On November 11, 2021 Notable Labs, Inc. (Notable), a pioneer and developer of predictive precision medicines, reported that it has obtained worldwide rights to volasertib from Oncoheroes Biosciences Inc., a Boston-based biotechnology company focused on advancing new therapies for childhood cancer (Press release, Notable Labs, NOV 11, 2021, View Source [SID1234595246]). Volasertib is a Polo-like kinase 1 (PLK-1) inhibitor with demonstrated activity in acute myeloid leukemia (AML) and other tumor types with significant unmet medical need.

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Notable will leverage its high-fidelity Predictive Precision Medicines Platform to identify and select volasertib-responsive patients prior to their treatment and fast-track volasertib’s clinical development in this patient population.

Notable’s proprietary platform was built upon deep expertise across therapeutics, diagnostics, software, engineering, machine learning and automation. It quickly determines the response profile of individual patients prior to their cancer treatment, allowing for selective enrollment of predicted clinical responders into clinical trials.

"Volasertib represents an exciting milestone towards fulfilling Notable’s mission to deliver life-changing therapies precisely to those who will benefit, and leads the way in a new era of predictive precision medicine," said Thomas Bock, M.D., Chief Executive Officer of Notable. "We targeted and licensed volasertib because of its compelling performance on our Predictive Precision Medicine Platform and as an important addition to our growing clinical pipeline. We plan to fast-track volasertib’s development with phase 2/3 clinical trials in AML and other cancers, selectively enrolling patients who are predicted to respond."

Dr. Bock added, "With the power of our high-fidelity prediction platform, volasertib represents just one of many compelling opportunities to match highly promising clinical candidates with the optimal patient population. We established our platform across a broad spectrum of drug classes and cancers, and are continuing to expand its capabilities across hematology and oncology. We are actively seeking in-licensing and partnership opportunities for those clinical-stage therapies that pass our platform’s rigorous demands. We are thrilled to be at the forefront in the field of predictive precision medicines and advance with the sense of urgency that patients with life-threatening conditions deserve."

License Agreement
Under terms of the agreement, Notable will have exclusive rights to develop and commercialize volasertib in leukemias, lymphomas and other adult cancer indications. Oncoheroes will retain the license for development and commercialization of volasertib in pediatric indications. Financial terms of this deal are not disclosed.

About Volasertib
Volasertib is an inhibitor of Polo-like-kinase 1 (PLK-1), an enzyme known to be involved in disease progression in a number of cancers. The compound was originally discovered and developed by Boehringer Ingelheim for the treatment of acute myeloid leukemia. Oncoheroes in-licensed volasertib from Boehringer Ingelheim and is developing volasertib for the treatment of rhabdomyosarcoma (RMS), the most common soft tissue sarcoma in children and young adults. Volasertib was previously granted Orphan Drug Designation (ODD) for its use in treating pediatric rhabdomyosarcoma and other rare soft tissue sarcomas and received Rare Pediatric Disease Designation in 2020, by the U.S. Food and Drug Administration (FDA).

On November 11, 2021 Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the U.S. Food and Drug Administration (FDA) has granted rivoceranib with orphan drug designation for the treatment of hepatocellular carcinoma (HCC) (Press release, Elevar Therapeutics, NOV 11, 2021, View Source [SID1234595245]). HCC is the most common primary liver malignancy and is a leading cause of cancer-related death worldwide.

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"The orphan drug designation granted by the FDA recognizes the potential of rivoceranib to address the urgent unmet need for new therapies that can improve patient outcomes for people with HCC," said Kate McKinley, Chief Executive Officer of Elevar Therapeutics. "The medical community is eager to see the results of clinical trials exploring new combination regimens in HCC and we look forward to rapidly advancing our clinical trial of rivoceranib and camrelizumab, an investigational PD-L1 inhibitor. This Phase 3 trial is being conducted in collaboration with Jiangsu Hengrui Medicine Company, Ltd., in patients with advanced HCC who have not received prior systemic therapy. In addition to our HCC program, we are committed to accelerating the clinical development for rivoceranib as a potential therapy for the treatment of gastric cancer, adenoid cystic carcinoma, and colorectal cancer."

HCC is a highly lethal form of liver cancer with limited treatment options, which is primarily caused by chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), nonalcoholic steatohepatitis (NASH), and excessive alcohol consumption.

"Unfortunately, HCC is often diagnosed at later stages of disease and there are limited treatment options currently available," said Maureen G. Conlan, M.D., F.A.C.P., Chief Medical Officer of Elevar Therapeutics. "We are encouraged by the progress that we are making in our Phase 3 clinical trial and believe that the combination of rivoceranib and camrelizumab, if approved, will offer an important new therapeutic option for clinicians and patients."

The FDA’s Office of Orphan Drug Products grants orphan status to medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user filing fees and potential eligibility for seven years of marketing exclusivity post-approval.

About Rivoceranib (apatinib)
Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer, under the name apatinib, in China (December 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Apatinib has been studied in over 1,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy.

Clinical studies are underway in multiple tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (combination with camrelizumab), adenoid cystic carcinoma, and colorectal cancer (combination with Lonsurf). Orphan Drug designations have been granted in gastric cancer (U.S., EU, and South Korea), adenoid cystic carcinoma (U.S.) and hepatocellular carcinoma (U.S.). Elevar Therapeutics holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Apatinib is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Medicine Co., Ltd under the brand name Aitan.

On November 11, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that two abstracts relating to GMI-1359, the Company’s dual antagonist of CXCR4 and E-selectin, have been accepted for poster presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held December 11-14, 2021 (Press release, GlycoMimetics, NOV 11, 2021, View Source [SID1234595244]).

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"The data to be presented at ASH (Free ASH Whitepaper) provide further support for targeting both CXCR4 and E-selectin as a novel treatment strategy for patients with AML, particularly patients with FLT-3 ITD mutations. Both posters detail preclinical studies conducted at the MD Anderson Cancer Center at the University of Texas in Houston, under the direction of Dr. Michael Andreeff. The first poster (#1171) describes the unexpected activities of FLT-3 inhibitors such as quizartinib and sorafenib to upregulate the expression of E-selectin ligands (sialyl Lex) and CXCR4 thereby increasing adhesion to protective niches in the bone marrow microenvironment and inducing chemoresistance. The addition of GMI-1359 to quizartinib in a PDX mouse model from a relapsed patient broke this induced chemoresistance, leading to a dramatic reduction in leukemic burden and a near-doubling of survival time. The second (#3348) demonstrates that GMI-1359 reduced adhesion and stimulated mobility of leukemic stem cells within the bone marrow microenvironment. In AML mouse models, GMI-1359 increased the efficacy and extended survival time in engrafted mice treated with venetoclax/HMA while protecting the hematopoietic stem cells and the bone marrow components from this treatment," said John Magnani, GlycoMimetics’ Chief Scientific Officer.

Details on GlycoMimetics posters at the ASH (Free ASH Whitepaper) Meeting are as follows:

1. Poster# 1171

Title: FLT3 Inhibitors Upregulate CXCR4 and E-selectin Ligands and CD44 Via ERK Suppression in AML Cells, and Blockade of CXCR4 and E-selectin Signaling with GMI-1359 Overcomes AML Resistance to Quizartinib In Vitro and In Vivo.
Authors: Y. Jia, M. Basyal, L. Ostermann, W.E. Fogler, J.L. Magnani, T. Seki, W. Zhang, M. Andreeff
Session Name: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster I
Date/Time: Saturday, December 11, 5:30-7:30 p.m. ET, Georgia World Congress Center, Hall B5

2. Poster# 3348

Title: Co-targeting E-selectin/CXCR4 with GMI-1359 Facilitates AML Stem Cell Mobilization and Protects BM Niches from Anti-leukemia Therapy.
Authors: K.-H. Chang, T. Zal, M. Basyal, L. Ostermann, M. Muftuoglu, P. Y. Mak, Y. Jia, W. Tao, A. Zal, W.E. Fogler, J.L. Magnani, W. Zhang, B.Z. Carter, M. Andreeff
Session Name: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III
Date /Time: Monday, December 13, 6:00-8:00 p.m. ET, Georgia World Congress Center, Hall B5

The accepted abstracts are available online through the ASH (Free ASH Whitepaper) meeting website.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4 — both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States.

On November 11, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that its Chief Executive Officer, Robert E. Hoffman, will present a corporate overview at the Q4 Investor Summit Conference, which is being held virtually on November 16 – 17, 2021 (Press release, Kintara Therapeutics, NOV 11, 2021, View Source [SID1234595243]).

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Mr. Hoffman will deliver his corporate presentation on November 17, 2021 at 1:15 p.m.ET.

Mr. Hoffman will be available for one-on-one meetings throughout the conference.

Register HERE to watch the presentation.

On November 11, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated therapeutics, reported that Sean McCarthy, D.Phil., president, chief executive officer, and chairman, will participate in virtual fireside chats at the following investor conferences in November (Press release, CytomX Therapeutics, NOV 11, 2021, View Source [SID1234595242]).

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12th Annual Jefferies Global Healthcare Conference
Date: Thursday, November 18, 2021

33rd Annual Piper Sandler Virtual Healthcare Conference
Date: Tuesday, November 30, 2021

The Jefferies fireside chat will be made available at 3:00 a.m. ET (8:00 a.m. GMT) on Thursday, November 18, 2021 on the Events and Presentations page of CytomX’s website at www.cytomx.com. The Piper Sandler fireside chat will be made available at 10:00 a.m. ET on Monday, November 22, 2021. Archived replays of both fireside chats will be available on the CytomX website for 30 days following the event. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.