On October 26, 2020 NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, reported healthcare industry veteran with proven operational skills Richard Adcock as its Chief Executive Officer, effective immediately (Press release, NantKwest, OCT 26, 2020, View Source [SID1234569049]). Adcock brings extensive leadership experience to NantKwest as the company advances rapidly in the development of natural killer cell-based immunotherapies for cancer and serious infectious diseases. Rich will assume the role of CEO from Dr. Patrick Soon-Shiong, who will become Executive Chairman of the Board. Dr. Soon-Shiong remains the largest shareholder in NantKwest.

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"I’m excited to have Rich, with his extensive experience and unwavering commitment to innovation and operations, at the helm of NantKwest at a crucial time for the company and for the entire healthcare industry," said Dr. Soon-Shiong. "Not only is Rich uniquely qualified to take on this role, but having worked with him for several years, I am confident that he is the right leader to advance NantKwest and its mission. As established leaders in the natural killer cell therapy space, we will leverage Rich’s unique combination of engineering and operational skills, as well as his understanding of the complex needs of health systems in cell therapy, to propel us forward. I intend to work closely with him and continue to maintain an active role in achieving NantKwest’s mission to harness the power of natural killer cells and the human immune system to transform the treatment of cancers and serious infectious diseases."

"I am thrilled to be joining Dr. Soon-Shiong and the NantKwest team on the quest to cure cancer and infectious diseases using natural killer cell therapy," said Richard Adcock. "I look forward to using my experience in healthcare research and delivery to help accelerate NantKwest’s growth."

Adcock was most recently CEO of Verity Health Systems, a California-based nonprofit healthcare system that he steered through a successful restructuring event. Prior to joining Verity Health, Adcock served as Executive Vice President and Chief Innovation Officer for Sanford Health, the largest rural nonprofit healthcare system in the U.S. with more than 382 locations and 28,000 employees. While at Sanford, he was responsible for leading the healthcare company’s growth and innovation, in addition to direct operational oversight of related entities including Sanford Research, Sanford Health Plan, Sanford Foundation and Sanford Frontiers. During his time at Sanford he learned firsthand how essential it is to keep the patient at the center of all healthcare decisions, this was even more important as Sanford Health brought forth many new exciting treatments, therapies and medical devices from their own research efforts. Earlier in his career, Adcock was director of engineering and a Six Sigma Master Black Belt for GE Medical Systems. He began his career in the medical field as co-owner and vice president of research and development at medical equipment supplier Micro Medical Systems.

As Executive Chairman, Soon-Shiong will continue to play a key, active role in NantKwest’s business and in the development of the company’s long-term business strategy.

On October 26, 2020 eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulation inhibitors (STRIs) for the treatment of cancer, reported that data presented over the weekend at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium (ENA 2020), showed that zotatifin, the company’s product candidate targeting eIF4A, downregulates key cancer-driving proteins including receptor tyrosine kinase (RTK) proteins (HER2, FGFR1, and FGFR2), as well as cell cycle protein Cyclin D1 (Press release, eFFECTOR Therapeutics, OCT 26, 2020, View Source [SID1234569048]). These data also show that the downregulation of these oncoproteins correlates with apoptosis (programmed cell death) and tumor regression in vivo. Further, vertical inhibition of the PI3K-AKT-mTOR-eIF4F pathway through combination of zotatifin with other agents acting in the pathway provided a synergistic effect in RTK-driven tumors. The data were presented in a poster titled "Dissection of cancer therapy combinations in RTK driven tumors using Zotatifin (eFT226), a potent and selective eIF4A inhibitor," in the New Drugs poster session, abstract 196. The poster can be found in the on the company’s website.

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"These studies not only confirm zotatifin’s specific activity of blocking expression of key oncoproteins and cell cycle targets leading to tumor regressions as a single agent, but also highlight the attractiveness of vertical inhibition within the very important PI3K-mTOR-eIF4F oncogenic pathway," said Steve Worland, Ph.D., president and chief executive officer of eFFECTOR. "These data informed our selection strategy for monotherapy and combination clinical expansion cohorts anticipated to start in early 2021."

A Phase 1/2 clinical trial of zotatifin in patients with KRAS- or RTK-mutant solid tumors is ongoing [NCT04092673]. The trial is enrolling patients with activating mutations, amplifications or fusions in HER2, ERBB3, FGFR1, or FGFR2 receptor tyrosine kinases, or any KRAS mutation subtype. The primary objectives of the trial include safety and tolerability of zotatifin as monotherapy. Secondary objectives include antitumor activity and survival, as well as pharmacokinetics of the drug. Exploratory objectives include pharmacodynamics of zotatifin.

About Zotatifin

Zotatifin is a potent and sequence-selective inhibitor of eukaryotic translation initiation factor 4A (eIF4A) mediated translation. Zotatifin is designed to inhibit the translation of mRNAs encoding several important oncogenes and survival factors, including several RTKS, KRAS, Cyclin D, CDK4/6, MYC, MCL1 and BCL-2 resulting in potent in vivo tumor regression in multiple tumor models dependent on these factors, including breast cancer, non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma and B cell lymphomas. Since zotatifin inhibits the translation of mRNA encoding KRAS and RTK, it is not limited to any mutation subtypes. The product candidate is currently being evaluated in a Phase 1/2 clinical trial in patients with solid tumors.

On October 26, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that preclinical data on SRF388, a first in class IL-27 blocking antibody in clinical trials for patients with cancer, will be presented at the International Cytokine and Interferon Society’s Cytokines (ICIS) 2020 Conference, to be held virtually on November 1–5, 2020 (Press release, Surface Oncology, OCT 26, 2020, View Source [SID1234569047]).

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"These data further support the growing body of preclinical evidence demonstrating that SRF388 binds to and blocks IL-27 to inhibit downstream signaling events that are important in regulating immune responses in certain tumor microenvironments," said Vito Palombella Ph.D., chief scientific officer. "We look forward to providing an update on our ongoing, open label, Phase 1 clinical trial of SRF388 in advanced solid tumors later this year."

Details of Surface’s ICIS presentation:

Session Title: Lightning Talk Session 1: Adaptive Immunity
Presentation Title: Crystal Structure of IL-27 in Complex with SRF388, a First-in-Class IL-27 Blocking Antibody Under Evaluation in a Phase 1 Clinical Trial in Patients with Advanced Solid Tumors (abstract number: LT027)
Lead Author: Jamie Strand, Ph.D.
Session Date and Time: Sunday, November 1, 2020, 2:30–4:30 p.m. PT

About SRF388:

SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including hepatocellular and renal cell carcinoma, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388.

On October 26, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer reported that the U.S. Food and Drug Administration ("FDA") has cleared the Company’s Investigational New Drug ("IND") application for 177Lu-omburtamab-DTPA for the treatment of B7-H3 positive Central Nervous System ("CNS") and Leptomeningeal Metastasis ("LM") from tumors in adult patients (Press release, Y-mAbs Therapeutics, OCT 26, 2020, View Source [SID1234569046]).

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177Lu-omburtamab-DTPA embodies the Company’s naked omburtamab antibody radiolabeled with lutetium-177, using DTPA to chelate the lutetium radioisotope to the antibody. Lutetium-177 is a beta-emitter with a half-life of 6.7 days and a maximum energy of 0.5 MeV, corresponding to a maximum soft-tissue penetration of approximately 1 mm from the binding site.

The Company anticipates that an international multicenter Phase 1/2 clinical trial will be opened for the screening of adult patients with CNS/LM from B7-H3 positive tumors during the fourth quarter of 2020.

"We are very pleased to move 177Lu-omburtamab-DTPA to the clinic. In this basket trial of B7-H3 positive CNS/LM cancers in adults, we hope to leverage our experience from treating more than 25 adults with 131I-omburtamab. 177Lu-omburtamab-DTPA is intended to address a clear unmet medical need for patients with B7-H3 positive brain metastasis, and we will open the study for the first adult patients during the fourth quarter of 2020. We are genuinely thrilled to widen our clinical reach for omburtamab to include adult indications," said Thomas Gad, founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer further notes, "Based on our clinical experience with 131I-omburtamab for B7-H3 positive brain metastasis, we are excited to see 177Lu-omburtamab-DTPA make its way to the clinic to establish the safety profile and to determine the maximum tolerated dose."

Researchers at Memorial Sloan Kettering ("MSK") developed the omburtamab antibody, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound and in Y-mAbs.

On October 26, 2020 Rain Therapeutics Inc., a privately-held, clinical stage biotechnology company focused on targeted therapies for patients with cancer, reported an update on data from the Phase 1 clinical trial of RAIN-32 (milademetan), an oral MDM2 inhibitor, during a late-breaker oral presentation at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Virtual Symposium on October 25, 2020 (Press release, Rain Therapeutics, OCT 26, 2020, View Source [SID1234569045]).

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The presentation highlighted the enhanced safety profile of RAIN-32, enabled by its unique drug-like properties, when administered on an intermittent dosing schedule as well as prolonged progression-free survival in patients with well-differentiated/de-differentiated (WD/DD) liposarcoma (LPS).

"We are pleased to highlight these positive data," said Avanish Vellanki, co-founder and chief executive officer of Rain. "These analyses of the Phase 1 study demonstrate the opportunity for RAIN-32 to provide safe and effective MDM2 inhibition. We look forward to further evaluating RAIN-32 both in liposarcoma, as well as in other solid tumor indications characterized by MDM2 gene amplification with this dosing regimen."

The Phase 1 dose escalation and expansion study evaluated RAIN-32 across four dose schedules in patients (n=107) with liposarcoma, solid tumors or lymphomas. Key findings from the oral presentation include:

An intermittent dose schedule of QD 3/14 x 2 of a 28-day cycle (Schedule D) allowed the highest MTD for RAIN-32 (260 mg) versus the more continuous dose schedules (Schedules A, B and C)
RAIN-32 dosed on Schedule D at 260 mg exhibited an improved safety profile versus the more continuous dosing schedules:
Incidence of all ≥ Gr 3 TEAEs in the 260 mg Schedule D cohort (n=20) fell to 20% versus 55% in the Schedules A, B, and C cohorts (n=78)
Incidence of ≥ Gr 3 thrombocytopenia, neutropenia and anemia, representing the predominant dose-limiting toxicities of MDM2 inhibition, fell to 15%, 5% and 0% in Schedule D from 35%, 18% and 10% in the other schedules, respectively
No Gr 4/5 toxicities were observed at 260 mg dose in Schedule D
The Schedule D regimen also conferred numerically improved progression-free survival as compared to the continuous dose schedules
In 17 patients evaluable for efficacy receiving Schedule D at doses ≤ 260 mg, median progression-free survival was 8.0 months
The 260 mg Schedule D regimen has been identified as the dose and schedule for further studies
Tumor shrinkage and objective responses were also observed in selected non-liposarcoma patients with MDM2 gene amplification, indicating potential for future agnostic clinical trials using biomarker selection
Rain intends to initiate subsequent clinical studies of RAIN-32 in liposarcoma and other tumors in the second half of 2021.

About RAIN-32
RAIN-32 has been evaluated in patients with various solid tumors, acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) and has received Orphan Drug Designation for the treatment of liposarcoma. RAIN-32 also has been evaluated in continuous and intermittent dose schedules that may offer a differentiated tolerability profile as compared to other MDM2 programs.

A separate clinical study for RAIN-32 is ongoing to evaluate safety and efficacy in patients with FLT3-ITD AML in combination with the FLT3 inhibitor, quizartinib. In addition, multiple investigator-sponsored studies are being conducted by MD Anderson Cancer Center (MDACC) as well as National Cancer Center Hospital (NCCH) in Tokyo, Japan.