On June 11, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that the Company has confirmed its path to submit umbralisib for accelerated approval based on data from the marginal zone lymphoma (MZL) cohort of the UNITY-NHL Phase 2b trial (Press release, TG Therapeutics, JUN 11, 2019, View Source [SID1234536991]). The Company recently had a productive Breakthrough Therapy Designation (BTD) meeting with the U.S. Food and Drug Administration (FDA) to discuss the MZL submission strategy. Based on this meeting, the Company anticipates initiating a New Drug Application (NDA) submission for patients with previously treated MZL by year-end 2019.

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Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "Marginal zone lymphoma is an incurable disease for which there are limited available therapies. As a non-chemotherapy, orally active, once daily medication, we believe umbralisib could represent a meaningful new treatment option for patients with MZL. Defining a path to a regulatory submission for umbralisib for this patient population marks an important step forward for the Company and we appreciate the guidance we have received from the FDA. We look forward to beginning the NDA process later this year, as we work expeditiously to bring umbralisib to the patients who need it." Mr. Weiss continued, "With our MZL NDA moving forward, and Phase 3 read-outs for CLL and MS targeted over approximately the next six to twelve months, we believe TG is well positioned for success."

ABOUT THE UNITY-NHL PHASE 2b STUDY—MARGINAL ZONE LYMPHOMA COHORT
The multicenter, open-label, UNITY-NHL Phase 2b study – Marginal Zone Lymphoma (MZL) cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. The primary endpoint is overall response rate (ORR) as determined by central Independent Review Committee (IRC) assessment.

The MZL cohort completed enrollment in August 2018 with a total of 69 patients enrolled and receiving at least one dose of umbralisib. In February of 2019, the Company announced that the MZL cohort met its primary endpoint of ORR as determined by central IRC for all treated patients (n=69). While the study has already met the Company’s target guidance of 40-50% ORR, the final analysis of ORR will be conducted when all treated patients have had at least 9 cycles (cycle = 28 days) of follow-up. Secondary endpoints include safety, duration of response, and progression-free survival (PFS).

ABOUT BREAKTHROUGH THERAPY DESIGNATION
The Company announced in January of 2019 that the U. S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for umbralisib for the treatment of adult patients with MZL who have received at least one prior anti-CD20 regimen.

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.

On June 11, 2019 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved its PD-L1 IHC 22C3 pharmDx assay for expanded use (Press release, Agilent, JUN 11, 2019, https://www.agilent.com/about/newsroom/presrel/2019/11jun-ca19016.html [SID1234536992]).

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The assay is now approved as an aid in identifying patients with head and neck squamous cell carcinoma (HNSCC) for treatment with KEYTRUDA (pembrolizumab), anti-PD-1 therapy manufactured by Merck (known as MSD outside the United States and Canada). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test.

PD-L1 IHC 22C3 pharmDx is the only companion diagnostic FDA-approved to aid in the identification of HNSCC patients for treatment with KEYTRUDA. HNSCC is the fifth cancer type for which PD-L1 IHC 22C3 pharmDx has gained FDA approval in the United States.

"Targeted immunotherapies are redefining standards of care in cancer treatment, and PD-L1 testing plays a crucial role in identifying patients who may benefit from this treatment," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "The expanded FDA approval of PD-L1 IHC 22C3 pharmDx provides critical information to physicians managing first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. By expanding the use of PD-L1 IHC 22C3 pharmDx, Agilent enables more patients to be identified for treatment with KEYTRUDA. Through these efforts, we reinforce our role as a worldwide leader in driving companion diagnostics to market in support of landmark therapies."

HNSCC is the seventh most common cancer worldwide3 and accounts for more than 90% of head and neck cancer cases.4 In the United States, approximately 65,000 new head and neck cancer cases are diagnosed annually.5,6 The five-year overall survival rate for this form of cancer is approximately 40–50 percent7.

KEYTRUDA is a humanized monoclonal antibody that increases 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, PDL1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment, and their therapeutic value is being demonstrated across a growing list of cancer types.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck & Co. PD-L1 IHC 22C3 pharmDx also helps physicians identify non-small cell lung cancer (NSCLC), cervical cancer, gastric or GEJ adenocarcinoma, and urothelial carcinoma patients for treatment with KEYTRUDA. PD-L1 expression in NSCLC tissues is interpreted using Tumor Proportion Score (TPS). PD-L1 expression in HNSCC, urothelial carcinoma, cervical cancer, and gastric or GEJ adenocarcinoma tissues is interpreted using Combined Positive Score (CPS).

On June 11, 2019. Xspray Pharma (Nasdaq First North: XSPRAY) reported that the United States Patent and Trademark Office (USPTO) has granted Xspray two new patents in the United States for its product candidates HyNap-Sora and HyNap-Nilo (Press release, Xspray, JUN 11, 2019, View Source [SID1234649564]). The new patents are Xspray’s sixth and seventh product patents, respectively, in the United States, which is Xspray’s main market. The new patents will expire January 11, 2033.
"The new patents for HyNap-Sora and HyNap-Nilo make it significantly more difficult for our competitors to copy upcoming products from our unique platform technology. The patents are also essential for our ability to do good business deals and they strengthen our position in the US market," says Per Andersson, CEO of Xspray.

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The new patents, US 10,314,829 and US 10,314,830 respectively, cover the pharmaceutical compositions of the company’s product candidates HyNap-Sora and HyNap-Nilo. Xspray is a product company with a broad portfolio of drug candidates in the same substance class that can be reformulated using the same technology platform.

At the end of 2018, Xspray was granted an additional patent for HyNap-Dasa for the US market. This patent, along with these two new ones, are strong and broad composition patents which relate to solid amorphous forms of the active substance. The original products for Dasatinib, Sorafinib and Nilotinib, had total US sales exceeding USD 2 billion in 2018.

On June 11, 2019 Ayala Pharmaceuticals, Inc., a clinical-stage company developing medicines for cancers that are genetically defined, reported that Roni Mamluk, Ph.D., Chief Executive Officer of Ayala, will present at the Raymond James Life Sciences and MedTech Conference being held June 18-19 in New York, NY (Press release, Ayala Pharmaceuticals, JUN 11, 2019, View Source [SID1234536993]).

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Event: Raymond James Life Sciences and MedTech Conference
Date: Tuesday, June 18
Time: 1:15 p.m. ET
Location: New York, NY

The audio webcast of the presentation will be available live on the Wall Street Webcasting website at View Source The presentation will be accessible for 30 days.

On June 11, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it has adjusted certain pricing information and key dates for its previously announced rights offering (Press release, DelMar Pharmaceuticals, JUN 11, 2019, View Source [SID1234536994]). The subscription period for the rights offering will now expire at 5:00 PM Eastern time on June 25, 2019, unless extended by the Company.

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The unit pricing remains $1,000 per unit, consisting of one share of Series C Convertible Preferred Stock with a stated value of $1,000 (and immediately convertible into shares of DelMar’s common stock) and warrants to purchase DelMar’s common stock. The Series C Convertible Preferred Stock conversion price will now be $3.10 and each unit will now consist of 209 warrants to purchase DelMar’s common stock at an adjusted exercise price of $3.10 per share. The warrants will still be exercisable for five (5) years after the date of issuance and shall be redeemable as described in the preliminary and final prospectus, when available.

If exercising subscription rights through a broker, dealer, bank or other nominee, rights holders should promptly contact their nominee and submit subscription documents and payment for the units subscribed for in accordance with the instructions and within the time period provided by such nominee. The broker, dealer, bank or other nominee may establish a deadline before June 25, 2019, by which instructions to exercise subscription rights, along with the required subscription payment, must be received.

All record holders of rights that wish to participate in the rights offering must deliver a properly completed and signed subscription rights statement, together with payment of the subscription price for both basic subscription rights and any over subscription privilege election for delivery no later than 5:00 PM Eastern Time on June 25, 2019 to the Subscription Agent:

By mail:

By hand or overnight courier:

Broadridge Corporate Issuer Solutions, Inc.

Attn: BCIS Re-Organization Dept.

P.O. Box 1317

Brentwood, New York 11717-0693

(888) 789-8409 (toll free)

Broadridge Corporate Issuer Solutions, Inc.

Attn: BCIS IWS

51 Mercedes Way

Edgewood, New York 11717

(888) 789-8409 (toll free)

Under the rights offering, DelMar distributed one non-transferable subscription right for each share of common stock and each participating warrant held on the record date. The subscription rights are exercisable for up to an aggregate of $1.9 million of units on a pro rata basis if subscriptions are received in excess of that threshold.

Holders who fully exercise their basic subscription rights will be entitled, if available, to subscribe for an additional amount of units that are not purchased by other holders, on a pro rata basis and subject to the $1.9 million aggregate offering threshold and other ownership limitations.

DelMar has engaged Maxim Group LLC and Dawson James Securities Inc. as co-dealer-managers in the rights offering. Questions about the rights offering or requests for copies of the preliminary and final prospectuses, when available, may be directed to Maxim Group LLC at 405 Lexington Avenue, New York, NY 10174, Attention Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission (the "SEC") and became effective on May 28, 2019, and is available on the SEC’s website located at View Source Additionally, a post-effective amendment to the registration statement was filed on June 10, 2019 for pricing and other adjustments discussed above. The rights offering is being made only by means of a written prospectus. A copy of the prospectus for the rights offering may be obtained, when available, from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.