On February 7, 2023 Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP), a biotechnology company advancing a diverse pre-clinical pipeline spanning cell therapies, RNA vaccines, RNA and DNA therapeutics and small molecule drugs reported that it will be presenting at the Emerging Growth Conference on February 8, 2023 (View Source) (Press release, Regen BioPharma, FEB 7, 2023, View Source [SID1234626943]).

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This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s CEO, Dr. David Koos, in real time. Please ask your questions during the event and Dr. Koos and his team will do their best to address as many of them as possible.

"We plan to use this time to update our stakeholders on our corporate strategic plans, drug pipeline, drug development strategy and answer shareholder questions," says Dr. David Koos, CEO and Chairman of the Company. "We also plan to address Regen’s forthcoming 1for1500 reverse stock split affecting all series of stock. We feel that effecting this change is integral to furthering the Company’s objectives of seeking uplistings for our Common and series A Preferred Stock as well as making our stock more attractive to institutional investors." The reverse stock split will be effective March 6, 2023.

Regen BioPharma, Inc. will be presenting from 2:20 – 2:50 Eastern time on Wednesday, February 8, 2023. Please register here to ensure you are able to attend the conference and receive any updates that are released View Source;tp_key=60f8292c14&sti=rgbp.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com.

About the Emerging Growth Conference

The Emerging Growth conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner.

The Conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of individual and institutional investors, as well as investment advisors and analysts.

On February 7, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported a corporate update and reported financial results for the fiscal first quarter ended December 31, 2022 (Press release, ESSA, FEB 7, 2023, View Source [SID1234626942]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"Building on our momentum and encouraging clinical results observed in 2022, we continue to advance our studies of EPI-7386, ESSA’s first-in-class N-terminal domain androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer ("mCRPC")," stated David Parkinson, MD, President and CEO of ESSA. "In the first half of 2023, we expect to complete the Phase 1 EPI-7386 combination study with Xtandi (enzalutamide) in patients with mCRPC naïve to second generation anti-androgens and to initiate the Phase 2 randomized study in the same patient population shortly thereafter. In addition, our cash runway continues to be strong and is expected to fund our operations and clinical programs through 2025."

Clinical and Corporate Highlights for the First Quarter Ended December 31, 2022
EPI-7386 Combination Studies

The Company continues to enroll patients in the third cohort of the Phase 1/2 study of EPI-7386 in combination with enzalutamide in patients with mCRPC naïve to second generation antiandrogens. The Company expects to complete the Phase 1 portion of the study and establish the recommended Phase 2 combination doses (for both EPI-7386 and enzalutamide when used in combination) in the first half of 2023, followed by initiation of the Phase 2 study. The open-label, randomized Phase 2 study will assess the anti-tumor activity of EPI-7386 in combination with enzalutamide at the recommended phase 2 combination dose of EPI-7386 and enzalutamide versus single agent enzalutamide at the standard of care dose.
Initial results from the first two cohorts of the Phase 1/2 study of EPI-7386 in combination with enzalutamide were presented at the Prostate Cancer Foundation Scientific Retreat in October 2022. Further analysis of these data will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium ("ASCO GU"), taking place February 16-19, 2023, in San Francisco, CA and online.
The Company continues to anticipate that enrollment of additional combination regimens of EPI-7386 with other antiandrogens in different studies will begin in 2023 in different prostate cancer patient populations.
EPI-7386 Monotherapy

The Phase 1b dose expansion study is ongoing and evaluating two doses/schedules of single agent EPI-7386 in mCRPC patients with less than three prior lines of therapy, no visceral disease and no prior chemotherapy who have progressed on second-generation antiandrogens
The Company is continuing to seek to enroll patients in the Window of Opportunity study in non-metastatic CRPC patients. Patients will receive 12 weeks of EPI-7386 monotherapy treatment before starting standard of care therapy.
Summary Financial Results
Net Loss. ESSA recorded a comprehensive loss of $6.7 million for the first quarter ended December 31, 2022, compared to a comprehensive loss of $9.1 million for the first quarter ended December 31, 2021. For the first quarter ended December 31, 2022, this included non-cash share-based payments of $1.6 million compared to $2.5 million for the prior year, recognized for stock options granted and vesting. The decrease in the first quarter was primarily attributed to decreases in research and development expenditures and general and administration expenditures in addition to an increase of $1.1 million in interest income.

Research and Development ("R&D") expenditures. R&D expenditures for the first quarter ended December 31, 2022 were $5.3 million compared to $6.0 million for the first quarter ended December 31, 2021 and include non-cash costs related to share-based payments ($791,192 for the first quarter ended 2022 compared to $1.3 million for the first quarter ended 2021). The R&D expenditures for the year ended December 31, 2022 is the result of decreased non-cash share-based payments, legal patents and license fees and manufacturing costs related to the Phase 1 clinical trial of EPI-7386.

General and administration ("G&A") expenditures. G&A expenditures for the first quarter ended December 31, 2022 were $2.5 million compared to $3.1 million for the first quarter ended December 31, 2021 and include non-cash costs related to share-based payments of $772,419 for the first quarter ended 2022 compared to $1.2 million for the first quarter ended 2021. The decrease in the first quarter is the result of decreased non-cash share-based payments and professional fees.
Liquidity and Outstanding Share Capital

At December 31, 2022, the Company had available cash reserves and short-term investments of $163.1 million reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period. The Company’s cash position is expected to be sufficient to fund current and planned operations through 2025.

As of December 31, 2022, the Company had 44,092,374 common shares issued and outstanding.

In addition, as of December 31, 2022 there were 3,234,750 common shares issuable upon the exercise of warrants and broker warrants. This includes 2,920,000 prefunded warrants at an exercise price of $0.0001, and 314,750 warrants at a weighted average exercise price of $49.69. There were 7,922,061 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.13 per common share.

On February 7, 2023 Nectin Therapeutics Ltd. (Nectin), a biotechnology company developing novel targeted immunotherapies that address resistance to approved immune oncology treatments, reported that it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada) (Press release, Nectin Therapeutics, FEB 7, 2023, View Source [SID1234626941]). Under this collaboration, Nectin will evaluate the safety, tolerability, and antitumor activity of its novel anti-PVR antibody, NTX1088, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD1 therapy, in patients with locally advanced and metastatic solid tumors.

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NTX1088 is a First-in-Class, highly potent monoclonal antibody directed against PVR (CD155), a transmembrane protein expressed on cancer cells and associated with resistance to PD1 and PDL1 immune checkpoint inhibitors. PVR blockade by NTX1088 is the first and only therapeutic approach aiming at restoring the antitumor immune activity of DNAM1 (CD226). DNAM1 is a cell surface glycoprotein, central to the function of T and NK cells, that is suppressed by PVR on tumor cells. Restoring the expression and activation of DNAM1 by blocking PVR results in increased antitumor activity from T and NK cells. PVR blockade by NTX1088 further stimulates an antitumor immune response by preventing the suppressing signaling of several immune checkpoint receptors, including TIGIT and CD96.

PVR is overexpressed in many solid tumors across different cancer indications, including lung, colorectal, liver, ovarian, breast, adrenal, pancreatic, uterine, head and neck, gastric and esophageal cancers. High PVR expression is associated with poor prognosis and with resistance to PD1 and PDL1 blockade, making PVR an attractive therapeutic target for novel immuno-oncology therapies, both as a monotherapy and in combination with PD1 blockers.

Phase 1 trial with NTX1088 was initiated in November 2022. KEYNOTE-E92 NCT05378425 is an open label study consisting of a dose escalation stage, followed by an expansion stage in 90 patients. NTX1088 will be investigated as a single agent and in combination with KEYTRUDA. The primary objectives of the dose escalation stage are to assess safety and tolerability and to select a recommended safe and effective Phase 2 dose. In the expansion stage, NTX1088’s safety and tolerability will be further evaluated, along with efficacy measures and exploratory assessments of pharmacodynamic and predictive biomarkers. Dr. Sarina Phia-Paul, Associate Professor of Investigational Cancer Therapeutics at MD Anderson Cancer Center, is the trial Principal Investigator.

"We are very pleased to partner with Merck to explore the therapeutic potential of NTX1088 in combination with KEYTRUDA. This collaboration represents an important milestone for Nectin, and a promising new therapy for cancer patients," said Dr. Keren Paz, Chief Development Officer of Nectin Therapeutics. "Our preclinical studies have shown that PVR blockade by NTX1088, as a monotherapy, and in combination with PD1 inhibitors, can significantly enhance antitumor immunity. We look forward to advancing the clinical trials for NTX1088, as we pursue the development of new treatment options for patients who do not respond to existing therapies."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About NTX1088

NTX1088 is a first-in-class monoclonal antibody directed against a key immune checkpoint, PVR, also known as CD155 currently in Phase I clinical trial. NTX1088 blocks the interaction between PVR and DNAM1, also known as CD226, a transmembrane molecule, involved in the activation of anti-cancer T and NK cells. By preventing internalization and degradation of DNAM1, NTX1088 leads to restoration of DNAM1 expression on the surface of immune cells, resulting in a robust antitumor activity. NTX1088 also blocks PVR interactions with its other ligands, TIGIT and CD96, preventing their immune inhibitory signaling. NTX1088 demonstrates superior antitumor activity compared to approved and investigational immune checkpoint inhibitors in preclinical models and had a favorable safety profile in non-human primates.

On February 7, 2023 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported the official dosing of its final patient from the safety cohort for ACHIEVE, its phase 2B clinical trial of OmnImmune (TCB008) for treatment of Acute Myeloid Leukemia (AML) (Press release, TC Biopharm, FEB 7, 2023, View Source [SID1234626940]).

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TC BioPharm’s trial involved administering TCB008, the Company’s novel drug to treat AML, to pathologically confirmed diagnosed patients afflicted with this type of cancer. The initial 5 patients of the trial were spaced two weeks apart with safety review by an oversight board.

This safety cohort is in line with TCBP’s stepwise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient. Pending the final review of the Data Safety Monitoring Board (DSMB), the Company will move to open enrolment of the trial, and expect a positive formal review from the DSMB in February.

"Completing dosing of the safety cohort is yet another step in our efforts and firmly plant TCBP as the leader in the allogeneic gamma delta space in regards to clinical data points and clinical stage," said Bryan Kobel, CEO of TC BioPharm. "I am extremely impressed with the effort of our clinical and operational teams, working collectively throughout the early stages of the trial to coordinate and successfully complete dosing our Safety Cohort. While we experienced minor unforeseen delays, as can be expected with trials involving very sick patients, we secured good visibility into positive levels of recruitment from our sites as we move towards open enrolment."

Kobel continued, "The next several months continue to be highlighted by various catalysts, including moving to our interim review to gauge our dosing levels of these patients. At the 19 patient review we will have the opportunity to increase the dose size for treatment based upon our review of the efficacy and the economies of scale. Additionally, we will be opening new sites to expand the reach of the trial and to increase recruitment success. We look forward to moving quickly to the next stages of this trial and continuing our leadership position and creating shareholder value."

The global market for AML is expected to reach $2.6 billion by 2027, growing at CAGR 15.2% over the forecast period, driven by introduction of high-priced products and strong pipeline of upcoming drugs. The Phase 2B clinical trial is ongoing and is expected to enroll approximately 37 patients. TC BioPharm will report additional results as they become available.

On February 7, 2023 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that the first patient in Spain has been enrolled in the Company’s ongoing potentially pivotal global trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer (Press release, CNS Pharmaceuticals, FEB 7, 2023, View Source [SID1234626939]).

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The Company has opened 37 clinical trial sites of the 59 sites selected across the U.S., Italy, France, Spain, and Switzerland. A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have reached the primary endpoint. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

"We continue to rapidly build momentum with patient enrollment across our clinical trial sites in Europe. The pace at which we are enrolling patients is encouraging and driving us toward our planned interim analysis, which we expect mid-year 2023. We sincerely appreciate the institutions, clinicians and staff that are contributing to the conduct of this trial, and are extremely grateful to the patients that choose to participate. We are laser focused on executing on clinical development plans and look forward to providing updates," commented John Climaco, CEO of CNS Pharmaceuticals.

Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. This trial is an adaptive, multicenter, open-label, randomized controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy compared to the standard of care (SOC). The primary endpoint of the study is Overall Survival (OS), a rigorous endpoint that the FDA has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Results from the trial will compare Berubicin to current SOC (Lomustine), with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine. The recently amended protocol expands eligibility for the study to patients who have received additional treatments as part of the first line therapy for their disease considering advancements in this area. This change was made due to the complexity of new agents introduced as a component of first line therapy, which allows an additional group of patients that can enroll on the study after what may constitute multiple procedures as their initial treatment. For more information about this trial, visit clinicaltrials.gov and reference identifier NCT04762069.

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with them to provide guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.