On January 17, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported the achievement of a new development milestone in its collaboration with Eli Lilly and Company ("Lilly") (Press release, Zymeworks, JAN 17, 2019, View Source;Submission [SID1234532710]). In accordance with Zymeworks’ 2014 licensing and collaboration agreement with Lilly, Zymeworks will receive a milestone payment of US$8.0 million for Lilly’s submission of an IND application for an immuno-oncology bispecific antibody enabled by Zymeworks’ proprietary Azymetric platform.

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"We believe that Lilly’s submission of a second IND on an Azymetric bispecific drug candidate within a six-month period is further evidence that Zymeworks’ platform technologies are enabling our global pharmaceutical partners to accelerate drug development into the clinic," said Ali Tehrani, Ph.D., President and Chief Executive Officer of Zymeworks. "As one of our first collaborators, Lilly’s successes demonstrate the ease of use, productivity and promise of our proprietary platforms, especially for advancing therapeutic programs into the clinical setting."

Under its two licensing and collaboration agreements with Lilly, Zymeworks has granted Lilly worldwide licenses to research, develop, and commercialize multiple bispecific therapeutics directed towards Lilly’s targets. To date, Zymeworks has received multiple equity investments, an upfront licensing payment and multiple research and development milestone payments under these agreements. Zymeworks is also eligible to receive further development and commercial milestone payments and tiered royalties on global product sales.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. This unique technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

On January 17, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that a poster entitled "Phase 1 Results from the Phase 1/3 FIGHT Study Evaluating Bemarituzumab and mFOLFOX6 in Advanced Gastric/GEJ Cancer" was presented today at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium in San Francisco (Press release, Five Prime Therapeutics, JAN 17, 2019, View Source [SID1234532709]). The poster (Board J1, Abstract #91) can be found online at Five Prime Therapeutics Scientific Publications.

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"Gastric cancer with FGFR2b overexpression or FGFR2 gene amplification is associated with a poor prognosis for patients with advanced disease," said Helen Collins, M.D., senior vice president and chief medical officer of Five Prime. "We completed the Phase 1 safety lead-in and saw no dose-limiting toxicities with the combination of bemarituzumab and mFOLFOX6. Additionally, we are encouraged to see evidence of clinical activity with the combination. The FIGHT Phase 3 study is currently enrolling patients worldwide with newly diagnosed advanced gastric and gastroesophageal junction cancer whose tumors overexpress FGFR2b with the goal of providing a better first-line treatment option for these patients."

The Phase 1 portion of the study achieved the primary objective of determining a recommended dose of bemarituzumab in combination with mFOLFOX6 to initiate the Phase 3 portion of the FIGHT trial. Key inclusion criteria for the Phase 1 patient population included: adults with incurable GI cancer for whom mFOLFOX6 was an appropriate therapy, an ECOG score of 0-1, and evaluable disease by RECIST v1.1. The patient population was not selected for FGFR2b status or limited to patients without prior chemotherapy treatment for advanced or metastatic disease. At the time of publication, 2 patients with gastric/esophageal cancer were confirmed to be FGFR2 positive with 1 achieving a PR and the other demonstrating a complete metabolic response.

FIGHT Trial

In December 2017, Five Prime initiated the Phase 1 portion (NCT03343301) of the Phase 1/3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) global registrational trial. The Phase 1 safety lead-in portion of the trial was designed to identify a recommended dose of bemarituzumab in combination with the modified FOLFOX6 standard-of-care chemotherapy regimen (mFOLFOX6) to support the initiation of the Phase 3 portion of the trial.

The Phase 3 portion of the FIGHT trial will evaluate bemarituzumab in combination with mFOLFOX6 versus placebo plus mFOLFOX6 in approximately 550 patients with gastric cancer (GC) or gastroesophageal junction (GEJ) cancer whose tumors overexpress FGFR2b. The Phase 3 portion of the trial began in September 2018 and will include more than 250 sites in the U.S., Europe and Asia.

The primary endpoint of the FIGHT trial is overall survival (OS) with secondary endpoints of progression-free survival (PFS), objective response rate (ORR), safety and pharmacokinetic (PK) parameters.

Previous Bemarituzumab Trial Results

Data from a Phase 1 clinical trial of single-agent bemarituzumab were presented at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting. Bemarituzumab demonstrated single-agent activity and an acceptable safety profile in heavily pretreated patients with metastatic gastric cancer whose tumors overexpress FGFR2b.

Efficacy:

In 21 treated patients with late-line GC/GEJ and high FGFR2b overexpression:
ORR was 19.0% with 4 confirmed PRs
Disease control rate at 6 weeks: 57.1%
Median duration of response was 15.4 weeks
Safety:

Bemarituzumab was well tolerated
There were no dose-limiting toxicities
Maximum tolerated dose was not reached during dose escalation
Unmet Need in GC and GEJ

GC, including GEJ cancer, is the fifth most common cancer worldwide and third leading cause of cancer death. The presence of FGFR2 gene amplification or FGFR2b overexpression is associated with a worse prognosis and is present in 10% of patients with GC/GEJ.

Current first-line chemotherapy treatments prolong survival by approximately 6 months compared to best supportive care, but median OS remains poor with literature-reported ranges of approximately 10 to 11 months and PFS from 5 to 5.6 months. An unmet medical need exists in the treatment for GC/GEJ since few treatment options following progression are available after first-line chemotherapy.

Companion Diagnostic Development for FGFR2b

Five Prime is using companion diagnostics to identify FGFR2b overexpression using an IHC test and FGFR2 gene amplification using ctDNA analysis. Five Prime will use both assays to select patients for the FIGHT trial to identify the estimated 10% of patients with gastric and GEJ tumors that would qualify for the trial.

About Bemarituzumab

Bemarituzumab is a first-in-class, isoform-selective, humanized monoclonal antibody in clinical development as a targeted immunotherapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. Bemarituzumab has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Clinical results to date suggest that the specificity of bemarituzumab avoids the dose-limiting toxicities that have been seen with less selective pan-FGFR tyrosine kinase inhibitors that act on multiple FGFRs, including FGFR2.

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 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 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