On November 9, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported the acceptance of an abstract at the upcoming 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held from December 11-14, 2021, both in Atlanta, Georgia, and virtually at View Source (Press release, Antengene, NOV 9, 2021, View Source [SID1234594934]).

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Antengene will release preliminary results of this Company-sponsored open-label Phase 1b study with selinexor (ATG-010) for the treatment of peripheral T-cell lymphoma and NK/T-cell lymphoma, in an offline poster presentation (full text of the abstract available at: View Source). Meanwhile, another seventeen abstracts related to selinexor and eltanexor will be presented at the 2021 ASH (Free ASH Whitepaper) Annual Meeting as announced by Antengene’s partner, Karyopharm Therapeutics, Inc. (Karyopharm) (see below for details of these abstracts).

"We are very pleased that the poster related to Antengene’s selinexor (ATG-010) T-Cell Lymphoma program has been accepted at the 2021 ASH (Free ASH Whitepaper) Annual Meeting," said Jay Mei, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Antengene. "Selinexor is Antengene’s first commercial stage product. We look forward to sharing more about this program following the poster session."

Details of the abstract that has already been published on the ASH (Free ASH Whitepaper) website are as follows:

XPO1 Inhibitor (ATG-010) Plus Chemotherapy per Investigator’s Choice for Heavily Pretreated Patients with Relapsed or Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL) and Extranodal NK/T-Cell Lymphoma (ENKTL)：Preliminary Results from a Multicenter, Single-Arm Phase Ib Study (TOUCH Trial) (Abstract# 2452)

Session:
624. Hodgkin Lymphomas and T/NK cell Lymphomas: Clinical and Epidemiological: Poster II
Abstract #: 2452
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET
Venue: Hall B5, Georgia World Congress Center

Details of these abstracts announced by Karyopharm in a press release dated November 4, 2021.

In total, 17 abstracts were selected for presentation at the meeting, including five oral presentations and 12 posters.

Oral Presentations

Title: A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor in Patients with Myelofibrosis Refractory or Intolerant to JAK Inhibitors
Presenter: Srinivas Tantravahi, University of Utah
Abstract #: 143
Session Type: Oral Presentation
Session: Myeloproliferative Syndromes: Clinical and Epidemiological: Non-JAK Inhibitor Therapies for Myelofibrosis
Date and Time: Saturday, December 11, 2021 at 1:00 p.m. ET

Title: Transcriptomic Correlates of Response to Selinexor in Multiple Myeloma Reveal a Predictive Signature
Presenter: Paula Restrepo, Icahn School of Medicine at Mount Sinai
Abstract #: 457
Session Type: Oral Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Multiple Myeloma and Waldenstrom Macroglobulinemia: Exploring Biomarkers in the Era of Personalized Medicine
Date and Time: Sunday, December 12, 2021 at 12:00 p.m. ET

Title: Enhanced p53 Activation by Dual Inhibition of MDM2 and XPO1 Disrupts MYC Transcriptional Program and Restores Sensitivity to BCL-2 Inhibition in Ven/HMA Resistant AML
Presenter: Yuki Nishida, Saga University
Abstract #: 505
Session Type: Oral Presentation
Session: Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Novel Strategies to Overcome Resistance to BCL-2 Inhibition
Date and Time: Sunday, December 12, 2021 at 4:30 p.m. ET

Title: Rationale for Selinexor Treatment in Daratumumab-Refractory MM Patients Identified by Paired Ex Vivo Drug Sensitivity and RNA-Seq
Presenter: Suresh Kumar Balasubramanian, Wayne State University
Abstract #: 683
Session Type: Oral Presentation
Session: Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Targeting
Mitochondrial Survival Pathways
Date and Time: Monday, December 13, 2021 at 3:45 p.m. ET

Title: Comparison of Salvage Autologous Hematopoietic Cell Transplantation with Outcomes Following Selinexor Combinations Among Double/Triple Refractory Myeloma Patients
Presenter: Praneeth Sudalagunta, H Lee Moffitt Cancer Ctr
Abstract #: 893
Session Type: Oral Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Myeloma Pathogenesis and Novel Targets
Date and Time: Monday, December 13, 2021 at 7:15 p.m. ET

Poster Presentations

Title: Efficacy and Safety of Selinexor-Containing Regimens in Patients with Multiple Myeloma Previously Treated with Anti-CD38 Monoclonal Antibodies (αCD38 mAb)
Presenter: Suzanne Lentzsch, Columbia University Irving Medical Center
Abstract #: 1651
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: Effects of Cytogenetic Risk on Outcomes in Multiple Myeloma Treated with Selinexor, Bortezomib, and Dexamethasone (XVd)
Presenter: Nizar Bahlis, University of Calgary
Abstract #: 1634
Session Type: Poster Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: Selinexor in Combination with Daratumumab-Bortezomib and Dexamethasone for the Treatment of Relapse or Refractory Multiple Myeloma: Initial Results of the Phase 2, Open-label, Multicenter GEM-SELIBORDARA Study
Presenter: Paula Rodríguez- Otero, Clínica Universidad de Navarra
Abstract #: 1677
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: Once Weekly Oral Selinexor, Pomalidomide, and Dexamethasone in Relapsed Refractory Multiple Myeloma
Presenter: Darrell White, QEII Health Sciences Center, Dalhousie University
Abstract #: 2748
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Selinexor-Based Regimens in Patients with Multiple Myeloma after Prior Anti-B-Cell Maturation Antigen Treatment
Presenter: Muhamed Baljevic, University of Nebraska Medical Center
Abstract #: 2751
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Single Cell RNA Sequencing of a Selinexor Clinical Trial Reveals Overexpression of Alternative Nuclear Export Pathways Associated with Resistance to Selinexor in RRMM Patients
Presenter: Yael Cohen, Tel Aviv Sourasky Medical Center
Abstract #: 2725
Session Type: Poster Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster I
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Selinexor Enhances NK Cell Activation Against Lymphoma Cells Via Downregulation of HLA
Presenter: Matthew Blunt, University of Southampton
Abstract #: 2411
Session Type: Poster Presentation
Session: Lymphomas: Translational—Non-Genetic: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Molecular Response Patterns in Relapsed/Refractory AML Patients Treated with Selinexor and Chemotherapy
Presenter: Piroska Klement, Hannover Medical School
Abstract #: 2369
Session Type: Poster Presentation
Session: Acute Myeloid Leukemias: Biomarkers, Molecular Markers and Minimal Residual Disease in Diagnosis and Prognosis: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Updated Efficacy of Eltanexor Monotherapy in Patients with Higher Risk Hypomethylating Myelodysplastic Syndrome Primary Refractory to Hypomethylating Agents
Presenter: Sangmin Lee, Weill Cornell Medical College
Abstract #: 3676
Session Type: Poster Presentation
Session: Myelodysplastic Syndromes — Clinical and Epidemiological: Poster III
Date and Time: Monday, December 13, 2021 at 6:00 – 8:00 p.m. ET

Title: Clinical Outcomes in Patients with Dose Reduction of Selinexor in Combination with Bortezomib, and Dexamethasone (XVd) in Previously Treated Multiple Myeloma from the BOSTON Study
Presenter: Sundar Jagannath, Mount Sinai School of Medicine
Abstract #: 3793
Session Type: Poster Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster III
Date and Time: Monday, December 13, 2021 at 6:00 – 8:00 p.m. ET

Title: Selinexor in Combination with R-GDP for Patients with Relapsed/Refractory B-Cell Lymphoma: SELINDA Phase Ib LYSA Study
Presenter: Marie Maerevoet, Jules Bordet Institute
Abstract #: 1411
Session Type: Poster Presentation
Session: Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) with or without Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)
Presenter: Seung Tae Lee, University of Maryland School of Medicine
Abstract #: 1420
Session Type: Poster Presentation
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021, 5:30-7:30 p.m. ET

About Selinexor (ATG-010)

Selinexor is so far the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) and the first drug approved for the treatment of both multiple myeloma and diffuse large B-cell lymphoma. By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins, thus induces apoptosis without affecting normal cells. Due to its novel mechanism of action, selinexor can be used in multiple combination regimens to improve treatment efficacy.

On November 9, 2021 Cellaria Inc (Wakefield, MA, USA), a scientific innovator with breakthrough tools for cancer research, reported the availability of a series of new products, including a panel of cell culture media optimized to grow clinically relevant cell types, an extra-cellular fully defined neutral collagen matrix (ECM), and validated protocols for a scalable and reproducible testing of small patient cohorts for screening of novel drug compounds (Press release, Cellaria, NOV 9, 2021, View Source [SID1234594950]). Cellaria continuously strives to deliver new platforms and methods for precision medicine and personalized drug screening for cancer and other complex diseases. All cell culture media products incorporate Cellaria’s own recombinant proteins in the formulation, where quality controls are combined with economic feasibility and competitiveness for each product.

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One pillar of Cellaria’s new platform is its Renaissance Essential Media, expanded for applications with lymphocytes (T-cells), mesenchymal stromal cells (MSCs), normal cells and cancer-associated fibroblasts (CAFs). The Renaissance line of media has been optimized to simplify the addition of these important cell types into more complex three-dimensional models (organoids) of the tumor microenvironment, which has emerged as critically important for the evaluation of targeted therapeutics, immune-oncology approaches, such as checkpoint inhibitor targets (e.g. PD-1), CAR-T, and multi-drug treatment methods. It also enables complex modeling of inflammatory diseases such as juvenile diabetes (T1D), neurodegenerative and brain diseases, and other difficult to model diseases.

The second pillar of Cellaria’s platform includes patient-matched cell types which can be easily combined in complex organoid models of tumor metastatic nodes and solid tumors. This means drug developers can utilize Cellaria’s 3D Organoid Model system using tumor cells, cancer associated fibroblasts and T cells all from the same patient, greatly increasing the validity of their findings and target identification. Cellaria applies this same approach for enhancing patient-matched models of diabetes, and brain inflammation.

The third pillar, supporting both pillars 1 and 2, is the introduction of Jellagen Extracellular Matrix, a fully defined neutral 3D cell culture scaffold. Cellaria has partnered with UK based Jellagen Ltd, a supplier of next generation Collagen Type 0, a biomaterial offering a paradigm shift in collagen chemistry. This naturally derived scaffold supports enhanced signaling that occurs between cells without artificial effects.

"An often overlooked hurdle for combining different cell types is the formulation of the cell culture medium to support robust function of multiple cell types," says David Deems, Cellaria’s President and Founder. "Our Renaissance Media Platform simplifies the process so anyone can design complex disease models in a high-throughput format, while reducing variability of response and increasing biological fidelity of the model," adds Dr. Dmitry Shvartsman, Cellaria’s Chief Technology Officer. "Cellaria’s approach increases patients’ involvement and the impact of their samples for truly meaningful research."

Cellaria’s Renaissance cell culture medias, and patient-specific cell models for Non-Small Cell Lung Cancer and Pancreatic Cancer have already demonstrated proven value in in vitro studies. Now, Cellaria’s 3D tools simplify the process for screening disease cohorts and understanding drug response on individual patients. Find out more about Cellaria’s 3D and Organoid tools and methods at:
www.cellariainc.com or email at [email protected].

On November 9, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology company, developing new precision medicine treatment options for cancer patients in indications with the greatest unmet medical need including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, reported that company management will present and participate in virtual 1×1 investor meetings at the Jefferies London Healthcare Conference and the Piper Sandler 33rd Annual Healthcare Conference, taking place November 16 – 19, 2021, and November 29 – December 2, 2021, respectively (Press release, Cardiff Oncology, NOV 9, 2021, View Source [SID1234594986]).

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Details on the presentations can be found below.

Jefferies London Healthcare Conference

Presentation Date:

Available on-demand beginning at 8:00 AM GMT (3:00 AM ET) on November 18, 2021

Piper Sandler 33rd Annual Healthcare Conference

Presentation Date:

Available on-demand beginning at 10:00 AM ET on November 22, 2021

Webcasts of the presentations will be available by visiting the "Events" section of the Cardiff Oncology website and will be archived for 30 days.

On November 9, 2021 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc. (NYSE: PFE), reported a strategic commercialization arrangement for rimegepant in markets outside of the United States upon approval (Press release, Biohaven Pharmaceutical, NOV 9, 2021, View Source [SID1234595037]). Rimegepant is commercialized as Nurtec ODT in the U.S., and is indicated for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine in adults. An application for the approval of rimegepant is currently under review by the European Medicines Agency and several additional regulatory authorities outside of the U.S.

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"We believe this collaboration, which brings together the winning combination of Biohaven’s Neuroscience R&D with Pfizer’s industry-leading expertise and large global footprint will help accelerate access to rimegepant for patients around the world," said Vlad Coric MD, Chief Executive Officer of Biohaven. "With this alliance, Biohaven Pharmaceutical and Pfizer believe there is an opportunity to change the paradigm in migraine treatment and potentially establish a new standard of care."

Under the terms of the arrangement, Biohaven would remain primarily responsible for further clinical development of rimegepant and the parties will cooperate in regulatory activities to secure approval for the product. Biohaven will continue to solely commercialize Nurtec ODT in the U.S and Pfizer would commercialize rimegepant, upon approval, in all regions outside the U.S. Additionally, per the arrangement, Pfizer gains rights outside of the U.S. to zavegepant, a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist, currently being studied in an intranasal delivery and a soft-gel formulation in Phase 3 clinical trials for migraine indications.
"We are excited to join forces with Biohaven in the fight against migraine and help those patients impacted by this debilitating neurological disease," said Nick Lagunowich, Global President, Pfizer Internal Medicine. "We believe our legacy in pain and Women’s Health combined with our experienced customer-facing colleagues, will enable us to maximize this opportunity with Biohaven, potentially bringing a valuable new treatment option to patients living with migraine pain."

Terms of the Arrangement
Biohaven and Pfizer are entering into a collaboration and license agreement and related sublicense agreement pursuant to which Pfizer will acquire rights to commercialize rimegepant and zavegepant outside of the U.S. Biohaven will continue to lead research and development globally and Pfizer would execute commercialization globally, outside of the U.S. Under the financial terms of all transaction agreements, Pfizer will make an upfront payment of $500 million, consisting of $150 million cash and $350 million in the purchase of Biohaven equity at a 25 percent market premium. Biohaven is also eligible to receive up to $740 million in milestones. In addition to the tiered double-digit royalties owed to Biohaven on net sales outside of the U.S., Pfizer will compensate Biohaven for the related royalties on net sales outside of the U.S. owed under the Company’s license and funding agreements with Bristol-Myers Squibb Company and Royalty Pharma.

As noted above, in connection with the transaction, Pfizer will make a $350 million investment in the common shares of Biohaven.
Closing of the license agreements and equity purchase are contingent on completion of review under applicable antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S. and equivalents outside the U.S., and other customary closing conditions.
Biohaven and Pfizer global collaboration will be discussed on Biohaven 3Q Earnings Investor Call 8:00AM ET on November 9, 2021. To access the call, please dial 877-407-9120 (domestic) or 412-902-1009 (international). The conference call webcast and accompanying slide presentation can be accessed through the "Investors" section of Biohaven’s website at www.biohavenpharma.com.

About Migraine
More than one billion people suffer from migraine worldwide, of which 75 percent are women. The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating headache attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a large unmet need for new acute and preventive treatments, as a significant portion of migraine patients are unsatisfied with current standard of care migraine treatments due to a lack of efficacy or safety or tolerability burden.

About Rimegepant
Rimegepant targets a root cause of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name Nurtec ODT for the acute treatment of migraine in February 2020 and for the preventive treatment of episodic migraine in May 2021. Nurtec ODT is the #1 prescribed migraine treatment in its class with a cumulative launch to date of U.S. net revenue of approximately $336 million and with more than one million prescriptions. A single dose of 75 mg Nurtec ODT provides fast pain relief, significant pain reduction and return to normal function, and has a lasting effect of up to 48 hours in some patients. Nurtec ODT is taken orally as needed, up to 18 doses/month to stop migraine attacks or taken every other day to help prevent migraine attacks and reduce the number of monthly migraine days. Nurtec ODT does not have addiction potential and is not associated with medication overuse headache or rebound headache.

NURTEC ODT U.S. IMPORTANT SAFETY INFORMATION
Nurtec ODT (orally disintegrating tablet) is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine. It is not known if Nurtec ODT is safe and effective in children.
Do not take Nurtec ODT if you are allergic to Nurtec ODT (rimegepant) or any of its ingredients.
Before you take Nurtec ODT, tell your healthcare provider (HCP) about all your medical conditions,
including if you:

•have liver problems,
•have kidney problems,
•are pregnant or plan to become pregnant,
•breastfeeding or plan to breastfeed.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Nurtec ODT may cause serious side effects including allergic reactions, including trouble breathing and rash. This can happen days after you take Nurtec ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. This occurred in less than 1% of patients treated with Nurtec ODT.
The most common side effects of Nurtec ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of Nurtec ODT. Tell your HCP if you have any side effects.

On November 9, 2021 Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative, targeted therapeutics to treat life-threatening cancers, reported that positive new data from the Phase 1b portion of its open-label Phase 1b/2 trial evaluating batiraxcept (AVB-500) in combination with cabozantinib in patients with clear cell renal cell carcinoma (ccRCC) will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting on November 13, 2021 (Press release, Aravive, NOV 9, 2021, View Source [SID1234594804]). The presentation will highlight interim safety, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity data.

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"We are encouraged by the preliminary performance of batiraxcept in combination with cabozantinib in patients with clear cell renal cell carcinoma," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "These results highlight the potential of batiraxcept to improve outcomes for patients with advanced kidney cancer. We look forward to sharing these new clinical data with the research and medical community at this year’s SITC (Free SITC Whitepaper) Annual Meeting."

As of July 21, 2021, seven patients received at least one dose of batiraxcept 15 mg/kg in combination with cabozantinib, six patients were ongoing treatment, and five patients were evaluable for efficacy. No dose-limiting toxicities were observed. Trough levels at cycle 1 day 15 were above the minimal efficacious concentration identified from the Company’s model informed drug development approach, and serum GAS6 levels were suppressed prior to cycle 2 day 1. A best overall response of partial response was observed in 3 of 5 patients (60%, unconfirmed as of July 21, 2021), based on investigator assessment, RECIST v 1.1 criteria. In addition, all patients demonstrated tumor decrease from baseline.

Aravive’s presentation at the SITC (Free SITC Whitepaper) Annual Meeting will include updated safety, PK, PD, and clinical activity data from a larger set of patients treated with batiraxcept 15 mg/kg in combination with cabozantinib as of October 16, 2021.

Poster Presentation Details

Title: A Phase 1b/2 randomized study of AVB-S6-500 in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma who have received front-line treatment

Presenter: Reshma Rangwala, M.D., Ph.D., Chief Medical Officer of Aravive

Date: November 13, 2021

Time: 7:00 AM – 8:30 PM ET

Location: Hall E

For additional information, please visit the SITC (Free SITC Whitepaper) 36th Annual Meeting website: View Source

Conference Call Information
Aravive will host a conference call and webcast on November 12, 2021 at 8:30 a.m. ET to discuss these clinical data. The conference call may be accessed by dialing (877) 423-9813 (domestic) and (201) 689-8573 (international) and referring to conference ID 13724115. A webcast of the conference call will be available in the Investors section of the Aravive website at View Source The archived webcast will be available on Aravive’s website after the conference call.

About the Batiraxcept (AVB-500) Phase 1b/2 ccRCC Trial
Aravive initiated the Phase 1b portion of the Phase 1b/2 trial of batiraxcept in ccRCC in March 2021. The Phase 1b portion of the clinical trial, a dose escalation study, is expected to enroll approximately 18 patients in three dosing arms (15 mg/kg, 20 mg/kg and 25 mg/kg) to evaluate tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of batiraxcept in combination with cabozantinib. The controlled, randomized, open-label Phase 2 portion of the clinical trial is expected to enroll approximately 45 patients and investigate the recommended batiraxcept dose identified during the Phase 1b portion of the clinical trial in combination with cabozantinib versus cabozantinib alone. The primary endpoint is progression-free survival. The trial is enrolling patients with advanced ccRCC who have progressed on front-line treatment. The Phase 1b/2 trial is listed on clinicaltrials.gov NCT04300140.

About Batiraxcept (AVB-500)
Batiraxcept is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, batiraxcept selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian, renal and pancreatic cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. Batiraxcept is currently being evaluated in multiple clinical trials and has been granted Fast Track designation by the U.S. Food and Drug Administration and orphan drug designation by the European Commission in platinum resistant recurrent ovarian cancer.