On December 7, 2020 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of fully human antibody therapeutics, reported that the company will present the updated interim data from the ongoing phase Ib trial of olinvacimab and pembrolizumab combination therapy in metastatic triple-negative breast cancer (mTNBC) patients at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020) taking place virtually over December 8-11, 2020 (Press release, PharmAbcine, DEC 7, 2020, View Source [SID1234572393]).

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Positive data from the ongoing safety and tolerability study will highlight safety and certain efficacy data including ORR (Overall Response Rate) & DCR (Disease Control Rate) from 11 patients diagnosed with mTNBC.

"We are excited to present highly encouraging data from our ongoing trial in the biggest breast cancer symposium. These data offer important insights into future development of the combo therapy," said Dr. Jin-San Yoo, CEO of PharmAbcine.

Following is the detail of the company’s virtual poster presentation at 2020 SABCS.

Title: Phase Ib trial of olinvacimab and pembrolizumab in patients with metastatic triple-negative breast cancer
Presenter: Arlene Chan, M.D.
Poster #PS10-18
Date/time: Wednesday, December 9, 2020; 8:00 a.m. CT

About San Antonio Breast Cancer Symposium

San Antonio Breast Cancer Symposium (SABCS) is the world’s largest breast cancer conference held every year. Nearly 10,000 researchers and medical experts participate in this event every year. The core mission of this event is to provide the latest research data in breast oncology to all participants around the globe. For the safety and security of all members in the COVID-19 global pandemic, the SABCS executive committee has decided to hold this year’s event virtually.

About metastatic triple-negative breast cancer

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 10-20% of all breast cancers and shows a 5-year survival rate of circa 11%. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

On December 7, 2020 Viracta Therapeutics, Inc. (Viracta or the Company), a precision oncology company targeting virus-associated malignancies, reported recent clinical and regulatory developments regarding its lead program for the treatment of relapsed/refractory (R/R) EBV+ lymphomas (Press release, Viracta Therapeutics, DEC 7, 2020, View Source [SID1234572391]).

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At the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Dr. Pierluigi Porcu of Sidney Kimmel Cancer Center, Thomas Jefferson University, presented updated data from Viracta’s ongoing clinical trial evaluating its all-oral combination regimen of nanatinostat and valganciclovir for the treatment of patients with R/R EBV+ lymphoma that had failed one or more prior therapies and lacked treatment options.

As of the data cutoff (October 27, 2020), 46 patients were enrolled (B-cell non-Hodgkin lymphoma (B-NHL; n=10), T/NK-cell non-Hodgkin lymphoma (T/NK-NHL; n=15), immunodeficiency-associated lymphoproliferative disorder (IA-LPD; n=13) and Hodgkin lymphoma (HL: n=8). The number of median prior therapies was 2; 80% were refractory to their last prior therapy and 80% had exhausted all prior therapies.

Key results include:

Complete responses were observed across multiple EBV+ lymphoma subtypes (diffuse large B-cell lymphoma (DLBCL), T/NK-NHL and IA-LPD); preliminary efficacy in Phase 2 is consistent with Phase 1b results
Highly active in T/NK-NHL (n=10) with an overall response rate (ORR) of 80% (8/10) and complete response rate (CR) of 40% (4/10)
Encouraging activity in DLBCL (n=6) with an ORR of 66% (4/6) and a CR of 33% (2/6); both CR’s were in patients refractory to first-line R-CHOP
Generally well-tolerated; most common Grade 3/4 toxicities were reversible cytopenias with limited extra-hematologic toxicity
Three patients (2 T/NK-NHL, 1 Hodgkin lymphoma) previously ineligible for immunotherapy approaches were withdrawn from the trial to undergo stem cell transplantation and CAR-T cell therapy respectively
Median duration of response of 10.4 months
In November 2020, Viracta held an End of Phase 2 Meeting with the United States Food and Drug Administration (FDA) to address various nonclinical and clinical topics. Based on the outcome of this meeting, the Company intends to initiate a global registration trial in R/R EBV+ lymphomas in 1H 2021. This trial is designed to support multiple potential marketing approvals across the various subtypes of EBV+ lymphoma. An End of Phase 2 Meeting with the United States FDA to address chemistry, manufacturing and controls is planned for December 2020, and preliminary comments from the Agency indicate alignment in key areas.

Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta commented, "EBV+ lymphoma is an area of high unmet medical need, with adverse survival outcomes reported with standard of care regimens and no approved therapies. The encouraging efficacy and safety profile observed thus far in these highly refractory patients underscores the potential of this oral combination regimen of nanatinostat with valganciclovir for the treatment of patients with recurrent disease. We look forward to advancing our clinical development program in EBV+ lymphoma into its next stages."

Ivor Royston, M.D., President and Chief Executive Officer of Viracta added, "Alignment with the FDA on our registrational trial design and manufacturing plans provide clarity about our development pathway to potential marketing approval for our combination product candidate. We believe the FDA’s support for our registrational trial design is a reflection of the Agency’s recognition of the unmet medical need of patients with EBV+ lymphoma and the promising potential of our inducible synthetic lethality approach. In addition, with our recently announced merger agreement with Sunesis Pharmaceuticals and significant financings, we are well capitalized with significant momentum to advance this and our EBV+ solid tumor program forward in 2021."

Details of ASH (Free ASH Whitepaper) Presentation

Abstract number: 624
Title: Oral Nanatinostat (Nstat) and Valganciclovir (VGCV) in Patients with Recurrent Epstein-Barr Virus (EBV)-Positive Lymphomas: Initial Phase 2 Results
Presenter: Pierluigi Porcu, MD, Sydney Kimmel Cancer Center, Thomas Jefferson University
Session: Hodgkin lymphoma and T/NK cell lymphoma—Clinical studies
A copy of the presentation can be accessed by visiting the "News/Media" section of the Viracta website: View Source

Viracta’s Planned Merger with Sunesis Pharmaceuticals

On November 30, 2020, Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) and Viracta announced the parties entered into a definitive merger agreement (the Merger Agreement) pursuant to which Viracta will combine with Sunesis in an all-stock transaction (the Merger). The merged company will focus on the advancement and expansion of Viracta’s clinical stage, precision oncology pipeline targeting virus-associated malignancies, including Viracta’s lead program for the treatment of EBV+ R/R lymphomas. Upon completion of the Merger, the combined company will operate under the name Viracta Therapeutics, Inc. and intends to be listed on the Nasdaq Global Market under the ticker symbol "VIRX".

Under the terms of the Merger Agreement, pending stockholder approval of the transaction, Viracta will merge with a wholly owned subsidiary of Sunesis, and stockholders of Viracta will receive shares of newly issued Sunesis common stock. Viracta stockholders are expected to own approximately 86% and Sunesis stockholders will own approximately 14% of the combined company on a fully diluted basis using the treasury stock method. The percentage of the combined company that Sunesis stockholders will own as of the close of the Merger may be subject to adjustment based on Sunesis’ net cash.

The Merger Agreement has been unanimously approved by the Board of Directors of each company. The transaction is expected to close in the first quarter of 2021, subject to approvals by stockholders of each company and other customary closing conditions.

A more complete description of the terms of and conditions of the merger can be found in Sunesis’ Form 8-K filed on November 30, 2020 with the Securities and Exchange Commission (SEC) and in the Merger Agreement, which is filed as an exhibit to that Form 8-K.

About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing latent viral genes which are epigenetically silenced in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in EBV+ lymphomas in an ongoing Phase 2 clinical trial [NCT03397706].

Viracta has received Fast Track designation from the FDA for the nanatinostat and valganciclovir combination in R/R EBV+ lymphomas, as well as orphan drug designations for the treatment of post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and T-cell lymphomas.

On December 7, 2020 Menarini Group reported that it will present the results of two different preclinical studies on MEN1611, a potent and selective phosphatidylinositol 3-kinase inhibitor (PI3Ki) currently in clinical development for the treatment of breast cancer, at the upcoming 2020 San Antonio Breast Cancer Symposium, which will be held virtually on December 8-11 (Press release, Menarini, DEC 7, 2020, View Source [SID1234572389]).

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"We are pleased to present at the San Antonio Breast Cancer Symposium and look forward to discussing in more detail the encouraging preliminary results achieved by our preclinical studies on MEN1611," commented Andrea Pellacani, General Manager of Menarini Ricerche, R&D Division of the Menarini Group. "This data contributes to a greater understanding of the mechanism of action of MEN1611 and further support its clinical development for the treatment of breast cancer, reinforcing our strong commitment to advancing precision oncology to the benefit of patients living with difficult-to-treat cancer."

MEN1611 is a potent and selective PI3Ki targeting the p110 α, β and γ isoforms, while sparing the δ subunit. B-PRECISE-01 is a multicenter, Phase Ib, dose escalation and expansion study, investigating MEN1611 in patients with HER2-positive, PIK3CA mutated, advanced or metastatic breast cancer.

The poster entitled "MEN1611 is a PI3K α/β selective and δ sparing inhibitor with long-lasting antitumor activity in different genetic backgrounds of PIK3CA mutant breast cancer models" presents the results of a preclinical study on the antitumor activity of MEN1611 in p110 α- and β-dependent tumors, providing evidence that in these animal models MEN1611 is active against HER2-positive, PIK3CA mutated and PTEN-null breast tumor.

A second poster, entitled "MEN1611 promotes immune activating myeloid cell polarization" presents the results of a study aimed at characterizing the effects of MEN1611 on the PI3Kγ isoform, highly expressed in tumor-associated macrophages, to investigate whether the anti-tumor activity of MEN1611 might also be mediated by MEN1611-mediated modulation of tumor inflammatory microenvironment. The results of this study show that MEN1611 inhibition of the PI3Kγ isoform leads to macrophage reprogramming, from an immune-suppressive to an immune-activating phenotype. Moreover, the tumor regression induced by MEN1611 was associated to changes of the inflammatory microenvironment, characterized by an increased recruitment of T cells, which may contribute to the anti-tumor activity of MEN1611 in this model.

About MEN1611

MEN1611 is a potent and selective PI3K inhibitor targeting the p110 α, β and γ isoforms, while sparing the δ subunit. It is an investigational compound, not approved for use by regulatory authorities, currently being evaluated in the B-PRECISE-01 trial (clinicaltrials.gov identifier: NCT03767335), and in the C-PRECISE-01 trial (clinicaltrials.gov identifier: NCT04495621) for the treatment of breast cancer and colorectal cancer, respectively.

On December 7, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported a poster presentation at the virtual 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting for the ongoing Phase 1 dose-escalation clinical trial for its CD74-targeted antibody drug conjugate (ADC) STRO-001 for patients with late-line Non-Hodgkin Lymphoma (NHL) (Press release, Sutro Biopharma, DEC 7, 2020, View Source [SID1234572388]). Additionally, data were presented from preclinical studies conducted in collaboration with researchers from the Fred Hutchinson Cancer Research Center.

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"With three product candidates in the pipeline actively enrolling patients—STRO-001, STRO-002, our folate receptor alpha- (FolRα) targeting ADC, and CC-99712 in partnership with Bristol Myers Squibb, a BCMA-targeting ADC—Sutro is working on addressing unmet needs via targeted therapies that can tackle cancer evolution," said Bill Newell, Sutro’s Chief Executive Officer. "The encouraging safety and preliminary efficacy clinical data presented at ASH (Free ASH Whitepaper) on STRO-001 for the treatment of late-line NHL further validates our platform and unique approach to ADC design, creating potential first-in-class and/or best-in-class therapeutic candidates."

STRO-001 Phase 1 Dose Escalation Interim Data
STRO-001-BCM1 is an ongoing first-in-human, phase 1 dose-escalation study evaluating the safety, tolerability, and preliminary antitumor activity of STRO-001 in adults with B-cell malignancies. The study is ongoing, and data presented at ASH (Free ASH Whitepaper) included results from the NHL cohort. There were 21 NHL patients treated and 18 evaluable patients for response. Patients had a median of 5 prior therapies. 6/21 patients (29%) had previous stem cell transplant or CAR-T therapy. Data as of October 30, 2020 are as follows:

Most (90%) treatment-emergent adverse events (TEAEs) were grade 1 or 2 and no ocular or neuropathy toxicity signals have been observed
Following a previously announced protocol amendment last year requiring pre-treatment screening imaging for patients at risk for thromboses, no additional thromboembolic events have been observed
In the 7 patients with diffuse large B-cell lymphoma (DLBCL), 1 complete response (CR) and 2 partial responses (PRs) were observed
Out of other NHL types, 2 patients with follicular lymphoma had stable disease (SDs), of which one is still on treatment at 9 weeks. One patient with marginal zone lymphoma had SD and is still on treatment at 39 weeks
"These results continue to demonstrate the potential clinical benefit of STRO-001 treatment in patients with NHL who are heavily pretreated, with a median of five prior lines of treatment," said Dr. Arturo Molina, Sutro’s Chief Medical Officer. "We are especially pleased for the patients who responded to STRO-001 after previously progressing on CAR-T treatments and an additional post- CAR-T regimen to which they had no response, seeing comparable duration of disease control to the duration on a cell therapy. STRO-001 has been well tolerated. We look forward to continuing the dose-escalation study to learn more about the potential for STRO-001 for patients with NHL."

Maximum tolerated dose (MTD) was not reached at 2.5 mg/kg. Active enrollment in the NHL cohort continues at the 3.5 mg/kg dose level and additional higher dose levels may be explored. The trial, registered with clinicaltrials.gov identifier NCT03424603, continues to enroll patients in dose escalation in both multiple myeloma (MM) and NHL cohorts.

The virtual poster titled "Preliminary Results of an Ongoing Phase 1 Dose Escalation Study of the Novel Anti-CD74 Antibody Drug Conjugate (ADC), STRO-001, in Patients with B-cell Non-Hodgkin Lymphoma," presented by Nirav N. Shah, M.D., Associate Professor of Medicine at Medical College of Wisconsin, is accessible through the Clinical/Scientific Presentation and Publication Highlights page of the News section of the company’s website at www.sutrobio.com.

Preclinical Data from Fred Hutchinson Cancer Research Center in Collaboration with Sutro
Fred Hutchinson Cancer Research Center, in collaboration with Sutro, presented preclinical models showing the potential of CD74-targeted therapies, and in particular STRO-001, for the treatment of acute myelogenous leukemia (AML). The research is out of the lab of Soheil Meshinchi, M.D., Ph.D., Professor, Clinical Research Division at Fred Hutchinson Cancer Center and Professor of Pediatrics at University of Washington School of Medicine.

"My team at Fred Hutchinson Cancer Research Center has built a robust computational platform leveraging our large AML transcriptome dataset to identify highly expressed antigens on leukemic cells that are being targeted by agents in early phase trials or preclinical development with the goal of repurposing these therapeutics for use in AML," said Soheil Meshinchi, M.D., Ph.D. "One of these therapies was the STRO-001 ADC which targets the cell surface protein CD74. We have demonstrated that CD74 is highly expressed in a significant proportion of patients with AML. Our initial studies of STRO-001 ADC in AML cell lines demonstrated robust in vitro cytotoxicity on AML cell lines expressing high- to moderate-levels of CD74, with no cytotoxicity in cells with no CD74 expression. This in vitro data, which identifies CD74 as a viable target in AML, coupled with the 27% incidence of CD74 in nearly 1,000 pediatric AML patients from our clinical trial with bortezomib, strengthens the notion that targeting CD74 with STRO-001 represents a viable targeted therapy in this patient population. In addition to AML, CD74 is highly expressed in high risk acute lymphoblastic leukemia (ALL), including Ph-positive and Ph-like ALL, thus providing rationale for exploring the efficacy of STRO-001 in all leukemias.

A virtual poster titled "Target-Informed Repurposing of Immunotherapies in AML – a Transcriptome Based Approach for Identifying Immediately Available Therapeutics," will be presented Amanda Leonti, MS, Computational Biology, Meshinchi lab, Fred Hutchinson Cancer Research Center, and include in vitro cytotoxicity data for STRO-001 in AML cell lines. See the abstract here.
A virtual oral session titled "Newly Diagnosed Childhood AML Patients Treated with Bortezomib Show Superior Survival If CD74 Is Expressed: A Report of 991 Patients from the Children’s Oncology Group AAML1031 Protocol," will be presented by Lisa Eidenschink Brodersen PhD HCLD, Director, Flow Cytometry, Hematologics, Inc in Seattle Washington, and will highlight the potential of CD74 targeted therapies in pediatric AML. See the abstract here.

On December 7, 2020 Beijing Biocytogen Co., Ltd., Biocytogen Boston Corp (collectively as "Biocytogen") reported that they have reached an agreement with Xencor, Inc., for the licensing of Biocytogen’s fully human antibody RenMab/RenLite Mouse platform to enhance Xencor’s monoclonal antibody drug discovery research (Press release, Biocytogen, DEC 7, 2020, View Source [SID1234572386]).

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The leading platform for fully human antibody generation

The RenMab Mouse was developed using Biocytogen’s unique chromosome engineering technique. In this model, the Ig genes that encode for antibody variable domains of heavy and κ light chains are fully replaced by human corresponding Ig genes . The RenLite Mouse is a genetically engineered model with complete humanization in the variable region of the heavy chains, while maintaining a single human light chain. These models can be used to fast generate and screen fully human antibody hits and thus identify therapeutic candidates with high affinities, specificities, and diversities more efficiently than by using other available technology platforms.

Xencor is a leading clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases. Xencor and Biocytogen have collaborated on preclinical pharmacology studies, and Xencor moved forward with the new licensing agreement after Biocytogen released RenLite’s robust validation data.

"We are excited to begin this collaboration," said Dr. John Desjarlais, Xencor’s CSO. "We anticipate the RenMab and RenLite platforms will extend our bispecific antibody discovery and look forward to working with the team at Biocytogen."

The agreement, reached on October 27, includes licenses for the RenMab and RenLite mouse platforms and Biocytogen’s ongoing support of Xencor’s drug development efforts to help meet the increasing global demand for effective biologic therapies.

"We are delighted that Xencor has selected the Biocytogen RenMab/RenLite mice for their development of novel fully human antibody candidates," said YueLei Shen, Founder and CEO of Biocytogen. "We are highly confident that the combination of our fully-humanized mouse model and Xencor’s proven expertise in drug discovery and development will provide the ideal collaboration for the Xencor’s discovery of clinically-relevant antibodies."

The RenMab and RenLite antibody platforms are available for licensing to pharmaceutical and biotechnology partners seeking to streamline their antibody discovery workflow. For more information on RenMab and RenLite, visit View Source