On March 12, 2019 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported an update on its clinical pipeline and financial results for the first quarter ended January 31, 2019 (Press release, Advaxis, MAR 12, 2019, View Source [SID1234534225]).

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Updates on the progress of the Company’s clinical pipeline include:

Cancer Type-Focused Hotspot/Off-the-Shelf Neoantigen Therapies (ADXS-HOT) – The Company initiated its first clinical trial using a novel and proprietary approach to cancer immunotherapy that targets hotspot mutations, cancer testis antigens and oncofetal antigens. The first drug candidate from this program, ADXS-503, is designed to treat all types of non-small cell lung cancer and is now enrolling patients. Safety, tolerability and immune correlative data from this Phase1/2 study are anticipated by the end of June 2019.
Personalized, Neoantigen-Directed Therapy (ADXS-NEO) – The Company continues to enroll patients in a Phase 1 dose-escalation study with its personalized antigen delivery program using whole-exome sequencing of a patient’s tumor to identify personal neoantigens. Early immune response data from the first cohort of this study were presented last month at the Immuno-Oncology 360o Conference, and safety, tolerability and immune correlative data from the first two cohorts will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on March 31, 2019.
Prostate Cancer (ADXS-PSA) – Previously reported data from a Phase 1/2 study of ADXS-PSA in combination with KEYTRUDA (pembrolizumab) demonstrated a manageable safety profile (mostly grade 1-2 treatment-related adverse events), in a cohort of 37 heavily pretreated metastatic castration-resistant prostate cancer patients and showed a greater level of clinical activity compared to monotherapy. The Company will be presenting updated clinical and biomarker data on this program at the AACR (Free AACR Whitepaper) Annual Meeting on April 1, 2019.
Cervical Cancer (ADXS-HPV) – In January 2019 the Company announced that the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the Company’s Phase 3 AIM2CERV clinical trial for axalimogene filolisbac (AXAL) in high-risk locally advanced cervical cancer. The partial hold relates to FDA’s request for additional information pertaining to certain AXAL chemistry, manufacturing and controls (CMC) matters. The FDA did not cite any safety issues related to the trial and all currently enrolled patients are continuing to receive treatment. The Company has submitted its initial response to the request for additional CMC information and is currently in discussions with the Agency. In parallel, Advaxis is in discussions with the Agency regarding the Company’s request, made late in 2018, to include a second interim analysis for efficacy. The Company is working diligently to reach a resolution with the Agency on both of these matters.
Management Commentary

"We reached an important milestone with our ADXS-HOT program last month when we enrolled the first patient in the ADXS-503 Phase 1/2 clinical trial. This is the first clinical trial initiated using a drug construct from our ADXS-HOT program, for which we have designed over 10 different drug constructs for various cancer types," said Kenneth A. Berlin, president and chief executive officer of Advaxis. "We continue to be very excited about our ADXS-HOT program and anticipate filing two additional INDs for drug constructs from this program during 2019."

He added, "We expect 2019 will be an important and eventful year for Advaxis due to the amount of information we anticipate generating from our programs and we look forward to reporting data throughout the year. In order to ensure our various programs progress to data readout, we are continually evaluating ways to increase our cash runway by controlling expenses and generating cash from potential out-licensing and/or financing transactions."

Financial Results for First Quarter Ended January 31, 2019

Research and development expenses for the first quarter of fiscal year 2019 were $6.7 million, compared with $16.8 million for the first quarter of fiscal year 2018. The $10.1 million decrease was primarily attributable to costs incurred during the last fiscal year related to the Company’s Marketing Authorization Application in Europe and cost controls initiated in the latter part of fiscal year 2018. Additionally, there was a decrease in clinical trial expenses resulting from the partial clinical hold on AIM2CERV and winding down of several older studies.

General and administrative expenses for the first quarter of fiscal year 2019 were $2.7 million, compared with $5.9 million for the first quarter of fiscal year 2018. The $3.2 million decrease was primarily attributable to professional and consulting fees relating to external strategy and program assessment work performed for the Company during fiscal year 2018 that did not recur in fiscal year 2019, in addition to improved cost controls initiated in the latter part of fiscal year 2018.

As previously reported, in December 2018 the Company received notice from Amgen of its intent to terminate its collaboration in the ADXS-NEO program. As a result, the Company adjusted its measure of progress for its performance obligations under the collaboration agreement and, based on the modified service period, reported incremental revenue of $15.6 million in the first quarter of fiscal year 2019. Net income for the first quarter of fiscal year 2019 was $12.8 million or $0.18 per share, compared with a net loss for the first quarter of fiscal year 2018 of $20.5 million or $0.49 per share. Net cash used during the first quarter ended January 31, 2019 was $12.4 million.

On March 12, 2019 Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, reported that it has entered into an agreement and plan of merger with Smith & Nephew plc pursuant to which Smith & Nephew will acquire Osiris for $19.00 per share in cash, a total of approximately $660.5 million in cash (Press release, Osiris Therapeutics, MAR 12, 2019, View Source [SID1234534284]). This offer represents a 37% premium to the company’s 90-day volume-weighted average stock price. The transaction was unanimously approved by the Boards of Directors of both companies.

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Peter Friedli, Chairman of the Board and co-founder of Osiris, said, "This is a very good outcome for Osiris’ shareholders. The Board concluded unanimously, after taking into account the requirements needed to take the business to the next level, that entering into this agreement represents the best way to maximize value for our stockholders." Mr. Friedli added, "I am immensely proud of the business we have built from our research into advanced regenerative technologies. I believe Smith & Nephew is the right home for Osiris and will allow our products to reach more customers, helping to restore quality of life for more patients.""This agreement reflects the significant value that the Osiris team has generated for our shareholders under Peter Friedli’s leadership. We believe this transaction will also benefit our customers, employees, and partners," said Samson Tom, President and Chief Executive Officer of Osiris.Completion of the transaction is expected in the second quarter of 2019, pending the successful completion of the tender offer and all other closing conditions. Osiris’ employees are expected to join Smith & Nephew on completion. Until that time, Osiris will continue to operate as a separate and independent company.Cantor Fitzgerald & Co. rendered a fairness opinion to the Board of Directors of Osiris in connection with the transaction. Hogan Lovells US LLP is acting as legal counsel for Osiris.Transaction DetailsUnder the terms of the agreement and plan of merger, Smith & Nephew has formed an acquisition subsidiary, Papyrus Acquisition Corp.

("Purchaser"), that will commence a tender offer no later than April 2, 2019 to purchase all outstanding shares of Osiris for $19.00 per share in cash, and Osiris will file a recommendation statement containing the unanimous recommendation of the Osiris Board that Osiris stockholders tender their shares to Smith & Nephew. Following the completion of the tender offer, Smith & Nephew expects to promptly consummate a merger of Purchaser and Osiris in which shares of Osiris that have not been purchased in the tender offer will be converted into the right to receive the same cash price per share as paid in the tender offer.The tender offer and the merger are subject to customary closing conditions, including the tender of at least a majority of the outstanding Osiris shares on a fully diluted basis and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

The merger agreement includes customary termination provisions for both Osiris and Smith & Nephew, including a right for either party to terminate if the transactions have not been completed by December 12, 2019. The merger agreement provides that, in connection with the termination of the merger agreement under specified circumstances, including termination by Osiris to accept a superior proposal, Osiris will be required to pay to Smith & Nephew a fee equal to $18,682,450.Smith & Nephew plc (LSE: SN, NYSE: SNN) is making a separate announcement regarding the transaction to its investors today. Annual Report on Form 10-KOsiris intends to file its Annual Report on Form 10-K for the year ended December 31, 2018 on Friday, March 15, 2019.

On March 12, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that data from the Phase 2 multicenter trial evaluating ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis (RMS) has been selected for presentation at the upcoming American Academy of Neurology (AAN) annual meeting, to be held May 4 – 10, 2019 in Philadelphia, Pennsylvania (Press release, TG Therapeutics, MAR 12, 2019, View Source [SID1234534250]). Final data from the core Phase 2 trial has been previously presented, most recently at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual meeting in Dallas, TX. In addition to highlighting the final Phase 2 data, the AAN presentation plans to include data from the open label extension (OLE), a trial made available to any patient who completed the core Phase 2 trial allowing them to continue treatment with ublituximab.

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The abstract is available online and can be accessed via the below link or on the AAN meeting website at www.aan.com.

Presentation Details:

Title:Open Label Extension (OLE) of Phase 2 Multicenter Study of Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb) in Patients with Relapsing Forms of Multiple Sclerosis (RMS)
— Presentation Date & Time:Tuesday May 7, 2019, 5:30 PM – 6:30 PM ET
— Session Title: Poster Session P3: MS Clinical Trials and Therapeutic Research
— Presenter:Edward Fox, MD, PhD, Central Texas Neurology Consultants, Round Rock, TX
— Location:Pennsylvania Convention Center
— Abstract Number: 2055
These data support the ongoing, fully enrolled, international Phase 3 program evaluating ublituximab for the treatment of RMS. The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, are being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and are being led by Lawrence Steinman, MD, of Stanford University.

On March 12, 2019 Bio-Path Holdings, Inc., (Nasdaq: BPTH) (Bio-Path), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it has entered into definitive agreements with several healthcare focused institutional investors for the issuance and sale in a registered direct offering of 712,910 shares of its common stock, at a purchase price of $25.95 per share, for aggregate gross proceeds of approximately $18.5 million (Press release, Bio-Path Holdings, MAR 12, 2019, View Source [SID1234534269]). The offering is expected to close on or about March 14, 2019, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Bio-Path currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

The shares of common stock described above are being offered and sold by Bio-Path pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-215205), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (SEC) on January 9, 2017. The offering of the shares of common stock will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

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

On March 12, 2019 Dong-A ST Co., Ltd. (170900: Korea SE), the Korean pharmaceutical company, and Beactica AB, the Swedish drug discovery company, reported an expansion of their research and licensing agreement (Press release, Dong-A ST, MAR 12, 2019, View Source [SID1234535724]). The collaboration – which was initiated in October 2016 – is now expanded with an aim to jointly identify and develop novel small molecules targeting a protein–protein interaction of therapeutic relevance for immuno-oncology. The partnership further builds on Beactica’s unique early-stage lead generation capabilities and Dong-A ST’s strengths in the pharmacological proof of novel target concepts as well as downstream pre-clinical and clinical development of new therapeutic agents.

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Under the terms of the additional agreement, Dong-A ST will gain exclusive global rights for the further development and commercialization of compounds discovered. In return, Beactica is eligible to receive research funding as well as milestone payments for certain research, preclinical, clinical and regulatory achievements as well as royalties on commercial sales of the products resulting from the partnership. Beactica is also entitled to a revenue share from any related future licensing activities by Dong-A ST. Full financial details remain undisclosed.

"The collaboration between Dong-A ST and Beactica brings together our complementary strengths and establishes a powerful platform for the discovery and development of next generation anti-cancer therapeutics" said Mr Daesik Eom, Chairman and CEO of Dong-A ST. "Beactica’s capabilities and expertise accelerates the advancement of Dong-A ST’s oncology pipeline and will enhance Dong-A ST’s global competitiveness in the pharmaceutical industry."

"Following recent success in our collaboration we are pleased with Dong-A’s confidence and trust to expand this partnership into new target areas." said Dr Per Källblad, CEO of Beactica. "As a long-term strategic partner we are proud to have delivered valuable contributions to Dong-A’s research and look forward to a continued successful collaboration."