Vivos Inc. Submits the Application to the FDA for Authority to Initiate Human Clinical Trials

On July 1, 2024 Vivos Inc. reported the company filed the application for an Investigational Device Exemption ("IDE") (Press release, Vivos, JUL 1, 2024, View Source [SID1234644629]).

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The filing was an amendment, addressing the FDA comments to our previous application (Q211938/S001). Today’s IDE submission marks our first filing with the FDA following the grant of the FDA Breakthrough Device Designation for the Radiogel Precision Radionuclide Therapy. We are appreciative of the improved communication with the FDA since receiving the breakthrough designation. Our IDE filing contained reports on two complex studies, RadioGel genotoxicity and the retention of RadioGel at the injection site in VX2 tumors in rabbits. This current IDE submission addressed the 63 FDA comments received in previous FDA correspondences. In some cases, we repeated underlying testing to strengthen our answers with current data. Dr. Korenko stated, "we are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly."

In closing Dr. Korenko stated, "We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic’s Internal Review Board (IRB) for clearance to initiate the first in human clinical trials. This is an exciting time for Vivos and we are committed to bringing a new treatment option to patients in the fight against challenging cancer types. Initially our collaboration with Mayo will be targeting solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.

Dr. Michael Korenko

Vivos Inc.

Michael K. Korenko, Sc.D.

President & CEO

Email: [email protected]

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Aptevo Therapeutics Announces Closing of $2.75 Million Offering

On July 1, 2024 Aptevo Therapeutics Inc., a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported the closing of its previously announced offering of (i) 5,339,806 shares of its common stock or pre-funded warrants in lieu thereof and (ii) warrants to purchase up to an aggregate of 10,679,612 shares of its common stock (the "Common Warrants") at a purchase price of $0.515 per share and associated Common Warrant in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Aptevo Therapeutics, JUL 1, 2024, View Source [SID1234644632]). Each share of common stock is being offered together with two Common Warrants, each to purchase one share of common stock. The Common Warrants have an exercise price of $0.515 per share, are exercisable upon stockholder approval, and will expire five years following the date stockholder approval.

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Roth Capital Partners acted as placement agent of the offering, with Dawson James Securities, Inc. acted as co-agent. Gross proceeds, before deducting placement agent fees and commissions and offering expenses, were approximately $2.75 million. The company intends to use the net proceeds from the offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-280226), as amended, that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on June 28, 2024. The offering was made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected]. This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. All offers were made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company also amended certain existing warrants that were previously issued in (i) August 2023 to purchase up to 41,239 shares of the Company’s common stock and have exercise price of $27.28 per share, (ii) November 2023 to purchase up to 610,334 shares of the Company’s common stock and have exercise price of $10.252 per share, and (iii) April 2024 to purchase up to 6,666,668 shares of the Company’s common stock and have exercise price of $1.35 per share, whereas effective upon the closing of the offering, such existing warrants have a reduced exercise price of $0.515 per share and shall become exercisable upon stockholder approval.

DiaMedica Therapeutics Announces Closing of $11.8 Million Private Placement

On July 01, 2024 DiaMedica Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing novel treatments for severe ischemic disease, reported the closing of its previously announced $11.8 million private placement to accredited investors (Press release, DiaMedica, JUL 1, 2024, View Source [SID1234644633]). The Company sold approximately 4.7 million common shares at a purchase price of $2.50 per share, a premium of approximately 10% above the Company’s per share closing price on Tuesday June 25, 2024. After deducting estimated offering expenses, the Company received net proceeds of approximately $11.7 million.

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The Company reported cash, cash equivalents and short-term investments of $46.5 million as of March 31, 2024. On a pro forma basis, including the estimated $11.7 million in net proceeds from the private placement, the Company’s cash, cash equivalents and short-term investments would have been $58.2 million as of such date.

The securities sold in the private placement have not been registered under the U.S. Securities Act of 1933, as amended, or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent such registration or an applicable exemption therefrom. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the common shares issued in the private placement.

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

Required Canadian Early Warning Reporting

Upon closing of the private placement, Thomas von Koch (the "von Koch"), c/o EQT Partners AB, Box 16509, 103 27 Stockholm, Sweden, will acquire indirect ownership, through TomEnterprise Private AB, of an aggregate of 1,200,000 common shares (the "von Koch Shares") of DiaMedica (the "von Koch Acquisition"). The Company’s head office is located at 301 Carlson Parkway, Suite 210, Minneapolis, Minnesota, 55305, U.S.A. Immediately prior to the completion of the von Koch Acquisition, von Koch had ownership of, and exercised control and direction over, an aggregate of 4,326,435 common shares of the Company representing approximately 11.4% of the issued and outstanding common shares of the Issuer on a non-diluted basis. Immediately following the completion of the von Koch Acquisition, von Koch will have ownership of, and exercise control and direction over, an aggregate of 5,526,435 common shares of the Company representing approximately 12.9% of the issued and outstanding common shares of the Company on a non-diluted basis. von Koch will pay aggregate cash consideration of US$3,000,000 (approximately C$4,098,000) for the von Koch Shares at a price of US$2.50 per common share (approximately C$3.41). The von Koch Shares are being acquired for investment purposes. von Koch may, from time to time, take such actions in respect of his holdings in securities of the Company as he may deem appropriate in light of the circumstances then existing, including the purchase of additional common shares or other securities of the Company or the disposition of all or a portion of his security holdings in the Company, subject in each case to applicable securities laws and the terms of such securities.

Upon closing of the private placement, Trill AB ("Trill"), Sveavägen 17, 18th Floor, SE-111 57, Stockholm, Sweden, acquired ownership of an aggregate of 1,200,000 common shares (the "Trill Shares") of the Company (the "Trill Acquisition"). Immediately prior to the completion of the Trill Acquisition, Trill had ownership of, and exercised control and direction over, an aggregate of 4,021,608 common shares of the Company representing approximately 10.6% of the issued and outstanding common shares of the Company on a non-diluted basis. Immediately following the completion of the Trill Acquisition, Trill will have ownership of, and exercise control and direction over, an aggregate of 5,221,608 common shares of the Company representing approximately 12.2% of the issued and outstanding common shares of the Company on a non-diluted basis. Trill will pay aggregate cash consideration of US$3,000,000 (approximately C$4,098,000) for the 1,200,000 Trill Shares at a price of US$2.50 per common share (approximately C$3.41). The Trill Shares are being acquired for investment purposes. Trill may, from time to time, take such actions in respect of its holdings in securities of the Company as it may deem appropriate in light of the circumstances then existing, including the purchase of additional common shares or other securities of the Company or the disposition of all or a portion of its security holdings in the Company, subject in each case to applicable securities laws and the terms of such securities.

Pursuant to National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting Issues, following the closing of the private placement, each of von Koch and Trill will file an early warning report in respect of the von Koch Acquisition and Trill Acquisition, respectively, with the applicable Canadian securities regulators, copies of which will be available under the Company’s profile at www.sedar.com. Following closing of the private placement, a copy of the early warning report relating to the von Koch Acquisition can be obtained by contacting von Koch at +46706034564, Per Colleen, CEO TomEnterprise Private AB. A copy of the early warning report relating to the Trill Acquisition can be obtained by contacting Trill at Sveavägen 17, 18th Floor, SE-111 57, Stockholm, Sweden.

The Canadian dollar values referred to above were determined using the Bank of Canada daily exchange rate on June 25, 2024.

About DM199 (rinvecalinase alfa)

DM199 is a recombinant (synthetic) form of human tissue kallikrein-1 (rhKLK1) in clinical development for acute ischemic stroke (AIS) and preeclampsia. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factor. In the case of AIS, DM199 is intended to enhance blood flow and boost neuronal survival in the ischemic penumbra by dilating arterioles surrounding the site of the vascular occlusion and inhibition of apoptosis (neuronal cell death) while also facilitating neuronal remodeling through the promotion of angiogenesis. In preeclampsia, DM199 is intended to lower blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta.

SCG Cell Therapy Announces FDA IND Clearance of SCG142, a next-generation HPV-specific TCR T cell therapy for patients with HPV-associated solid tumors

On June 30, 2024 SCG Cell Therapy Pte Ltd (SCG), a biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, reported that U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate Phase 1/2 clinical trial for SCG142, a novel next-generation human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T) cell therapy for patients with HPV-associated solid tumors (Press release, SCG Cell Therapy, JUN 30, 2024, View Source;hpv-specific-tcr-t-cell-therapy-for-patients-with-hpv-associated-solid-tumors-302186559.html [SID1234644617]).

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"This FDA IND approval of another TCR T cell therapy candidate generated from our proprietary GianTCRTM platform is an important milestone for SCG. It marks the advancement of our TCR-based therapeutic program to treat unmet needs in different major cancer indications", said Christy Ma, Chief Executive Officer of SCG Cell Therapy. "We are ready to commence multi-center Phase 1/2 clinical trials, assessing the potential benefits for patients via our proprietary TCR T technology."

SCG142 is a high-avidity fully natural HPV-specific TCR armoured with a TGFβRII-41BB chimeric switch receptor. In May 2024, SCG presented preclinical data of SCG142 at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting. The data indicates SCG142 had exhibited high polyfunctional avidity. It recognized both HPV-16 and HPV-52 genotypes, with a favourable safety profile with no alloreactivity or off-target toxicity. In addition, SCG142 demonstrated dual CD8 and CD4 TCR T cell proliferation and tumor inhibition in both in vitro and in vivo models, indicating CD8 co-receptor independent T cell functionality, as well as promoting long-term persistence of memory T cells.

"SCG142 is a novel and differentiated HPV-specific TCR T cell therapy. By armoring the TCR T cells with the chimeric switch receptor, it overcomes the hostile tumor microenvironment and converts inhibitory effects into a co-stimulatory signal. This process is essential for effective immunotherapy treatment of solid tumors. With this unique next-generation design, SCG142 represents a groundbreaking innovation that translates from our in-house discovery platforms into clinics", said Dr. Ke Zhang, Chief Scientific Officer of SCG Cell Therapy.

Significant Tumor Reductions in Neoadjuvant MSS Colon Cancer Patients Treated with Botensilimab/Balstilimab Presented at ESMO GI Conference

On June 28, 2024 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, reported results from an investigator-sponsored trial (IST) of botensilimab and balstilimab (BOT/BAL) in the neoadjuvant setting for colon cancer (Press release, Agenus, JUN 28, 2024, View Source [SID1234644598]). Data were presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress in Munich, Germany.

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Dr. Pashtoon Kasi, the originator of this groundbreaking study, stated, "The rapid and complete resolution of aggressive MSS colorectal cancer tumors observed in this study is unprecedented in the field. The exceptional activity of the BOT/BAL combination therapy in the neoadjuvant setting offers new hope for patients facing this challenging cancer subtype. Furthermore, the pattern of response and the lack of clinical recurrence speaks to the curative potential of one’s own body to fight cancer."

Study Highlights:

Enrollment: 20 patients were evaluable at the data cutoff with available pathology results, 17 microsatellite stable (MSS) and 3 high microsatellite instability (MSI-H).
Treatment Regimens: Both cohorts received one dose of botensilimab with balstilimab. The NEST-1 cohort received one additional dose of balstilimab two weeks later, whereas the NEST-2 cohort received up to 3 additional doses of balstilimab.
Clinical Findings:

Pathologic Response: In the NEST-2 cohort, 78% (7/9) of MSS patients achieved pathologic responses of at least 50% tumor regression, with 56% (5/9) reaching complete pathologic responses.
Surgical Outcomes and Safety: No surgeries were delayed due to adverse events, and no patients had unresolved immune related adverse events. Side effects were manageable, and no new safety concerns emerged.

Pathologic Response

(>50% Regression)

Complete Pathologic Response

(100% Regression)

NEST-1 (N=10)

MSS (N=8)

5 (63%)

1 (13%)

MSI-H (N=2)

2 (100%)

1 (50%)

NEST-2 (N=10)

MSS (N=9)

7 (78%)

5 (56%)

MSI-H (N=1)

1 (100%)

1 (100%)

Overall

MSS (N=17)

12 (71 %)

6 (35%)

MSI-H (N=3)

3 (100%)

2 (67%)

"The significant tumor reductions observed with the early use of BOT/BAL therapy before surgery underscore its paradigm-changing potential in neoadjuvant colon cancer, potentially minimizing the rate of disease recurrence and the need for invasive procedures and chemotherapy in the future," said Dr. Steven O’Day Chief Medical Officer at Agenus. "The responses in MSS patients were particularly profound, and extending the treatment duration in the NEST-2 cohort further amplified these effects. We are focused on expanding BOT/BAL’s application in the neoadjuvant setting to improve treatment for individuals living with cancer."

The presentation is available on the Agenus website at View Source

About Botensilimab

Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 900 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.

About Colorectal Cancer

Colorectal cancer (CRC) is the second leading cause of cancer death in the United States, comprising an estimated 8.3% of cancer-related deaths annually. Although overall mortality from CRC has declined, survival remains poor for advanced disease, and the burden is shifting to a younger population. Alarmingly, from 1995 to 2019, the number of patients under the age of 55 who were diagnosed with CRC in the United States nearly doubled.