On January 17, 2019 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI) reported that it has entered into a definitive agreement to sell its portfolio of seven FDA-approved hematology/oncology products to Acrotech Biopharma L.L.C. Acrotech Biopharma is a New Jersey-based wholly-owned subsidiary of Aurobindo Pharma USA Inc (Press release, Spectrum Pharmaceuticals, JAN 17, 2019, View Source [SID1234532706]).

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"This divestiture marks a major strategic shift for Spectrum to ensure laser-focus on novel, oncology drug development and commercialization," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The proceeds generated by the sale will significantly strengthen the financial position of the company, providing the capital to develop and commercialize our two late-stage pipeline assets, and placing us in a solid position to evaluate additional growth opportunities."

The seven products included in the sale are: FUSILEV (levoleucovorin), FOLOTYN (pralatrexate injection), ZEVALIN (ibritumomab tiuxetan), MARQIBO (vinCRIStine sulfate LIPOSOME injection), BELEODAQ (belinostat) for injection, EVOMELA (melphalan) for injection, and KHAPZORY (levoleucovorin). The products generated combined sales of $76.4 million during the first nine months of 2018.

"Along with this divestiture, the majority of impacted staff will transition to Acrotech thereby right sizing Spectrum for our development efforts. Additionally, we are retaining a core group of commercial talent to lead the launch of ROLONTIS and poziotinib," added Joe Turgeon.

The Boards of Directors of Spectrum Pharmaceuticals and Aurobindo have both approved the transaction, which is subject to regulatory approvals and expected to close within 90 days. Jefferies LLC is acting as exclusive financial advisor to Spectrum. Paul Hastings LLP is acting as exclusive legal counsel to Spectrum.

Conference call details:

Thursday, January 17, 2019 at 8:30 a.m. Eastern/5:30 a.m. Pacific

Domestic: (877) 837-3910, Conference ID# 2890988
International: (973) 796-5077, Conference ID# 2890988

The conference call will also be webcast live. To access the webcast, please visit the Investor Relations page of the Spectrum Pharmaceuticals website at View Source

For interested individuals unable to join the call, a replay will be available from January 17, 2019 @ 11:30 p.m. ET/8:30 p.m. PT through January 24, 2019, until 11:30 p.m. ET/8:30 p.m. PT.

Domestic Replay Dial-In: (855) 859-2056, Conference ID# 2890988
International Replay Dial-In: (404) 537-3406, Conference ID# 2890988

Terms of Purchase and Sale Agreement

Under the terms of the deal, Acrotech will make a $160 million up-front cash payment and up to $140 million in milestones listed below:

Marqibo Milestones

$30 million for FDA Product Approval for MARQIBOwith label indicated for diffuse large B-cell lymphoma
$10 million for FDA Product Approval for MARQIBO for any indication other than the B-Cell Lymphoma Indication, single vial or pediatric ALL
$30 million for Net Sales of MARQIBOduring any trailing twelve (12) month period during the Milestone Period are equal to or greater than $300,000,000
$10 million for Net Sales of MARQIBO during any trailing twelve (12) month period during the Milestone Period are equal to or greater than $400,000,000
Khapzory Milestones

$5 million for Net Sales of KHAPZORY during any trailing twelve (12) month period during the Milestone Period are equal to or greater than $50,000,000
$5 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $150,000,000 at any time during the Milestone Period
$10 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $200,000,000 at any time during the Milestone Period
$15 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $300,000,000 at any time during the Milestone Period
$25 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $400,000,000 at any time during the Milestone Period
The milestone period lasts for five years post the closing of the transaction. KHAPZORY milestones only payable in the event KHAPZORY is assigned a unique J-code

On January 17, 2019 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will host its 15th annual International Symposium on Melanoma and Other Cutaneous Malignancies Saturday, Feb. 9, at the InterContinental New York Times Square in New York City. This educational conference will be co-chaired by Omid Hamid, M.D., chief of translational research and immunotherapy and director of melanoma therapeutics at The Angeles Clinic and Research Institute and Jeffrey S. Weber, M.D., Ph.D., deputy director of the Perlmutter Cancer Center at New York University Langone Health.

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"We are looking forward to hosting our International Symposium on Melanoma and Other Cutaneous Malignancies once again in New York City," said Phil Talamo, president of PER. "Now in its 15th year, the symposium continues to provide physicians with the tools they need to personalize care for every patient they treat with skin and other cutaneous including some very exciting data in the adjuvant setting."

Throughout the international conference, world-renowned melanoma experts Hamid and Weber, along with distinguished skin cancer specialists, will host several sessions covering topics such as current advances in immunotherapy and targeted therapies, the benefits of regional therapy, how to use predictive and prognostic modeling and how to manage treatment-related adverse events associated with emerging strategies. This symposium will also feature a Medical Crossfire, in which the expert panel will address attendees’ questions and participate in a rigorous debate on pressing issues faced by the skin cancer treatment community.

This highly interactive symposium will also feature a special presentation, "We Are What We Eat: How the Microbiome Influences Responses to Immunotherapy in Cancer," by Thomas F. Gajewski, M.D., Ph.D., AbbVie Foundation professor of cancer immunotherapy at University of Chicago Medicine. Gajewski investigates and develops new treatments for patients with melanoma. He also serves as an editor for Cancer Research and the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

The 15th annual International Symposium on Melanoma and Other Cutaneous Malignancies is a one-day conference, revolutionizing the presentation of emerging therapies and evolving standards of care in the management of patients with melanoma and other skin cancers. Attendees who attend this educational conference will gain insight on the latest strategies for the use of checkpoint inhibitors, current and emerging treatments for the BRAF gene as it affects mutant melanoma, and mitigating treatment-related toxicities with targeted therapy and immunotherapies.

On January 16, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company dedicated to developing innovative treatments for patients suffering from cancer and autoimmune/inflammatory diseases, reported it has entered into a definitive securities purchase agreement for the sale of units consisting of shares of common stock and warrants to purchase common stock, as described below, in a private placement expected to result in gross proceeds to the Company of approximately $25.3 million, before deducting placement agent commissions and other offering expenses (Press release, Alpine Immune Sciences, JAN 16, 2019, View Source [SID1234532670]). The private placement is being led by Decheng Capital with participation from existing investors OrbiMed Advisors, Frazier Healthcare Partners, Alpine BioVentures, and BVF Partners L.P. Effective on the closing of the private placement, the Company expects to appoint Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, to the Alpine Board of Directors.

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Pursuant to the terms of the securities purchase agreement, at the closing of the private placement, Alpine will issue units representing an aggregate of approximately 4.7 million shares of common stock and warrants to purchase an aggregate of approximately 1.8 million shares of common stock. The aggregate purchase price of each unit, which consists of one share of common stock plus a warrant to purchase 0.39 shares of common stock, is $5.37. The warrants to purchase common stock will have a per share exercise price of $12.74 and will be exercisable at any time on or after the closing date and through the fifth anniversary of the closing date. The price per unit was based in part upon the average of the last five closing prices of the common stock on the Nasdaq Global Market.

The private placement is expected to close on or about January 18, 2019, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by Alpine with the Securities and Exchange Commission ("SEC").

Alpine intends to use the net proceeds to fund development of lead programs ALPN-101 in autoimmune and inflammatory indications and ALPN-202 in cancer.

Piper Jaffray & Co. acted as sole placement agent in the transaction.

The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. Alpine has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement and upon exercise of the warrants.

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 January 16, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1B clinical trial investigating the Company’s ROOT OF CANCER technology in patients with metastatic melanoma (Press release, AIVITA Biomedical, JAN 16, 2019, View Source [SID1234532688]). The trial marks the first time AIVITA’s cancer immunotherapy technology will be tested in combination with checkpoint inhibitors.

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"As our non-responding patients all have elevated checkpoint levels, this combination therapy is a natural extension of our technology, and indeed, checkpoint inhibitors," said Dr. Robert O. Dillman, Chief Medical Officer at AIVITA. "Now that the limitations of anti-PD-1 therapy have been realized, many experts are touting the advantages of adding a personalized vaccine to an anti-PD-1 approach."

AIVITA’s open-label, single-arm, phase 1B treatment study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AV-MEL-1 in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients.

AIVITA’s personalized patient-specific platform cancer technology uniquely and selectively targets the patient’s tumor-initiating cells, which seed tumor growth, metastases and tumor recurrence. Previously, this treatment was tested in two Phase 2 trials in patients with advanced melanoma and approved for Phase 3 testing. These clinical studies demonstrated the efficacy of the approach in a randomized trial, yielding a 72% 2-year survival rate and a 54% 5-year survival rate.

AIVITA’s ROOT OF CANCER technology is currently the subject of two ongoing multi-center Phase 2 trials in the USA, one in patients with a primary diagnosis of advanced ovarian cancer and another in patients with newly diagnosed glioblastoma. The Company is also applying to commercialize the treatment of melanoma patients in Japan and is considering Japanese strategic partners for this program, having just received an enabling approval of its manufacturing, quality systems and safety by Japan’s PMDA.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who will be randomized in a 2:1 ratio to receive either the autologous dendritic cell vaccine or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

AIVITA’s glioblastoma Phase 2 single-arm study is active and will enroll approximately 55 patients to receive the treatment candidate.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

On January 16, 2019 Massive Bio, Inc., a leader in providing simplified and affordable access to precision oncology to cancer patients treated at community-based oncology practices, reported that its Trials-in-Progress poster titled "SYNERGY-AI: Artificial intelligence based precision oncology clinical trial matching and registry (Press release, Massive Bio, JAN 16, 2019, View Source [SID1234532689])." will be presented by Selin Kurnaz, PhD., a lead investigator, at the ASCO (Free ASCO Whitepaper)-Gastrointestinal Cancers Symposium on January 19, 2019 in San Francisco, California, USA.

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The poster, Abstract # TPS717, is available at View Source, and discusses the ongoing, pivotal global registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool powered by a virtual tumor board (VTB) program. The SYNERGY-AI registry which can be found at ClinicalTrials.Gov View Source, is the first of its kind to combine artificial intelligence, genomic biomarkers and multi-variate analysis to accelerate clinical trial matching and promote access to promising cancer therapies.

"We are very excited to be among the highly selected group of clinical trials and registries to be presented at the largest GI Oncology meeting in the United States. It is our goal to continue to promote precision oncology approaches at the point-of-care and enable easy access to clinical trials at scale to all cancer patients, while reducing operational complexities and costs. We are the first oncology dedicated company that has achieved the ability to combine patient centricity, technology and sub-specialist expertise while consistently delivering quadruple better results than national averages in clinical trial enrollment," said Selin Kurnaz, PhD., CEO and Co-Founder of Massive Bio.

Massive Bio has also expanded its Patient Contact and Clinical Research Center and opened a second location in Newtown, Pennsylvania, in addition to its main headquarters in New York City. This center is staffed with a team of oncology nurse navigators, patient advocates and research coordinators and focuses on Massive Bio’s growing portfolio of clinical trials and patient support services. The center is designed to have 24/7 customer support, patient pre-screening and real-world analytics capabilities to further guide and assist patients enrolling in all-phases of clinical trials.

Commenting on the announcement, Chief Medical Advisor and Co-Founder of Massive Bio Inc., Dr. Arturo Loaiza-Bonilla, MD, MSEd, stated, "We are very pleased to have our patient support division grow both in New York and Pennsylvania, and continue to be trusted by some of the world’s top CROs, pharmaceutical companies, patient advocacy groups, and the many patients who are reaching out to our call center directly every day". Chief Business Officer of Massive Bio Inc, Harry Buchman also stated, "We look forward to constantly exceeding our clients’ expectations of our services and professionalism while helping patients explore all of their treatment options from access to clinical trials through new and innovative therapies, which may have not previously been considered for all cancer patients."