On January 17, 2019 RhoVac AB ("RhoVac") reported today, 17th January 2019, positive interim immune-results on 3- and 6-month’s follow-up testing in their phase I/II clinical study RhoVac-001 in prostate cancer patients (Press release, RhoVac, JAN 17, 2019, View Source [SID1234532778]).

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In the clinical study RhoVac-001 all patients treated are monitored for duration of immune response over a 12-month period following completion of treatment. At this time RhoVac can present interim results after 3- and 6-month’s follow-up analysis. The result show that 18 of 21 of the patients (86%) still have a robust immune response to RV001. In other words, all 18 patients measured as Confirmed Immune Responders following completion of treatment, still show comparable response after 3- and 6-month’s follow-up.

The clinical study RhoVac-001
The study RhoVac-001 (ClinicalTrials.gov identifier: NCT03199872) is a first-in-man trial studying the cancer vaccine RV001. Twenty-two prostatectomised patients were enrolled in the study. The primary endpoint of the study was to evaluate the safety and tolerability of the RV001 cancer vaccine. The primary end-point was met and the results reported in August 2018 confirmed that treatment with RV001 is safe and well tolerated by the prostate cancer patients.

The secondary endpoint was to investigate the RV001-specific immunological response to treatment. The immune response was analysed before -, two time during – and once, one month after completion of treatment. The result reported in August 2018 was that 86% (18 of 21 of the eligible patients) showed a significant immune response to RV001 in the three samples taken during or after treatment. All 18 responding patients also qualified as Confirmed Immune Responders as they showed a significant response in two of the three samples taken during or after treatment. The conclusion on the immune monitoring during treatment was that a vaccine mediated immune response was established following treatment with RV001 and the dose administered in the study was biologically active.

Final results, including 9- and 12 month’s follow-up immunological analysis, is expected to be reported mid-2019.

Comments from RhoVac´s CEO, Anders Ljungqvist
-The interim results at 3- and 6 month’s follow-ups are exciting data and the results confirm that the RV001 mediated immune response is maintained in the patients. Again, the data shows that the response is very consistent over time as already indicated at completion of treatment. The T-cell monitoring group, Department of Immunology at the University of Tübingen, has again performed a timely and dedicated work enabling us to report the interim results as planned. We are now looking forward to completing the follow-up phase and after this, focus on the phase IIb clinical study.

For more information, please contact:
Anders Ljungqvist – CEO, RhoVac AB
Phone: +45 4083 2365
E-mail: [email protected]

This information is such that RhoVac AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 17th January 2019.

On January 17, 2019 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that its President and CEO, Peter L. Hoang, will present a corporate overview at the upcoming Phacilitate Leaders World & World Stem Cell Summit 2019 on Wednesday, January 23, 2019 (Press release, Marker Therapeutics, JAN 17, 2019, View Source;utm_medium=email&utm_campaign=investor_alerts&utm_content=Marker+Therapeutics+to+Present+at+the+Phacilitate+Leaders+World+%26+World+Stem+Cell+Summit+2019 [SID1234532705]).

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Presentation Details

Title: Efficacy without Toxicity: A Multi-Antigen, Non Gene-Modified Therapy That May Address Current CAR-T Limitations
Date: Wednesday, January 23, 2019
Time: 2:20 p.m. EST
Location: Hyatt Regency, Miami, FL

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 16, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patient has been dosed in its Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-601 in patients with selected solid tumors that are locally advanced or metastatic (Press release, ADC Therapeutics, JAN 16, 2019, View Source [SID1234596066]).

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ADCT-601 is an ADC composed of a humanized monoclonal antibody against human AXL, conjugated using GlycoConnect site specific conjugation technology to a pyrrolobenzodiazepine (PBD) dimer toxin. In preclinical studies, ADCT-601 demonstrated potent and specific in vitro and in vivo anti-tumor activity in multiple cancer-derived models with different levels of AXL expression, and was stable and well tolerated.

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "AXL is a novel and ideal target for an ADC approach, as it is overexpressed in many solid tumor types. We look forward to exploring the effect of ADCT-601 on patients with selected advanced solid tumors who have failed or are intolerant to any established therapy. With five ADCs in eight ongoing clinical trials for multiple indications, we believe our highly targeted therapies have the potential to meaningfully improve outcomes for patients with solid tumors and hematological cancers."

The open-label, multicenter, single-arm trial will include a Phase Ia dose-escalation part followed by a Phase Ib dose-expansion part. The dose-escalation part is designed to determine the maximum tolerated dose of ADCT-601. The identified dose will be evaluated in the dose-expansion part. Approximately 75 patients will be enrolled in the trial. For more information, please visit www.clinicaltrials.gov (identifier NCT03700294).

About ADCT-601

ADCT-601 is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human AXL, conjugated using GlycoConnect technology to a linker with a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to an AXL-expressing cell, ADCT-601 is internalized into the cell where enzymes release the PBD-based warhead. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and ultimately killing the cancer cell. ADCT-601 is being evaluated in a Phase I clinical trial in patients with advanced solid tumors (NCT03700294).

On January 16, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the first patient has been dosed in a phase III clinical trial (ORIENT-16) that is to evaluate Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection), in combination with capecitabine and oxaliplatin, as first-line treatment for patients with advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma (GC or GEJ) (Press release, Innovent Biologics, JAN 16, 2019, View Source [SID1234532687]).

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The ORIENT-16 study is a randomized, double-blind, multi-center, phase III trial conducted in China to evaluate the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic GC or GEJ. The phase III study will enroll 650 patients. The study follows a phase Ib study that evaluated Tyvyt (sintilimab injection) in combination with chemotherapy in patients with gastric cancer.

"Over the past decade, the treatment of various malignant tumors has progressed rapidly. From traditional chemotherapy to targeted molecular therapy and immunotherapy, the prognosis of cancer patients has been improved remarkably. However, breakthroughs in the treatment of gastric cancer have been few. With the exception of trastuzumab in first-line use for HER-2 positive patients, several phase III clinical trials have failed successively. Based on the efficacy signals and the safety profile from previous trials, we hope to validate the therapeutic potential of sintilimab in combination with chemotherapy in ORIENT-16, a phase III trial," said Dr. Jianming Xu, a professor from the Chinese PLA General Hospital.

"Gastric cancer is the second most common malignant tumor in China. The development of new agents for the treatment of advanced gastric cancer has been stagnant, and unmet clinical need is huge. Based on the encouraging efficacy signal we have observed in our phase Ib study, we have decided to conduct ORIENT-16, a phase III study in first-line gastric cancer. Our goal is to provide more effective cancer treatment options for the benefit of these patients and for their families," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed by Innovent and Eli Lilly and Company in China. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to the PD-1 molecule on the surface of T-cells, blocks the PD-L1（Programmed Cell Death-1 Ligand-1, PD-L1 pathway）and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company.

About ORIENT-16 Study

The ORIENT-16 study is a randomized, double-blind, multi-center, phase III trial which evaluates the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic GC or GEJ. Patients will receive Tyvyt (sintilimab injection) or placebo in combination with capecitabine and oxaliplatin, followed by Tyvyt (sintilimab injection) or placebo and capecitabine until disease progression. Participants will be randomly assigned in a 1:1 ratio into the experimental or control groups. The study will enroll 650 patients. The primary endpoints are overall survival in both the entire population and in PD-L1 positive population of patients.

About Advanced, Recurrent or Metastatic Gastric Cancer (GC)

Gastric cancer is one of the most common malignant tumors worldwide, ranking fifth in incidence and third in cancer-related deaths. More than half of the cases and deaths from gastric cancer occur in China. Many patients have advanced disease at the initial diagnosis and have little opportunity for therapy with curative intent. The prognosis of patients with advanced and metastatic gastric cancer is poor with an overall survival less than 12 months.