On August 15, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the Safety Review Committee (SRC) has approved continuation of the Acclaim-1 Phase 1/2 clinical trial of REQORSA in combination with Tagrisso(osimertinib) to treat late-stage non-small cell lung cancer (NSCLC) following a review of the first cohort of patients in the Phase 1 portion of the trial (Press release, Genprex, AUG 15, 2022, View Source [SID1234618364]). In 2020, Genprex received U.S. Food and Drug Administration’s (FDA) Fast Track Designation for treatment of the Acclaim-1 patient population.

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Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with Tagrisso (osimertinib) in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso.

"The SRC approval to advance Acclaim-1 to the higher dose in the second cohort of patients is an important milestone that further supports REQORSA’s safety profile and brings us one step closer to bringing this potentially ground-breaking gene therapy approach to treating NSCLC to the patients who need it most," said Mark Berger, M.D., Chief Medical Officer of Genprex. "Enrollment in Acclaim-1 remains on track to complete the Phase 1 portion of the study by year end."

The Accaim-1 trial includes up to three sequential dose escalation cohorts that will be treated with REQORSA intravenously on Day 1 in addition to osimertinib 80 mg fixed dose oral daily tablet during 21-day treatment cycles until disease progression or unacceptable toxicity. The first group received REQORSA IV infusion at 0.06 mg/kg, the second group will receive 0.09 mg/kg, and the third will receive 0.12 mg/kg (if approved by the SRC) in order to identify the recommended Phase 2 dose.

"REQORSA is a pan-kinase inhibitor shown to inhibit both the EGFR and AKT oncogenic kinase pathways. We believe that REQORSA’s multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops," added Dr. Berger. "Confirmation of the safety in this first cohort of Acclaim-1 patients is particularly important as these relapsed patients represent a very sick and compromised population."

The SRC is comprised of three physicians who are principal investigators in the trial. The SRC may recommend that the trial continues at the same dose or at a lower dose, that it escalates to a higher dose, or it can recommend terminating the study altogether due to safety concerns.

About Acclaim-1

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA, in combination with Tagrisso in patients with late-stage NSCLC with activating epidermal growth factor receptor ("EGFR") mutations whose disease progressed after treatment with Tagrisso. Genprex expects the Phase 1 portion of the Acclaim-1 trial to enroll up to 18 patients in a dose escalation study to determine the maximum tolerated dose of the combination. The Phase 2 portion of the study is expected to enroll approximately 74 patients to be randomized 1:1 to receive either REQORSA and Tagrisso combination therapy or Tagrisso monotherapy. The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An interim analysis will be performed at 25 events.

About REQORSA

REQORSA Immunogene Therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC) uses Genprex’s unique, proprietary ONCOPREX Nanoparticle Delivery System, which is the first systemic gene therapy delivery platform used for cancer in human clinical trials. The active ingredient in REQORSA is the TUSC2 gene, a tumor suppressor gene. REQORSA consists of the TUSC2 gene encapsulated in a nanoparticle made from lipid molecules with a net positive electrical charge. REQORSA is injected intravenously and is preferentially taken up by cancer cells. Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed, and the TUSC2 protein is capable of restoring certain defective functions arising in the cancer cell. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells.

Tagrisso is a registered trademark of AstraZeneca plc and its largest selling drug with 2021 sales of over $5 billion.

On August 15, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on second quarter ended June 30, 2022, and provided an update on recent corporate developments (Press release, vTv Therapeutics, AUG 15, 2022, View Source [SID1234618363]).

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"I have been with vTv for only about two weeks but the strategic steps that have been taken toward initiating the TTP399 pivotal study and the energy displayed by the team to execute on that program have been truly impressive," said Paul Sekhri, newly appointed Chief Executive Officer of vTv. "I am looking forward to working with our management team and with our new partners, G42 Healthcare and CinRx Pharma, to accomplish our objective of improving the care and quality of life for T1D patients."

Recent Achievements

Leadership. On July 27, 2022, the Company appointed Paul Sekhri as President, Chief Executive Officer (CEO) effective August 1, 2022, and was confirmed as a member of the board of directors on August 9, 2022. Mr. Sekhri brings nearly 30 years of healthcare industry experience, including serving as President and CEO of several healthcare companies, experience in several senior business development and strategy roles and he has been a director on more than 30 private, public company and non-profit boards.
Partnership. On July 25, 2002, the Company entered into agreements with CinRx Pharma and its subsidiary, CinPax. CinPax agreed to acquire $10.0 million in vTv Class A common stock at approximately $2.41 per share with $6.0 million paid at closing and the remaining $4.0 million payable on November 22, 2022. vTv will issue a warrant to CinRx to acquire 1.2 million additional shares of Class A common stock at an exercise price of approximately $0.72 per share that will become exercisable upon agreed vesting triggers. In addition, the agreements set forth terms under which vTv will leverage the CinRx team’s industry experience to collaborate on the oversight of the clinical trials for pharmaceutical products that contain TTP399.
Publication. In June, results of a Phase 1 trial that assessed the effects of TTP399 on ketoacidosis risk in individuals with T1D on insulin pump therapy during acute insulin withdrawal was published in Diabetes Obesity and Metabolism (View Source) and presented at The American Diabetes Association’s 82nd Scientific Sessions on June 5, 2022. The results suggested that TTP399 does not increase, and may decrease, the risk of diabetic ketoacidosis (DKA) in subjects with T1D.
Partnership. On May 31, 2022, the Company entered into agreements with G42 Healthcare ("G42") and an affiliate. G42 agreed to acquire $25.0 million in vTv Class A common stock at approximately $2.41 per share with $12.5 million paid at closing and the remaining $12.5 million payable on May 31, 2023. The agreements also provide for the potential issuance of $30.0 million in additional shares of Class A common stock to G42 (or cash in lieu of such issuance at the option of G42) if the U.S. Food and Drug Administration (FDA) approves the marketing and sale of a pharmaceutical product containing TTP399. vTv and an affiliate of G42 plan to collaborate on clinical trials for pharmaceutical products that contain TTP399, including G42’s affiliate funding a portion of the Phase 3 clinical trials for TTP399, and vTv granting G42’s affiliate an exclusive license to develop and commercialize pharmaceutical products containing TTP399 in certain territories in the Middle East, Africa, and Central Asia.
Upcoming Milestones and Events

Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with T1D and has engaged with the FDA on the optimal clinical trial designs for these studies. The studies will recruit a total of approximately 1,000 patients and at least one of the studies will be one year of treatment. The FDA and the Company have agreed on the primary endpoint for the studies as the difference between placebo and TTP399-treated group in number of hypoglycemia events. These pivotal studies are expected to start in the fourth quarter of 2022.
Second Quarter 2022 Financial Results

Cash Position: The Company’s cash position as of June 30, 2022, was $17.9 million compared to $13.4 million as of December 31, 2021.
Research & Development (R&D) Expenses: R&D expenses were $2.2 million and $2.4 million in each of the three months ended June 30, 2022, and 2021, respectively. The decrease of $0.2 million is attributable to a decrease in clinical trial costs for azeliragon, which was mainly driven by discontinuance of its development as a potential treatment of Alzheimer’s disease in patients with type 2 diabetes and a decrease in spending related to a multiple ascending dose study for HPP737, due to its completion in 2021, offset by higher spending on TTP399 due to trial preparation costs.
General & Administrative (G&A) Expenses: G&A expenses were $1.8 million and $2.2 million for each of the three months ended June 30, 2022, and 2021, respectively. The decrease was due to lower payroll costs and lower share-based expense partially offset by higher legal expense and higher other G&A costs.
Other (Expense)/Income: Other expense for the three months ended June 30, 2022, was $0.1 million and was driven by an unrealized loss related to the investment in Reneo as well as the gains related to the change in the fair value of the outstanding warrants to purchase shares of our own stock issued to a related party ("Related Party Warrants"). Other income for the three months ended June 30, 2021, was $3.8 million and was related to the unrealized gain recognized related to the investment in Reneo as well as gains related to the change in the fair value of the outstanding warrants in our own stock held by a related party.
Net Loss: Net loss attributable to vTv shareholders for the three months ended June 30, 2022, was $3.2 million or $0.04 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $0.6 million or $0.01 per basic share.

On August 15, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL) ("Isofol"), reported that it will publish the company’s results for the second quarter of 2022 on Tuesday, August 23, 2022 (Press release, Isofol Medical, AUG 15, 2022, View Source [SID1234618362]). On the same day, Isofol invites investors, analysts, and media to an audiocast with a subsequent question and answer session.

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In conjunction with the publication of the interim report for the second quarter of 2022, Isofol invites investors, analysts, and media to an audiocast on August 23, 2022 at 12:30 p.m. CEST. The presentation will be held by Isofol´s CEO Ulf Jungnelius and CFO Gustaf Albèrt, who will present and comment the report, followed by a Q&A-session. The presentation will be held in English.

On August 15, 2022 EpiAxis Therapeutics and Peptilogics, a biotech company engineering peptide therapeutics by combining computation and biology to improve the treatment landscape for patients with life-threatening diseases, reported that they have entered a collaboration to leverage AI for drug discovery to inhibit epigenetic oncology targets, aiming to reprogram cancer cells and drive immune reinvigoration (Press release, EpiAxis Therapeutics, AUG 15, 2022, View Source;utm_medium=rss&utm_campaign=epiaxis-peptilogics-enter-strategic-drug-discovery-partnership [SID1234618361]).

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The collaboration will combine EpiAxis Therapeutics’ deep epigenetic expertise and Peptilogics’ AI platform (Nautilus) to advance drug discovery for cancers that escape existing therapies through epigenetic change, including metastatic breast cancer.

Dr Jeremy Chrisp, CEO of EpiAxis Therapeutics, commented on the significance of the collaboration: "We are very pleased to be partnering with Peptilogics to use their receptor pharmacology and AI computing expertise to accelerate innovation and hopefully expand our candidate pipeline.

"An AI-driven paradigm shift is happening in drug discovery and EpiAxis is excited to be working with Peptilogics at the forefront of applying AI to the highly valuable space around novel epigenetic targets."

Peptilogics’ Nautilus platform enables in silico predictive peptide design across diverse targets to efficiently access new functional chemical space and design therapeutics. Additionally, Peptilogics’ purpose-built supercomputer accelerates model development, prediction, and evaluation of peptide sequences to produce higher quality hits with greater chance of success.

"We are equally delighted to launch this collaboration with EpiAxis Therapeutics, a pioneer in the field of epigenetic cancer therapy," said Nicholas Nystrom PhD, Chief Technology Officer of Peptilogics.

"We will focus on lead optimization using Peptilogics’ Nautilus platform, which combines proprietary deep generative models, predictive models, and biophysical simulation to design multiparameter-optimized peptides with potential to address historically challenging and novel drug targets.

"With EpiAxis Therapeutics, we will explore further optimizing lead candidates for epigenetic cancer treatment, with the goal of reducing the risk, time, and cost for epigenetic drug design and development."

The strategic partnership follows the recent publication of the results of EpiAxis’ pioneering clinical trial EPI-PRIMED in leading cancer journal Frontiers in Oncology. The study was the first time an epigenetic inhibitor has been used in combination with chemotherapy to treat metastatic cancer. The results provided proof of concept for the company’s drug development program for its first-in-class therapies to inhibit nuclear LSD1.

On August 15, 2022 Exicure, Inc. (Nasdaq: XCUR), an early-stage biotechnology company focused on the development of next generation nucleic acid therapies targeting RNA to address both genetic and non-genetic neurological and hair loss disorders, reported financial results for the quarter ended June 30, 2022 and provided an update on its business strategy and corporate progress (Press release, Exicure, AUG 15, 2022, View Source [SID1234618360]).

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"Exicure continues to make progress with our preclinical SCN9A program for the treatment of pain with ongoing initial in vivo animal studies to support candidate selection in 2023," commented Matthias Schroff, Ph.D., Chief Executive Officer of Exicure. "We also continue to advance our partnered programs with Ipsen and AbbVie," concluded Dr. Schroff.

Corporate Progress

Corporate highlights for the second quarter of 2022 include:

We advanced the Company’s SCN9A preclinical discovery program. Exicure anticipates results from initial in vivo animal studies by year-end 2022, with the goal of therapeutic candidate selection in the second half of 2023.
We progressed work with partnered programs towards potential pre-clinical milestones in 2023.
We actively pursued out-license opportunities for the Company’s clinical asset, cavrotolimod.
We are continuing to pursue near-term partnering opportunities for pain and other neuroscience programs.
On June 28, 2022, we filed a Certificate of Amendment to our Amended and Restated Certificate of Incorporation (the "Amendment") with the Secretary of State of the State of Delaware to effect a one-for-thirty (1-for-30) reverse stock split of our outstanding common stock. The Amendment became effective at 5:00 p.m. Eastern Time on June 29, 2022.
At the effective time of the Amendment, every thirty (30) shares of our issued and outstanding common stock were automatically combined and converted into one issued and outstanding share of common stock, without any change in par value per share. No fractional shares of the Company’s common stock was issued to any stockholders in connection with the reverse stock split and holders of record received a cash payment in lieu of fractional shares.
Our common stock began trading on The Nasdaq Capital Market on a split-adjusted basis when the market opened on Thursday, June 30, 2022. The new CUSIP number for our common stock following the reverse stock split is 30205M 200.
On May 18, 2022, we closed the previously announced $5 million private placement transaction priced at market premium.
We sold an aggregate of 867,369 shares of the Company’s common stock to certain accredited investors in a private placement in public equity ("PIPE") financing at a purchase price of $5.81 per share, representing an approximately 45% premium to the 10-day volume weighted-average share price from May 9, 2022.
New investor CBI USA, Inc. led the transaction; existing investor, Abingworth LLP, also participated.
Net proceeds from the transaction are expected to support the Company’s advancement of its preclinical program, including the development of its SCN9A product candidate, as well as other working capital and general corporate purposes.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and short-term investments, and restricted cash were $23.4 million as of June 30, 2022, as compared to $48.3 million as of December 31, 2021. The Company expects that its existing cash and cash equivalents, and short-term investments will enable it to fund its current operations early into the first quarter of 2023.

Revenue: Revenue was $2.5 million for the quarter ended June 30, 2022, reflecting an increase of $2.4 million from revenue of $0.1 million for the quarter ended June 30, 2021. The increase in revenue of $2.4 million is mostly due to the recognition of non-cash revenue of $1.8 million associated with the Company’s collaboration with Ipsen Biopharm Limited, as well as an increase in revenue of $0.6 million associated with the Company’s collaboration with AbbVie Inc.

Research and Development (R&D) Expense: Research and development expenses were $6.7 million for the quarter ended June 30, 2022, as compared to $10.8 million for the quarter ended June 30, 2021. The decrease in R&D expense for the three months ended June 30, 2022 of approximately $4.1 million reflects a reduction in employee headcount and fewer discovery, preclinical, and clinical program activities resulting from the restructuring activities that the Company announced in December 2021.

General and Administrative (G&A) Expense: General and administrative expenses were $3.2 million for the quarter ended June 30, 2022, as compared to $3.1 million for the quarter ended June 30, 2021. The increase in G&A expense of approximately $0.1 million for the three months ended June 30, 2022 was mostly due to higher legal costs and retention award expense for current employees, partially offset by lower compensation and related costs in connection with a lower average headcount during the period resulting from the restructuring activities that were announced in December 2021, as well as lower costs for consulting, investor relations, and board fees.

Net Loss: The Company had a net loss of $7.5 million for the quarter ended June 30, 2022, as compared to a net loss of $14.3 million for the quarter ended June 30, 2021. The decrease in net loss was primarily driven by lower R&D expense and higher non-cash revenue during the period.

Going Concern: Given the Company’s current cash position, operating plans and forecasted negative cash flows from operating activities over the next twelve months, management believes there is substantial doubt regarding the Company’s ability to continue as a going concern within one year after the date that its unaudited condensed consolidated financial statements for the quarter ended June 30, 2022 are issued. The Company will require substantial additional financing to address the Company’s working capital and other financing needs to pursue its business strategy.