City of Hope Doctors Present Research on First KRAS Inhibitor and CAR T Cell Therapy at ASCO

On May 29, 2019 A first-ever inhibitor of a cancer gene found in some lung, colorectal and other cancers and the effectiveness of chimeric antigen receptor (CAR) T cell therapy for patients with chronic lymphocytic leukemia are just some of the research topics that City of Hope physicians and scientists reported that it will present at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 annual meeting May 31 – June 4 in Chicago’s McCormick Place (Press release, City of Hope, MAY 29, 2019, View Source [SID1234536662]).

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More than 38,000 oncology professionals and others will attend the conference to learn about the latest scientific research on cancer treatment, detection and prevention.

"ASCO brings together doctors, nurses and other medical professionals with the important goal of discussing and sharing the latest cancer research and treatment," said Michael Caligiuri, M.D., president of City of Hope National Medical Center and Deana and Steve Campbell Physician-in-Chief Distinguished Chair. "The annual meeting contributes to City of Hope’s deep commitment to developing and implementing the most effective and innovative therapies. City of Hope patients ultimately benefit from the knowledge shared at ASCO (Free ASCO Whitepaper)."

City of Hope doctors and scientists will present oral and poster presentations on a wide array of topics. They include:

First clinical trial testing KRAS G12C inhibitor in lung, colorectal and other cancers

Abstract No: 3003

Phase 1 study evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of AMG 510, a novel small molecule KRASG12C inhibitor, in advanced solid tumors.

Monday, June 3, 8-11 a.m.

McCormick Place, S406

Marwan Fakih, M.D., professor of City of Hope’s Department of Medical Oncology & Therapeutics Research and medical director of Judy & Bernard Briskin Center for Clinical Research, will present a study on the first in-human trial targeting the KRAS G12C oncogene (a gene that when mutated drives tumor growth), which is found in up to 15% of lung cancer patients and 3% of colorectal cancer patients. City of Hope is one of the leading centers evaluating AMG 510, a targeted therapy that, when taken orally on a daily basis, inhibits the growth of KRAS G12C tumors.

The study examined the safety and efficacy of AMG 510 in 20 patients who continue to take the therapy. Most of the patients had advanced cancer and had taken three or more prior lines of treatment; the majority also had colorectal cancer.

Initial results show that two patients with nonsmall cell lung cancer (NSCLC) had partial remissions and six patients (two with NSCLC and four with colorectal cancer) had cancer that had stop growing.

Results so far have demonstrated that the disease is safe for use in patients and very well-tolerated with minimal side effects.

"This is the first-ever KRAS inhibitor that shows anti-tumor activity," Fakih said. "That is quite significant and depending on future results, it has the potential to be life-changing for patients with KRAS G12C."

Fakih will discuss updated clinical results during his ASCO (Free ASCO Whitepaper) presentation.

CAR T therapy for chronic lymphocytic lymphoma

Abstract No: 7501

TRANSCEND CLL 004: Minimal residual disease (MRD) negative responses after lisocabtagene maraleucel (Liso-Cel; JCAR017), a CD19-directed CAR T cell product, in patients (pts) with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).

Tuesday, June 4, 9:45 a.m. – 12:45 p.m.

McCormick Place, E451

Tanya Siddiqi, M.D., associate clinical professor of hematology and director of the chronic lymphocytic lymphoma program within City of Hope’s Toni Stephenson Lymphoma Center, will present an oral abstract on a CAR T cell therapy for chronic lymphocytic leukemia (CLL). Lisocabtagene maraleucel, also known as liso-cel and JCAR017, targets CD19-positive cancer cells. There is not a lot of current data on CAR T cell therapies for CLL, which is an incurable but slow, growing chronic cancer.

"At some point, CLL can become more aggressive and resistant to even the new targeted therapies," Siddiqi said. "Therefore, novel therapeutics are needed, especially for patients with high risk disease (having markers like deletion 17p, complex cytogenetics, unmutated IGVH) or those who have not responded to other therapies."

The phase 1 study had 15 evaluable patients who had all received prior therapies, including ibrutinib (a multikinase inhibitor), and whose cancer had returned. Initial data shows that there was no minimal residual disease, or traces of cancer, in about 70% of patients as early as 30 days after receiving the CAR T cells. Seven patients also achieved complete remission. The overall response rate (patients who showed a response to the therapy) at six months was 83%.

Patients also had manageable toxicities, or side effects caused by the treatment; these included low grade cytokine release syndrome and neurotoxicity.

"Our study brings additional information showing that the product is efficacious with manageable toxicities in patients who have progressed after ibrutinib," Siddiqi said.

Siddiqi will also present updated study results at the ASCO (Free ASCO Whitepaper) presentation.

In addition, City of Hope doctors will also speak at plenary and education sessions. They include: Saro Armenian, D.O., M.P.H., a City of Hope pediatric hematologist/oncologist, will discuss pediatric oncology abstracts on Sunday, June 2; Tanya Dorff, M.D., associate clinical professor in City of Hope’s Department of Medical Oncology & Therapeutics Research, will discuss prostate cancer abstracts on Sunday, June 2, and will also speak at an education session on diagnostics and therapeutics for prostate cancer on Friday, May 31; Karen Reckamp, M.D., M.S., co-director of City of Hope’s Lung Cancer and Thoracic Oncology Program, will discuss lung cancer abstracts on Monday, June 3; Alex Herrera, M.D., assistant professor in City of Hope’s Department of Hematology & Hematopoietic Cell Transplantation, will discuss relapsed Hodgkin lymphoma at an education session on Monday, June 3; Kim Margolin, M.D., clinical professor in City of Hope’s Department of Medical Oncology & Therapeutics Research, will discuss immunotherapy for brain metastases at an education session on Tuesday, June 4; and Jasmine Zain, M.D., director of City of Hope’s T cell Lymphoma Program, will discuss non-Hodgkin lymphoma abstracts on Tuesday, June 4.

AgilVax Triggers $2 Million Phase II Fast Track SBIR Grant and Initiates GMP Manufacturing

On May 29, 2019 AgilVax, Inc., a biotechnology company developing targeted antibody-based therapies for the treatment of various cancers, including metastatic breast cancer (MBC), reported that the company has triggered Phase II funding of $2 million from its Fast Track Small Business Innovation Research (SBIR) grant awarded by the National Cancer Institute (NCI) (Press release, Agilvax, MAY 29, 2019, View Source [SID1234536661]). AgilVax accomplished its Phase I goals ahead of schedule, which enabled the early initiation of the Phase II portion of the grant. Phase II is focused on studies that support an Investigational New Drug (IND) application for AgilVax’s lead product, AX09. As a result of the grant award, AgilVax selected a prominent Contract Manufacturing Organization (CMO) and initiated cGMP manufacturing of AX09.

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AX09 is being developed as an antibody-based therapy for the treatment of MBC by inhibiting the function of xCT, which is associated with tumor growth and metastatic progression. xCT overexpression occurs in several cancers leading to overarching metabolic changes that reprogram cells for tumor growth and survival. AgilVax’s AX09 shows significant anti-xCT immune response in preclinical breast cancer models, where tumor impairment and reduced metastatic progression have been demonstrated. Several peer reviewed publications elucidate the preclinical evidence of AX09 and the importance of xCT in cancer metastasis.

Dr. Federica Pericle, President and CEO of AgilVax and Principal Investigator, stated, "Initiating the GMP manufacturing program for AX09 is an important milestone for the company. We are now one-step closer to the clinic, where we can provide patients suffering from metastatic breast cancer and other cancers a novel therapeutic option. We are also grateful to NCI for the continued support, which is instrumental in supporting the development of AX09."

AVEO Oncology to Present at the 2019 BIO International Convention

On May 29, 2019 AVEO Oncology (NASDAQ: AVEO) reported that Mike Ferraresso, Senior Vice President, Business Analytics and Commercial Operations, will present at the 2019 BIO International Convention in Philadelphia on Wednesday, June 5, 2019 at 4:30 p.m. EDT (Press release, AVEO, MAY 29, 2019, View Source [SID1234536660]).

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A live webcast of the presentation can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

Zymeworks Earns Milestone Payment in Merck Collaboration

On May 29, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that it has earned a milestone payment from Merck (known as MSD outside the US and Canada) achieved under the companies’ 2014 research and license agreement (Press release, Zymeworks, MAY 29, 2019, View Source [SID1234536659]). Zymeworks will receive US$2.0 million in connection with Merck’s completion of a late-stage preclinical study for a bispecific antibody candidate using Zymeworks’ proprietary Azymetric and EFECT therapeutic platforms.

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"Merck’s completion of this milestone is great news," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "We believe this accomplishment from another one of our long-term partners provides additional evidence of the potential of our bispecific antibody technology. We expect similar advancements from our other partners’ therapeutic programs in the years ahead."

Under the terms of the research and license agreement, Zymeworks has granted Merck a worldwide, royalty-bearing license to research, develop and commercialize certain bispecific therapeutic candidates toward Merck’s therapeutic targets for which Zymeworks is eligible to receive additional development and commercial milestone payments as well as tiered royalties on 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. Azymetric bispecific 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.

About the EFECT Platform

The EFECT platform is a library of antibody Fc modifications engineered to modulate the activity of the antibody-mediated immune response, which includes both the up- and down-regulation of effector functions. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization of therapeutic responses for different diseases.

Epizyme to Present at Jefferies 2019 Healthcare Conference

On May 29, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that Robert Bazemore, president and chief executive officer, will present at the Jefferies 2019 Healthcare Conference on June 5, 2019 at 3:00 p.m. ET in New York City (Press release, Epizyme, MAY 29, 2019, View Source [SID1234536658]).

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The live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast will be archived for 60 days following the presentation.