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AstraZeneca advances ambition to redefine care for blood cancer at ASH 2021

On November 5, 2021 AstraZeneca reported that it will present new data underscoring its commitment to transforming haematologic cancer care at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, 11 to 14 December 2021 (Press release, AstraZeneca, NOV 5, 2021, View Source [SID1234594577]).

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More than 25 abstracts will feature data across the Company’s haematology portfolio and pipeline, including new analyses from the Calquence (acalabrutinib) Phase III programme such as an oral presentation of three-year follow-up data from the ASCEND Phase III trial in relapsed or refractory chronic lymphocytic leukaemia (CLL).

Overall, data will span over 10 types of blood cancers and related conditions with a focus on CLL, mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL) and acute myeloid leukaemia.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our robust Calquence data at ASH (Free ASH Whitepaper) will include an important new formulation designed to expand the pool of patients who may benefit from Calquence. Moreover, data from three Phase III trials will show the sustained efficacy and safety of Calquence, which is central to our commitment to prioritise the patient experience while providing long-term control of the disease in those with chronic lymphocytic leukaemia."

Anas Younes, Senior Vice President, Haematology R&D, AstraZeneca, said: "Testing new ways of overcoming drug resistance and continually pushing for better and deeper responses for patients are core focus areas of our early haematology portfolio. The preclinical data we are presenting at this year’s ASH (Free ASH Whitepaper) meeting for capivasertib and AZD4573 add to the emerging body of evidence showing the potential for new approaches to become the cornerstones of tomorrow’s combination therapies for hard-to-treat blood cancers."

AstraZeneca’s commitment to putting CLL patients first

A risk-benefit analysis showing quality-adjusted time without symptoms or toxicity (Q-TWiST) from the ELEVATE-RR and ASCEND trials in relapsed or refractory CLL will report the difference between Calquence and either ibrutinib or the combination of rituximab with idelalisib or bendamustine, balancing risk (toxicity) and benefit (prolonged survival without symptoms of progression or adverse events)
Data introducing a maleate tablet formulation of Calquence will establish bioequivalence to the current capsule and would enable co-administration with proton pump inhibitors or via nasogastric tube for patients with swallowing challenges, offering an opportunity to provide Calquence to patients for whom it was previously not an option
Further analyses from Calquence Phase III trial programme reinforce long-term safety and efficacy for patients with CLL

An oral presentation will show durable efficacy for Calquence over three years in relapsed or refractory CLL from the ASCEND trial, evaluating the treatment versus investigator’s choice of rituximab combined with either idelalisib or bendamustine
A sub-analysis from the head-to-head ELEVATE-RR trial for Calquence versus ibrutinib in relapsed or refractory CLL will further characterise adverse events related to Bruton’s tyrosine kinase (BTK) inhibition
A matching-adjusted indirect comparison using data from the ELEVATE-TN trial will compare the safety profile of Calquence alone or in combination with obinutuzumab to either ibrutinib monotherapy or venetoclax in combination with obinutuzumab
Emerging pipeline molecules show therapeutic potential in novel combinations

Preclinical data will be presented showing that capivasertib (AZD5363), an AKT inhibitor being evaluated in a number of solid and haematological tumours, showed significant activity in murine DLBCL models when combined with venetoclax. This data continues to broaden our understanding of the role of AKT inhibitors in B-cell non-Hodgkin lymphomas (NHL). Capivasertib monotherapy is being explored in sub-sets of relapsed or refractory B-cell NHL in the CAPITAL Phase II trial
Additionally, new data will demonstrate AZD4573, a highly selective and potent cyclin dependent kinase 9 inhibitor from AstraZeneca’s cell death portfolio, effectively induces apoptosis in vivo in relapsed or refractory MCL xenograft models both alone and when combined with Calquence
Key AstraZeneca presentations during the 63rd ASH (Free ASH Whitepaper) Annual Meetingi

Lead author

Abstract title

Presentation details

Calquence (acalabrutinib)

Jurczak, W

Three-Year Follow-Up of the ASCEND Trial Investigating Acalabrutinib vs Rituximab plus Idelalisib or Bendamustine in Relapsed/Refractory Chronic Lymphocytic Leukemia

Abstract # 393

Oral Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I

12 December 2021

10:00 ET

Location: Room B401-B402

Seymour, JF

Characterization of Bruton Tyrosine Kinase Inhibitor (BTKi)-Related Adverse Events in a Head-to-Head Trial of Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia (CLL)

Abstract # 3721

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

13 December 2021

18:00-20:00 ET

Location: Hall B5

Sharma, S

New Acalabrutinib Formulation Enables Co-administration with Proton Pump Inhibitors and Dosing in Patients Unable to Swallow Capsules (ELEVATE-PLUS)

Abstract # 4365

Online only

Davids, MS

MAJIC: A Phase 3 Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib plus Venetoclax versus Venetoclax plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Abstract # 1553

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I

11 December 2021

17:30-19:30 ET

Location: Room B5

Davids, MS

Matching-Adjusted Indirect Treatment Comparison (MAIC) of Acalabrutinib Alone or in Combination With Obinutuzumab Versus Ibrutinib or Venetoclax Plus Obinutuzumab in Patients With Treatment-naïve Chronic Lymphocytic Leukemia

Abstract # 2633

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

12 December 2021

18:00-20:00 ET

Location: Room B5

Seymour, JF

A Quality-Adjusted Survival (Q-TWiST) Analysis to Assess Benefit-Risk of Acalabrutinib Versus Idelalisib/Bendamustine Plus Rituximab or Ibrutinib Among Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) Patients

Abstract # 3722

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

13 December 2021

18:00-20:00 ET

Location: Room B5

Roschewski, M

Phase 2 Study of Acalabrutinib Window Prior to Frontline Therapy in Untreated Diffuse Large B-cell Lymphoma: Preliminary Results and Correlatives of Response to Acalabrutinib

Abstract # 524

Oral Session: 626. Aggressive Lymphomas Prospective Therapeutic Trials: Novel Agents and Combinations

12 December 2021

16:45 ET

Location: Thomas Murphy Ballroom 1-2

Capivasertib (AZD5363)

Willis, B

Combination benefit of capivasertib and venetoclax in preclinical models of Diffuse Large B-cell Lymphoma

Abstract # 802

Poster Session: 802. Chemical Biology and Experimental Therapeutics: Poster I

11 December 2021

17:30-19:30 ET

Location: Room B5

AZD4573

Roderick, J

AZD4573 effectively induces apoptosis in r/r MCL as a monotherapy or in combination with acalabrutinib

Abstract # 605

Poster Session: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II

12 December 2021

18:00-20:00 ET

Location: Room B5

i28 company-sponsored or supported abstracts will be presented at ASH (Free ASH Whitepaper) 2021.

Notes

Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. It binds covalently to BTK, thereby inhibiting its activity.1,2 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.1

Calquence is approved for the treatment of CLL and small lymphocytic lymphoma (SLL) in the US, approved for CLL in the EU and several other countries worldwide, and approved in Japan for relapsed or refractory CLL and SLL. A Phase I trial is currently underway in Japan for the treatment of front-line CLL.

In the US and several other countries, Calquence is also approved for the treatment of adult patients with MCL who have received at least one prior therapy. The US MCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Calquence is not currently approved for the treatment of MCL in Europe or Japan.

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being evaluated for the treatment of multiple B-cell blood cancers including CLL, MCL, DLBCL, Waldenström’s macroglobulinaemia, follicular lymphoma and other haematologic malignancies.

AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. Applying our deep understanding of blood cancers and leveraging our strength in solid tumour oncology, we are driving the development of novel therapies designed to target underlying drivers of disease across six scientific platforms.

By addressing blood cancers with high unmet medical needs, our aim is to deliver innovative medicines and approaches to healthcare services that have a meaningful impact on patients and caregivers, transforming the haematologic cancer care experience.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

Viracta Therapeutics Secures $50 Million Credit Facility from Silicon Valley Bank and Oxford Finance

On November 5, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company primarily focused on targeting virus-associated malignancies, reported that the Company has entered into a loan and security agreement with Silicon Valley Bank (SVB) and Oxford Finance LLC (Oxford) for up to $50.0 million (Press release, Viracta Therapeutics, NOV 5, 2021, View Source [SID1234594576]). In connection with the $50.0 million credit facility, the Company and SVB agreed to terminate the Company’s prior $15.0 million loan and security agreement and the existing $5.0 million debt balance was refinanced. Under this new $50.0 million credit facility, the remaining $45.0 million is available in two additional tranches of $20.0 million and $25.0 million. The Company is under no obligation to draw funds in the future.

"This expanded credit facility increases our financial strength and provides the Company with significant strategic and operational flexibility by securing access to a non-dilutive and immediately available financing option that carries an attractive single-digit cost of capital," said Dan Chevallard, Chief Operating Officer and Chief Financial Officer at Viracta. "We appreciate SVB’s continued support, are pleased to welcome the Oxford team to Viracta, and believe broadening the relationship at this time offers external validation in addition to valuable access to capital that could potentially support our future prospects and corporate strategy."

Michael White, National Head of Business Development and Managing Director for SVB’s Life Sciences and Healthcare Practice added, "We are excited to expand our already strong relationship with Viracta and partner with the Oxford team. We believe Viracta is well-positioned to advance towards multiple value-creating inflection points, with the initiations of its pivotal NAVAL-1 trial and its Phase 1b/2 solid tumor trial, as well as the progress of its preclinical pipeline."

"Viracta’s platform technology has enabled broad applicability in a variety of EBV positive cancers and has the potential to create therapies for other virus-related cancers through its inducible, synthetic lethality approach," said Christopher A. Herr, Senior Managing Director at Oxford. "Oxford is happy to enter this partnership with SVB and support Viracta’s focus on advancing new medicines for the treatment of virus-associated malignancies."

ADCC-enhanced CTLA-4 Antibody of ImmuneOnco Received Approval of NMPA for Clinical Trial

On November 4, 2021 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. reported that IMM27M, the newly developed ADCC-enhanced CTLA-4 antibody was approved by NMPA for clinical trial research (Press release, ImmuneOnco Biopharma, NOV 4, 2021, View Source [SID1234655627]). This is another major milestone for ImmueOnco.

CTLA-4 is the first clinically proven check point for immunotherapy, as the first antibody approved in 2011, Ipilimumab is still the only approved drug in the global market. Three weeks ago, the first prescription came out priced at￥28,000 per dose in China.

The IMM27M is an IgG1 antibody targeting CTLA-4. It has been genetically modified to enhance ADCC activity. In the preclinical research, IMM27M appeared to be more efficacious than that of Ipilimumab since it completely removes tumors at a lower dose (0.3 mg/kg) in animal models.

Dr. Tian, Wenzhi, the founder and chairman of ImmueOnco said, "We are pleased that our next-generation CTLA-4 antibody program has been approved by NMPA for clinical trial research. Repeatable in vivo studies have demonstrated that IMM27M has robust anti-tumor activity and also, can be used in combination with a variety of drugs in the company’s pipeline for clinical research. We believe that the IMM27M has great value for clinical development. "

"We will make our best to develop IMM27M to benefit more patients."

Biosight Announces Upcoming Presentation at the 63rd American Society of Hematology Annual Meeting

On November 4, 2021 Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, reported that an abstract has been accepted for presentation at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 11-14, 2021 in Atlanta, GA (Press release, Advaxis, NOV 4, 2021, View Source [SID1234595577]).

Title: Aspacytarabine (BST-236) As Monotherapy Is Safe, Well-Tolerated and Effective for the Treatment of Adults with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Therapy. Results of a Phase 2 Study

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I

Date: Saturday, December 11, 2021

Time: 5:30 PM – 7:30 PM

Location: Hall B5
The above abstract was published today and is now available on the ASH (Free ASH Whitepaper) website at www.hematology.org.

About Aspacytarabine (BST-236)

Aspacytarabine is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine. Cytarabine serves as the backbone of AML therapy for over 45 years due to its superior efficacy, however, it is associated with severe bone marrow, gastrointestinal, and neurological toxicities, which significantly limit its use, especially in older and medically compromised patients. Due to its unique pharmacokinetics and metabolism, aspacytarabine enables high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues. As such, aspacytarabine may serve as a new therapy for AML and other hematological malignancies and disorders, including for older adults who are unfit for intensive therapy.

Aspacytarabine was granted FDA Fast Track Designation for treatment of AML patients unfit for standard chemotherapy, and FDA and EMA Orphan Drug Designations, which entitle Biosight to seven and ten years of market exclusivity in the U.S. and Europe, respectively, upon aspacytarabine marketing approval for the treatment of AML in each territory.

Interim results from an ongoing Phase 2b study evaluating aspacytarabine as a single-agent first-line AML therapy demonstrate safety and single-agent activity, and additional studies are ongoing to evaluate aspacytarabine as a second line treatment for patients with relapsed or refractory MDS or AML. For more information regarding the Phase 2b clinical study of BST-236, please visit www.clinicaltrials.gov.

Orion Receives Funding to Advance its Lead GPCR-Targeted Therapeutic

On November 4, 2021 Orion Biotechnology Canada Ltd., a clinical stage company unlocking the therapeutic potential of G Protein-Coupled Receptors (GPCRs) with a novel drug modality, proven discovery platform and best-in-class molecules, reported that it is receiving advisory services and conditional funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) (Press release, Orion Biotechnology, NOV 4, 2021, View Source [SID1234595541]). The funding will support the development of Orion’s lead compound, OB-002, a GPCR analog of CCL5 with best-in-class potency and broad applicability across a range of serious diseases including cancer and neuroinflammation. Working in collaboration with NRC’s Human Health Therapeutics Research Centre, the objectives of the project will be to further expand the translational research of OB-002, including an assessment of the molecules’ ability to cross the blood brain barrier (BBB).

"We are very pleased to receive advisory services and this funding from NRC IRAP," said Mark Groper, President and CEO of Orion Biotechnology. "Their support will help accelerate development of OB-002 as a potentially important therapy for the treatment of serious illnesses".

"GPCRs are implicated in a wide range of human physiological processes and we are interested in expanding our knowledge of OB-002’s pharmacological profile and mechanism of action," commented Ian McGowan, Orion’s Chief Medical Officer. "This project, supported by NRC IRAP and our collaborators, will prove important as we continue to progress OB-002 into the clinic"