Alpha1H Patent granted in Europe

On November 25, 2020 Hamlet Pharma AB reported its successfully secured patent protection in Europe for its lead clinical candidate, Alpha1H (Press release, HAMLET Pharma, NOV 25, 2020, View Source;utm_medium=rss&utm_campaign=alpha1h-patent-granted-in-europe [SID1234574599]). This protection is granted as European patent number EP 3618848 B1, which will remain valid until May 14, 2038.

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Alpha1H is currently used in clinical trials in patients with bladder cancer. With this patent, Hamlet Pharma AB continues to expand it’s intellectual property portfolio in areas where its key products show benefit. Following this success at the European Patent Office, where the claims of EP 3618848 B1 were readily accepted for grant, Hamlet Pharma AB plans to seek equivalent protection in further key countries around the world.

"This demonstrates the uniqueness of the innovation and the opportunities Alpha1H may offer cancer patients" says Catharina Svanborg, CMO and chairman of the board of Hamlet Pharma Ltd.

"Alpha1H is our lead drug candidate and this is an important milestone to secure long-term protection in Europe" says Mats Persson, CEO of Hamlet Pharma Ltd.

Surface Oncology to Participate in the 3rd Annual Evercore ISI HealthCONx Conference

On November 25, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that Jeff Goater, chief executive officer, and Robert Ross, M.D., chief medical officer, will participate in the upcoming 3rd Annual Evercore ISI Global HealthCONx Conference on December 2, 2020 at 12:10 p.m. ET (Press release, Surface Oncology, NOV 25, 2020, https://investors.surfaceoncology.com/news-releases/news-release-details/surface-oncology-participate-3rd-annual-evercore-isi-healthconx [SID1234571714]). The discussion will focus on Surface Oncology’s lead programs, SRF617 (targeting CD39) and SRF388 (targeting IL-27), as well as Surface’s emerging pre-clinical pipeline, highlighted by SRF813 (targeting PVRIG, also known as CD112R) and SRF114 (targeting CCR8).

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Senhwa Announces Multiple IND Application Submissions to US FDA and Health Canada for the Treatment of Solid Tumors with BRCA2 or PALB2 Mutations

On November 25, 2020 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, reported that it has submitted multiple Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) and Health Canada evaluating its investigational drug, CX-5461, for the treatment of patients with solid tumors with BRCA2 or PALB2 mutations (Press release, Senhwa Biosciences, NOV 25, 2020, View Source [SID1234571753]).

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"This IND submission is a key milestone in the clinical development of CX-5461. In a phase I study conducted by Senhwa’s clinical partner, Canadian Cancer Trial Group (CCTG), CX-5461 demonstrated clinically meaningful and lasting benefits in patients with specific tumor biomarkers that were resistant to platinum and other chemotherapeutics. The US and Canada clinical trials are being designed to further confirm the efficacy seen," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

CX-5461 was recently named as a PCF-Pfizer Global Challenge Award recipient. Specifically, it will be used in combination with Pfizer’s PARP inhibitor (PARPi), Talazoparib, to explore the therapeutic potential in prostate cancer, which is the second-leading cause of cancer death for men in the United States. In 2016, a recipient of the Stand Up to Cancer’s Dream Team Grant selected CX-5461 to study in their Phase I trial. This study’s clinical findings were featured in a spotlighted presentation at the 2019 annual San Antonio Breast Cancer Symposium (SABCS 2019). Due to the DNA repair defect, BRCA1/2 deficient tumor cells are more sensitive to PARPi through the mechanism of synthetic lethality. However, PARPi resistance is ubiquitous in clinic. More than 40% of BRCA1/2-deficient patients fail to respond to PARPi.

"CX-5461 is a first-in-class G-quadruplex stabilizer within a novel class of therapy that accelerates dsDNA breaks and has proven human efficacy across certain tumor types. We believe CX-5461 has great potential as a therapeutic for patients who have developed resistance to PAPRi or other chemotherapies. This continues to be an unmet medical need in cancer treatment," said Dr. Tai-Sen Soong, CEO of Senhwa Biosciences.

About CX-5461

CX-5461 is designed to stabilize DNA G-quadruplexes of cancer cells and leads to disruption of the cell’s replication fork. While acting in concert with Homologous Recombination (HR) pathway deficiency, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, resulting in cancer cell death. CX-5461 in combination with Homologous Recombination Deficiency (HRD) tumors may be exploited through a synthetic lethality approach, targeting DNA repair defects in HRD tumors.

TRILLIUM THERAPEUTICS TO PRESENT CLINICAL DATA AT THE 62ND AMERICAN SOCIETY OF HEMATOLOGY ANNUAL MEETING

On November 25, 2020 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported the presentation of clinical data at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held virtually from December 5-8, 2020 (Press release, Trillium Therapeutics, NOV 25, 2020, View Source [SID1234571715]).

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TTI-622: Poster Presentation, Publication Number 1191

Investigational CD47-Blocker TTI-622 Shows Single-Agent Activity in Patients with Advanced Relapsed or Refractory Lymphoma: Update from the Ongoing First-in-Human Dose Escalation Study

Presenter: Krish Patel, M.D., Center for Blood Disorders and Stem Cell Transplantation, Swedish Cancer Institute, Seattle, WA

Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)-Results from Prospective Clinical Trials: Poster I

Date: Saturday, December 5, 2020; available from 10:00AM EST

TTI-621: Oral Presentation, Publication Number 646

Updates from Ongoing, First-in-Human Phase 1 Dose Escalation and Expansion Study of TTI-621, a Novel Biologic Targeting CD47, in Patients with Relapsed or Refractory Hematologic Malignancies
Presenter: Steven M. Horwitz, M.D., Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York, NY

Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma-Clinical Studies: Immunotherapy in T/NK Cell Lymphoma

Date: Monday, December 7, 2020; Presentation at 3:00PM EST

The presentations will be available in the Events & Presentations section of Trillium’s website once released by the American Society of Hematology (ASH) (Free ASH Whitepaper).

Trillium will host a conference call on Monday, December 7th at 4:30PM EST.

Approval of Phase I/II Clinical Trial of ATG-016 (Eltanexor), a Second Generation Selective Inhibitor of Nuclear Export (SINE), in Mainland China for the Treatment of Myelodysplastic Syndrome

On November 25, 2020 Antengene Corporation Limited ("Antengene", HKSE stock code: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-inclass therapeutics in hematology and oncology, reported that the National Medical Products Administration (NMPA) has approved the clinical trial of ATG-016 (eltanexor) in patients with intermediate and higher risk myelodysplastic syndrome (MDS) according to the Revised International Prognostic Scoring System (IPSS-R) after the failure of hypomethylating agents (HMA) based therapy (Press release, Antengene, NOV 25, 2020, View Source [SID1234571754]). The trial is a Phase I/II, single-arm, open-label clinical study, aiming to evaluate the pharmacokinetics, safety and efficacy of ATG-016 (eltanexor) monotherapy.

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MDS is a heterogeneous group of clonal disorders of the bone marrow hematopoietic stem cells (HPSCs), characterized by ineffective hematopoiesis with peripheral blood cytopenia and a higher risk for developing acute myeloid leukemia (AML). Patients with high-risk MDS refractory to hypomethylating agents have a median overall survival (OS) of only 4 to 6 months with limited options for follow-up treatment. Pre-clinical studies have demonstrated that selective inhibitor of nuclear export (SINE) compounds are able to block the nuclear export of many tumor suppressor proteins (e.g. p53, IkB, p21) leading to their accumulation and activation in the nucleus thereby exerting anti-tumor effects. In addition, SINE compounds can also reduce the nuclear export and translation of many oncogenic mRNA (c-Myc, Bcl-2, Bcl-6, cyclin D) which are bound to elF4E and result in selective apoptosis of tumor cells. ATG-016 is a member of the latest-generation of SINE compounds. Compared to the first-generation nuclear export inhibitor, ATG-016 demonstrates minimal blood-brain barrier permeability and a broader therapeutic window. It has shown preliminary anti-cancer activity in high-risk MDS patients.

Dr. Jay Mei, the Founder, Chairman and CEO of Antengene expressed, "The approval of the ATG-016 clinical trial demonstrates the efficient execution of the Antengene R&D team and is also the first clinical trial approval obtained by Antengene in mainland China after its listing." He also mentioned, "Selinexor, the first-generation selective inhibitor of nuclear export, has shown extensive activity against hematological malignancies and solid tumors, and has been approved by the FDA for relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma. As a second-generation orally available SINE compound, ATG-016 can reduce the blood-brain barrier penetration, thereby representing a broader therapeutic window with potentially less adverse events and better drug tolerability."

About ATG-016

ATG-016 (eltanexor) is a second-generation selective inhibitor of nuclear export compound. Compared to the