On November 19, 2020 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 new clinical results from its Phase 1 study evaluating rivoceranib (apatinib) in combination with nivolumab in patients with locally advanced unresectable or metastatic solid tumors will be presented in an oral session at the virtual 2020 Connective Tissue Oncology Society "CTOS" annual meeting being held November 18-20, 2020 (Press release, LSK BioPharma, NOV 19, 2020, View Source [SID1234571415]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are encouraged by these initial Phase 1 results, which demonstrate a compelling safety profile and provide early evidence that rivoceranib may enhance the efficacy of commonly used FDA-approved systemic therapies, including checkpoint inhibitors such as nivolumab," said Steven Norton, Ph.D., chief drug development officer of Elevar Therapeutics. "With encouraging preliminary activity, including prolonged disease control, objective tumor responses, and progression-free survival rates, the results of this study reinforce the potential clinical rationale for combining rivoceranib with nivolumab for a range of difficult-to-treat solid tumors. We look forward to the continued development of this promising combination treatment regimen."

A total of 30 patients were recruited for the two-part study, which contained a dose escalation phase (Part I) followed by a dose expansion phase (Part II). In Part I, ten patients received escalating doses of rivoceranib starting at 400 mg in combination with nivolumab at 240 mg iv q2w. Meanwhile, two additional cohorts received rivoceranib at 300 and 200 mg (concomitant with nivolumab) respectively. In Part II, 20 patients initially received 300 mg rivoceranib in combination with nivolumab therapy at 240 mg q2w. Some received a reduced dose of nivolumab (200 mg) in later treatments. Main eligibility criteria included patients with primary diagnosis of histologic- or cytologic-confirmed solid tumor cancers.

The overall response rate (ORR) was 13.3% (95% CI: 3.8 % to 30.7%), and the disease control rate (complete response, partial response, stable disease) was 76.7% (95% CI: 57.7 % to 90.1 %). The median progression-free survival (PFS) was 7.2 months (95% CI: 5.3 to 9.0 months). Partial response was observed in four patients (13.3%).

Grade 3 and greater treatment-emergent adverse events occurred in 23 (76.7%) patients (7 patients from Part I and 16 patients from Part II). Two patients (6.7%) experienced fatal AEs. The rate of discontinuation was 30.0% and the rate of dose reduction was also 30% due to AEs. There were no unexpected side effects, no additive side effects of the combined treatment (nivolumab and rivoceranib), and no drug related death noted.

Abstract 3465673: Updated Phase I Study to Evaluate the Safety and Efficacy of Rivoceranib (Apatinib) and Nivolumab in Patients with Unresectable or Metastatic Cancer
Date and time: November 19, 2020 from 11:30 AM to 12:30 PM
Session 3: Leiomyosarcoma and Undifferentiated Pleomorphic Sarcoma
About Rivoceranib (apatinib)

Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer (China, Dec 2014). It has been granted Orphan Drug designation in the U.S., Europe and South Korea and has been clinically tested in over 1,000 patients worldwide. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib potently and selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. As a best-in-class therapeutic known for its safety and tolerability, Elevar believes rivoceranib has the potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. Elevar Therapeutics is developing rivoceranib for the treatment of patients with gastric cancer, colorectal cancer, hepatocellular carcinoma, and adenoid cystic carcinoma.

On November 19, 2020 Novartis announced today that new research data from a broad range of hematology medicines and investigational therapies will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, taking place virtually December 5-8 (Press release, Novartis, NOV 19, 2020, View Source [SID1234571414]). More than 65 abstracts from Novartis-sponsored and investigator-initiated trials that include results for asciminib (ABL001), Kymriah (tisagenlecleucel), Jakavi (ruxolitinib)*, sabatolimab (MBG453) and Adakveo (crizanlizumab) underscore the Novartis vision to deliver transformative innovation to address unmet medical needs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our research and development strategy focuses on developing transformative treatments with the aspiration of dramatically improving quality of life and addressing the underlying disease process," said Susanne Schaffert, PhD, President, Novartis Oncology. "The ASH (Free ASH Whitepaper) presentations demonstrate how we are pursuing these goals in hematology with research that focuses on developing advanced therapeutic approaches across an array of blood cancers and difficult-to-treat hematologic diseases."

Key highlights of data accepted by ASH (Free ASH Whitepaper):

Novel, investigational STAMP inhibitor asciminib (ABL001) evaluated for safety and efficacy for TKI-resistant and intolerant CML patients:

Efficacy and Safety Results From ASCEMBL, a Multicenter, Open-label, Phase 3 Study of Asciminib vs Bosutinib (BOS) in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Previously Treated with ≥2 Tyrosine Kinase Inhibitors (TKIs) [Abstract #LBA-4; oral presentation; Tuesday, December 8, 8:15 AM PST]
Asciminib, a First-in-Class STAMP Inhibitor, Provides Durable Molecular Response in Patients (Pts) With Chronic Myeloid Leukemia (CML) Harboring the T315I Mutation: Primary Efficacy and Safety Results From a Phase 1 Trial [Abstract #650; oral presentation: Monday, December 7, 12:15 PM PST]
Structural and Biochemical Studies Confirming the Mechanism of Action of Asciminib, an Agent Specifically Targeting the ABL Myristoyl Pocket (STAMP) [Abstract #3961; online publication]
New data for the first anti-TIM-3 antibody in hematology, sabatolimab (MBG453):

Efficacy and Safety of Sabatolimab (MBG453) in Combination With Hypomethylating Agents (HMAs) in Patients With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (HR-MDS): Updated Results From a Phase 1b Study [Abstract #657; oral presentation: Monday, December 7, 12:30 PM PST]
Sabatolimab (MBG453) Dose Selection and Dose-Response Analysis in Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML): Population Pharmacokinetics (PK) Modeling and Evaluation of Clinical Efficacy/Safety by Dose [Abstract #2192; poster presentation: Sunday, December 6, 7:00 AM PST]
Kymriah (tisagenlecleucel) results from the first analysis of the Phase II ELARA trial in r/r follicular lymphoma and a clinical update of 40-month median follow-up from the pivotal JULIET trial in r/r diffuse large B-cell lymphoma (DLBCL):

Efficacy and Safety of Tisagenlecleucel in Adult Patients With Relapsed/Refractory Follicular Lymphoma: Interim Analysis of the Phase 2 ELARA Trial [Abstract #1149; poster presentation: Saturday, December 5, 7:00 AM PST]
Myc Expression and Tumor-Infiltrating T Cells Are Associated With Response in Patients (Pts) With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) Treated With Tisagenlecleucel in the JULIET Trial [Abstract #1194; poster presentation: Saturday, December 5, 7:00 AM PST]
Adakveo (crizanlizumab) results from the SOLACE trial and a post-hoc analysis of the SUSTAIN trial for vaso-occlusive pain crises in sickle cell disease, and extended results from the Sickle Cell World Assessment Survey (SWAY):

Pharmacokinetics/Pharmacodynamics, Safety and Efficacy of Crizanlizumab in Patients With Sickle Cell Disease and a History of Vaso-Occlusive Crises: Results From the Phase II, Multicenter, Open-Label SOLACE-Adults Study [Abstract #1715; poster presentation: Sunday, December 6, 7:00 AM PST]
The Effect of Crizanlizumab on the Number of Days Requiring Opioid Use for Management of Pain Associated With Vaso-Occlusive Crises in Patients With Sickle Cell Disease: Results From the SUSTAIN Trial [Abstract #796; poster presentation: Saturday, December 5, 7:00 AM PST]
Global Treatment Satisfaction Levels and Treatment Patterns From the International Sickle Cell World Assessment Survey (SWAY): Hydroxyurea (HU) Versus No HU [Abstract #17; oral presentation: Saturday, December 5, 8:30 AM PST]
Primary findings from the REACH3 trial for steroid-refractory chronic graft-vs-host disease (GvHD) and additional findings from REACH2 for steroid-refractory acute GvHD treated with Jakavi (ruxolitinib)*:

Ruxolitinib vs Best Available Therapy in Patients With Steroid-Refractory/Steroid-Dependent Chronic Graft-vs-Host Disease: Primary Findings From the Phase 3, Randomized REACH3 Study [Abstract #77; oral presentation: Saturday, December 5, 8:00 AM PST]
Biomarker Analysis in Patients With Steroid-Refractory Acute Graft vs Host Disease Treated With Ruxolitinib or Best Available Therapy in the Randomized, Phase 3 REACH2 Study [Abstract #1519; poster presentation: Saturday, December 5, 7:00 AM PST]
Safety Analysis of Ruxolitinib (RUX) vs Best Available Therapy in Patients With Steroid-Refractory Acute Graft-vs-Host Disease in the Randomized Phase 3 REACH2 Study [Abstract #2440; poster presentation: Sunday, December 6, 7:00 AM PST]
Early pipeline results for ianalumab (VAY736) in chronic lymphocytic leukemia:

Phase Ib Study of Ianalumab (VAY736) and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy [Abstract #1309; poster presentation: Saturday, December 5, 7:00 AM PST]
Product Information
Approved indications for products vary by country and not all indications are available in every country. Safety and efficacy profiles have not been established for investigational compounds or are outside the approved indications for marketed products. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available or receive additional indications if already marketed.

On November 19, 2020 Varian (NYSE: VAR) and the Cincinnati Children’s/UC Health Proton Therapy Center reported the start of the first clinical trial of FLASH therapy as part of the recently opened FAST-01 study (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases) (Press release, Varian Medical Systems, NOV 19, 2020, View Source [SID1234571413]). The clinical trial involves the investigational use of Varian’s ProBeam particle accelerator modified to enable radiation therapy delivery at ultra-high dose rates (dose delivered in less than 1 second) and is being conducted at the Cincinnati Children’s/UC Health Proton Therapy Center with John C. Breneman M.D., Medical Director of the center, serving as principal investigator.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The first clinical trial patient was treated this week. The FAST-01 study is expected to enroll up to 10 patients with bone metastases to evaluate clinical workflow feasibility, treatment-related side effects, and efficacy of treatment as assessed by measuring pain relief of trial participants. The clinical trial, informed by years of preclinical work, was designed by experts at Varian and multiple centers in the FlashForwardTM Consortium, including Cincinnati’s Children’s/UC Health Proton Therapy Center and the New York Proton Center.

Varian FLASH Cincinnati

Varian FLASH Cincinnati
"Treating the first patient in this FLASH clinical trial is a milestone that many thought was still years ahead of us," said Kolleen Kennedy, Chief Growth Officer and President of Proton Therapy Solutions at Varian. "There was overwhelming support from Dr. Breneman and his team for this clinical trial, which was designed in collaboration with the FlashForward Consortium and with significant contributions from the New York Proton Center. These efforts help Varian safely advance potential therapy options towards our vision of a world without fear of cancer."

Breneman noted that, because this is the first in human trial of FLASH radiotherapy, it will build a foundation for extending this therapy to other types of cancer treatments.

"Trials using FLASH radiotherapy for lung cancer and other malignancies are currently being developed," said Breneman, a UC Health radiation oncologist and a professor emeritus at the University of Cincinnati College of Medicine. "Using FLASH treatment for these cancers could deliver higher cancer-killing doses without causing inordinate side effects, which would be a real advance."

"FLASH therapy has the potential to be practice changing and dramatically improve the experience of cancer care for a new generation of patients. The launch of the first FLASH clinical trial, a project that has come to fruition after years of intensive study, is an important milestone in the progress of radiation therapy," said FlashForward Consortium member Dr. Charles B. Simone, II, FACRO, Chief Medical Officer at New York Proton Center. "We are optimistic that the results of the FAST clinical development program will transform the way the industry approaches treatment. The New York Proton Center is proud to be a partner in this future-focused study."

John Perentesis, MD, Director of the Division of Oncology & Cancer Programs at Cincinnati Children’s, said FLASH is potentially a transformational advance for cancer treatment for many patients."If the side effects of radiation on the normal tissues surrounding a tumor can be significantly reduced, the dose of radiation to treat a cancer can be greatly increased," Perentesis said. "This would raise hope to cure malignancies that respond to radiation but aren’t completely cured at current doses, including pediatric brain tumors like DIPG/pontine glioma and medulloblastoma, sarcomas, and neuroblastoma."

On November 19, 2020 OBI Pharma, Inc. (TPEx: 4174), a leader in Glycosphingolipid Immuno-Oncology therapeutics targeting the Globo Series antigens (Globo H and SSEA-4), reported that data from the OBI-833 Phase 1 clinical study targeting the Globo H antigen in lung cancer will be presented at the European Society of Clinical Oncology Asia (ESMO Asia) 2020 Virtual Scientific Program from November 20-22, 2020 (Press release, OBI Pharma, NOV 19, 2020, View Source [SID1234571406]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833.

"Based upon our anti-Globo H targeted approaches in cancers of high unmet needs, OBI Pharma is proud to have presentations on the progress of our trial presented at ESMO (Free ESMO Whitepaper)-Asia 2020 for our novel therapeutic cancer vaccine, OBI-833." Ming-Tain Lai, PhD, Chief Scientific Officer at OBI Pharma stated, "In the trial, OBI-833 demonstrated a favorable safety profile and generated detectable anti-Globo H IgM/IgG responses. In addition, OBI-833 can elicit a beneficial immune response in NSCLC patients and had rendered some TKI-treated patients a durable stable disease status. We look forward to providing updates of our study, which we believe could offer potential therapeutic benefits to patients suffering from lung cancer."

1. Presentation number: 397P / Poster: ID 680

Title: A phase I cohort expansion trial of OBI-833 in non-small cell lung cancer patients

Presenter: Ching-Liang Ho MD, et.al. Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan.

Session Title: E-poster Display session – Thoracic tumours, metastatic

Session Date and Time: Friday, November 20, 2020. 9:00 – 20:00 Eastern Time

View Source

2. Presentation number: 71MO / Oral: ID 798

Title: OBI-833 was safe and immunogenic, without treatment-related SAEs, in a Phase 1 dose-escalation trial

Presenter: Her-Shyong Shiah, MD*., et.al. Department of Hematology and Oncology, Taipei Medical University Hospital, Taipei, Taiwan

*current affiliation: Department of Hematology and Oncology, Taipei Tzu Chi Hospital, Taipei, Taiwan

Session Title: Mini-oral session – Developmental and Precision Medicine

Session Date and Time: Friday, November 20, 2020. 19:52 – 19:57 Eastern Time

View Source

The above poster presentations will be available online at www.obipharma.com on November 23, 2020

On November 19, 2020 Achilles Therapeutics ("Achilles"), a clinical-stage biopharmaceutical company developing personalised T cell therapies targeting clonal neoantigens, a novel class of tumour target, reported it has raised £52.7 million in an oversubscribed Series C financing (Press release, Achilles Therapeutics, NOV 19, 2020, View Source [SID1234571405]). OrbiMed, Boxer Capital of Tavistock Group, and other prominent US-based, healthcare-focused institutional investors join existing investors including RA Capital, Syncona, Forbion, Invus, Perceptive Advisors and Redmile Group.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Proceeds from this financing will be used to accelerate the Company’s R&D activities and further build the clinical network to support the Company’s ongoing Phase I/IIa trials, the THETIS trial in patients with recurrent or metastatic malignant melanoma and the CHIRON trial in patients with advanced non-small cell lung cancer. Both clinical trials use the Company’s innovative personalised T cell therapy approach targeting clonal neoantigens and are currently enrolling patients with interim data expected from both studies in the first half of 2021. In addition, the financing will enable the continued build out of Achilles’ manufacturing capabilities and broaden its growing pipeline of solid tumour pre-clinical product candidates.

"Achilles has made tremendous progress since its founding in 2016, and with this financing round we are further strengthening our outstanding syndicate with more leading US healthcare investors. I am delighted with this strong support for our innovative platform, team, and ambitious development strategy," said Dr. Iraj Ali, CEO of Achilles Therapeutics. "As we progress our two lead programmes in non-small cell lung cancer and melanoma through clinical trials, we believe that our personalised T cell therapy approach has the potential to transform how certain cancers are treated, bringing much needed novel cancer therapies to patients."