Spectrum Pharmaceuticals to Present Corporate Update at the Jefferies 2019 Global Healthcare Conference on June 5th

On May 29, 2019 Spectrum Pharmaceuticals (NasdaqGS: SPPI) reported that an overview of the company’s business strategy and development-stage programs will be given at the Jefferies 2019 Global Healthcare Conference being held in New York (Press release, Spectrum Pharmaceuticals, MAY 29, 2019, http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-present-corporate-update-jefferies-2019 [SID1234536645]). The company presentation is on Wednesday, June 5, 2019, at 3:30 PM EDT.

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A live webcast of Spectrum’s presentation will be available at View Source

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."

Bausch Health Companies Announces Participation in Upcoming Investor Conferences

On May 29, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) reported that the Company will participate in two investor conferences in June (Press release, Valeant, MAY 29, 2019, View Source [SID1234536630]).

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Paul S. Herendeen, executive vice president and chief financial officer, Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, and William Woodfield, vice president and treasurer, are scheduled to participate at the Barclays High Yield Bond & Syndicated Loan Conference in Colorado Springs, Colo., on June 6, 2019 at 10:50 a.m. MDT (12:50 p.m. EDT).

Joseph C. Papa, chairman and chief executive officer, Sam Eldessouky, senior vice president and corporate controller, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the BMO Prescription for Success Healthcare Conference in New York on June 25, 2019 at 10:00 a.m. EDT.

Live webcasts and audio archives of the presentations will be available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source

Arvinas Receives Fast Track Designation for its Targeted Protein Degrader ARV-110 as a Treatment for Men with Metastatic Castration-Resistant Prostate Cancer

On May 29, 2019 Arvinas, Inc. (Nasdaq: ARVN), a biopharmaceutical company creating a new class of therapies that degrades disease-causing proteins, reported that its lead PROTAC protein degrader, ARV-110, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed after treatment with two or more systemic therapies (Press release, Arvinas, MAY 29, 2019, View Source [SID1234536646]). ARV-110 is an orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR) protein. ARV-110 is currently being evaluated in a Phase 1 clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics of ARV-110 in men with mCRPC whose disease has progressed after treatment with standard of care therapies.

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"While great strides have been made in the treatment of men with metastatic castration-resistant prostate cancer, current AR-targeted standard of care treatments are less effective in patients whose disease includes increased levels of androgen production or mutations in the androgen receptor," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "We believe, due to its ability to iteratively degrade the AR protein, ARV-110 could represent a meaningful new therapy to improve the lives of patients battling mCRPC, and for whom current therapies are not effective. The Fast Track designation by the FDA recognizes the urgency for improved treatments for these patients."

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
In the United States, prostate cancer is both the second most prevalent cancer in men and the second leading cause of cancer death in men. The American Cancer Society predicts that one in nine men will be diagnosed with prostate cancer in his lifetime. Metastatic castration-resistant prostate cancer (mCRPC) is defined by disease progression despite androgen deprivation therapy and is often correlated with rising levels of prostate-specific antigen (PSA).

Current AR-targeted standard of care treatments for mCRPC are less effective in patients whose disease has increased levels of androgen production, AR gene or gene enhancer amplification, or AR point mutations. Between 15-25% of patients do not respond to second-generation hormone therapies like abiraterone and enzalutamide, and the majority of responsive patients will ultimately become resistant, resulting in poor prognoses for men diagnosed with this devastating condition.

About PROTAC Protein Degraders
Arvinas’ PROTAC protein degraders harness the body’s own natural protein disposal system to degrade disease-causing proteins. PROTAC protein degraders recruit an E3 ligase to tag the target protein with ubiquitin, which directs its degradation through the proteasome, a large protein complex that breaks down the ubiquitinated target protein into small peptides and amino acids. As the target protein is degraded, the PROTAC protein degrader is released and acts iteratively to destroy additional target protein.

PROTAC protein degraders offer numerous potential therapeutic advantages, including broad tissue distribution, routes of administration that include oral delivery, and simpler manufacturing than other new modalities, such as cell-based therapies. Arvinas has developed and optimized a proprietary library of protein targeting ligands, E3 ligase ligands, and linkers, which allow the company to rapidly identify and optimize efficient protein degraders with favorable characteristics for successful drug development.

About ARV-110
ARV-110 is an orally bioavailable PROTAC protein degrader designed to selectively target and degrade androgen receptor (AR) protein. ARV-110 is being developed as a potential treatment for men with mCRPC. ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies. Arvinas believes the differentiated pharmacology of ARV-110, including its iterative activity, has the potential to translate into improved clinical outcomes for patients.

The Phase 1 clinical trial of ARV-110, for men with mCRPC whose disease has progressed after treatment with standard of care therapies, began in 1Q2019. Preliminary clinical data for the trial will be shared in 2H2019, including safety, tolerability, and PK data. Full disclosure of trial information is expected in 1H2020, including prostate-specific antigen (PSA) data and Response Evaluation Criteria in Solid Tumors (RECIST) data.

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.