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Advaxis Reports First Quarter Fiscal 2019 Financial Results and Provides Clinical Pipeline Update

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.

Varian and Tata Trusts Sign Framework Agreement for Advanced Cancer Care Solutions to Address Growing Need in India

On March 11, 2019 With an estimated 1.8 million new cancer cases a year in India expected by 20251, Tata Trusts and Varian (NYSE: VAR) announced the signing of a framework agreement intended to increase patient access to advanced radiation therapy treatments in the country (Press release, Varian Medical Systems, MAR 11, 2019, View Source [SID1234553812]). The three-year agreement is focused on world-class cancer care delivery through the installation of radiation therapy treatment systems across India where Varian has been selected as the preferred supplier by Tata Trusts.

The agreement is part of a program undertaken by Tata Trusts with the goal of creating patient-centric cancer institutions to deliver standardized and affordable care closer to patients’ homes in different regions in India, including rural areas where many patients do not have the financial means to access existing care options. Included in the scope of the agreement, is the creation of a significant number of new cancer centers, as well as the installation of advanced radiotherapy equipment in already existing centers in these areas. At its culmination, the program is targeted to bring world-class cancer care to an estimated quarter million patients per year that previously did not have easy or affordable access to treatment options.

In addition to the installation of the radiation therapy treatment systems, the Varian ARIA oncology information system and Eclipse treatment planning system will be implemented in a secure network hosted on a private cloud, to assist in elevating the level of care across India. The first systems are estimated to begin installation later in 2019.

"We are delighted to work together with Tata Trusts to achieve innovative, sustainable and world class standards of cancer care, while making a real difference in communities across India, beginning with the initial installations of systems over the coming months," said Dow Wilson, president and chief executive officer of Varian. "Working with Tata Trusts on this project is perfectly aligned with our core strategy of increasing access to high-quality care and creating a world without fear of cancer. We are proud that the Tata Trusts have put their faith in our solutions with this commitment to both our hardware and software platforms."

Nordic Nanovector to attend Cowen Health Care Conference, BioCapital Europe and Stifel Nordic Healthcare Seminar

On March 11, 2020 Nordic Nanovector ASA (OSE: NANO) reported that members of its senior management team will participate and present at the following upcoming investor conferences during March (Press release, Nordic Nanovector, MAR 11, 2019, View Source [SID1234553477]):

Cowen 39th Annual Health Care Conference in Boston, USA on 11-13 March
BioCapital Europe in Amsterdam, the Netherlands on 14 March
Stifel Conference – Nordic Healthcare Seminar in London, UK on 27 March
The company presentation will be available on the investors and media page on the first day of the conference.

Sermonix to Present at Boston Oncology Investor Conference on Potential for Lasofoxifene in Metastatic Breast Cancer Treatment

On March 11, 2019 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, reported that founder and Chief Executive Officer Dr. David Portman will present at the Boston Oncology Investor Conference (Press release, Sermonix Pharmaceuticals, MAR 11, 2019, View Source [SID1234534397]). Dr. Portman will discuss the Phase 2 study of its lead investigational drug, lasofoxifene, and the drug’s potential as a novel precision medicine treatment for metastatic breast cancer patients with an ESR1 mutation identified through a liquid biopsy.

Dr. Portman will speak at 6 p.m. on Thursday, March 14. The conference, held at McDermott Will & Emery law firm, 28 State Street in Boston, is organized by the National Foundation for Cancer Research, OneMedMarket and the Altru Institute.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s binding affinity and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized and bioavailable SERM, lasofoxifene, if approved, could play a critical role in the personalized treatment of advanced ER+ breast cancer.

Horizon Pharma plc Announces Closing of Public Offering of Ordinary Shares and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On March 11, 2019 Horizon Pharma plc (Nasdaq: HZNP) reported the closing of its underwritten public offering of 14,081,632 of its ordinary shares at a price to the public of $24.50 per share (Press release, Horizon Pharma, MAR 11, 2019, View Source [SID1234534254]). This includes the exercise in full by the underwriters of their option to purchase up to 1,836,734 additional ordinary shares. The estimated net proceeds to the Company from this offering are approximately $326.8 million, after deducting underwriting discounts and other estimated offering expenses payable by the Company.

Citigroup, Morgan Stanley, Goldman Sachs & Co. LLC and Cowen acted as joint book-running managers for the offering.

Also on March 11, 2019, the Company secured incremental revolving loan commitments pursuant to an amendment to its existing credit agreement. The new incremental revolving commitments have been established pursuant to a revolving credit facility, and provide an additional $200 million of borrowing capacity.

A registration statement relating to the ordinary shares described above was previously filed with and became effective by rule of the Securities and Exchange Commission ("SEC"). A final prospectus supplement and accompanying prospectus related to the offering was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and accompanying prospectus may be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by phone at 800-831-9146; Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department; Goldman Sachs & Co. LLC, c/o: Prospectus Department, 200 West Street, New York, NY 10282, by email at [email protected] or by phone at 866-471-2526; or Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department or by phone at 631-274-2806.

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