On September 21, 2020 Novartis reported that Kisqali (ribociclib) has achieved a score of five out of five on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for first-line premenopausal patients with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer1 (Press release, Novartis, SEP 21, 2020, View Source [SID1234565405]). This perfect score was achieved as a result of the significant overall survival benefit and the quality of life improvements demonstrated by Kisqali plus endocrine therapy for premenopausal women in the Phase III MONALEESA-7 trial.

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Kisqali also received an ESMO (Free ESMO Whitepaper)-MCBS score of four out of five, the highest score achieved by any CDK 4/6 inhibitor in combination with fulvestrant for first-line postmenopausal patients, based on the statistically significant overall survival benefit observed in the Phase III MONALEESA-3 study and maintained quality of life2. A score of four out of five was also granted for Kisqali plus fulvestrant in the second-line setting based on the MONALEEA-3 study.

Achieving a five on the ESMO (Free ESMO Whitepaper)-MCBS is the highest grade in the non-curative setting, and Kisqali received the highest scores across the board in advanced or metastatic breast cancer due to the body of evidence supporting the overall survival and quality of life benefits it provides. The ESMO (Free ESMO Whitepaper)-MCBS is a validated tool for physicians to assess the value of cancer treatments, and ultimately make informed treatment decisions for their patients.

Additionally, new Kisqali data will be presented during the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 further build on the robust body of evidence. Key presentations include:

An analysis that found Kisqali plus endocrine therapy demonstrated consistent improvement in overall survival in patients with endocrine-resistant HR+/HER2- advanced breast cancer, which is typically more challenging to treat. Treatment with Kisqali in patients with endocrine resistance led to a 30% and 41% reduction in the risk of death in the MONALEESA-3 and -7 studies over standard endocrine therapy, respectively. Safety was consistent with the overall study populations in both trials4.
An oral presentation of a robust pooled analysis of patient-reported outcomes from MONALEESA-2, -3, and -7 trials in first-line patients, which demonstrated improvement in quality of life for patients with HR+/HER2- advanced breast cancer upon receiving Kisqali plus endocrine therapy with consistency in different subgroups analyzed5.
A matching-adjusted indirect comparison (MAIC), a method used to estimate the comparative effectiveness of treatments after adjusting for differences in the patient populations where head-to-head trials do not exist, indicated that patients taking Kisqali plus fulvestrant as first-line therapy may live significantly longer than those taking palbociclib plus letrozole, based on the MONALEESA-3 and PALOMA-1 trials, respectively6. A trend toward improved progression free survival (PFS) for Kisqali plus fulvestrant versus palbociclib plus letrozole was also observed.
"The totality of these data presented at ESMO (Free ESMO Whitepaper) confirm the proven overall survival and quality of life benefits with Kisqali, reinforcing it as the standard of care for advanced breast cancer patients," said Susanne Schaffert, PhD, President, Novartis Oncology. "We are proud to continue advancing the science across multiple breast cancer patient populations, including exploring the potential of Kisqali in early breast cancer."

Visit View Source for the latest information from Novartis including our bold approach to reimagining cancer care, and access to our ESMO (Free ESMO Whitepaper) Virtual Congress 2020 symposia and data presentations (for registered participants).

About Kisqali (ribociclib)
Kisqali is the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent and sustained efficacy compared to endocrine therapy alone. Overall survival results from MONALEESA-7 and MONALEESA-3 were presented at ASCO (Free ASCO Whitepaper) 2019 and ESMO (Free ESMO Whitepaper) 2019 respectively, demonstrating Kisqali plus endocrine therapy significantly extends life in pre/perimenopausal or postmenopausal women with HR+/HER2- advanced breast cancer. Overall survival follow-up is ongoing for the Phase III MONALEESA-2 trial.

Kisqali was initially approved by the US Food and Drug Administration (FDA) in March 2017 and by the European Commission (EC) in August 2017, as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial. Kisqali in combination with an aromatase inhibitor was approved for the treatment of pre-, peri- or postmenopausal women as initial endocrine based therapy, and also indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women by the FDA in July 2018 and by the EC in December 2018. Regulatory filings are underway with other health authorities worldwide.

Novartis is continuing to reimagine cancer by investigating Kisqali in early breast cancer. The NATALEE study is a Phase III clinical trial of Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer being conducted in collaboration with Translational Research In Oncology (TRIO).

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

About Novartis in Advanced Breast Cancer
Novartis tackles breast cancer with superior science, collaboration and a passion for transforming patient care. We’ve taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer.

Important Safety Information from the Kisqali EU SmPC
Kisqali (ribociclib) is a prescription medicine approved in combination with an aromatase inhibitor as initial endocrine – based therapy in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer or fulvestrant as initial endocrine – based therapy or following disease progression on endocrine therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. It is not known if Kisqali is safe and effective in children or adolescents. Kisqali can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Kisqali is not indicated for concomitant use with tamoxifen due to an increased risk of QT prolongation. Patients should tell their health care provider right away if they have a change in their heartbeat (a fast or irregular heartbeat), or if they feel dizzy or faint. Kisqali can cause serious liver problems. Patients should tell their health care provider right away if they get any of the following signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), dark or brown (tea-colored) urine, feeling very tired, loss of appetite, pain on the upper right side of the stomach area (abdomen), and bleeding or bruising more easily than normal. Low white blood cell counts are very common when taking Kisqali and may result in infections that may be severe. Patients should tell their health care provider right away if they have signs and symptoms of low white blood cell counts or infections such as fever and chills. Before taking Kisqali, patients should tell their health care provider if they are pregnant, or plan to become pregnant as Kisqali can harm an unborn baby. Females who are able to become pregnant and who take Kisqali should use highly effective birth control during treatment and for at least 3 weeks after the last dose of Kisqali. Do not breastfeed during treatment with Kisqali and for at least 3 weeks after the last dose of Kisqali. Patients should tell their health care provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements since they may interact with Kisqali. Patients should avoid grapefruit or grapefruit juice while taking Kisqali. The most common side effects (incidence >=20%) include infections, white blood cell count decreases, headache, cough, nausea, tiredness, diarrhea, vomiting, constipation, hair loss and rash. The most common Grade 3/4 side effects (incidence >5%) were infections, low neutrophils, low leukocytes, low red blood cells, abnormal liver function tests, low lymphocytes, low phosphate levels and vomiting. Abnormalities were observed in hematology and clinical chemistry laboratory tests.

On September 21, 2020 T-knife GmbH, a next-generation adoptive T-cell company using its proprietary humanized T-cell receptor (HuTCR) mouse platform to treat solid tumors, and Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products reported they have signed an agreement to provide technology transfer and CGMP clinical manufacturing of T-knife’s T1367 T-cell receptor (TCR) program (Press release, Catalent, SEP 21, 2020, https://www.catalent.com/catalent-news/t-knife-and-catalent-collaborate-on-autologous-tcr-based-cell-therapy/ [SID1234565403]).

STARTPRODUCTCLEAR|

T1367 is an autologous T-cell receptor-based cell therapy derived from T-knife’s proprietary humanized T-cell receptor (HuTCR) mouse platform and specifically targets MAGE-A1 positive tumors in cancer patients. The therapy is expected to be manufactured for clinical trials in both the European Union and the United States.

Under the terms of the agreement, Catalent will undertake transfer of T-knife´s platform process for T-cell receptor-based cell therapy at its site in Gosselies, Belgium, with the goal of manufacturing clinical batches for European trials in 2021. T-knife will also prepare for the transfer of the TCR manufacturing platform to Catalent’s Houston, Texas, facility with a view to initiating clinical trials in North America in the future.

"The product candidates based on our proprietary HuTCR platform require sophisticated, state-of-the-art manufacturing capabilities and deep cell and gene therapy know-how," said Michael Buchholz, Director Manufacturing of T-knife. "We are convinced that Catalent is the right partner for T-knife to ensure premier manufacturing of our pipeline programs, covering all stages from clinical trials to market."

"Catalent is well-suited to support T-knife with focused technology transfer and process industrialization in both Gosselies and Houston," commented Manja Boerman, Ph.D., President, Cell & Gene Therapy, Catalent. "Emerging and innovative treatments like T1367 are moving rapidly to the clinic. Catalent is committed to continual investment and expansion to support our clients as they continue on the journey to commercialization."

Catalent’s 2,400 square-metre (25,830 square-foot) facility in Gosselies, Belgium, provides clinical through commercial-scale cell therapy manufacturing, for both autologous and allogeneic cell therapy treatments. The facility accommodates four process development laboratories, nine flexible manufacturing clean rooms for CGMP manufacturing, as well as fill and finish services and quality control laboratories. An additional large-scale commercial manufacturing plant is currently under construction at the site and expected to be fully commissioned in 2021. The company also has a clinical manufacturing site in Houston, which is under qualification and expected to be fully commissioned in 2020.

On September 21, 2020 AstraZeneca and MSD’s Lynparza (olaparib) reported that has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer (Press release, AstraZeneca, SEP 21, 2020, View Source [SID1234565401]).

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on a biomarker subgroup analysis of the PAOLA-1 Phase III trial, which was published in The New England Journal of Medicine.

The trial showed that Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% (based on a hazard ratio of 0.33; 95% confidence interval 0.25-0.45). The addition of Lynparza improved progression-free survival (PFS) to a median of 37.2 months versus 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.

For patients with advanced ovarian cancer, the primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission.1-3

Ovarian cancer is the fifth most common cause of cancer death in Europe and the five-year survival rate is approximately 45%, due in part because women are often diagnosed with advanced disease (Stage III or IV).4,5

José Baselga, Executive Vice President, Oncology R&D, said: "Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumours. Lynparza together with bevacizumab has demonstrated a median progression-free survival benefit of more than three years, offering new hope for women in this setting. This recommendation is a vital step toward addressing a significant unmet need and could bring a new treatment option that delays relapse in this devastating disease."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "HRD is an important biomarker of advanced ovarian cancer that can inform how physicians in the EU treat this aggressive type of cancer. This recommendation and the results from the PAOLA-1 trial underscore the importance of HRD testing at diagnosis to determine the best course of treatment for women with advanced ovarian cancer."

The CHMP recommendation is for Lynparza in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with HRD positive status defined by either a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation and/or genomic instability.

Further results from the PAOLA-1 trial recently presented during the 2020 European Society for Medical Oncology virtual congress showed that Lynparza in combination with bevacizumab maintenance treatment demonstrated a statistically significant improvement in the time to second disease progression (PFS2) versus bevacizumab alone in patients with HRD-positive advanced ovarian cancer, a key secondary endpoint. The results showed Lynparza with bevacizumab provided benefit beyond first disease progression, improving PFS2 to a median of 50.3 months versus 35.3 months with bevacizumab alone.

Lynparza in combination with bevacizumab is approved in the US and several other countries as a 1st-line maintenance treatment for patients with HRD-positive advanced ovarian cancer and is currently under regulatory review in other countries around the world.

Ovarian cancer

In 2018, there were nearly 68,000 new cases of ovarian cancer diagnosed in Europe and around 45,000 deaths.4 Approximately 50% of ovarian cancers are HRD-positive including BRCA1/2 mutation.6,7 Approximately 22% of ovarian cancers have a BRCA1/2 mutation.6-8

Homologous recombination deficiency

HRD, which defines a subgroup of ovarian cancer, encompasses a wide range of genetic abnormalities, including BRCA mutations and beyond. As with BRCA gene mutations, HRD interferes with normal cell DNA repair mechanisms and confers sensitivity to PARP inhibitors including Lynparza.9

PAOLA-1

PAOLA-1 is a double-blind Phase III trial testing the efficacy and safety of Lynparza added to standard-of-care bevacizumab versus bevacizumab alone, as a 1st-line maintenance treatment for newly diagnosed advanced FIGO Stage III-IV high-grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy and bevacizumab. AstraZeneca and MSD announced in August 2019 that the trial met its primary endpoint of PFS in the overall trial population.

Lynparza

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR), such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.

Lynparza is currently approved in a number of countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer. It is approved in the US, the EU, Japan, China, and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in the US as a 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced ovarian cancer (BRCAm and/or genomic instability). Lynparza is approved in the US, Japan, and a number of other countries for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. It is also approved in the US and several other countries for the treatment of germline BRCAm metastatic pancreatic cancer. Lynparza is approved in the US for HRR gene-mutated mCRPC (BRCAm and other HRR gene mutations). Regulatory reviews are underway in several countries for ovarian, breast, pancreatic and prostate cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 30,000 patients worldwide. Lynparza has the broadest and most advanced clinical trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On September 21, 2020 Universal Diagnostics (UDX), an in-vitro diagnostics company developing minimally-invasive, blood-based solutions for detecting cancer early, reported that promising new data for its investigational advanced adenoma (precursor lesions of colorectal cancer) detection blood test and multi-cancer detection test was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Universal Diagnostics, SEP 21, 2020, View Source [SID1234565395]).

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Despite the fact that more than 80% of colorectal cancers (CRC’s) originate from advanced adenomas (AA), current screening methods are not accurate enough to provide detection early enough to prevent CRC. The data presented at ESMO (Free ESMO Whitepaper) 2020, shows that the evaluation of a panel of cell free DNA (cfDNA) open chromatin regions in plasma can be successfully used for AA detection with high accuracy. These results are further supporting the companies previous findings on using cfDNA derived methylation signals for AA and early colorectal cancer detection.

"Only about a quarter of colorectal cases are caught in the very early, precancerous stages. By screening and detecting molecular changes early, there is a better chance of effectively treating patients or even preventing cancer altogether. Previous research suggests that kinetic analysis and molecular profiling of cfDNA could potentially be used in non-invasive cancer detection and management. The data presented at ESMO (Free ESMO Whitepaper) 2020 supports this proposition, particularly in screening for colorectal adenomas," said Michael H. A. Roehrl, MD, PhD, Director, Precision Pathology Center at Memorial Sloan Ketting Cancer Center and Member of the Scientific Advisory Board of UDX. "We urgently need a population-scale colon cancer screening that is cost-effective and blood based, to encourage higher patient compliance and to detect patients with precancerous lesions. The UDX approach could potentially provide that platform."

In Poster ID 479P titled "Open chromatin region (OCR) based model predicts advanced adenoma in plasma cell-free DNA whole genome bisulfite sequencing data", the researchers validated an OCR panel performance on plasma cfDNA samples. The results show that 50% of AA samples being correctly identified at 90% specificity. The test is able to detected 100% serrated adenoma, 50% tubulovillous adenoma and 25% tubular adenoma patients. More importantly, the detection rate is comparable for patients with high grade dysplasia (50%) and with low grade but >1cm findings (50%). With this abstract UDX confirms the test’s ability to pick up the signal coming from advanced adenomas. The ability to add open chromatin information to its panel could potentially enhance the already strong results presented at ESMO (Free ESMO Whitepaper) GI in July 2020, which showed 62.5% sensitivity and 88% specificity.

A second poster (ID 97P), titled "A panel of methylation markers for multi-cancer detection from plasma", shows performance data of UDX’s blood test in the detection of four cancer types – colorectal (CRC), lung (LC), pancreatic (PaC) and breast (BC) cancer. The methylation marker panel based test is able to detect 100% of the CRC, 80% of the PaC, 75% of the BC and 73% of LC with low false-positive rate at 90% specificity. Importantly, the sensitivity for earlies, stage I cancers is 75%, further solidifying the tests potential. Further on, for cancers detected, the test also identifies where the cancer is located in the body with 80% of CRC, 78% of LC, 75% of PaC and 62% of BC cases correctly assigned to tissue of origin.

"Building on encouraging preliminary data in colorectal cancer and adenomas, the data presented at ESMO (Free ESMO Whitepaper) 2020 suggests that the UDX test may also have an application in the early detection of lung, pancreatic and breast cancers," said Dr. James Kinross, Senior Lecturer in Surgery at Imperial College Healthcare NHS Trust and co-author of the study. "Of course these data need now to be validated in larger prospective cohorts but it does suggest that UDX are developing a highly promising and minimally invasive blood-based cancer screening test to detect and ultimately prevent multiple cancers."

"These data presented at ESMO (Free ESMO Whitepaper) 2020 continue to show that our cfDNA panels have potential for use in the early, blood-based detection of colorectal cancer, our lead indication, but also in other cancers types, all with high sensitivity and specificity," said Juan Martínez-Barea, Co-Founder and President of Universal Diagnostics. "We intend to complete our ongoing verification study by end of 2020 and plan to finalize internal validation of our CRC/AA test by the end of 2021. In parallel, we will expand our cancer diagnostic platform to create more substantial data for other cancers, for example, the most frequently diagnosed cancers such as lung cancer."

About the Colorectal Cancer and Advanced Adenoma Test

UDX’s first product is a simple, non-invasive and accurate blood-based screening test that allows early stage colorectal cancer detection and cancer prevention through advanced adenoma detection. Using profiling of DNA methylation changes in large number of tissue and plasma samples, UDX has identified and quantified a proprietary panel of biomarkers that has been combined into targeted assays that have shown 77% sensitivity for colorectal cancer, 62.5% sensitivity of adenomas and 88-90% specificity and tissue of origin accuracy across different verification studies.

On September 21, 2020 Scenic Biotech BV ("Scenic"), a pioneer in the discovery of genetic modifiers to enable the development of disease modifying therapeutics for rare genetic disorders and other devastating illnesses, reported that it has entered into a multi-year strategic collaboration with Genentech, a member of the Roche Group, to discover, develop and commercialize novel therapeutics that target genetic modifiers (Press release, Scenic Biotech, SEP 21, 2020, View Source [SID1234565394]).

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Genetic modifiers are genes that counteract the effect of a disease-causing gene. They may explain why some people with genetic mutations linked to severe disease end up having only mild or no symptoms. Also known as disease suppressors, genetic modifiers therefore positively influence the severity of disease and act as a ‘natural form of protection’. Their discovery is leading to a completely new class of drug targets.

Under the terms of the agreement, Scenic will utilize its Cell-Seq platform and its data warehouse of genetic modifiers to identify drug targets in multiple therapeutic areas. The collaboration enables Genentech to select multiple targets for further development with an option to extend the collaboration. Scenic will receive an undisclosed upfront payment and is eligible to receive additional target selection fees for drug targets taken forward by Genentech. In addition, Scenic is eligible for success-based payments for each target based on achievement of certain predetermined milestones, as well as royalties on sales of certain products resulting from the collaboration. Total deal value could exceed US $375M.

Scenic has built an extensive proprietary data warehouse of genetic modifiers and its Cell-Seq platform enables the development of potential disease modifying therapeutics for devastating diseases with an in-house focus on inherited rare diseases and immuno-oncology/inflammation.

The Company was founded in 2017 as a spin-out of the Netherlands Cancer Institute, and Oxford University and recently appointed Oscar Izeboud, PhD as its Chief Executive Officer.

Dr Sebastian Nijman, Co-founder and CSO of Scenic Biotech said: "Genentech is the pioneer in innovative biotech and has world leading research and development capabilities. Scenic is a science-driven company and having Genentech as our first major industry partner is a great validation of our technology and by working together it will extend the utility of our platform beyond our current therapeutic areas of interest. The collaboration also brings significant strategic value for Scenic as it enables us to realise the potential of our genetic modifier expertise alongside independently advancing our own programs towards clinical development."