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ReCode Therapeutics to Present at Guggenheim Healthcare Talks: Genomic Medicines and Rare Disease Days

On March 27, 2023 ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics, reported that David Lockhart, Ph.D., President and Chief Scientific Officer of ReCode Therapeutics, will participate in a fireside chat at 9:35 a.m. ET on Monday, April 3, 2023 at the virtual Guggenheim Healthcare Talks: Genomic Medicines and Rare Disease Days (Press release, ReCode Therapeutics, MAR 27, 2023, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-to-present-at-guggenheim-healthcare-talks-genomic-medicines-and-rare-disease-days [SID1234629389]).

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Precision BioSciences to Participate in Upcoming Guggenheim Healthcare Talks Conference

On March 27, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that the Company will participate in the Guggenheim Healthcare Talks – Genomic Medicines and Rare Disease Days taking place April 3-4, 2023 (Press release, Precision Biosciences, MAR 27, 2023, View Source [SID1234629388]).

Details for the company presentation are as follows:
Date: Monday, April 3, 2023
Time: 3:20 PM ET
Location: Lotte New York Palace Hotel

The presentation will be available via a recorded webcast accessible on Precision’s website in the Investors section under Events & Presentations: View Source An archived replay will be available for approximately 30 days following the event.

Oncternal Therapeutics Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4)

On March 27, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the approval of an inducement award to one new employee, Erik S. Nelson, who joined Oncternal as Head of IT (Press release, Oncternal Therapeutics, MAR 27, 2023, View Source [SID1234629387]).

The award will be made on April 3, 2023 under Oncternal’s 2021 Employment Inducement Incentive Award Plan, which provides for the granting of equity awards to new employees of Oncternal as an inducement to join the Company. The award will consist of an option to purchase 64,900 shares of Oncternal common stock. The option will have a 10-year term and an exercise price equal to the closing price of Oncternal’s common stock on the date of grant. The option will vest over a four-year period, with 25% of the shares subject to the option vesting on the first anniversary of the employee’s start date, and the rest vesting in equal monthly installments over three years thereafter. The award was approved by Oncternal’s compensation committee, comprised entirely of independent directors, as required by Nasdaq Rule 5635(c)(4), and will be granted as an inducement material to the employee entering into employment with Oncternal in accordance with Nasdaq Rule 5635(c)(4).

Monopar Announces Result of Interim Analysis of Phase 2b/3 VOICE Trial Evaluating Validive for Severe Oral Mucositis

On March 27, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported completion of a pre-specified interim analysis for its Validive Phase 2b/3 VOICE trial for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) (Press release, Monopar Therapeutics, MAR 27, 2023, View Source [SID1234629386]). This is an indication for which there is currently no FDA-approved preventative or treatment.

The interim analysis included the first approximately 50% of the total planned patients to be enrolled. It was conducted by an independent Data Safety Monitoring Board (DSMB), which informed the Company that the trial did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo. The DSMB also reported that there were no safety concerns attributed to Validive. Based on not meeting the pre-specified efficacy threshold, Monopar announced today that it will be discontinuing the study along with the active development of Validive.

"We are very grateful to the patients and investigators who participated in the VOICE trial. The Phase 2b/3 VOICE trial was intended to further evaluate a novel treatment for SOM following the promising signals observed in a prior randomized, double-blinded Phase 2 study with OPC patients. While we are disappointed with the outcome of this study, we are now focused on re-deploying the financial and human resources previously dedicated to Validive in order to advance our Phase 1b camsirubicin clinical trial and our MNPR-101 radiopharmaceutical program partnered with NorthStar Medical Radioisotopes," said Chandler Robinson, MD, Monopar’s Chief Executive Officer.

Monopar also noted today that it has sufficient funds to support its currently planned activities further beyond the first quarter of 2024.

New Preclinical R&D Programme Focused on Leptomeningeal Disease

On March 27, 2023 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and bio-distribution of medicines, reported a new research programme coded MTD217 focusing on developing new therapeutic options for metastatic cancers with high unmet needs (Press release, Midatech Pharma, MAR 27, 2023, View Source [SID1234629385]).

Background

Many cancers exhibit high levels of metabolic plasticity, i.e. the ability to switch between energy-generating pathways in response to cellular stresses1, such as those caused by chemotherapy. Highly proliferative cancers frequently use the aerobic glycolysis pathway, known as "the Warburg effect", to generate energy2. Oxidative Phosphorylation (OXPHOS) is another critical mechanism that enables a variety of fuel sources to be used to generate adenosine triphosphate (ATP), a molecule present in cells that provides energy for metabolic processes. When under induced stress, cancer cells switch away from aerobic glycolysis and significantly increase reliance on the alternative OXPHOS pathway. Inhibiting the OXPHOS pathway represents a potential means of targeting both primary and metastatic tumour lesions in patients. OXPHOS can be inhibited by a range of small molecule therapeutics, however systemic administration of these generally causes undesirable toxic effects in healthy cells3.

MTD217

Midatech’s MTD217 programme explores simultaneous inhibition of key metabolic pathways, including the Warburg effect and OXPHOS. The research is centred around a number of new water-soluble drug formulations that can be easily infused or injected simultaneously, or sequentially, directly into the cancer microenvironment, disrupting metabolic functions in a highly localised manner, thus limiting off-target toxicity. The Company has already been able to demonstrate up to a six-fold synergistic effect of administering its formulation of panobinostat, known as MTX110, with an OXPHOS inhibitor in vitro with three patient-derived cells lines. On the back of those data, Midatech has established new patent positions to protect these combination formulations.

The Company’s initial target is treatment of leptomeningeal disease, a lethal complication in which metastatic cancer cells invade the cerebrospinal fluid and central nervous system4. In collaboration with several large academic centres, Midatech is now accelerating preclinical studies to generate proof of concept data in this setting that can support a future clinical trial application.