On August 15, 2022 Pyxis Oncology, Inc. (Nasdaq: PYXS), a diversified oncology company focused on developing an arsenal of next-generation therapeutics to target difficult-to-treat cancers and improve quality of life for patients, reported financial results for the second quarter and six months ended June 30, 2022 and provided a corporate update (Press release, Pyxis Oncology, AUG 15, 2022, View Source [SID1234618366]).

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"Our strong balance sheet and cash runway will allow us to fund the Company through the second half of 2024, solidifying our position to potentially capitalize on multiple expected near-term catalysts and advance our programs to clinical development," said Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "We have elected to sharpen our near-term focus on the clinical execution of our two most advanced programs, anti-EDB Antibody Drug Conjugate (ADC), PYX-201, and anti-Siglec-15 monoclonal antibody (mAb), PYX-106. We also look forward to leveraging our team’s extensive industry network in identifying and facilitating opportunities where we can forge strategic partnerships to efficiently advance therapies that might change the treatment paradigm for patients with cancer."

Corporate Development Highlights

Focus on advancing lead programs toward the clinic with near-term catalysts: Pyxis Oncology is on track to file Investigational New Drug applications (INDs) for PYX-201 and PYX-106 in 2022. Pyxis Oncology remains confident in the clinical and commercial opportunity for both programs based on the in vivo preclinical data to date and looks forward to working with the FDA to advance both programs into clinical development. PYX-201 is a novel, non-internalized ADC directed against a first-in-class target (EDB), which is selectively expressed in a large population of non-small cell lung cancer (NSCLC), breast cancer, and other solid tumors. PYX-106 is a potentially best-in-class mAb targeting Siglec-15, which has demonstrated over six-fold binding affinity for human Siglec-15 vs. prior attempts against this target.

Pausing development of anti-CD123 ADC, PYX-203, and anti-KLRG1 IO program, PYX-102: The Company will pause the preclinical development of PYX-203 and PYX-102. Pyxis Oncology remains optimistic about the long-term clinical promise of both assets and will consider both strategic collaboration and licensing opportunities and potential future in-house development to maximize value for both programs.

Ceasing development of anti-DLK1 ADC, PYX-202: On March 29, 2022, Pyxis Oncology disclosed it was conducting additional GLP and non-GLP toxicology studies on PYX-202, the ADC in-licensed from LegoChem Biosciences, to determine the clinical viability of the candidate. Upon review and analysis of the data, the Company has elected to stop the continued development of PYX-202. Preclinical data suggests DLK1 has the potential to be a novel therapeutic target in the treatment of small-cell lung cancer and soft tissue sarcoma. As LegoChem continues to work on the development of ADCs targeting DLK1 using its proprietary next generation payloads, Pyxis Oncology looks forward to leveraging its collaboration with LegoChem to evaluate the potential of these new candidate ADCs.
Jay Feingold, M.D., Ph.D., Chief Medical Officer of Pyxis Oncology, commented, "We believe that our therapeutic candidates have distinct advantages and are ideally suited for targeting difficult-to-treat tumors. PYX-201 represents a potentially first-in-class ADC with a novel mechanism of action, and PYX-106 has a differentiated activity profile with the potential to help patients who don’t respond or have stopped responding to current PD-1 targeted therapies. We look forward to progressing these two most advanced programs towards the clinic and filing INDs in the second half of this year."

Addition to Board of Directors

Pyxis Oncology has appointed Rachel Humphrey, M.D., to its Board of Directors. Dr. Humphrey brings over 20 years of experience in oncology drug development and extensive experience in product development from pre-IND to commercialization of small molecules, cytotoxics and biologics in oncology and immuno-oncology. She currently serves as President and Chief Executive Officer of Normunity, an innovative immuno-oncology company. She was previously Chief Medical Officer at Black Diamond Therapeutics, a precision oncology medicine company, and was a member of the Board of Directors at Xilio Therapeutics. Prior to that, she served as Chief Medical Officer and a member of the Board of Directors of CytomX Therapeutics, a clinical stage oncology company, where she was responsible for the clinical development of Probody Therapeutics for the treatment of cancer. She oversaw the early and late-stage clinical development of two new oncology molecular entities, ipilimumab (Yervoy) while serving as Vice President, Clinical Development at Bristol-Myers Squibb, and sorafenib (Nexavar) at Bayer.

Dr. Sullivan commented, "We are excited to welcome Rachel to our Board of Directors. Her experience and successful track record in oncology drug development spanning across large pharmaceutical and small biotechnology companies will add incredible value to our already deep bench of industry leaders as we near the clinic with two promising oncology therapeutic candidates."

Financial Update for Quarter Ended June 30, 2022

Pyxis Oncology had cash and cash equivalents of $223 million as of June 30, 2022, and approximately $207 million (preliminary, unaudited) as of August 15, 2022, which is expected to fund operations through the second half of 2024.
Research and development expenses were $17.2 million for the three months ended June 30, 2022, compared to $3.2 million for the three months ended June 30, 2021. The increase was primarily due to increased expenses associated with contract manufacturing of drug products and drug substance, preclinical cost related to toxicity studies and an increase in employee headcount to support research and development activities.
General and administrative expenses were $8.6 million for the three months ended June 30, 2022, compared to $2.7 million for the three months ended June 30, 2021. The increase was primarily due to higher personnel-related expenses (including stock-based compensation), increases in legal and professional fees, rent, and directors and officers insurance expense to support our growth and operations.
Net loss was $25.6 million, or $(0.79) per common share, for the three months ended June 30, 2022, compared to $8.1 million, or $(5.54) per common share, for the three months ended June 30, 2021. Net loss for the three months ended June 30, 2022 and 2021 included $4.0 million and $0.6 million, respectively, related to non-cash stock-based compensation expense.
As of August 15, 2022, the outstanding number of shares of Common Stock of Pyxis Oncology was 32,834,561.

On August 15, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company reported financial results for the second quarter ended June 30, 2022 (Press release, Alaunos Therapeutics, AUG 15, 2022, View Source [SID1234618365]).

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"The team has made tremendous progress building a strong operational, manufacturing, and clinical foundation over the past year. Our TCR-T Library Phase 1/2 trial is actively enrolling, and I am pleased to announce that we are moving ahead at the second dose level," commented Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "The recent hiring of Abhi Srivastava as our VP of Technical Operations strengthens our manufacturing capabilities as we work to increase our manufacturing capacity to support future clinical expansion. In addition to our internal efforts, we were privileged to extend our collaboration with Dr. Rosenberg and the National Cancer Institute to develop personalized cancer therapies using our novel TCR-T cell platform. We believe that Alaunos is poised for long term success. We look forward to presenting early data from our Phase 1/2 trial in the third quarter and remain committed to improving the lives of cancer patients with solid tumors."

Recent Developments and Upcoming Milestones

TCR-T Library Phase 1/2 Trial: The Company continues to advance its TCR-T Library Phase 1/2 trial targeting KRAS, TP53, and EGFR mutations across six solid tumor indications. In May 2022, the Company announced dosing of the first patient in the trial. The patient has non-small cell lung cancer and was treated with TCR-T cells targeting a KRAS G12D mutation. Following a safety review by the safety review committee at the MD Anderson Cancer Center, the Company is now moving ahead at the second dose level. The main study objectives are to define the maximum tolerated dose, recommended Phase 2 dose and safety profile. The Company expects to present early data in the third quarter of 2022. Additional information about the trial is available at www.clinicaltrials.gov using the identifier: NCT05194735.

Extended Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for Development of Personalized TCR-T Cell Therapies: In June 2022, the Company announced that it had extended its CRADA with the NCI, regarding the Company’s Sleeping Beauty technology, through January 2025. Under the CRADA, the NCI will work to generate proof of concept data utilizing the Company’s proprietary non-viral Sleeping Beauty technology for personalized TCR-T cell therapies. In this approach, T-cell receptors (TCRs) that react to the patient’s tumor are identified from the patient and used in an effort to generate a fully autologous, personalized TCR-T cell therapy. Research conducted under the CRADA will be led by Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI’s Center for Cancer Research.

cGMP Manufacturing Facility: The Company’s state-of-the-art good manufacturing practice (cGMP) TCR manufacturing facility is fully operational for the manufacture and release of clinical product. The Company is executing on a multi-pronged strategy to expand its manufacturing capabilities. Alaunos is implementing new standard operating procedures that allow for simultaneous production of multiple products, including further optimizing the manufacturing process by introducing cryopreserved cell products. In addition, the Company is hiring additional staff to support increased manufacturing and is evaluating additional strategies including physically expanding its cGMP footprint.

Corporate Updates: In August 2022, Abhishek Srivastava, Ph.D. was appointed Vice President, Technical Operations. Dr. Srivastava joined Alaunos from Athenex, where he was Vice President, Cell Therapy Development.

Second Quarter Ended June 30, 2022 Financial Results

Research and Development Expenses: Research and development expenses were $5.9 million for the second quarter of 2022, compared to $13.6 million for the second quarter of 2021, a decrease of approximately 56%. The decrease was primarily due to lower program-related costs of $2.0 million as a result of the winding down of the Company’s IL-12 and CAR-T programs, a $5.2 million decrease in employee related expenses due to reduced headcount following the restructuring in the third quarter of 2021, and a $0.3 million decrease in consulting expenses.

General and Administrative Expenses: General and administrative expenses were $3.4 million for the second quarter of 2022, compared to $9.1 million for the second quarter of 2021, a decrease of approximately 62%. The decrease was primarily due to lower employee related expenses of $5.4 million due to reduced headcount following the restructuring in the third quarter of 2021 and a $0.2 million decrease in consulting and professional services expenses.

Net Loss: Net loss was $9.9 million, or $(0.05) per share, for the second quarter of 2022, compared to a net loss of $22.7 million, or $(0.11) per share, for the same period in 2021.

Cash and Cash Equivalents: As of June 30, 2022, Alaunos had approximately $60.0 million in cash and cash equivalents. The Company anticipates its cash runway will be sufficient to fund operations into the second quarter of 2023. Operating cash burn for the second quarter of 2022 was $8.2 million compared to $21.5 million in the second quarter of 2021, a decrease of $13.3 million or 62%.

Conference Call and Webcast

Alaunos will host a conference call and webcast today, August 15, 2022, at 8:30am ET. Participants may access the live webcast using the link here or by visiting the "Investors" section of the Alaunos website at www.alaunos.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. After the live webcast, the event will be archived on the Company’s website for approximately 30 days after the call.

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.