Novartis powers Notch cancer biotech Ayala to $30M series B

fiercebiotech | May 29, 2019

Novartis has powered Ayala Pharmaceuticals to a $30 million series B round. Ayala will use the cash to fund mid-phase development of pan-Notch inhibitor AL101 in adenoid cystic carcinoma (ACC).
Israel’s Ayala has advanced quickly since beginning life with two former Bristol-Myers Squibb cancer drugs late in 2017. The following year, Ayala raised a $17 million series A round, started a phase 2 trial of AL101 in ACC and granted Novartis an option on the rights to a second asset in multiple myeloma.

Spotlight

The recent discovery of the CRIPSR technique now allows scientists to edit your DNA with unprecedented ease and accuracy. Learn how it works.A simple version of the CRISPR/Cas system, CRISPR/Cas9, has been modified to edit genomes. By delivering the Cas9 nuclease complexed with a synthetic guide RNA (gRNA) into a cell, the cell's genome can be cut at a desired location, allowing existing genes to be removed and/or new ones added..

Spotlight

The recent discovery of the CRIPSR technique now allows scientists to edit your DNA with unprecedented ease and accuracy. Learn how it works.A simple version of the CRISPR/Cas system, CRISPR/Cas9, has been modified to edit genomes. By delivering the Cas9 nuclease complexed with a synthetic guide RNA (gRNA) into a cell, the cell's genome can be cut at a desired location, allowing existing genes to be removed and/or new ones added..

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MEDICAL

Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)

LBCL | April 04, 2022

Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved Yescarta® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS; hazard ratio 0.398; P< 0.0001) over the current standard of care (SOC) that has been in place for decades. EFS was determined by blinded central review and defined as the time from randomization to the earliest date of disease progression, commencement of new lymphoma therapy, or death from any cause. Additionally, 2.5 times more patients receiving Yescarta (40.5%) were alive at two years without disease progression or need for additional cancer treatment, after their one-time infusion of Yescarta vs. SOC (16.3%), and the median EFS was four-fold greater (8.3 months vs. 2.0 months) with Yescarta vs. SOC. Yescarta is also being reviewed by global regulatory authorities for additional indications inclusive of the ZUMA-7 patient population. ZUMA-7 is considered a landmark trial for being the first and largest trial of its kind, with the longest follow-up. Earlier this month, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for B-cell Lymphomas to include Yescarta for “Relapsed disease <12 mo or Primary Refractory disease” under Diffuse Large B-cell Lymphoma (DLBCL) as a Category 1 recommendation. Yescarta is the first CAR T-cell therapy to receive a NCCN Category 1 recommendation. NCCN defines Category 1 as recommendations based upon high-level evidence with uniform NCCN consensus that the intervention is appropriate. Kite started with a very bold goal: creating the hope of survival through cell therapy. Today’s FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey. This milestone has been years in the making. On behalf of the entire Kite community, we would like to thank the patients and physicians who have been on this journey with us. You are what drives us every day to explore the full potential of cell therapy.” Christi Shaw, Chief Executive Officer of Kite. CAR T-cell therapies are individually made starting from a patient’s own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite’s specialized manufacturing facilities where they are engineered to target the patient’s cancer, expanded, and then returned to the hospital for infusion back into the patient. Referring physicians and patients can immediately begin accessing Yescarta CAR T-cell therapy for this new FDA-approved indication through Kite’s 112 authorized treatment centers across the U.S. Definitive clinical trial results such as these do not come along often and should drive a paradigm shift in how patients with relapsed or refractory LBCL are treated moving forward. Patients who do not respond to or relapse after initial treatment should quickly be referred to a CAR T-cell therapy authorized treatment center for evaluation.” Jason Westin, MD, MS, FACP, ZUMA-7 Principal Investigator, Director, Lymphoma Clinical Research, and Associate Professor, Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. Kite CAR T-cell therapy products are widely covered by commercial and government insurance programs in the U.S. Kite has also invested in expansion of manufacturing capacity ahead of today’s FDA decision to support patient access. LLS was an early supporter of CAR T-cell therapy research, and to be able to see this innovative advance become available as an earlier line of treatment is truly remarkable. Current standard of care is a difficult process for patients, and no one knows at the start who will make it to stem cell transplant. With today’s FDA decision, patients will have earlier access to this potentially curative treatment.” ​ Lee Greenberger, PhD, Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS). Yescarta was initially approved by the FDA in 2017 based on the ZUMA-1 trial for a smaller population of LBCL patients who failed two or more lines of therapy. The ZUMA-1 trial has recently reported durable 5-year survival results, with Yescarta showing 42.6% of study patients alive at 5 years and that 92% of those patients alive at 5 years have needed no additional cancer treatment at this important milestone. As the only company dedicated exclusively to the research, development, commercialization, and manufacturing of cell therapy on a global scale, Kite has all functions critical to cell therapy vertically integrated. This structure enables the continual refinement and support of the highly specialized and complex end-to-end processes needed to support and improve upon patient outcomes with CAR T-cell therapy. About ZUMA-7 Study The FDA approval of Yescarta CAR T-cell therapy for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy is based on results from the ZUMA-7 study. Patients had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous stem cell transplant (ASCT). Results were presented in a Plenary session at the American Society of Hematology’s (ASH) Annual Meeting & Exposition in December 2021 and simultaneously published in the New England Journal of Medicine (NEJM). About LBCL Globally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). In the United States, more than 18,000 people are diagnosed with LBCL each year. About 30-40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to initial treatment.

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MEDICAL

HealthMyne's Radiomic Technology Leveraged to Identify Biomarkers That Predict Immunotherapy Treatment Responses

HealthMyne | September 22, 2021

HealthMyne, a pioneer in applied radiomics, announced that peer-reviewed research recently published in the journal Cancers has demonstrated the ability of its radiomics technology to identify biomarkers that predict whether patients with lung adenocarcinoma would benefit from immunotherapy. In the Cancers article, researchers led by Vincenza Granata evaluated HealthMyne's technology as a quantitative imaging decision support tool for radiomic analysis of lung adenocarcinoma in chest CT scans. Researchers analyzed radiomic biomarkers to predict Overall Survival (OS) and Progression Free Survival (PFS) time. To perform the study, researchers selected 74 patients with histologically confirmed lung cancer who underwent immunotherapy and compared them with 50 patients with histologically confirmed lung adenocarcinoma who underwent chemotherapy alone or in combination with targeted therapy. Researchers segmented each patient's lesion leveraging HealthMyne's advanced imaging analytics solution to extract 573 radiometric metrics from the cohort images to predict OS and PFS time. Researchers found that 19 radiomic features were significant for predicting OS and 108 radiomic features for predicting PFS time. Researchers concluded that the study demonstrated the relationship between radiomics and immunotherapeutic response and that specific radiomic features can be used to select patients with lung adenocarcinoma who would benefit from immunotherapy. To maximize the value of research and development investments, drug developers need an accurate and efficient means of selecting and stratifying patients for clinical studies. Numerous examples of peer-reviewed research have shown that radiomics and precision image analysis identifies biomarkers that drive greater personalization of treatment and provides new insights for better decisions. At HealthMyne, we strive to develop innovative radiomic solutions that contribute to the advancement of this critical body of evidence. - Rose Higgins, CEO, HealthMyne. About HealthMyne HealthMyne® is a pioneer in applied radiomics, the cutting-edge field of extracting novel data and biomarkers from medical images. Our FDA-approved and CE marked, AI-enabled solutions allow organizations to easily access and translate groundbreaking radiomic insights into use in research, clinical outcomes, and treatment pathways. By leveraging radiomics, our clients and partners can accelerate the development and delivery of the best possible treatments. HealthMyne's approach is based upon the premise that every cancer patient's story begins with an image. We believe that unleashing the hidden power of imaging data and radiomics will revolutionize personalized care -- ensuring the right treatment every time. Our mission is to advance precision health initiatives through accessible and translatable radiomic data.

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INDUSTRIAL IMPACT

Enteris BioPharma Completes Manufacturing Facility Expansion and Announces the Launch of CDMO Business Segment

Enteris BioPharma | May 04, 2021

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