On August 4, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported the grant of 72,000 restricted stock units of Atara’s common stock to two newly hired employees (Press release, Atara Biotherapeutics, AUG 4, 2023, View Source [SID1234633816]). These awards were approved by the Compensation Committee of Atara’s Board of Directors and granted under the Atara Biotherapeutics, Inc. 2018 Inducement Plan, with a grant date of August 1, 2023, as an inducement material to the new employees entering into employment with Atara, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The restricted stock units vest over four years, with 25 percent vesting on the first quarterly vesting date after the first anniversary of the vesting commencement date and the remainder vesting in 12 approximately equal quarterly installments over the following three years, subject to the employee being continuously employed by Atara as of such vesting dates.

Atara is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

On August 4, 2023 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, reported its financial results for the quarter ended June 30, 2023, and recent business highlights (Press release, Achilles Therapeutics, AUG 4, 2023, View Source [SID1234633813]).

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"We look forward to additional clinical data in the fourth quarter of this year from our clonal neoantigen-reactive T cell (cNeT) therapy for the treatment of advanced NSCLC (CHIRON) and metastatic malignant melanoma (THETIS) and are encouraged by the improved manufacturing performance of our VELOS Process 2," said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. "We are also very excited about the developments in our AI-driven bioinformatics platform PELEUSTM. PELEUS uses a unique multi-region approach to provide validated and accurate identification of personalized clonal neoantigens. Our newly developed neoRankerTM tool is trained on a proprietary dataset of over 10,000 neoantigens and we calculate that it is potentially twice as good at identifying multiple memory T cell responses than existing deep-learning models. We believe this could be highly differentiated in the design of neoantigen vaccines and further strengthens our leadership position in the field of neoantigen identification."

Business Highlights

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Introduced and presented data at the 7th Annual Immuno-Oncology Summit Europe on the neoRankerTM tool, Achilles Therapeutics’ new immunogenicity prediction module of the AI-Powered PELEUS platform that uniquely identifies the most potent clonal neoantigens. The new AI module demonstrated potential superiority to commonly used AI tools (BigMHC) in identifying and prioritizing targets for personalized antigen approaches, supporting potential implementation into the Company’s ongoing TIL-based clinical programs in advanced non-small cell lung cancer (NSCLC) and melanoma, and into other modalities including clonal neoantigen cancer vaccines
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US patent number 11,634,773 granted on technology exclusively licensed by Achilles from the Francis Crick Institute, University College London, and Cancer Research Horizons, for selecting neoantigens that are presented by HLA molecules determined to be present in a patient’s tumor

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Regained compliance with the minimum bid price requirement of Nasdaq Listing Rule 5450(a)(1) on July 28, 2023, as confirmed by a written notice received from the Listing Qualifications Department of The Nasdaq Stock Market on July 31, 2023

Financial Highlights

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Cash and cash equivalents: Cash and cash equivalents were $143.7 million as of June 30, 2023, as compared to $173.3 million as of December 31, 2022. The Company anticipates that its cash and cash equivalents are sufficient to fund its planned operations through 2025.
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Research and development (R&D) expenses: R&D expenses were $13.8 million for the second quarter ended June 30, 2023, a decrease of $1.0 million compared to $14.8 million for the second quarter ended June 30, 2022. The decrease was primarily driven by changes to R&D priorities.
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General and administrative (G&A) expenses: G&A expenses were $4.3 million for the second quarter ended June 30, 2023, a decrease of $1.5 million compared to $5.8 million for the second quarter ended June 30, 2022. This decrease was primarily driven by changes in cost allocations, as well as lower professional fees and personnel costs.
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Net loss: Net loss for the second quarter ended June 30, 2023 was $16.8 million or $0.42 per share compared to $17.3 million or $0.44 per share for the second quarter ended June 30, 2022.

2H 2023 Focus and Upcoming Events

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Clinical Data: Report clinical and translational science data from 15 to 20 additional patients treated with cNeT monotherapy in NSCLC and melanoma, and with a cNeT/anti-PD-1 checkpoint inhibitor combination in melanoma, in the fourth quarter of the year
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Translational Science: Leverage the Company’s translational science platform to define the cNeT product features associated with clinical responses
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Clinical Activity: Drive the potential for additional confirmed responses in CHIRON and THETIS patients by delivering higher cNeT doses and improved product design
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Manufacturing Development: Continue VELOS and PELEUS development to optimize cNeT dose and functionality

Members of the Achilles team will participate in the following upcoming conferences. Additional details will be available in the Events & Presentations section of the Company’s website:

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11th Annual Immuno-Oncology Summit: August 7-9, 2023, Boston, MA
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Advanced Therapies Europe: September 6-7, 2023, Estoril, Portugal
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5th Annual TIL Therapies Summit: October 2-4, 2023, Boston, MA

On August 3, 2023 RS Oncology reported exciting new science to patients who will have the best chance of benefiting from new therapies (Press release, RS Oncology, AUG 4, 2023, View Source [SID1234633791]). PRX3 is a novel drug target with potential for treating patients with the asbestos related cancer, mesothelioma. It is a key defense against oxidative stress and is located in the mitochondria, the energy generating factories. Inhibiting PRX targets cancer, not normal cells.

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MITOPE, a first-in-human Phase 1 clinical trial, is investigating a first-in-class PRX3 inhibitor, RSO-021 (clinicaltrials.gov using the identifier NCT05278975, sponsor RS Oncology, LLC [RSO], Boston, USA). Dose escalation is ongoing across four UK sites with a planned enrollment by Q2 2024. Phase 2 expansion will bring on board additional sites in Q4 of 2023.

Early experience with RSO-021 in MITOPE was presented to a global audience of mesothelioma clinicians, scientists, and allied professionals at the 2023 International Mesothelioma Interest Group (iMig) conference hosted in Lille, France in June. The industrial symposium was entitled New Horizons for Cancer Therapy – Targeting Oxidative Stress Vulnerabilities.

Brian Cunniff, Ph.D., Chief Science Officer for RSO, and Assistant Professor of Pathology and Laboratory Medicine at the University of Vermont Cancer Center, explained how tumor cells utilize increased levels of Reactive Oxygen Species (ROS) as a driver of pro-tumor signaling pathways. He also described the discovery of PRX3 as a target to leverage ROS dependency in cancer. RSO-021 irreversibly binds and inhibits PRX3, leading to tumor-specific cell death. Dr. Cunniff stated that "RSO-021 is an exciting new therapeutic option for patients suffering with mesothelioma. RSO-021 exploits a universal vulnerability of tumor cells through a novel mechanism of action, leaving tumor cells unable to clear toxic waste products. We are excited to see our laboratory findings translated to patients in collaboration with RS Oncology."

Dr. Sean Dulloo, a UK investigator based at the University Hospitals of Leicester and University of Leicester, shared early insights in the safety and activity in MITOPE. Three cases were presented demonstrating the impactful tumor responses and reduced MPE levels with disease stabilization and improved quality of life.

Key opinion leader and IMIG 23 research medal winner, Professor Dean Fennell, also from Leicester, summarized the evolving mesothelioma treatment landscape and unmet needs. "PRX3 is a novel and interesting therapeutic drug target with potential for treating cancers, especially those with unmet need such as mesothelioma. We await the first clinical results with interest."

For more information about MITOPE clinical trial visit Mesothelioma UK. The study is supported by NIHR.

On August 3, 2023 Celaid Therapeutics reported the company and The National Cancer Center have signed a collaborative research agreement on the use of ex vivo expansion technology of hematopoietic stem cells for multiple myeloma (Press release, National Cancer Center of Japan, AUG 3, 2023, View Source [SID1234649812]).

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Multiple myeloma, in which plasma cells in the blood become cancerous, is a disease that is difficult to cure completely, with most patients relapsing within five years after treatment. During autologous transplantation for multiple myeloma, it is difficult to eliminate the risk of myeloma cell contamination of peripheral blood mobilization grafts, and past studies have reported an association between the degree of myeloma cell contamination and the risk of relapse.

Sporadic attempts to remove myeloma cells from grafts have been reported, but no company has successfully developed a cell therapy product.

The purpose of the collaborative research by the National Cancer Center Hospital East (Hospital Director: Atsushi Otsu, Co-Principal Investigator: Junichiro Yuda, Medical Director, Department of Hematology/Oncology) and Celaiid Therapeutics is as follows:
(1) Verification of basic technology for ex vivo expansion of human hematopoietic stem cells while removing myeloma cells from the peripheral blood of multiple myeloma patients
(2) Establishment of a preclinical Proof Of Concept (POC) through experiments on the engraftment of myeloma cell-eliminated human hematopoietic stem cells in a mouse model.

HSCT products with myeloma cells removed have the potential to prevent relapse or prolong the time to relapse after transplantation, and are expected to become a new treatment option in autologous transplantation for patients suffering from multiple myeloma.

On August 3, 2023 Blue Water Biotech, Inc. ("Blue Water" or the "Company") (Nasdaq: BWV), reported the closing of its previously announced exercise of certain existing warrants to purchase 2,486,214 shares of its common stock at a reduced exercise price of $1.09 per share, in exchange for new warrants as described below (Press release, Onconetix, AUG 3, 2023, View Source [SID1234641119]). The aggregate gross proceeds from the exercise of the existing warrants were approximately $2.7 million, before deducting placement agent fees and other offering expenses payable by the Company.

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H.C. Wainwright acted as the exclusive placement agent for this transaction.

The Company expects to use the net proceeds from the transaction for working capital and general corporate purposes, including executing on launch activities for Blue Water’s commercial portfolio announced in a letter to shareholders issued earlier this month.

The shares of common stock issued upon exercise of the existing warrants are registered pursuant to an existing registration statement on a Post-Effective Amendment No. 1 to Form S-1 on Form S-3 (File No. 333-267142), declared effective by the Securities and Exchange Commission (the "SEC") on May 4, 2023.

In consideration for the immediate exercise of the existing warrants for cash, the Company issued new unregistered warrants to purchase up to an aggregate of 4,972,428 shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The new warrants are exercisable immediately upon issuance at an exercise price of $1.09 per share and have a term of exercise equal to five years from the date of issuance.

The new warrants offered in the private placement have not been registered under the 1933 Act, or applicable under state securities laws. Accordingly, the new warrants and shares of common stock issuable upon the exercise of the new warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the offering, the Company has agreed to file a resale registration statement on Form S-3 with the SEC as soon as practicable to register the resale of the shares of common stock issuable upon the exercise of the new warrants issued in the private placement, and to have such resale registration statement declared effective within 90 days following the date of the agreement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.