On November 14, 2019 Ascentage Pharma (6855.HK), a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, reported that the updated preliminary results from a Phase I clinical trial on the company’s novel investigational drug HQP1351 has been accepted for oral presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Ascentage Pharma, NOV 14, 2019, View Source [SID1234551340]). Qian Jiang, M.D., who will be presenting, and Xiaojun Huang, M.D. from Peking University People’s Hospital, are the principal investigators of this study. HQP1351 is a third-generation BCR-ABL inhibitor for the treatment of drug-resistant chronic myeloid leukemia (CML).

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Early results from this Phase I study had been accepted for oral presentation at the ASH (Free ASH Whitepaper) Annual Meeting in 2018. Being accepted for oral presentations two years in a row is a strong indication of the interest on HQP1351’s promising efficacy and safety data and updates.

The 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition will be held on December 7–10, 2019, in Orlando, Florida, United States. The ASH (Free ASH Whitepaper) Annual Meeting is the largest gathering of the international hematology field, bringing together the latest and most cutting-edge research and development in hematology.

The oral report will present updated safety and efficacy data from the Chinese Phase I trial of HQP1351. As of May 27, 2019, a total of 101 Chinese patients were enrolled in the study. Trial data have demonstrated that HQP1351 was well tolerated with good and durable anti-tumor activity in TKI-resistant CML patients, including those with the T315I mutation. HQP1351 is Ascentage Pharma’s novel investigational drug with the potential to effectively address the acquired drug resistance commonly associated with the first- and second-generation BCR-ABL inhibitors.

At ASH (Free ASH Whitepaper) 2019, in addition to the oral presentation on HQP1351, Ascentage Pharma will also release data in a poster presentation for a new research on the BCL-2/BCL-xL dual inhibitor APG-1252, which can overcome ibrutinib-resistance conferred by the upregulation of integrin pathway and BCL-xL. APG-1252 is one of the key drug candidates in Ascentage Pharma’s pipeline that focuses on restoring cell apoptosis function and inhibiting cancer growth.

Oral Presentation

Title: An Updated Safety and Efficacy Results of Phase 1 Study of HQP1351, a Novel Third Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI), in Patients with TKI-Resistant Chronic Myeloid Leukemia

Report#: 493
Session: 632
Presenter: Qian Jiang, MD
Time: Sunday, December 8, 4:30 pm (EST)
Location: W308, Orange County Convention Center (OCCC)

Poster Presentation

Title: A Novel BCL-2/BCL-xL Dual Inhibitor Overcomes Ibrutinib-Resistance Conferred By the Upregulation of Integrin Pathway and BCL-xL

Poster#: 2573
Session: 605
Time: Sunday, December 8, 6:00 PM – 8:00 PM (EST)
Location: Hall B, Orange County Convention Center (OCCC)

About HQP1351

HQP1351 is a novel kinase inhibitor developed by Ascentage Pharma. It is an oral third-generation BCR-ABL inhibitor targeting a broad spectrum of BCR-ABL mutants, including those with the T315I mutation, to treat drug-resistant CML patients. A Phase I clinical trial for patients with TKI-resistant CML has been completed and pivotal Phase II clinical trial are ongoing in China. In addition, a Phase I trial in patients with GIST has been initiated in China.

About APG-1252

APG-1252 is a novel, highly potent, small molecule drug designed to restore apoptosis through selective inhibition of the Bcl-2 and Bcl-xL proteins for the treatment of SCLC (small-cell lung cancer), lymphoma and other solid tumors. Ascentage is currently conducting two Phase I dose-escalation trials in patients with advanced cancers in the United States and Australia, and Phase I dose-escalation/expansion trial as a monotherapy in patients with SCLC in China.

On November 14, 2019 Theragnostics, which is developing molecular radiotherapy for imaging and treating a broad range of cancers, reported two strategic hires to its leadership team with the appointment of Dr Daniel Stevens as Chief Medical Officer (CMO) and Chris Stirling to the Board as Non-Executive Director (Press release, Theragnostics, NOV 14, 2019, View Source [SID1234551133]).

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Chris Sterling has extensive experience in the life sciences industry advising multinational companies such as GlaxoSmithKline and Syngenta (Novartis/AstraZeneca) in cross-border acquisitions, mergers and disposals. He was previously Chairman of KPMG’s Global Life Sciences sector where he built the practice in markets across the world including China, India and Brazil as well as the established markets in North America, Europe and Japan. He has held many leadership positions and senior client facing roles at KPMG both as an Audit and Transaction Services partner. Chris is an FCA Chartered Accountant and holds a Master’s in Engineering Science from the University of Oxford.

Recently appointed CMO Dr Daniel Stevens has a successful track record in US and EU radiopharmaceutical registrations and has led development teams through Phase 1 to Phase 3 of novel radiopharmaceutical therapies. Daniel is a UK trained physician with a broad frontline clinical experience including five years working as both an academic and a clinician, and a specialist period undertaking basic cancer research at the University of Oxford.

Commenting on the news, Nick Stevens, Executive Chairman of Theragnostics, said:
"As we continue to grow, it is important to be able to attract high calibre individuals who have the global experience to help Theragnostics on its journey. Chris’ business acumen, extensive experience and exemplary track record in striking deals with large players in the sector will be invaluable in implementing our strategy of bringing novel diagnostic agents and new targeted therapies to patients."

Greg Mullen, Chief Executive Officer of Theragnostics, added:
"I’m very pleased to have someone of Dan’s expertise and track record join our team. This appointment comes at a pivotal moment when we prepare for the next stage of growth as a company and complements the management team as we advance our programmes into clinical development."

Theragnostics’ technology platform enables the development of molecular radiotherapy based on a PARPi for imaging and treating cancer. Theragnostics modifies a PARPi drug molecule with a radioactive atom to create a radionuclide PARPi (rPARPi). This can either be used to image PARP in a cancer patient for diagnostic use or the radioactive isotope can be used to deliver a therapeutic dose of radiation into tumour cells, which offers the potential to molecularly target the radiation in order to hit and kill tumour cells whilst avoiding damage to healthy cells and associated side effects.

On November 14, 2019 AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) reported that the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for selumetinib as a potential new medicine for paediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs) (Press release, AstraZeneca, NOV 14, 2019, View Source [SID1234551243]).

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This is the first acceptance of a regulatory submission for an oral monotherapy for the treatment of NF1, a rare and incurable genetic condition. A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020.

The regulatory submission was based on positive results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored SPRINT Phase II Stratum 1 trial. An Objective Response Rate (ORR) was achieved in 66% of paediatric patients with NF1 and symptomatic, inoperable PNs (n=33/50 patients) when treated with selumetinib as a twice-daily oral monotherapy. ORR was defined as the percentage of patients with a confirmed complete or partial response of ≥ 20% tumour volume reduction.

Selumetinib, a MEK 1/2 inhibitor was granted US FDA Breakthrough Therapy Designation in April 2019, Orphan Drug Designation in February 2018, EU Orphan Designation in August 2018 and Swissmedic Orphan Drug Status in December 2018. AstraZeneca and MSD are jointly developing and commercialising selumetinib globally under a license agreement.

About SPRINT

SPRINT is a US NCI CTEP-sponsored Phase I/II trial. The Phase I trial was designed to identify the optimal Phase II dosing regimen, and the results were published in The New England Journal of Medicine.1

About selumetinib
Selumetinib is a MEK 1/2 inhibitor. It is designed to inhibit the MEK enzyme in the RAS/MAPK pathway, a cell-signalling pathway, associated with cancer cell growth and proliferation in a number of different tumour types.

About NF1

NF1 is an incurable genetic condition that affects one in every 3,000 to 4,000 individuals.2,3 It is caused by a spontaneous or inherited mutation in the NF1 gene and is associated with many symptoms, including soft lumps on and under the skin (cutaneous neurofibromas), skin pigmentation (so-called ‘cafe au lait’ spots) and, in 30-50% of patients, tumours develop on the nerve sheaths (plexiform neurofibromas).1 These plexiform neurofibromas can cause clinical issues such as pain, motor dysfunction, airway dysfunction, bowel/bladder dysfunction and disfigurement as well as having the potential to transform into malignant peripheral nerve sheath tumours (MPNST).1

People with NF1 may experience a number of complications such as learning difficulties, visual impairment, twisting and curvature of the spine, high blood pressure, and epilepsy. NF1 also increases a person’s risk of developing other cancers, including malignant brain tumours, MPNST and leukaemia. Symptoms begin during early childhood, with varying degrees of severity, and can reduce life expectancy by up to 15 years.4

About the AstraZeneca and MSD strategic oncology collaboration

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

About 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 at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as one of AstraZeneca’s four Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

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 November 14, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics, will present at the Jefferies London Healthcare Conference on Thursday, November 21, 2019 at 5:20 p.m. GMT (12:20 p.m. EST) at the Waldorf Hilton London hotel (Press release, Heron Therapeutics, NOV 14, 2019, View Source [SID1234551289]).

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A live webcast of the presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

On November 14, 2019 BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, reported that it will present at the Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019, at 6:20 a.m. ET (Press release, BD Pharmaceutical Systems, NOV 14, 2019, View Source [SID1234551323]).

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A live webcast of BD’s presentations can be accessed from the BD corporate website at www.bd.com/investors and will be available for replay through Thursday, November 28, 2019.