On April 13, 2020 Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell and gene therapy company, reported that their first-in-human phase I data of Universal TruUCAR GC027 in relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) was accepted for plenary oral presentation at the America Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Gracell Biotechnologies, APR 13, 2020, View Source [SID1234556271]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This year’s AACR (Free AACR Whitepaper) presentations are moved to be held virtually to allow sharing the data in a timely fashion. A series of online sessions featuring presentations will be provided. Gracell will report the clinical safety and efficacy of GC027, an off-the-shelf CAR-T product based on Gracell’s TruUCAR technology, for treatment of adult T-ALL patients.

"We are very pleased that AACR (Free AACR Whitepaper) has accepted the phase I results of GC027, a first-in-human off-the-shelf TruUCAR product for plenary oral presentation. Gracell’s proprietary TruUCAR platform was protected with patents of novel designs and unique features. Remarkably, GC027 derived from HLA unmatched donor’s cells, is a monotherapy without co-administration of other immunosuppressive drug." said Dr. William CAO, founder and CEO of Gracell. "We are pleased to share the first-in-human phase I data with the scientific community."

Presentation: Safety and efficacy clinical study of TruUCART GC027: the first-in-human, universal CAR-T therapy for relapsed/refractory T-cell acute lymphoblastic leukemia
Abstract #9564
Online live section: Apr. 27-28, EDT

About GC027
GC027 was manufactured from T cells of human leukocyte antigen (HLA) unmatched healthy donors using TruUCAR technology. TruUCAR allows the allogeneic CAR-T cells to proliferate and persist in HLA-unmatched patients (recipients) with minimized risk of graft-versus-host-disease (GvHD). GC027 is currently being developed as an investigational, off-the-shelf CAR-T cell therapy for treatment of T cell malignancies. The use of HLA unmatched healthy donor’s cells may improve efficacy and reduce production time, available for off-the-shelf use in a timely manner.

About TruUCAR
TruUCAR is Gracell’s proprietary and patented platform technology, with selected genes being edited to avoid GvHD and immune rejection without using strong immunosuppressive drugs. In addition to T-ALL antigen, the platform technology can also be implemented for other targets of hematological malignancies.

About T-ALL
T – Lymphoblastic Leukemia (T-ALL) is an aggressive form of acute lymphoblastic leukemia, with a diffuse invasion of bone marrow and peripheral blood. In 2015, T-ALL affected around 876,000 people globally and resulted in 110,000 deaths worldwide. T-ALL compromises about 15%-20% of all children and adult acute lymphoblastic leukemia[1]. Current standard of care therapies for T-ALL are chemotherapy and stem cell transplantation. 40-50% of patients will experience relapse within two years following front line therapy with limited treatment options available[2] [3]. Treatment of relapsed and refractory T-ALL remains a high unmet medical need.

On April 13, 2020 Dr. Reddy’s Laboratories Ltd., reported the launch of Invista, a formulation of Dasatinib that is bioequivalent to the innovator brand. It is indicated for the treatment of chronic accelerated or myeloid or lymphoid blast phase and newly diagnosed in chronic phase adult patients with Chronic Myeloid Leukemia (CML) in India (Press release, Dr Reddy’s, APR 13, 2020, View Source [SID1234556255]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Commenting on the launch, M V Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s Laboratories said, "We are pleased to bring this important and complex product to the market in India. The development and launch of Invista is a significant step forward in improving access to medicines at an affordable price for CML patients in India.

Dr. Reddy’s Invista is available in strengths of 50, 70 and 100 mg tablets.

Chronic Myeloid Leukemia is a type of blood-cell cancer that begins in the bone marrow. The median age of the patients in India is a decade earlier than the west, and every year about nine thousand new patients are diagnosed in the country.

On April 13, 2020 Natera, Inc. (NASDAQ: NTRA) reported that it proposes to offer $250 million aggregate principal amount of convertible senior notes due 2027 (the "notes"), subject to market conditions and other factors (Press release, Natera, APR 13, 2020, View Source [SID1234556272]). The notes are to be offered and sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Natera also intends to grant to the initial purchasers of the notes a 13-day option to purchase up to an additional $37.5 million aggregate principal amount of the notes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The notes will be senior, unsecured obligations of Natera, and interest will be payable semi-annually in cash on May 1 and November 1 of each year, beginning on November 1, 2020. The notes will mature on May 1, 2027 unless redeemed, repurchased or converted prior to such date. Prior to February 1, 2027, the notes will be convertible at the option of holders during certain periods, upon satisfaction of certain conditions. Thereafter, the notes will be convertible at any time until the close of business on the second business day immediately preceding the maturity date. Upon conversion, the notes may be settled in shares of Natera common stock, cash or a combination of cash and shares of Natera common stock, at Natera’s election.

The interest rate, initial conversion rate, offering price, and other terms are to be determined by negotiations between Natera and the initial purchasers.

Natera expects to use a portion of the net proceeds from the offering of the notes to repay its obligations under its 2017 Term Loan with OrbiMed and the remainder of the net proceeds will be used for working capital and general corporate purposes and continued investments in research and development of its core technology and development of Natera’s product offerings. In addition, Natera may use a portion of the net proceeds for acquisitions of complementary businesses, technologies or other assets. Natera has no agreements or understandings with respect to any material acquisitions or strategic transactions at this time.

Natera may redeem all or any portion of the notes, at its option, on or after May 6, 2024, at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest thereon, if the last reported sale price of Natera’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Natera provides written notice of redemption.

Holders of notes may require Natera to repurchase their notes upon the occurrence of certain events that constitute a fundamental change under the indenture governing the notes at a purchase price equal to 100% of the principal amount thereof, plus accrued and unpaid interest to, but excluding, the date of repurchase. In connection with certain corporate events or if Natera issues a notice of redemption, it will, under certain circumstances, increase the conversion rate for holders who elect to convert their notes in connection with such corporate event or during the relevant redemption period.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities (including the shares of Natera common stock, if any, into which the notes are convertible) and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.

The notes and any shares of common stock issuable upon conversion of the notes have not been, nor will be, registered under the Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements.

On April 13, 2020 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the appointment of Carrie Brownstein, M.D., to the role of Chief Medical Officer (Press release, Cellectis, APR 13, 2020, View Source [SID1234556257]). In Dr. Brownstein’s new role, she will oversee clinical research and development for Cellectis’ UCART clinical trial programs. Dr. Brownstein joins Cellectis from Celgene, with a strong track record in hematology and myeloid diseases. She is assuming her new position based in the Cellectis New York office and is joining the Company’s executive committee.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are thrilled to have Dr. Brownstein bringing her strong industry expertise and impressive leadership at a time when our three proprietary product candidates are advancing in clinical studies," said Dr. André Choulika, Chairman and CEO, Cellectis. "Carrie has an impressive track record in clinical development across all phases of the product lifecycle, including successful regulatory filings in the US and EU for novel products. With that solid experience, her hands-on approach and passion for developing innovative therapies, I am confident that Carrie will be a pivotal addition to our leadership team and I look forward to working alongside her and the team to bring Cellectis’ allogeneic CAR-T product candidates to patients in need."

Dr. Brownstein joins Cellectis as a seasoned clinical and medical expert from Celgene, where she most recently served as Vice President, Global Clinical Research and Development, Therapeutic Area Head for myeloid diseases. In this role, Dr. Brownstein managed a clinical team of physicians and scientists across multiple global sites and was responsible for management and cross-functional development of products to treat patients with myeloid diseases. Prior to Celgene, Dr. Brownstein served as Executive Director, Clinical Sciences Oncology at Regeneron Pharmaceuticals where she led teams investigating multiple early development programs and assets, including T-cell engaging bispecific antibodies. Dr. Brownstein started her industry career at Hoffman-La Roche (Roche Pharmaceuticals), where she held roles of increasing responsibility, and most recently served as Senior Medical Director supporting the development and approval of a number of hematology and oncology therapies. Prior to her career in an industry setting, Dr. Brownstein practiced medicine as a pediatric oncologist within notable New York institutions such as New York Presbyterian Columbia University and Mount Sinai Medical Center.

Dr. Brownstein received her M.D. from Tufts University School of Medicine and completed her internship and residency at the Babies and Children’s Hospital of Columbia Presbyterian Medical Center (NYP, Morgan Stanley Children’s Hospital) in New York, NY. She completed a fellowship in pediatric hematology and oncology at Memorial Sloan Kettering Cancer Center also New York, NY.

"Throughout my career, I’ve always been passionate about the field of hematology and oncology and have sought opportunities where I could make a meaningful impact on the lives of patients with unmet medical needs," noted Dr. Brownstein. "Cellectis is a pioneer in gene editing and immuno-oncology and is laying the groundwork to innovate the CAR T-cell field with their allogeneic approach. I am eager to join Cellectis at such a pivotal time, and look forward to joining the talented team and leading these truly transformative therapies through the clinic towards commercialization."

On April 13, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported preliminary operational and financial results for the quarter ended March 31, 2020 (Press release, Natera, APR 13, 2020, View Source [SID1234556273]). Natera generated total revenues of approximately $89 million to $91 million and processed approximately 235,000 total tests in Q1. Operating losses were generally consistent with Q4 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Q1 represented another record volume and revenue quarter for Natera, and quarterly unit growth was the largest in company history despite the impact from COVID-19. Volumes declined approximately 15% in the last two weeks of March from record Q1 levels, or to roughly the average weekly volumes in Q4 2019. As expected, the New York area and our in-vitro fertilization channels were most severely impacted.

Natera responded quickly to the outbreak by implementing key safety protocols for its employees and laboratories, and by expanding its remote capabilities. "We are very pleased with our performance in the second half of March given the pandemic, and before seeing the extent of the impact of our recent remote initiatives. Customers and patients have begun to take advantage of our remote access platforms in record numbers, and we are encouraged to see the recent expansion in average risk NIPT covered lives that occurred in late March," said Steve Chapman, Natera’s CEO.

Fiscal Year 2020 Outlook:

As a result of the highly dynamic situation and ongoing disruptions from COVID-19, the company is withdrawing its financial guidance for the 2020 fiscal year. At the present time, the Company cannot predict the extent or duration of the impact of the COVID-19 outbreak on its operating results.