Jubilant Therapeutics Inc. Doses First Patient in Phase I/II Trial Evaluating JBI-802, dual inhibitor of LSD1 and HDAC6, in patients with advanced solid tumors

On April 26, 2022 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported the dosing of the first patient in a Phase I/II clinical trial of JBI-802 in patients with advanced solid tumors (Press release, Jubilant Therapeutics, APR 26, 2022, View Source [SID1234612999]). JBI-802 is a first-in-class, small-molecule, orally administered dual inhibitor of LSD1 and HDAC6 that has demonstrated synergistic anti-tumor activity in animal models.

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The Phase I/II trial is an open label, two-part dose escalation and expansion study designed to define the safety and tolerability, explore predictive biomarkers and assess preliminary activity of JBI-802 in more than 100 study participants with advanced solid tumors. More information on the clinical trial can be found at NCT05268666.

Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement, "We have come a long way from drug discovery to first-in-human dosing. We look forward to making a difference in patients’ lives. Our expertise in structure-based drug design and medicinal chemistry enables us to create differentiated precision therapeutics with truly innovative properties."

Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said, "JBI-802, effectively modulates two validated oncology targets with similar affinity and quick on/off exposure kinetics, leading to synergistic anti-tumour activity with a reduced risk of thrombocytopenia. This is our first internally developed product candidate to enter clinical development. Other advancing programs include an oral brain penetrant inhibitor of PRMT5, JBI 778, and an oral brain penetrant PDL1 inhibitor, JBI 2174, for neurological cancers among others."

About JBI-802

JBI-802 is novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior vs. either target alone and a favorable safety profile with no significant safety concerns or accumulation. It will be evaluated in both solid tumors, such as small cell lung cancer and neuroendocrine prostate cancer and hematological cancers such as acute myelogenous leukemia, myelodysplastic syndrome, and other myeloproliferative cancers.

TG Therapeutics to Participate in the B. Riley Securities’ 2022 Virtual Neuro & Ophthalmology Conference

On April 26, 2022 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in a fireside chat during the B. Riley Securities’ 2022 Virtual Neuro & Ophthalmology Conference, taking place on Thursday, April 28, 2022, at 12:30 PM ET (Press release, TG Therapeutics, APR 26, 2022, View Source [SID1234612949]).

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A live webcast of this fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source A replay of the webcast will be available on TG’s website following the event.

Rubius Therapeutics to Announce First Quarter 2022 Financial Results

On April 26, 2022 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is biologically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported plans to report first quarter financial results on Tuesday, May 10, 2022, before market open (Press release, Rubius Therapeutics, APR 26, 2022, View Source [SID1234612967]).

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The company will not be hosting a teleconference in conjunction with its financial results press release.

PAVmed to Hold a Business Update Conference Call on May 12, 2022

On April 26, 2022 PAVmed Inc. (Nasdaq: PAVM, PAVMZ), a highly differentiated, multi-product, commercial-stage medical device company reported that the Company will host a business update conference call on Thursday, May 12, 2022, at 4:30 PM EDT (Press release, PAVmed, APR 26, 2022, View Source [SID1234612984]). During the call, Lishan Aklog, M.D., Chairman and Chief Executive Officer, will provide a business update including an overview of the Company’s near-term milestones and growth strategy. In addition, Dennis McGrath, PAVmed’s Chief Financial Officer, will discuss the Company’s first quarter 2022 financial results.

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To access the conference call, U.S.-based listeners should dial 800-458-4121 and international listeners should dial 856-344-9290. All listeners should provide the operator with the conference call name "PAVmed, Inc. Business Update Conference Call" to join. Individuals interested in listening to the live conference call via the webcast may do so by visiting the investor relations section of the Company’s website at www.pavmed.com.

Following the conclusion of the conference call, a replay will be available for one week and can be accessed by dialing 844-512-2921 from within the U.S. or 412-317-6671 from outside the U.S. To access the replay, all listeners should provide the following pin number: 7771455. The webcast will be available for replay on the investor relations section of the Company’s website at www.pavmed.com.

GT Medical Technologies Announces the Presentation of Clinical Data on GammaTile® Therapy in the Treatment of Recurrent Glioblastomas at the 2022 American Association of Neurological Surgeons Scientific Meeting

On April 26, 2022 GT Medical Technologies, Inc. reported that new data on the company’s innovative GammaTile Therapy for patients with operable brain tumors will be presented via an oral, live presentation at the 2022 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Philadelphia, PA (Press release, GT Medical Technologies, APR 26, 2022, View Source [SID1234613000]). The abstract will provide the first report of clinical outcomes for recurrent glioblastoma patients treated with FDA-cleared GammaTile Therapy. Impressive clinical outcomes were reported, with a Median Local Control of 81% at 12 months and Median Overall Survival reaching 37 months in MGMT methylated patients. The safety profile was comparable to patients undergoing repeat surgery without GammaTile treatment.

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GammaTile Therapy is a bioresorbable 3D-collagen tile embedded with Cesium-131 sources that is implanted in the last five minutes of brain tumor removal surgery. The sustained, controlled, and therapeutic dose of radiation immediately begins targeting remaining tumor cells, sparing healthy tissue. "There is no established standard of care today for patients with recurrent glioblastoma. This abstract, along with other studies and clinical publications, supports that GammaTile Therapy should be considered for all patients with operable recurrent glioblastomas," says Matthew Likens, President and CEO of GT Medical Technologies. "Patients receiving GammaTile Therapy have the benefit of prolonged survival without sacrificing quality of life. Our company purpose is to improve the lives of patients with brain tumors, and Dr. Chen’s early clinical experience at University of Minnesota advances this purpose."

The abstract will provide a report of clinical outcomes for recurrent GBM patients treated with FDA-cleared GammaTile.

The abstract, titled GammaTile Brachytherapy in the Treatment of Recurrent Glioblastomas, earned lead author Clark C. Chen, MD, PhD, M Health Fairview neurosurgeon and the head of the University of Minnesota Medical School Department of Neurosurgery, the prestigious Brainlab Neurosurgery Award. This award is presented at both the annual meetings of AANS and the Congress of Neurological Surgeons (CNS) and is given to a neurosurgeon with a high-scoring abstract relating to central nervous system tumors.

"The treatment of recurrent glioblastoma remains a major challenge in our field, without consensus for a standard of care. Our published results suggest clinical benefit from GammaTile treatment and warrant consideration in this setting, especially given the highly favorable safety profile," said Dr. Chen. "Recapitulation of our results in a larger, multi-institution cohort has the potential to redefine the standard of care for recurrent glioblastoma patients."

The abstract will be presented on Monday, May 2nd at 4:16 PM in the Tumor Abstract Session in Philadelphia. This will be the first in-person AANS meeting since 2019. Read the abstract here.