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Legend Biotech Announces Data Presentations at ASH 2019 for
JNJ-68284528 (JNJ-4528)/LCAR-B38M, an Investigational B-Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor (CAR)-T Cell Therapy being Studied in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM)

On November 6, 2019 Legend Biotech reported data from the Janssen Research & Development, LLC (Janssen) CARTITUDE-1 study (US) and the LEGEND-2 study (China) will be presented during the 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual meeting in Orlando, Florida taking place December 7-10, 2019 (Press release, Legend Biotech, NOV 6, 2019, View Source [SID1234550607]).

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"The data presentations at ASH (Free ASH Whitepaper) 2019 represent two key milestones; the initial data from CARTITUDE-1 study in the US and the long term follow-up for the LEGEND-2 study in China," stated Yuan Xu, PhD, CEO of Legend Biotech. "In collaboration with Janssen, we are committed to the clinical development of LCAR-B38M/JNJ-4528 and are working diligently together to bring this investigational therapy to patients with multiple myeloma."

On Monday, December 9th during the Myeloma session titled: Therapy, excluding Transplantation: Novelty in CAR-T in RRMM, the first clinical data from the CARTITUDE-1 study will be presented. In the same session, long-term follow-up data from the previously reported LEGEND-2 study in China for the 57 patients enrolled at the Second Affiliated Hospital of Xi’an Jiaotong University will be presented, with updated data.

Additionally, updated results for the 17 patients enrolled in the LEGEND-2 study at the Shanghai Ruijin Hospital, Shanghai Changzheng Hospital, and Jiangsu Province People’s Hospital will be presented by the investigators.

Abstracts will be presented during the following dates and times:

Abstract#/Title Presenting Author Date and Time ABSTRACT #577: Results from CARTITUDE-1: a Phase 1b/2 study of JNJ-4528, a CAR-T cell therapy directed against BCMA, in patients with RRMM D Madduri Oral Presentation Monday, December 9, 7:00 am Hall D ABSTRACT #579: Long-term follow-up of a Phase 1, first-in-human open-label study of LCAR-B38M, a structurally differentiated CAR-T cell therapy targeting BCMA, in patients with RRMM BY Wang Oral Presentation Monday, December 9, 7:30 am Hall D ABSTRACT #928: Translational analysis from CARTITUDE-1, an ongoing Phase 1b/2 study of JNJ-4528 BCMA-targeted CAR-T cell therapy in RRMM, indicates preferential expansion of CD8+ T Cell central memory cell subset E Zudaire Oral Presentation Monday, December 9, 7:00 pm Valencia A (W415A) ABSTRACT #1858: Updated Phase 1 results of a first-in-human open-label study of LCAR-B38M, a structurally differentiated CAR-T cell therapy targeting BCMA LJ Chen Poster Presentation Saturday, December 7, 5:30 pm Hall B In February 2019, the US Food and Drug Administration granted Janssen an Orphan Drug Designationfor JNJ-4528. On April 3, 2019, Legend announced that the European Medicines Agency (EMA) granted Janssen a PRIME1 designationfor JNJ-4528, which was supported by results from the Phase 1b/2

CARTITUDE-1 study (NCT03548207) 2 and the Phase 1/2 LEGEND-2 study (NCT03090659)3 evaluating LCAR-B38M in RRMM. About LEGEND-2 LEGEND-2 (NCT03090659) is an ongoing single-arm, open-label Phase 1/2 study of 74 patients being conducted at four participating hospitals in China evaluating the efficacy and safety of LCAR-B38M for the treatment of relapsed or refractory multiple myeloma.

About CARTIFAN-1
In China, the Phase 2 CARTIFAN-1 (MMY2002, NCT03758417)4 confirmatory trial registered with the Center for Drug Evaluation (CTR20181007), is actively recruiting to further evaluate LCARB38M in patients with advanced relapsed or refractory multiple myeloma. About CARTITUDE-1 In the US, JNJ-4528 is currently being investigated in the Phase 1b/2 CARTITUDE-1 (MMY2001, NCT03548207) registration study for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a PI and IMiD, received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy. About CARTITUDE-2 In the global, multi-cohort Phase 2

CARTITUDE-2 (MMY2003, NCT04133636) 5 study, JNJ-4528 will be investigated in patients with multiple in various clinical settings. This study is being conducted to evaluate the overall minimal residual disease (MRD) negative rate of participantswho receive JNJ-4528.

About LocoMMotion
In the US and EU, a prospective observational study LocoMMotion (MMY4001, NCT04035226) 6 is being conducted to evaluate current real-world standards of care in patients with RRMM who received at least 3 prior lines of therapy including a PI, an IMiD, and anti-CD38 antibody. The abstract will be published in Blood.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells. 7 Although treatment may result in remission, unfortunately, patients will most likely relapse. 8 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy. 9,10 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory. 11 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.12 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.13

MEDx (Suzhou) and Lucence Partner to Co-Develop Cutting-Edge Cancer-Care Tests

On November 6, 2019 MEDx (Suzhou) Translational Medicine, and Singapore-based Lucence – a leading genomic medicine company reported an agreement to pursue a strategic partnership in China to co-develop cancer-care tests that would benefit patients and pharmaceutical companies (Press release, MedX Health, NOV 6, 2019, View Source [SID1234550594]).

By melding MEDx’s industry-leading biomarker discovery, cancer molecular diagnostics, high-throughput sequencing and bioinformatics platforms; with Lucence’s proprietary technology platform that identifies PD-L1 rearrangement, as well as multiplex immunofluorescence that allows better prediction of anti-PD1/PD-L1 treatment outcomes, this partnership is poised to go from strength to strength in this sunrise industry of precision medicine.

"Immunotherapy is becoming more and more popular for drug development and personalized medicine in China. A good companion diagnosis is needed to complement immunotherapy. We believe through this strategic partnership with Lucence, we will achieve better outcomes for cancer diagnosis and treatment selection for cancer patients," said Dr. Nick Zhang, Chairman and CEO of MEDx (Suzhou) Translational Medicine.

"The complementary strengths of Lucence and MEDx to co-develop cancer-care tests in China will ensure that patients have access to non-invasive, cost-effective, faster and better diagnosis. With our steadfast focus on reducing avoidable cancer deaths, coupled with MEDx’s deep experience and wide presence in China, we are confident that this partnership will drive better cancer care in China," said Dr. Min-Han Tan, Founder and CEO of Lucence.

Innate Pharma to share new long-term data on Lumoxiti at 2019 American Society of Hematology annual meeting

On November 6, 2019 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will share new, long-term data from the pivotal Phase III trial of Lumoxiti (moxetumomab pasudotox) at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, December 7-10 (Press release, Innate Pharma, NOV 6, 2019, View Source [SID1234550593]).

"At this year’s ASH (Free ASH Whitepaper), we look forward to providing important new follow-up data from the Lumoxiti phase III trial and engaging with the hemato-oncology community on improving treatment outcomes for patients with relapsed or refractory hairy cell leukemia," commented Pierre Dodion, MD, Executive Vice President and Chief Medical Officer of Innate Pharma.

Details of the poster presentation at ASH (Free ASH Whitepaper) are as follows:

Moxetumomab Pasudotox-tdfk in Heavily Pretreated Patients with Relapsed/Refractory Hairy Cell Leukemia (HCL): Long-Term Follow-up from the Pivotal Phase 3 Trial, [poster#2808]
Authors: Robert J Kreitman, Claire Dearden, Pier Luigi Zinzani, Julio Delgado, Tadeusz Robak, Philipp D le Coutre, Bjørn T Gjertsen, Xavier Troussard, Gail J Roboz, Lionel Karlin, Douglas E Gladstone, Nataliya Kuptsova-Clarkson, Shiyao Liu, Priti Patel, Wyndham H Wilson, Ira Pastan, Francis Giles, on behalf of the Study 1053 investigators
Date: Sunday December 8 | 6:00-8:00 pm ET

About Lumoxiti (moxetumomab pasudotox):
Lumoxiti is a CD22-directed cytotoxin 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 for the treatment of r/r HCL. AstraZeneca is the current Biologics License Application (BLA) holder for Lumoxiti.

About the ‘1053’ Phase III trial:
The AstraZeneca-sponsored ‘1053’ trial is a single-arm, multicenter Phase III clinical trial assessing the efficacy and safety of Lumoxiti monotherapy in patients with r/r HCL who have received at least two prior therapies, including one purine nucleoside analog. The trial enrolled 80 patients and was conducted across 34 sites in 14 countries. The primary endpoint was durable complete response (CR), defined as CR with hematologic remission (blood count normalization) for >180 days. Secondary outcome measures included objective response rate, duration of complete and objective response, progression-free survival, safety/tolerability, pharmacokinetics and immunogenic potential.

Primmune Therapeutics Announces Presentation at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 6, 2019 Primmune Therapeutics reported that it will present primate pharmacology data on PRX034 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2019 in National Harbor, MD (Press release, Primmune Therapeutics, NOV 6, 2019, View Source [SID1234550592]). PRX034 is a novel orally bioavailable small molecule toll-like receptor 7 (TLR7) agonist that activates innate immunity by systemically targeting plasmic cytoid dendritic cells in vivo. PRX034 was derived from Primmune’s lead series of novel TLR7 agonists and demonstrates the potential of these compounds to improve response rates and treatment durability of adaptive immune therapies.

"There is a very strong rationale for combining agents that activate innate immunity, like PRX034, with drugs that engage adaptive immunity, like checkpoint inhibitors, to potentially address patients who inadequately respond to approved treatments," said James Appleman, Ph.D., Co-founder and Chief Scientific Officer at Primmune Therapeutics. "Our program builds upon historical clinical experience with TLR7 agonists, which we used to identify an ideal pharmacologic profile supporting the notion that long-term systemic dosing with TLR7 agonists best complements adaptive immunity approaches."

"PRX034 meets the initial target product profile criteria that we outlined at the beginning of our discovery campaign and we are in the process of completing the final set of confirmatory studies before entering formal IND enabling GLP non-clinical studies," said Charlie McDermott, Chairman & Chief Executive Officer of Primmune Therapeutics.

Poster presentation details:

Title: Pharmacodynamic response in vitro and in vivo of novel orally administered Toll¬-like Receptor 7 agonists for systemic immunotherapy of cancer
Abstract #: P670
Category: Immune stimulants and immune modulators
Presentation: Saturday, November 9, 2019 by James R. Appleman, Ph.D.

AstraZeneca Chooses China for R&D and AI Centers, $1B Biotech Fund

On November 6, 2019 AstraZeneca reported it will establish centers for drug research and artificial intelligence development in China (Press release, Xconomy, NOV 6, 2019, View Source [SID1234550560]). The pharmaceutical giant has also set up a $1 billion fund to foster biotech innovation in that country.

The move – which was announced at the China International Import Expo this week – will see the AstraZeneca found a global R&D center in Shanghai’s central Jing’an district. The company currently operates R&D centers at its Cambridge, UK, headquarters as well as at sites in Maryland and Sweden.

The new China facility will carry out R&D for innovative drugs, with the focus being on diseases that are prevalent in China. The site will bring AstraZeneca’s R&D headcount in China to 1,000 people.

According to AstraZeneca, the firm will seek collaborations with local companies for drugs developed at the center as well as legacy products. A spokesman declined to specify which therapy areas will be the focus of R&D activities. Instead, he says AstraZeneca is "open to working with others through this infrastructure to tackle the key unmet needs, whatever they may be."

He also says AstraZeneca has no plans to co-locate all China R&D facilities, adding "we see benefit in locating facilities across China; the new site will be a complement to existing facilities in Shanghai, and Wuxi [City]."

The AI centre—which will also be located in Shanghai—will focus on the development of systems that are relevant to the discovery, development and production of biopharmaceuticals. Again, part of the center’s role will be to help AstraZeneca partner with local startup technology companies.

AstraZeneca’s China announcements comes as other biopharma firms position themselves to sell more drugs in that country. Earlier Wednesday, Biogen (NASDAQ: BIIB) expanded a pact with Samsung Bioepis to include the commercialization of three inflammation biosimilars in China. And last week, Amgen (NASDAQ: AMGN) announced it would pay $2.7 billion for a 20.5 percent stake in Beijing-based drug developer BeiGene (NASDAQ: BGNE). The companies will work together to sell Amgen’s cancer drugs in China; BeiGene will also help to develop 20 cancer drugs in Amgen’s pipeline for the Chinese market.

AstraZeneca’s focus on China makes sense as the country is the company’s most important market after the US.
According to the firm’s first half, 2019 financial results, drug sales in China were $2.4 billion, a 27 percent increase over the same period last year, and 22 percent of total product sales. The US accounted for more than $3.6 billion of AstraZeneca’s revenue in the first half of this year.

In addition to the new R&D and AI centres, AstraZeneca said it would set up five regional headquarters in China in Beijing, Chengdu, Guangzhou and Hangzhou. The new facilities—and the commercial innovation centers to be set up at each site—will work with the commercial operation the firm set up in Wuxi in 2017.

AstraZeneca has also partnered with state-owned bank CCIC to set up a $1 billion fund to foster biotech innovation in China.

The Healthcare Industrial Fund is intended to support domestic companies and partners including those based in the Wuxi International Life Science Innovation Campus.

Additionally, AstraZeneca says, the fund will support international companies that are looking to set up R&D operations and or partnerships in China.