On December 11, 2020 In a spotlight poster discussion at the 2020 San Antonio Breast Cancer Symposium (SABCS), Myriad Genetics (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, reported a new study that shows how its myRisk Hereditary Cancer and riskScore tests can better inform individualized clinical screening and prevention strategies for women at risk of developing breast cancer (Press release, Myriad Genetics, DEC 11, 2020, View Source [SID1234572653]). The new Myriad study highlights how riskScore, a proprietary tool used to evaluate a woman’s risk of developing breast cancer, can accurately provide breast cancer risk information into a personalized assessment model for women carrying a pathogenic variant (PV) in the ATM gene.

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"This new study will enable a highly personalized risk calculation for patients who carry mutations in the ATM gene," said Nicole Lambert, president of Myriad Genetic Laboratories. "As a result, women carrying gene mutations will be able to make more informed choices about how to manage their risk; if increased surveillance is sufficient or if they would consider surgical options."

Myriad’s riskScore test combines data from 20 years of genome-wide association studies with a validated algorithm that uses personal and family history. riskScore is performed in conjunction with Myriad’s myRisk Hereditary Cancer test, where myRisk identifies people who carry specific cancer-linked genetic mutations.

A summary of the study is below. Follow Myriad on Twitter via @myriadgenetics and keep up to date with SABCS meeting news and updates by using the #SACBS20 hashtag.

riskScore Poster at SABCS
Title: Development of a breast cancer risk assessment model for ATM mutation carriers incorporating Tyrer-Cuzick and a polygenic risk score
Program Number: PD10-09
Session Title: Spotlight Poster Discussion 10
This study highlights the development of a comprehensive breast cancer risk model for ATM PV carriers incorporating an 86-variant PRS, along with family history and clinical information captured by Tyrer-Cuzick (a tool used to calculate the risk of breast cancer). The study found that with ATM PV carriers (N=216), a comprehensive model allowed for differentiation of carriers into low, moderate, and high breast cancer risk categories (See figure 1 below).

To view Figure 1. Remaining Lifetime Risk for ATM PV Carriers, please visit the following link: View Source

About riskScore
riskScore is a clinically validated personalized medicine tool that enhances Myriad’s myRisk Hereditary Cancer test. riskScore helps to further predict a women’s lifetime risk of developing breast cancer using clinical risk factors and genetic markers throughout the genome. The test incorporates data from more than 80 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer and was prospectively validated in our laboratory to predict breast cancer risk in women of European descent. This data is then combined with a personal history and family history algorithm, the Tyrer-Cuzick model, to provide an individualized breast cancer risk assessment. Myriad is committed to advancing the validation of risk-assessment tools and making them available to all women, regardless of ancestry.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 35 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.

On December 11, 2020 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will present at the JMP Securities Hematology Summit, which is being conducted as a virtual event, on Tuesday, December 15, 2020 at 3:30 p.m. ET (Press release, BioCryst Pharmaceuticals, DEC 11, 2020, View Source [SID1234572652]).

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Links to a live audio webcast and replay of the presentation may be accessed in the Investors section of BioCryst’s website at http://www.biocryst.com.

On December 11, 2020 Takeda reported that Alunbrig (brigatinib) has been recommended by the UK’s National Institute for Health and Care Excellence (NICE) for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) (Press release, Takeda, DEC 11, 2020, View Source [SID1234572651]).

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Although ALK-positive NSCLC is rare, it is a particularly resistant disease which mainly affects younger people and non-smokers.

Although a number of ALK inhibitors have recently been introduced to this therapy area in recent years, some patients still progress within two to three years of starting treatment. In addition, up to 75% of patients develop brain metastases during the course of their disease.

Alunbrig has demonstrated efficacy against cancer both in the lungs and secondary cancer in the brain, and is administered as a single tablet taken once daily.

The NICE recommendation is based on results from the phase III ATLA-1L trial, which evaluated Alunbrig to Pfizer’s ALK and ROS1 inhibitor Xalkori (crizotinib) in ALK-positive locally advanced or metastatic NSCLC patients who had not previously been treated with an ALK inhibitor.

Results from this trial found that Alunbrig halved the risk of disease progression or death versus Xalkori, with a 24-month median progression-free survival rate.

Takeda’s therapy also showed a two thirds reduction in the risk of intracranial disease progression or death in patients with any brain metastases at baseline.

The most common side effects associated with Alunbrig in the ATLA-1L trial included diarrhoea, increased blood creatine phosphokinase (CPK), cough, hypertension, nausea and increased aspartate aminotransferase (AST).

"We are delighted that NICE has recommended Alunbrig as a first-line ALK inhibitor for ALK-positive advanced NSCLC. The clinical evidence supporting the value of Alunbrig is compelling; and having it available at the initial stage of treatment for advanced disease gives physicians broader options to ensure optimum quality of life and survival for patients," said Emma Roffe, oncology country head, UK & Ireland, Takeda UK.

"At Takeda, we are proud of our ongoing commitment to ensuring patients have access to innovative therapies, through our effective partnerships with NICE, NHS England and clinical and patient communities," she added.

On December 11, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the publication of a second poster for the GP2 Phase III clinical trial design for recurring breast cancer at the San Antonio Breast Cancer Symposium (SABCS) in a virtual format (Press release, Greenwich LifeSciences, DEC 11, 2020, View Source [SID1234572649]). The Global Principal Investigator of the GP2 Phase III clinical trial, Dr. Mothaffar F. Rimawi of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, is the lead author of the poster and has recorded an audio track providing an overview. The full poster with audio can be accessed or downloaded here on the Company website, as well as on the conference website by attendees.

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Poster OT-13-03 is entitled: A prospective, randomized, multicenter, double-blinded, placebo-controlled Phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer.

The Phase III clinical trial is designed as a single registration trial that will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data readout, after which a Biologics Licensing Application will be submitted. The Phase III clinical trial aims to reproduce the Phase IIb clinical trial that concluded that the completion of the first 6 intradermal injections of GP2 + GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients who received a standard course of trastuzumab after surgery.

Snehal Patel, CEO of Greenwich LifeSciences, commented, "We are preparing diligently for our pivotal Phase III clinical trial, aligning ourselves with one of the leading cancer institutions in the world. We appreciate the overwhelming response to our first poster, where we reported the final efficacy results of our Phase IIb clinical trial showing no breast cancer recurrences in HER2/neu 3+ patients if they were fully immunized with GP2. Our partnership with Dr. Rimawi and Baylor College of Medicine gives us great confidence in our objective to replicate this data in the Phase III clinical trial."

The Phase III clinical trial is a prospective, randomized, double-blinded, multi-center study. After 1 year of trastuzumab-based therapy or an approved biosimilar, treatment with GP2 + GM-CSF or placebo will be administered intradermally for the 6 primary immunization series over the first 6 months and 5 subsequent boosters over the next 2.5 years for a total of 11 injections over 3 years of treatment. The participant duration of the trial will be 3 years of treatment plus 2 years of follow-up for a total of 5 years following the first year of treatment with trastuzumab-based therapy or approved biosimilar. The majority of the patient population will be HER2/neu positive, HLA 2+, disease-free, conventionally treated node-positive, post- surgery, and post- first year of treatment with trastuzumab. An interim analysis is planned and patients will be stratified based on prior and current treatments, among other factors.

About SABCS

The 43rd annual SABCS has grown to be the industry’s premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. Baylor College of Medicine became a joint sponsor of SABCS in 2005. The Cancer Therapy & Research Center at UT Health Science Center San Antonio and American Association for Cancer Research (AACR) (Free AACR Whitepaper) began collaborations with SABCS in 2007. For more information, please visit the conference website at: View Source

Baylor College of Medicine

Baylor College of Medicine (www.bcm.edu) in Houston is recognized as a health sciences university and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked 22nd among medical schools for research and 4th for primary care by U.S. News & World Report. Baylor is listed 21st among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. The Baylor pediatrics program is ranked 6th among all pediatric programs, reflecting the strong affiliation with Texas Children’s Hospital where our faculty care for pediatric patients and our students and residents train. Nationally, our physician assistant program was ranked 3rd in the health disciplines category and our nurse anesthesia program ranked 2nd. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, part of CHI St. Luke’s Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and genetic counseling as well as residents and postdoctoral fellows. Follow Baylor College of Medicine on Facebook (View Source) and Twitter (View Source).

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On December 11, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will return the US and EU commercialization rights of Lumoxiti (moxetumomab pasudotox-tdfk) to AstraZeneca* (Press release, Innate Pharma, DEC 11, 2020, View Source [SID1234572642]). Innate licensed the US and EU rights to AstraZeneca’s FDA-approved Lumoxiti for certain patients with relapsed or refractory hairy cell leukemia in October 2018.

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The companies will develop a transition plan, including costs and transfer of the US marketing authorization and distribution of Lumoxiti back to AstraZeneca in 2021. AstraZeneca will remain the marketing authorization applicant for the EU filing.

"Since in-licensing Lumoxiti from AstraZeneca, we have been committed to delivering this medicine to patients and healthcare professionals in the US, and moving towards commercialization in the EU. However, we’ve determined that there is low strategic value for us in maintaining Lumoxiti in our portfolio due to lower than anticipated product sales, further compounded by the ongoing COVID-19 pandemic. This has led us to make the decision to re-prioritize our investments in our R&D portfolio," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We will continue to embed a commercial mindset into our R&D programs, which is a key success factor for the development and future commercialization of our pipeline assets."

As part of this decision, Innate will immediately begin to reduce its US commercial operations; however, it will maintain the appropriate patient and customer support services, as well as product supply, during this transition period. In the EU, Innate will no longer progress Lumoxiti regulatory or commercial activities.

The accounting impacts will be presented in the December 31, 2020 financial statements. As a reminder, the net book value of Lumoxiti intangible assets amounted to €45.2 million, as of June 30, 2020.

All other agreements with AstraZeneca remain unchanged.

About Lumoxiti (moxetumomab pasudotox-tdfk):
Lumoxiti is a CD22-directed immunotoxin and a first-in-class treatment in the US for adult patients with relapsed or refractory (r/r) hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min). It comprises the CD22 binding portion of an antibody fused to a truncated pseudomonas exotoxin. The toxin inhibits protein synthesis and ultimately triggers apoptotic cell death. Lumoxiti received U.S. FDA approval in September 2018 and has been granted Orphan Drug Designation by the FDA and the EMA for the treatment of r/r HCL. AstraZeneca is the marketing authorization applicant for the EU filing.