On January 14, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported an agreement with Lentigen Technology, Inc. ("Lentigen"), a wholly-owned subsidiary of Miltenyi Biotec B.V. & Co. KG, to manufacture lentiviral vectors for Oncternal’s investigational ROR1-targeting CAR-T cell therapy program (Press release, Oncternal Therapeutics, JAN 14, 2021, View Source [SID1234574015]).

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Lentigen is a leader in translating gene therapy products into the clinic, including design, construction and production of lentiviral vectors, from research through GMP manufacturing.

As part of the agreement, Lentigen will reserve capacity in 2021 to manufacture, test and release GMP lentivirus to support and accelerate the development of Oncternal’s CAR-T cell therapy program.

"Lentiviral vectors are an essential component in the CAR-T cell manufacturing process. Lentigen has successfully developed a large-scale, chemically-defined, serum-free lentiviral vector manufacturing process that ensures high quality and conformity with regulatory requirements," said Boro Dropulic, Ph.D., M.B.A., General Manager and Chief Science Officer of Lentigen Technology, Inc. "We are excited to support Oncternal by manufacturing lentiviral vectors for its ROR1-targeting CAR-T program and help bring these novel cell therapies to patients with cancer."

"Oncternal is working on rapidly advancing its ROR1-targeting CAR-T cell immunotherapy program, and we are pleased to work with Lentigen that is widely recognized as a global leader in producing GMP lentiviral vectors for the biopharma industry," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "ROR1 has emerged as an important target for cancer therapy, and we believe that our ROR1-targeting CAR-T program holds significant promise for patients with both hematologic cancers and solid tumors. Our goal is to achieve first-in-human dosing of the ROR1-targeting CAR-T therapy in the second half of 2021."

On January 14, 2021 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that John A. Scarlett, M.D., Chairman and Chief Executive Officer, will present a company overview at the B. Riley Securities Virtual Oncology Investor Conference on Wednesday, January 20, at 3:00 p.m. ET (Press release, Geron, JAN 14, 2021, View Source [SID1234574012]).

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A live audio webcast of the presentation will be available on Geron’s website, www.geron.com/investors/events. A replay of the webcast will be available on the Company’s website for 30 days.

On January 14, 2021 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported the appointment of Dr. Han Myint, MD, FACP as chief medical officer (Press release, NextCure, JAN 14, 2021, View Source [SID1234574011]). Dr. Myint will oversee the clinical development of key products in NextCure’s product pipeline, including NC318, a first-in-class immunomedicine, targeting Siglec-15 (S15), and NC410, recombinant LAIR-2 fusion protein designed to block immune suppression mediated by the immune modulator LAIR-1. Prior to joining NextCure, Dr. Myint held senior roles at both Celgene (a Bristol Myers Squibb Company) and NexImmune Inc.

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"We are very excited that Han has joined the NextCure team. We believe the depth of his expertise in oncology product development will prove instrumental in the advancement of our product pipeline," said Michael Richman, NextCure’s president and chief executive officer. "Han’s strong industry track record is highlighted by his involvement in the development of multiple U.S. Food and Drug approved products."

"I’m thrilled to join NextCure at this important time in the company’s growth," said Dr. Myint. "I believe that the company, through its powerful discovery platform, has created a pipeline of novel immunomedicines, including NC318 and NC410, with the potential to have a significant impact in cancer treatment."

Dr. Myint has over 20 years of experience in both academia and the biopharma industry. Before joining NextCure, he was chief medical officer at NexImmune, a clinical-stage biotechnology company developing unique approaches to T cell immunotherapies. Prior to NexImmune, he was Vice President of Global Medical Affairs and the Myeloid Diseases Lead at Celgene. His work in myeloid diseases at Celgene contributed to a number of FDA approvals, successful launches of those products and high-impact publications. Prior to joining the biopharma industry, Dr. Myint practiced medicine specializing in hematological oncology and conducted clinical and laboratory research at multiple prestigious academic institutions in the UK and USA including Rush University Medical Center in Chicago and University of Colorado, Denver. Dr. Myint, Professor of Medicine, built a FACT-accredited and Center of Excellence-Designated Stem Cell Transplant Program at the University of Colorado, Denver. He has in-depth scientific knowledge, a wealth of clinical experience and expertise in hematological malignancies and stem cell transplantation. Dr. Myint graduated from the Institute of Medicine in Yangon with a MBBS degree and subsequently emigrated to the UK to do his postgraduate training in Internal Medicine, followed by his training in Hematology. Accordingly, he was awarded as a fellow from the Royal Colleges of Physicians and Pathologists from the UK and also from the American College of Physicians.

On January 14, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the first patient enrolled in a Phase 1 investigator sponsored trial (IST), named rESPECT, of its lead product eryaspase for the first-line treatment of pancreatic cancer (Press release, ERYtech Pharma, JAN 14, 2021, View Source [SID1234574010]).

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On January 14, 2021 Eversana reported that China’s National Healthcare Security Administration (NHSA) and Ministry of Human Resources and Social Security (MOHRSS) issued the 2020 Edition of the National Reimbursement Drug List (NRDL) (Press release, EVERSANA, JAN 14, 2021, View Source [SID1234574008]).

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The finalized 2020 NRDL, which comes into effect on March 1, 2021, contains 119 additional drugs across 31 therapeutic classes compared to the 2017 list – when the NHSA took hold of procurement – but has also removed 29. On average, pharma companies agreed to cut drug prices by 51% in order to gain access to the list.

This year, PD-1 inhibitors – a category of drugs which are often costly yet highly effective – were the hot issue between multinational corporations (MNCs). The group of checkpoint inhibitor anticancer drugs work by blocking the activity of PD-1 and PDL1 immune checkpoint proteins present on the surface of cells.

Following three-day negotiations that started on December 17, 2020 in Beijing, MSD’s Keytruda (pembrolizumab), Bristol Myers Squibb’s Opdivo (nivolumab), AstraZeneca’s Imfinzi (durvalumab) and Roche’s Tecentriq (atezolizumab) all failed to make their way into the finalized 2020 list.

Instead, home-grown PD-1 efforts from Shanghai Junshi Biosciences, Beigene Ltd and Jiangsu Hengrui Medicine took the coveted spots. The three China-based companies offered up to a hefty 80% off the drugs’ prices to win their places on the list, significantly more than the already staggering 64% that Eli Lilly offered to slash Tyvyt (sintilimab) by in the previous year’s NRDL.

In 2019, Tyvyt – which is co-developed by Innovent and Lilly in China – was the only PD-1 to make the list, under the indication of relapsed/refractory classical Hodgkin’s lymphoma after at least two lines of chemo.

The 2020 price reductions won Jiangsu’s camrelizumab coverage for four indications, BeiGene’s Baizean (tislelizumab) two indications and Junshi Biosciences’ Tuoyi (toripalimab) reimbursement in one indication.

At the time of the list’s release, the prices were not officially disclosed, but Chinese media has since clarified them as the below:

Hengrui Medicine’s Camrelizumab (200 mg): CNY 3,000
BeiGene’s Tislelizumab (100 mg): CNY 1,500
Junshi’s Teriprizumab (80 mg): CNY 906
China has always been favorable of national drugmakers when choosing drugs for reimbursement. As such, it has an ongoing aim to ramp up production capabilities of domestic manufacturers, issuing guidance on which now off-patent medicines should be the focus of production and passing domestic manufacturers though generic quality and clinical equivalence evaluation (GQCE) to ensure their products are safe to market.

Pricentric is in the process of releasing the full list with an accompanying evaluation, but more information on the 2020 NRDL can already be found in the Pricentric Insights Newsfeed.