On September 20, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported its VERSATILE-002 Phase 2 study for the treatment of advanced human papillomavirus (HPV16)-associated head and neck cancer achieved its preliminary safety benchmark in its first 12 patients (Press release, PDS Biotechnology, SEP 20, 2021, View Source [SID1234588076]). Enrollment in the trial, which studies PDS0101 administered in combination with KEYTRUDA (pembrolizumab), will now continue to full enrollment of the first stage of the study, which will assess efficacy in 17 checkpoint inhibitor (CPI) naïve patients and in an additional group of 21 patients who have also failed prior therapy with checkpoint inhibitors (CPI refractory). The trial is being conducted in collaboration with Merck & Co.

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VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including CPI therapy (CPI refractory). As specified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more) among at least four of the first 17 patients in the CPI naïve arm and at least 2 patients in the first 21 patients of the CPI refractory arm will trigger advancement to the second stage of the study and full enrollment of the planned 95 patients.

"The achievement of this important milestone in the VERSATILE-002 Phase 2 clinical trial strengthens the evidence regarding the safety of PDS0101. Treatment-related adverse events (TRAEs) generally appear to be limited to transient, manageable local injection site reactions," commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "There is an enormous unmet medical need for more effective treatment of advanced head and neck cancer. We believe the combination of PDS0101 and KEYTRUDA has the potential to significantly improve clinical outcomes for these patients who have limited treatment options. We look forward to continuing to share data from this trial as they become available."

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email [email protected] or visit the website at View Source to learn more.

The advancement of the VERSATILE-002 trial follows the previously disclosed presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting of interim data in a separate Phase 2 trial (NCT04287868) being led by the National Cancer Institute (NCI). That trial is evaluating the combination of PDS0101 with two investigational immunotherapies in patients with advanced HPV-related cancers. That trial has enrolled patients with anal, cervical, head and neck, vaginal and vulvar cancer, who have failed prior treatment. Objective responses measured according to RECIST 1.1 (tumor reduction of 30% or more) were reported in 83% (5/6) of HPV16-positive patients who had failed chemotherapy and radiation but were CPI naive. In CPI refractory patients, tumor reduction was reported in 58% (7/12) and objective responses in 42% (5/12). Two patients, one in each group were reported to have a complete response (no evidence of disease) at the time of reporting. Clinical responses were observed in all HPV16-positive tumor types enrolled. More information on this study can be found on PDS Biotech’s website.

On September 20, 2021, Lixte Biotechnology Holdings, Inc. ("we," "our" or the "Company") reported that it entered into an at-the-market sales agreement (the "Sales Agreement") with WestPark Capital, Inc. (the "Agent") pursuant to which we may offer and sell from time to time through the Agent, acting as agent, shares of our common stock, $0.0001 par value per share, having an aggregate offering price of up to $10,000,000, subject to the terms and conditions of the Agreement (Filing, 8-K, Lixte Biotechnology, SEP 20, 2021, View Source [SID1234588075]). The issuance and sale, if any, of shares of common stock through the Agent under the Sales Agreement will be will be made pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-252430) (the "Registration Statement") filed with the Securities and Exchange Commission, or "SEC," on January 26, 2021, and declared effective on February 5, 2021, and are described in detail in the related base prospectus, dated February 5, 2021 and prospectus supplement, dated September 20, 2021, included as part of our Registration Statement.

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Under the sales agreement, the Agent may sell shares of our common stock by any method permitted by law deemed to be an "at-the-market" offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, but not limited to, sales made directly on the Nasdaq Capital Market, on any other existing trading market for our common stock or to or through a market maker other than on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, and/or any other method permitted by law. The Agent has agreed in the sales agreement to use its commercially reasonable efforts consistent with its respective normal trading and sales practices to sell shares in accordance with our instructions (including any price, time or size limit or other customary parameters or conditions we may impose). Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. The Company is not obligated to make any sales of common stock under the Sales Agreement and the Company cannot provide any assurances that it will issue any shares pursuant to the Sales Agreement.

We have agreed to pay the Agent a commission rate of 2.5% of the gross sales price per share of any of our shares of common stock sold through the Agent under the sales agreement, and have provided the Agent with customary indemnification and contribution rights. In addition, we have agreed to reimburse certain legal expenses and filing fees incurred by the Agent in connection with the offering pursuant to the Sales Agreement, including fees and expenses of the Agent’s legal counsel not to exceed $50,000, plus certain ongoing disbursements of its legal counsel up to $1,250 per calendar quarter.

The offering of shares of our common stock pursuant to the Sales Agreement will terminate upon the earliest of (i) the sale of the maximum dollar amount of shares of common stock subject to the Sales Agreement, (ii) the termination of the Sales Agreement by us or the Agent, and (iii) the expiration of the shelf registration statement on Form S-3 (File No. 333-252430) on the third anniversary of the initial effective date of such registration statement.

A copy of the Sales Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K (this "Report") and is incorporated herein by reference. The description of the Agreement is qualified in its entirety by reference to Exhibit 10.1 to this Report.

This Report, including the exhibits filed herewith, is not an offer to sell or the solicitation of an offer to buy the shares or any other securities of the Company, nor shall there by any offer, solicitation or sale of the shares or any other securities of the Company in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.

A copy of the opinion of TroyGould PC relating to the legality of the shares is filed as Exhibit 5.1 to this Report and is filed with reference to, and is hereby incorporated by reference into, the Registration Statement.

On September 20, 2021 The Board of Directors of Nordic Nanovector ASA ("Nordic Nanovector" or the "Company") reported that it has on 20 September 2021 decided to grant 350,000 Performance Share Units ("PSUs") to the Company’s new CEO and primary insider Mr. Erik Skullerud in accordance with the authorisation granted at the Annual General Meeting held on 28 April 2021 (the "AGM") (Press release, Nordic Nanovector, SEP 20, 2021, View Source;allocation-of-psus-301380251.html [SID1234588073]).

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The terms and conditions of the PSUs, which are part of the Company’s long-term incentive plan for employees, are described on pages 25-27 in the Company’s annual report for 2020.

The PSUs are granted without consideration. The PSUs are non-transferable and will vest three years after the date of grant subject to satisfaction of the applicable vesting conditions. Each vested PSU will give the holder the right to acquire one share in the Company at an exercise price corresponding to the par value of the shares being NOK 0.20.

In accordance with the resolution at the AGM, the PSUs are secured by a corresponding number of free-standing warrants. The sole purpose of the warrants is to ensure delivery of shares in the Company upon exercise of the PSUs. The warrants do not give the PSU holders (or the option holders) a right to subscribe for any additional shares in the Company.

Mr. Skullerud will hold 350,000 PSUs and 0 shares after the transaction.

The allocation of PSUs is in accordance with the Board of Director’s declaration on salaries and other remuneration to the senior executive management, as approved by the Company’s AGM.

Primary insider notification pursuant to the Market Abuse Regulation article 19 are attached.

On September 20, 2021 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company developing a next-generation mental health and oncology treatment clinical discovery platform for the mind and body using psychedelics and cannabinoids, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences, will participate in two upcoming investor conferences (Press release, Enveric Biosciences, SEP 20, 2021, View Source [SID1234588070]):

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Maxim’s Advances in Mental Health Virtual Conference
Wednesday, September 22nd at 10:00 a.m. ET
Panel titled: Next Gen Psychedelics: Novel Chemical Entities
To attend, register here

Benzinga’s Healthcare Small Cap Virtual Conference
Thursday, September 30th at 3:40 p.m. ET
To attend, register here

For more information about the conferences, or to schedule a one-on-one meeting with Enveric’s management, please contact your appropriate representative directly, or send an email to Maxim at [email protected], Benzinga at [email protected], or KCSA Strategic Communications at [email protected].

On September 20, 2021 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE platform, reported Dr. Jeffrey Miller’s mini-oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, GT Biopharma, SEP 20, 2021, View Source [SID1234588066]). Jeffrey Miller, MD is a Professor of Medicine, University of Minnesota Medical School, Division of Hematology, Oncology and Transplantation and GT Biopharma’s consulting Chief Scientific Officer.

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The presentation at ESM0 highlighted the activity of camelid TriKEs in preclinical B7H3 positive and HER2+ solid tumor cancer models. GT Biopharma plans to advance these TriKEs into the clinic in 2022. The abstract is currently available on the ESMO (Free ESMO Whitepaper) website at www.esmo.org.

In addition to the ESMO (Free ESMO Whitepaper) presentation, GT Biopharma provided an update on its ongoing Phase 1 safety and feasibility clinical trial with GTB-3550. A total of 12 relapsed/refractory acute myelogenous leukemia (AML) and high grade myelodysplastic syndromes (MDS) patients have now been administered one cycle of GTB-3550, the company’s first-generation TriKE which targets CD33 on the surface of the leukemic cells in patients with AML and MDS.

The three most recent patients (numbers 10-12) have all tolerated the treatment well. One patient at the 150 mcg/kg/day dose experienced a mild Grade 1 cytokine release syndrome (CRS) event (fever), which was not dose limiting. Immune monitoring on these three most recent patients was consistent with the data previously reported on the first nine patients, and demonstrated activation, proliferation, and persistence of CD16 positive NK cells. Patient 11 had a bi-phenotypic leukemia which co-expressed both CD19 (a lymphoid marker) and CD33 (the myeloid marker which is targeted by GTB-3550); this patient showed a 50% reduction in CD33-positive leukemic cells (blasts), evidence of anti-leukemic activity of GTB-3550. Patients 10 and 12 did not experience blast cell reduction. The Company has previously reported that three of the first nine patients experienced a reduction in blast cells.

Gregory Berk, MD, President of R&D and Chief Medical Officer of GT Biopharma commented "We are very pleased with what we have learned from the Phase 1 GTB-3550 clinical trial. The TriKE is safe and well tolerated. The TriKE results in NK cell activation, proliferation, and persistence. There are also early signs of anti-leukemic activity. We are excited to advance GT Biopharma’s next generation camelid program for this difficult-to-treat patient population."

About Camelid Antibodies

Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce 2 main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of 2 heavy chains and 2 light chains. They also produce another type of antibody that is made up of only 2 heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.