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Aspyrian Therapeutics, Inc. closes $15.1M as part of a Series B-1 financing to support the advancement of its proprietary precision targeted therapy, RM-1929, to late stage clinical development and the progression of new proprietary immune oncology assets into the clinic.
Aspyrian will be presenting findings of its ongoing trials on RM-1929, at European Society of Medical Oncology (ESMO) held in Madrid, Spain, from 8th-12th September 2017Aspyrian is in the process of initiating Phase I trials for RM-1929 in Japan in 2017Aspyrian plans to initiate registration trials for RM-1929 in the first half of 2018
SAN DIEGO, July 19, 2017 /PRNewswire/ — Aspyrian Therapeutics, Inc., a biotechnology company developing precision-targeted cancer therapies based on the proprietary Photoimmunotherapy (PIT) platform, has closed $15.1 million as part of a Series B-1 financing round, expected to reach about $19 million in the next few weeks. The series B-1 financing was provided by private investors including Hiroshi Mikitani, the CEO of Rakuten Inc., and Chairman of Aspyrian Therapeutics’ board. This financing will accelerate clinical development of its proprietary investigational compound, the antibody conjugate RM-1929, in recurrent head and neck cancer as well as other cancer areas. Development activities include initiating Phase 1 trials in Japan in 2017, completion of the ongoing Phase 2 study in the USA, initiation of a global registration clinical trial in the first half of 2018, and CMC manufacturing processes to support the launch and commercialization of RM-1929.
Aspyrian recently presented findings from an ongoing clinical trial of RM-1929 at the American Head & Neck Society meeting, April 27, 2017 in San Diego. The presentation received the American Head & Neck Society Poster of Distinction Award in the category of Clinical Trials/NMSC/Immunotherapy. More information available at: http://www.aspyriantherapeutics.com/news-room/
Aspyrian today announced that an abstract describing clinical study results of RM-1929 was accepted for presentation at European Society of Medical Oncology (ESMO) held in Madrid, Spain from 8th -12thSeptember 2017.
In addition to the development of RM-1929, Aspyrian is progressing with preclinical development of new proprietary immune oncology approaches that rapidly eliminate the immunosuppressive tumor environment and elicit innate and adaptive systemic immune responses to destroy tumors that are resistant to other classes of immune modulators, such as anti-PD1 antibodies.
“We are honored to work with visionary private investors that support our long-term vision to create a fully integrated R&D and commercial biopharmaceutical company and realize our mission to conquer cancer. Aspyrian is fully committed to develop and commercialize novel and potentially transformative approaches to treat cancer, including RM-1929“. said Miguel Garcia-Guzman, President and CEO of Aspyrian. “The Series B-1 funding will also support the progression into the clinic of novel proprietary ways to eliminate the immunosuppressive tumor environment. These approaches are designed to empower the patient’s immune system so it can recognize its own tumor neoantigens and attack cancer cells, as a personalized treatment to conquer their disease”.
RM-1929, a conjugate of Cetuximab and IRDye 700DX®, targets epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck squamous cell carcinomas, esophagus, lung, colon, pancreas and other cancers. This first-in-class therapy uses an antibody conjugate to precisely target cancer cells after which it is locally activated with red light to elicit rapid anti-cancer responses. The dual specificity resulting from local activation of a tumor-selective conjugate promises to deliver oncologists the ability to achieve locoregional tumor control with minimal damage to surrounding healthy tissues and structures.
RM-1929 is an investigational compound that is not approved for any use in any country.
For more information on the clinical trial, please follow this link to the study record on ClinicalTrials.gov:
Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer
About Aspyrian Therapeutics, Inc.
Aspyrian Therapeutics, Inc., is a privately funded clinical stage biotechnology company developing a new class of precision targeted oncologic drugs for the treatment of solid tumors based on the PIT platform licensed from the National Cancer Institute (NCI). Aspyrian has secured the exclusive license to use IRDye 700DX® from LI-COR (Lincoln, Nebraska) for development of PIT products. The Company is currently working with a number of monoclonal antibodies with the potential to treat various types of cancers, including head and neck, esophageal, lung, brain, pancreatic, colorectal, breast and ovarian.
Aspyrian Therapeutics, Inc. Forward Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Aspyrian Therapeutics, Inc. actual results, plans and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to Aspyrian Therapeutics’ products such as RM-1929. Such approvals or success may not be obtained or achieved on a timely basis or at all. Forward-looking statements include statements relating to the potential benefits, safety and efficacy of RM-1929, and the status of current regulatory filings. These statements may be identified by words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “intends,” “potential,” “may,” “suggest, “plan,” “strategy,” “should,” “will” and similar expressions, and are based on our current beliefs and expectations. In addition, this press release include qualifying terms such as “significant,”, “remarkable,” “extraordinary,” etc. that describe opinions on clinical data. Ongoing clinical studies involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in regulatory approval or commercialization of RM-1929 which may be impacted by, among other things, problems with the manufacturing process for RM-1929, the occurrence of adverse safety events, failure to demonstrate therapeutic benefit, and the other risks and uncertainties. We undertake no obligation to publicly update any forward-looking statement, whether because of new information, future developments or otherwise.
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SOURCE Aspyrian Therapeutics, Inc.
Imago BioSciences Doses First Patients in the Phase 2a Portion of the Study of IMG-7289 in Acute Myeloid Leukemia and Myelodysplastic Syndrome
– Study Advances Following Successful Completion of Multiple Ascending Dose Portion –
SAN CARLOS, Calif., July 19, 2017 /PRNewswire/ — Imago BioSciences, a clinical-stage pharmaceutical company developing novel anti-cancer therapies, announced today that the first patients have been dosed in the Phase 2a portion of their clinical trial of IMG-7289 for the treatment of high-risk acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The company recently completed the Phase 1 multiple ascending dose portion of the study assessing the safety, pharmacokinetics and pharmacodynamics of IMG-7289. IMG-7289, an inhibitor of the epigenetic enzyme lysine-specific demethylase 1, is an orally available, once-daily treatment for myeloid diseases. The Phase 2a component of the study assesses the safety and pharmacodynamic effects of IMG-7289 in combination with all-trans retinoic acid (ATRA). In non-clinical models, IMG-7289 in combination with ATRA demonstrated potent and synergistic anti-tumor activity against neoplastic myeloid cells, especially AML cells.
“Rational combinations of agents that exert synergistic effects against neoplastic cells have been the foundation of successful oncologic treatments. A key aspect of our development strategy is to clinically test the combination of our molecule IMG-7289 and other agents that show the greatest promise in non-clinical studies. ATRA was the most compelling molecule to combine with IMG-7289,” said Hugh Young Rienhoff, Jr. M.D., Imago’s Chief Executive Officer.
With the enrollment of 19 patients leading to the completion of the Phase 1 portion, up to 20 patients may now enroll in the Phase 2a component of the study evaluating the safety and anti-tumor activity of IMG-7289 in combination with ATRA. The study is being conducted at five sites in Australia (www.clinicaltrials.gov Identifier NCT02842827).
IMG-7289 is a small molecule developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. IMG-7289 is an investigational agent currently being evaluated in ongoing clinical trials (www.clinicaltrials.gov Identifiers: NCT02842827 and NCT03136185).
About Imago BioSciences
Imago BioSciences is a clinical-stage pharmaceutical company, funded by Clarus Ventures, Frazier Healthcare Partners, Amgen Ventures, and MRL Ventures Fund. Imago is focused on discovering and developing novel anti-cancer therapeutics. These include a range of hematologic malignancies including AML, MDS and the myeloproliferative neoplasms. The company is based in California.
Please see the website at www.imagobio.com for additional information.
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SOURCE Imago BioSciences
For the first time, the horde of 100,000+ attendees at San Diego Comic-Con can count a local university among its ranks. UC San Diego’s presence will be seen on MTS trolleys, outdoor boards — even street teams wearing sandwich-boards and aluminum-foil-hats.
Audentes Therapeutics Announces Appointment of Fulvio Mavilio, Ph.D. to Vice President Scientific Affairs, Europe
SAN FRANCISCO, July 18, 2017 /PRNewswire/ — Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, today announced the appointment of Fulvio Mavilio, Ph.D. to Vice President Scientific Affairs, Europe. Dr. Mavilio will be based in Paris.
“We are extremely pleased to add Fulvio to the Audentes team,” stated Matthew R. Patterson, President and Chief Executive Officer. “He is an internationally recognized scientific leader who has made important contributions to the fields of molecular genetics and gene therapy for rare diseases. He will be a significant resource as we continue to advance our pipeline of programs, highlighted in the near term by the planned initiation of international Phase 1/2 clinical trials of AT132 to treat X-Linked Myotubular Myopathy and AT342 to treat Crigler-Najjar Syndrome.”
Prior to joining Audentes, Dr. Mavilio served as Scientific Director of Genethon, Evry, France (2012-2017). Prior to that he was co-Director of the Center for Regenerative Medicine of the University of Modena, Italy (2006-2011), Director of Discovery of Molmed SpA (2002-2005), founder and Chief Scientific Officer of Genera SpA (1999-2002), and co-Director of the San Raffaele-Telethon Institute of Gene Therapy in Milan, Italy (1995-2002). Dr. Mavilio is a member of the European Molecular Biology Association (EMBO), Member of the Board of the American Society of Gene and Cell Therapy (ASGCT), and a member of the Editorial Board of many international journals in the fields of genetics, molecular biology and gene therapy. He graduated in Biology at the University of Rome in 1976, obtained a Ph.D. in Medical Genetics at the School of Medicine of the same University in 1979, and trained as a visiting scientist at the Wistar Institute in Philadelphia, PA from 1985 to 1989. An expert and a pioneer in the fields of gene therapy and stem cell research, Dr. Mavilio has published over 170 articles in major international journals. He also serves as Professor of Molecular Biology at the University of Modena and Reggio Emilia (Modena, Italy).
“I am thrilled to be joining Audentes at such an exciting time and look forward to continuing to develop the company’s European efforts in particular,” stated Dr. Mavilio, Ph.D. “With its multi-product pipeline, established large-scale cGMP manufacturing capability, and world-class team, Audentes has established itself as a leading gene therapy company and is well-positioned for future success.”
About Audentes Therapeutics, Inc.
Audentes Therapeutics (Nasdaq: BOLD) is a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases. We have four product candidates in development, AT132 for the treatment of X-Linked Myotubular Myopathy (XLMTM), AT342 for the treatment of Crigler-Najjar Syndrome, AT982 for the treatment of Pompe disease, and AT307 for the treatment of the CASQ2 subtype of Catecholaminergic Polymorphic Ventricular Tachycardia (CASQ2-CPVT). We are a focused, experienced and passionate team committed to forging strong, global relationships with the patient, research and medical communities.
For more information regarding Audentes, please visit www.audentestx.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the company’s 2017 development and manufacturing plans and the expected benefits of the company’s product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercial its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Thomas Soloway, CFO
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SOURCE Audentes Therapeutics, Inc.
Renova Therapeutics co-founder presents encouraging data at the American Heart Association’s Basic Cardiovascular Sciences Scientific Sessions 2017
SAN DIEGO, July 17, 2017 /PRNewswire-USNewswire/ — Dr. H. Kirk Hammond, Professor of Medicine at UCSD and Co-founder of Renova™ Therapeutics, a biotechnology company developing gene and peptide-based treatments for cardiovascular and metabolic diseases, presented preclinical data regarding safety and efficacy of intravenous delivery of an adeno-associated virus 8 vector encoding urocortin 2 (AAV8.UCn2) in the treatment of mice with insulin resistance, a key feature of type 2 diabetes. Urocortin 2 is a member of the corticotropin releasing factor (CRF) family of peptides and elicits its pharmacologic action by selectively binding to and activating the CRF type 2 receptor.
Dr. Hammond presented his findings at the American Heart Association’s Basic Cardiovascular Sciences Scientific Sessions 2017 in Portland, Oregon.
The pioneering research of Dr. Hammond and his colleagues has demonstrated that in murine models of heart failure, insulin resistance or type 2 diabetes, gene transfer of urocortin 2 and/or urocortin 3 – peptides with paracrine activity – is associated with significant and long-lasting beneficial effects on heart function, glucose disposal, weight loss and other benefits, including reduction in fatty liver infiltration.
To date, preliminary data in mice indicate that high doses of AAV8.UCn2 are not associated with behavioral or marked laboratory abnormalities, or serious or severe adverse effects. Studies showing efficacy in two murine models of insulin resistance have previously been reported by Dr. Hammond and colleagues in JCI Insight.
Highlighting pilot data, Dr. Hammond now suggested that the same AAV8.UCn2 gene transfer approach holds promise in a disease model in non-human primates with insulin resistance and, potentially, in a murine model of type 1 diabetes.
Renova Therapeutics is planning to conduct a first-in-human, dose-escalation trial with urocortin 2 gene transfer in type 2 diabetes patients in 2018. Urocortin 2 gene transfer in diabetes will be developed as an investigational gene therapy product known as RT-200.
About Renova Therapeutics
Renova Therapeutics is developing definitive, one-time gene therapies and peptide infusion treatments to restore the health of people suffering from chronic diseases. The first indications the company is pursuing are gene therapy treatments for heart failure and type 2 diabetes, two of the most common and devastating chronic diseases in the world. The company’s lead product, RT-100, is a treatment that delivers a therapeutic gene directly to the heart during a routine outpatient procedure and has the potential to increase heart function in millions of patients with heart failure. The company’s product pipeline also includes a groundbreaking gene therapy in preclinical stage for sufferers of type 2 diabetes, as well as a peptide infusion therapy for the treatment of acute decompensated heart failure. Renova Therapeutics was founded in 2009 and is led by an experienced management team in biopharmaceuticals and gene therapy. For additional information about the company, please visit www.renovatherapeutics.com.
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SOURCE Renova Therapeutics
Kocal Consulting Corporation Announces Collaboration with South Korea’s Largest Hospital to Develop New Cancer Treatment
Well Marker Bio Co. Ltd., a biotech division of Asan Medical Center of South Korea, signs Memorandum of Understanding with CZ Biomed Corp. and Kocal Consulting Corporation to develop and market promising new cancer treatment.
COSTA MESA, Calif., July 17, 2017 /PRNewswire/ — The first ever biotech division of Asan Medical Center, the largest medical institution in South Korea, agrees to combine efforts in making significant advances in cancer treatment using CZ Biomed’s patented RVLYSIS®.
Kocal Consulting Corporation recently announced the signing of the Memorandum of Understanding between the three parties at Bio 2017 (BIO International Convention) held on June 19-22 in San Diego, California.
CEO of CZ Biomed Corporation Calvin Cao stated, “Signing of this agreement is monumental. Asan Medical Center is aggressively seeking new and innovative ways to advance their treatment of diseases. We look forward to working with them to develop the most effective cancer treatment.”
“It is clear that CZ Biomed has successfully developed a new class of cancer treatment using oncolytic virotherapy,” commented Andrew Lim, CEO of Kocal Consulting Corporation. “Our goal is the development and commercialization of a safe and effective cancer treatment. Well Marker Bio sees the technological and market potential of RVLYSIS®.”
Oncolytic viruses, viruses that infect and kill cancer cells, must not harm other organs or healthy cells in cancer patients. Respiratory Syncytial Virus (RSV), an oncolytic virus, is a respiratory tract-specific children’s virus that is similar to the common cold and does not cause disease in young and older adults. This trait alone may prove to be much more easily accepted by patients, compared with some much more dangerous viruses currently being investigated for their oncolytic properties.
RVLYSIS® is a genetically engineered form of RSV by CZ Biomed Corp. that can be administered multiple times to allow for maximum effect in targeting, attacking and eradicating cancer cells.
“In 2013, a stage 4 colon cancer patient received 48 doses of RVLYSIS®. That patient is now living a healthy, active, cancer-free lifestyle,” Lim added. “We are extremely excited to be working with Well Marker Bio and the vast resources of Asan Medical Center, the largest medical institution in South Korea. We are one step closer to licensing and commercializing CZ Biomed’s high-tech biological products for the treatment of various cancers.”
For more information on Kocal Consulting Corporation be sure to visit http://www.kcccorp.com.
About Well Marker Bio Co. Ltd.
Well Marker Bio Co. Ltd. is the first ever biotech division from Asan Medical Center. Asan Medical Center, the parent hospital of eight hospitals under the ASAN Foundation, is the largest medical institution in South Korea.
About CZ Biomed Corp:
CZ Biomed Corp. is a privately held Biotechnology company based in Tampa, FL, focused on the discovery, development and commercialization of a new class of high-tech biological products for the treatment of a wide variety of human cancers. CZ Biomed products use novel oncolytic viruses that have been genetically engineered to selectively target tumor cells, but not normal healthy cells.
About Kocal Consulting Corporation:
Kocal Consulting Corporation (KCC Corp.) is a private consulting agency. KCC Corp. was formed to facilitate a network of clients and partners to connect globally to provide innovative solutions with global objectives that offer quick and powerful results.
Forward Looking Statements
This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. The information in this news release includes certain forward-looking statements that are based upon assumptions that in the future may prove not to have been accurate and are subject to significant risks and uncertainties. Although the company believes that the expectations reflected in its forward-looking statements are reasonable, it can give no assurance that such expectations or any of its forward-looking statements will prove to be correct. Factors that could cause results to differ include, but are not limited to, successful performance of internal plans, product development acceptance, and the impact of competitive services and general economic risks and uncertainties.
SOURCE Kocal Consulting Corporation
Phoenix Molecular Designs Appoints Leading Oncology Expert Dr. Gerrit Los as Chief Scientific Officer
VANCOUVER, British Columbia and SAN DIEGO, July 17, 2017 /PRNewswire/ — Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics by targeting essential kinases, announced today the appointment of Dr. Gerrit Los as Chief Scientific Officer and a member of the executive management team. Dr. Los brings over 25 years of oncology, management and operations experience in both the biotechnology industry and academia to PhoenixMD. Dr. Los will be responsible for leading translational biology and medicine for PhoenixMD’s emerging cancer therapeutics pipeline.
“I am truly excited to welcome Gerrit as a member of PhoenixMD’s executive management team as we expand our oncology expertise and advance our lead asset, PMD-026, for triple negative breast cancer toward the clinic,” said Sandra Dunn, Ph.D., Chief Executive Officer of PhoenixMD. “Gerrit’s impressive background in developing targeted cancer drugs aligns perfectly with our approach to design precise therapies that target kinases essential to the development of devastating oncology diseases. The breadth and depth of his expertise bodes well for the future of PMD-026 and we look forward to his contributions.”
Dr. Los added, “My career long passion for oncology research and advancing novel therapies drew me to PhoenixMD and I’m excited to be assuming executive leadership at the company. Our ability to target kinases is greatly needed to develop the next generation of novel oncology therapeutics and I look forward to harnessing this technology and know-how to advance PMD-026 and our emerging oncology pipeline toward the clinic.”
Dr. Los joins PhoenixMD from AnaptysBio, an inflammation and immuno-oncology biotech company, where he served as Vice President of Pharmacology and provided direction and leadership during the preclinical development of two lead compounds in preparation for Phase 1 clinical trials. Prior to that, Dr. Los was Senior Director at Five Prime Therapeutics, where he led translational medicine across several novel oncology antibody programs. Before that, Dr. Los led oncology teams at Pfizer for over a decade in San Diego, CA and directed teams developing several targeted cancer therapeutics such as Crizotinib, axitinib, and palbociclib, which is used for advanced stage estrogen receptor breast cancers. Prior to his industry career, Dr. Los was an Adjunct Professor at the University of California San Diego where he focused on identifying response markers in cancer. Dr. Los received his Ph.D. in Pharmacology from the Free University in Amsterdam, Netherlands and was a Dutch Cancer Society post-doctoral fellow at the Netherlands Cancer Institute. Throughout his career, Dr. Los has published more than 100 peer-reviewed papers and is recognized as a leading expert in oncology research and development and pharmacology.
About Triple Negative Breast Cancer (TNBC) and RSK Kinases
Approximately 400,000 cases of TNBC are diagnosed every year worldwide and it is one of the most difficult breast cancer subtypes to treat due to lack of effective, targeted therapies. TNBC also claims the lives of young women more than any other type of breast cancer due to a lack of understanding around the therapeutic bullseye. It is also a very heterogeneous disease, therefore a common denominator across TNBC types was necessary to identify the bullseye. Through genome-wide screens, RSK was identified as the prime target for TNBC by scientists at PhoenixMD. Currently, there are still no targeted therapies available for TNBC.
There are four types of RSK involved in cancer, known as RSK1-4, and each type has a unique role in the development of the disease. RSK1 is responsible for cancer cell invasion and is an important driver in the spread of cancer. RSK2 controls cancer cell growth, while RSK3 and RSK4 are associated with drug resistance.
RSK1 and RSK2 have been proven critical to the survival of patients with TNBC. Over 90% of primary TNBC express high levels of RSK1 and RSK2. Inhibiting RSK2 eliminates TNBC cells completely, including cancer stem cells, which give rise to cancer recurrence. PhoenixMD, with its novel, targeted approach, is focused on creating patented cancer RSK inhibitors and companion diagnostics for cancer indications – initially in breast cancer – with the potential to treat blood, brain, ovarian, lung, skin, prostate, colon, head and neck cancers.
PhoenixMD is a privately-held biopharmaceutical company designing precise cancer therapeutics and companion diagnostics by targeting kinases, a class of highly druggable enzymes to treat a wide range of oncology indications. PhoenixMD is focused on developing first-in-class inhibitors against ribosomal S6 kinase (RSK), an important drug target for cancer, heart disease, and inflammation. Due to its emerging leadership in kinase inhibition, PhoenixMD has entered into partnerships with well-recognized academic and non-profit institutions such as the National Cancer Institute (NIH), University of Florida, Kyushu University, Mayo Clinic, and University of Hawaii Comprehensive Cancer Center. PhoenixMD is headquartered in Vancouver, British Columbia Canada with U.S. operations in San Diego, CA. For more information, visit phoenixmd.ca.
Ph: (858) 366-3243
SOURCE Phoenix Molecular Designs
STRO-001 Targets CD74, Eradicates B-Cell Hematologic Malignancy & Prolongs SurvivalA Powerful Attack on Multiple Myeloma & Lymphoma
SOUTH SAN FRANCISCO, Calif., July 17, 2017 /PRNewswire/ — STRO-001, Sutro Biopharma‘s antibody drug conjugate targeting the CD74 cell surface protein in hematologic B-cell malignancies, has been shown to eradicate tumors in human xenograft models of non-Hodgkin lymphoma and multiple myeloma – diseases that Sutro plans to evaluate for treatment in a Phase I clinical trial planned for early 2018.
The research findings, which come as Sutro prepares to file an investigational new drug application to begin the clinical testing, show that STRO-001 eliminated tumors or significantly delayed tumor growth in diffuse large B-cell lymphoma and mantle cell lymphoma xenograft models and prolonged survival in the disseminated Mino mantle cell lymphoma xenograft model compared to tumor models treated with vehicle, which developed advanced disease with palpable neck and abdominal tumors.
The Sutro antibody drug conjugate, or ADC, also suppressed tumor growth in a diffuse large B-cell lymphoma tumor model, SU-DHL-6, when administered with standard of care chemotherapy.
In immunohistochemistry testing using the unconjugated antibody component of STRO-001 with a large number of human lymphoma tissue samples, researchers also confirmed that CD74 is highly-expressed in diffuse large B-cell lymphoma, follicular lymphoma and mantle cell lymphoma.
Sutro presented the findings on June 14-16 in Lugano, Switzerland at the 14th International Conference on Malignant Lymphoma, and on June 23 in Madrid at the 22nd Congress of the European Hematology Association.
Additionally, research on STRO-001 revealed potent antitumor activity in multiple myeloma xenograft models and potent in vitro cytotoxicity in multiple non-Hodgkin lymphoma cell lines.
Bioluminescence imaging with the luciferase MM.1S xenograft model showed that a single dose of the Sutro ADC eradicated multiple myeloma at each post-treatment time point investigated, compared to animals treated with vehicle, which experienced diffuse replacement of bone marrow with malignant myeloma. The imaging enabled researchers to quantify tumor growth in response to treatment and vehicle more precisely than in earlier xenograft tumor models designed to assess survival. Sutro presented the findings on June 23 in Madrid at the 22nd Congress of the European Hematology Association.
“These results are the clearest, most compelling evidence that STRO-001 performs effectively in multiple malignant B-cell lines and xenograft tumor models,” Sutro CEO Bill Newell remarked.
Preventing the ‘Bystander Effect’
“STRO-001 was developed with Sutro’s proprietary cell-free protein synthesis and site-specific conjugation platforms, which facilitate multiple rounds of antibody and ADC optimization,” said Dr. Arturo Molina, a medical oncologist and Sutro’s Chief Medical Officer.
“Sutro’s Xpress CF+™ platform enables us to produce novel ADCs that directly target cancer cells while minimizing a toxic ‘bystander effect’ on adjacent healthy cells,” he added.
Unlike conventional cell-based expression systems, Sutro’s technology isolates a cell’s protein production machinery into a cell-free extract, Xtract CF™, which includes all the necessary biochemical components for energy production, transcription and translation to generate aglycosylated homogeneous antibodies. The Xpress CF+™ platform allows the incorporation of non-natural amino acids into specific positions of the generated antibody, allowing for site-specific conjugation of cytotoxins and the creation of homogeneous ADCs. This process is capable of producing homogeneous proteins at large scale within 24 hours, unconstrained by cellular structures and their limitations.
Sutro’s manufacturing facility in San Carlos, California, is built to maximize the speed and efficiency of cell-free extract and protein production. The cell-free extract is manufactured by a multi-day continuous process producing extract for large scale Xpress CF™ and Xpress CF+™ reactions.
About Sutro Biopharma
Sutro Biopharma, located in South San Francisco, has pioneered a compelling and unique way of discovering, developing and manufacturing therapeutics. Sutro’s focus is primarily next generation cancer therapeutics — antibody drug conjugates, or ADCs, and bispecific antibodies.
Without the traditional constraints of cell-based protein generation, Sutro’s cell-free technology enables the rapid design, optimization and scale-up of novel proteins. Using this novel cell-free technology, Sutro is also transcending the limitations of biologics manufacturing with the world’s only cGMP cell-free manufacturing facility located in San Carlos, California. This state-of- the-art facility provides an important competitive advantage to Sutro as the company heads into human clinical trials in 2018. In addition to developing its own oncology pipeline, Sutro Biopharma is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics.
Follow Sutro on Twitter, @Sutrobio, and at www.sutrobio.com to learn more about our passion for changing the future of oncology.
SOURCE Sutro Biopharma
Apexigen, Inc. Announces First Patient Dosed in Phase 1b/2 Clinical Trial of APX005M in Combination with Opdivo (nivolumab) in Advanced Solid Tumors
–Trial Enrolling Second-line Metastatic Non-small Cell Lung Cancer (NSCLC) Patients Who Have Failed Prior Chemotherapy and Metastatic Melanoma Patients Who Have Failed Prior I-O Therapy–
SAN CARLOS, Calif., July 17, 2017 /PRNewswire/ — Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing antibody-based therapeutics for the treatment of cancer with an emphasis on new Immuno-Oncology (I-O) agents, today announced that the first patient has been dosed in a new multicenter Phase 1b/2 clinical trial. Under a clinical trial collaboration, with Bristol-Myers Squibb Company Apexigen is evaluating the safety, tolerability and preliminary efficacy of Apexigen’s APX005M in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) in second-line metastatic NSCLC patients who have failed prior chemotherapy and in metastatic melanoma patients who have failed prior I-O therapy.
“We are excited to dose the first patient in this clinical trial to evaluate the potential of a new treatment approach, combining our CD40 agonist APX005M with Opdivo, a PD-1 immune checkpoint inhibitor,” said Xiaodong Yang, M.D., Ph.D., President and CEO of Apexigen. “Previously, APX005M has demonstrated safety and activity in a Phase 1 clinical trial and dosing the first patient in this Phase 1b/2 trial is an important milestone as we advance our clinical development plans for our novel I-O agents.”
In the Phase 1b dose-escalation portion of this clinical trial, patients with non-small cell lung cancer or metastatic melanoma plan to be enrolled to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of APX005M in combination with nivolumab. In the Phase 2 dose-expansion portion of this trial, additional patients plan to be enrolled and all will be treated with the RP2D of APX005M with nivolumab. The primary endpoints will be safety and overall response rate (ORR) measured by RECIST 1.1 criteria. Secondary endpoints include determining the pharmacokinetic (PK) profile of APX005M, assessing the incidence of APX005M anti-drug antibodies (ADA), and evaluating the duration of response (DOR) and median progression-free survival (PFS) for patients.
Additional information on this clinical trial is available at www.clinicaltrials.gov (identifier: NCT03123783).
APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response in the tumor microenvironment through antigen-presenting cells (APC) of the immune system. APX005M is engineered to selectively activate CD40 in tumor tissues, rather than broadly in the bloodstream like other CD40 agonists. This selective approach has demonstrated potent immune activation with few safety signals, which offers our antibody the potential for a broad therapeutic window to fight cancer.
About Non-small Cell Lung Cancer
Lung cancer is the leading cause of cancer death. According to the American Cancer Society’s estimates, approximately 222,500 individuals will be diagnosed with lung cancer and 155,870 people will die from this form of cancer in 2017 in the United States. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer.
About Metastatic Melanoma
According to the American Cancer Society’s estimates, approximately 87,110 individuals will be diagnosed with melanoma and 9,730 people will die from this form of cancer in 2017 in the United States. Patients diagnosed with metastatic melanoma, or Stage IV melanoma, have a 5-year survival rate of between 15% and 20%.
About Apexigen, Inc.
Apexigen is a clinical-stage biopharmaceutical company discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents that could harness the patient’s immune system to combat and eradicate cancer. APX005M and the Company’s additional preclinical programs were discovered using APXiMAB™, Apexigen’s proprietary product discovery platform. This platform has enabled the Company and its collaboration partners to discover and develop high-quality therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. Seven product candidates discovered using APXiMAB™ are currently in clinical development, either internally by Apexigen or by its partners. For more information, please visit www.apexigen.com.
Vice President, Business Development
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SOURCE Apexigen, Inc.
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