data that will be featured as an oral presentation at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, OncoSec Medical, APR 13, 2016, View Source [SID:1234510751]).

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The webcast will be held on Wednesday, April 20, 2016 at 11:00 AM ET/8:00 AM PT.

The webcast will include a round table discussion to enable key opinion leaders in the fields of melanoma and immuno-oncology to contribute their respective insights on data from the AACR (Free AACR Whitepaper) abstract entitled: "Intratumoral electroporation of plasmid IL-12 can prime response to anti-PD1/PD-L1 blockade in patients with Stage III/IV-M1a melanoma" (Abstract #CT134). Webcast participants will include:

Alain Algazi, MD, Skin Cancer Specialist, Melanoma Center, University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
Adil Daud, MD, Clinical Professor, Department of Medicine (Hematology/Oncology), UCSF; Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center
Robert Andtbacka, MD, CM, Associate Professor, Division of Surgical Oncology, Department of Surgery, University of Utah School of Medicine; Surgeon and Investigator, Intermountain Healthcare and Huntsman Cancer Institute
Sharron Gargosky, PhD, Head of Clinical Development and Operations, OncoSec*
Moderator: Robert Pierce, MD, Chief Scientific Officer, OncoSec
To join via webcast, please use the following link: View Source To listen to the conference call, please dial (877) 731-1960 and enter conference ID number: 84899794. An archived version of the presentation will be available for 90 days on the "Investors" section of OncoSec’s website: ir.oncosec.com/events.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Oncbiomune has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, OncBioMune Pharmaceuticals, 2017, APR 13, 2016, View Source [SID1234522115]).

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Obesity fuelling leap in womb cancer cases

On April 13, 2016 PharmaTimes reported that Rising levels of obesity among UK women have helped drive a 54 percent jump in womb cancer rates over the last two decades, according to new figures released by Cancer Research UK (Press release, PharmaTimes, APR 13, 2016, View Source [SID:1234510735]).

Back in the early 1990s around 19 women in every 100,000 developed the disease, but that has now risen to 29 women in every 100,000, with obesity being the most likely driving force behind the increase, according to the charity.
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UK womb cancer rates highest in 30 years

In the UK around 9,000 women are now diagnosed with womb cancer every year, and around 2,000 die from the disease, a marked difference from the 4,800 annual new cases and 1,500 deaths recorded twenty years ago.

"It’s worrying that womb cancer cases are going up so sharply," said Professor Jonathan Ledermann, director of the Cancer Research UK and UCL Cancer Trials Centre. "We don’t know all the reasons why. But we do know that about a third of cases are linked to being overweight so it’s no surprise to see the increases in womb cancer cases echo rising obesity levels."

On the plus side, the figures also show that survival is improving. "In the 1970s, almost six in 10 women diagnosed with the disease survived for at least 10 years. Now almost eight in 10 women survive," said Prof Lederman. "But we need more research to understand the biology of the disease better and to know more about how it is caused so that we can improve the treatment of these women as well as preventing more cases."

Why extra weight can cause cancer is not entirely clear, but there is evidence to show that extra fat in the body can increase the risk by producing hormones and growth factors that promote cell division, the charity noted.

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