On January 27, 2022 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported the first patient has been dosed in a combination cohort of its anti-CD137 agonist, ADG106, with its anti-CTLA-4 monoclonal antibody (mAb), ADG116, in patients with advanced/metastatic solid tumors (Press release, Adagene, JAN 27, 2022, View Source [SID1234607446]). The dose escalation cohort will evaluate the safety and tolerability of this novel, proprietary combination in patients with advanced/metastatic solid tumors.

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"Existing cancer therapies that target CD137 and CTLA-4 are associated with safety concerns, creating a significant unmet need and high threshold for agents that are both safe and potent. With ADG106 and ADG116, we now have two promising agents to test the therapeutic potential of these two potent pathways together to safely inhibit tumor growth," said Anthony W. Tolcher, M.D., FRCPC, FACP, co-founder of NEXT Oncology and study investigator. "While the oncology community has long known of the compelling preclinical rationale for this intriguing combination, safety has been a barrier to further exploration. Given the encouraging individual safety profiles of both ADG 106 and ADG116 in patients so far, we finally have the rare and exciting opportunity to be the first to move this combination into clinic and improve patient care."

The combination is part of an open-label, global phase 1b/2 clinical trial (ADG116-1003) at multiple sites in the U.S. and Asia Pacific (APAC). The combination part begins with dose-escalation, followed by dose expansion once a recommended dose is established.

"Published research in preclinical models underscores the potential synergistic effect of combining these two potent pathways. We are proud to pioneer exploration of this novel combination, which also demonstrates the translational power of our NEObody platform — targeting unique epitopes with novel mechanisms of action by species cross reactive antibodies that can move directly from preclinical syngeneic mouse models to clinical studies," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "This innovative clinical research will establish the safety and potential complementary effects of ADG106 and ADG116 against two challenging but orthogonal pathways for T-cell priming by anti-CTLA-4 and proliferation by anti-CD137, respectively, building on the promising preclinical and clinical data on safety and preliminary efficacy from our global trials. This pursuit aligns with our goal to transform the development paradigm of antibody-based immunotherapies for global cancer care."

As single agents, both ADG106 and ADG116 have demonstrated robust safety profiles and early signals of efficacy. In monotherapy trials in 98 patients, ADG106 was well tolerated at doses of 3 mg/kg and 5 mg/kg and at 300mg and 400mg flat doses, with limited liver toxicity or hematologic abnormalities observed. Results showed evidence of efficacy and a potential biomarker associated with tumor shrinkage was identified.

In monotherapy evaluation, ADG116 demonstrated a strong safety profile at doses up to 10 mg/kg, and showed early signals of efficacy, including in treatment-resistant "cold" and "warm" tumors such as ovarian and pancreatic cancers. ADG116 has achieved the recommended dosing range as a single agent and for evaluation in combination therapy.

About ADG116

ADG116 is a fully human ligand-blocking anti-CTLA-4 mAb generated using Adagene’s proprietary NEObody technology and being developed for the treatment of advanced/metastatic solid tumors. ADG116 is designed to enhance efficacy by potent Treg depletion in the tumor microenvironment (TME) and to maintain its physiological function by soft ligand blocking thereby addressing safety concerns associated with existing CTLA-4 therapeutics.

About ADG106

ADG106, is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb generated using Adagene’s proprietary NEObody technology and being developed for the treatment of advanced solid tumors and non-Hodgkin’s lymphoma. CD137 stimulates the immune system to attack cancer cells and is a key driver for long-lasting T-cell proliferation and survival. Clinical trials of ADG106 as monotherapy have been conducted in the U.S. and China, and combination trials are underway with multiple anti-PD-1 therapies.

On January 27, 2022 OS Therapies, a research and clinical-stage biopharmaceutical company reported that the Data Safety & Monitoring Committee (DSMC) approved open enrollment for AOST-2121: an open label Phase IIb Trial of OST-HER2 (Listeria monocytogenes) in Recurred, Resected Osteosarcoma (OS) (Press release, OS Therapies, JAN 27, 2022, View Source [SID1234607463]). OS is a deadly and debilitating cancer of the bone that usually occurs in adolescence and young adults (AYA).

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OS Therapies’ OST-HER2 is a Lm vector-based off-the-shelf Immunotherapy intended to prevent metastasis, delay recurrence, and increase overall survival. The FDA had requested a safety roll-out staggering the first three patients by three weeks – safety data from these patients has given the safety committee the ability to open the trial nationally to the remaining patients.

"The Osteosarcoma Community has been anxiously awaiting the clinical trial of this very promising technology ever since it was provisionally approved for dogs by the USDA – we just want to try it on our kids," said Miriam Cohen, Chair of the Osteosarcoma Collaborative (www.oscollaborative.org), an OS patient advocacy organization that has supported the trial.

Eleven of the twenty clinical trial sites currently open include:
Seattle Children’s Hospital
Connecticut Children’s Hospital
UPMC Children’s Hospital of Pittsburgh
Kaiser Permanente Downey Medical Center
St. Jude’s Children’s Research Hospital
Johns Hopkins Baltimore
UT Southwestern Children’s Medical Center
Hackensack University Medical Center
Children’s Hospital of Orange County
Rady Children’s Hospital
Children’s Hospital of Philadelphia (CHoP)

About Osteosarcoma
Osteosarcoma is a solid tumor of the bone that predominantly occurs in adolescent and young adults (AYA). Standard treatment includes surgery and chemotherapy. For patients with initially metastatic or recurrence after chemotherapy, there is a significantly poorer prognosis.

On January 27, 2022 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-centric biotechnology company developing next-generation mental health and oncology treatments by leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences, will participate in two upcoming investor conferences (Press release, Enveric Biosciences, JAN 27, 2022, View Source [SID1234607447]):

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Citi’s Psychedelic Drug Call Series
Tuesday, February 8th at 10:00 a.m. ET
A fireside chat hosted by Neena Bitritto-Garg, Citi’s Biotech analyst.

Aegis Capital Corp. Virtual Conference
Friday, February 25th at 3:00 p.m. ET
To access the event, please download and import the following iCalendar (.ics) files to your calendar system: Aegis Virtual Conference Calendar.

For more information about the events, or to schedule a one-on-one meeting with Enveric’s management team, please contact your appropriate Citi or Aegis representative, respectively, or send an email to KCSA Strategic Communications at [email protected].

On January 27, 2022 Dizal Pharmaceutical Co., Ltd. (SHEX:688192) ("Dizal"), reported that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation to DZD9008 (Sunvozertinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy (Press release, Dizal Pharma, JAN 27, 2022, View Source [SID1234607464]).

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"Lung cancer patients with exon20 insertion mutations need better treatment. Sunvozertinib was specifically designed with high selectivity for inhibiting mutated EGFR, which causes cancers. Available clinical evidence shows that Sunvozertinib has the potential to provide the patients with a new and much improved targeted therapy," said Dr. Xiaolin Zhang, Chief Executive Officer at Dizal. "We are very pleased with FDA’s decision. Now Sunvozertinib has received Breakthrough Therapy Designation from both US FDA and China CDE, which validates Sunvozertinib’s differentiated profile. At Dizal, we are committed to discover and develop innovative medicines for the benefit of cancer patients globally."

Breakthrough Therapy designation is a process designed by US FDA, China CDE, and other regulatory agencies to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)[1].

About DZD9008 (Sunvozertinib)

DZD9008 is a rationally designed selective, irreversible, novel EGFR inhibitor. In global Phase 1/2 studies, it has demonstrated promising antitumor efficacy in pre-treated NSCLC patients with EGFR exon20 insertion mutations. Its confirmed ORR is 45.5% at 200 mg and 41.9% at 300 mg (data cut-off by July 30, 2021). It also shows efficacy among patients with brain metastasis or previously treated by Amivantamab. It was well tolerated with a manageable AE profile.

Dizal is conducting Phase 2 pivotal clinical trials in China, U.S., EU, Japan, Australia, South Korea and other countries and regions.

On January 26, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that David E. Anderson, Ph.D, VBI’s Chief Scientific Officer, will present an overview of VBI-1901, the Company’s cancer immunotherapeutic for the treatment of glioblastoma (GBM), at B. Riley’s Oncology Investor Conference (Press release, VBI Vaccines, JAN 26, 2022, View Source [SID1234607395]). During his presentation, Dr. Anderson will highlight data from the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent GBM patients.

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Presentation Details

Event: B. Riley Securities 2022 Oncology Investor Conference
Date: Friday, January 28, 2022
Time: 1:30-2:00 PM ET
Webcast: View Source
A live webcast of the presentation will also be available on the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the Company’s website following the presentation.

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.