On June 21, 2023 Interius BioTherapeutics, a leading developer of in vivo cell-specific genetic medicine therapeutics, reported the presentation of compelling preclinical data at the Cellicon Valley 2023 Meeting in Philadelphia, PA (Press release, Interius BioTherapeutics, JUN 21, 2023, View Source [SID1234632824]). The data demonstrates the potential of Interius Bio’s lead program (INT2104) to generate biologically active CAR cells directly in vivo for the treatment of B-cell malignancies. The company will also be unveiling non-human primate data from multiple studies at the In Vivo Engineering of Therapeutic Cells Summit in Boston, MA on July 10-12, 2023.

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In mouse models of systemic lymphoma, complete tumor clearance occurs across a wide dose range after a single intravenous infusion of Interius Bio’s targeted cell-specific lentiviral vector. The proprietary vector mediates direct in vivo creation of CAR T and NK cells that specifically kill malignant B cells. In non-human primates treated with a single vector infusion in the absence of conditioning chemotherapy, significant B cell depletion is observed with no toxicity and has been sustained in one animal for over 6 months.

Interius President and CEO Phil Johnson, MD states "The company’s preclinical data address three critical questions: Does it work? Can you make it? Is it safe? We are thrilled that the answer to each of these questions is yes based on extensive animal model work, including dosing of over 20 cynomolgus macaques, with a vector dose equivalent or exceeding the highest proposed human dose. In all models we have observed no signs of cytokine release syndrome (CRS) or neurotoxicity, no clinical symptoms, and no laboratory abnormalities."

"The compelling preclinical findings of specificity, biologic effect, tolerability and pharmacologic profile in multiple animal models following intravenous administration support the advancement of INT2104 to the clinic as a promising treatment option for B-cell malignancies," says Tim Culp, PhD, VP of Research and Development. "We continue to maintain our timeline to IND with initial human data expected in 2024."

On June 21, 2023 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported separate collaborations with two renowned healthcare organizations at the forefront of cancer research (Press release, Exact Sciences, JUN 21, 2023, View Source [SID1234632822]). The agreements aim to improve patient care by increasing access to genomic information. Combining cutting-edge technologies with expertise from thought leaders at Broad Institute of MIT and Harvard and Baylor Scott & White, Exact Sciences will provide smarter answers before diagnosis and throughout cancer treatment.

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"These collaborations mark a significant milestone in Exact Sciences’ pursuit to eradicate cancer," said Jorge Garces, Chief Science Officer at Exact Sciences. "Our combined efforts will unlock new insights into the complexities of cancer. We hope to enable preventive measures and treatments that address the unique needs of each patient to maximize their chances of achieving positive outcomes."

Agreements with Broad Institute of MIT and Harvard provide e xclusive license to next-generation technology for ultra-sensitive detection of molecular residual disease and ongoing research

Exact Sciences and Broad Institute have entered into a 5-year sponsored research agreement and an exclusive license agreement to utilize Minor Allele Enriched Sequencing Through Recognition Oligonucleotides (MAESTRO) as its molecular residual disease diagnostic testing platform. MAESTRO is a next-generation circulating tumor DNA technology that can detect thousands of patient-specific mutations using minimal sequencing and advanced bioinformatics, creating a scalable test platform for enhanced detection of molecular residual disease. The Broad Institute is globally recognized for leading innovations in the field of genomics and next-generation sequencing methodology. MAESTRO was developed at the Broad Institute’s Gerstner Center for Cancer Diagnostics which is focused on breakthrough innovations for significant unmet needs in cancer diagnostics.

Collaboration with Baylor Scott & White creates real-world experience and evidence supporting Exact Sciences’ multi-cancer early detection (MCED) approach

Exact Sciences and Baylor Scott & White (BSW) have entered an agreement to establish the Texas Multicancer Early Detection Registry program, including implementation of Exact Sciences’ MCED test within a subset of BSW primary care clinics. As part of the program, Exact Sciences will generate real-world evidence related to MCED testing in a clinical setting and provide comprehensive support to patients, ordering providers, and clinical staff. The program aims to provide about 50,000 testing opportunities over three years, helping optimize the clinical workflows of MCED testing. The collaboration will also generate data to support discussions with regulatory agencies, payers, and guideline bodies.

On June 21, 2023 Exact Sciences presented its corporate presentation (Presentation, Exact Sciences, JUN 21, 2023, View Source [SID1234632821]).

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On June 21, 2023 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases ("DiaMedica" or the "Company"), reported that it has entered into definitive agreements to sell its common shares in a private placement with accredited investors (Press release, DiaMedica, JUN 21, 2023, View Source [SID1234632820]). The transaction is expected to result in gross proceeds of $37.5 million.

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Pursuant to the terms of the securities purchase agreements, the Company will issue a total of 11,011,406 common shares at a purchase price of $3.40 per share, equal to the average per share closing price of the Company’s common shares for the five trading days ended June 20, 2023, except in the case of DiaMedica management who agreed to a higher purchase price of $3.91 per share, equal to the closing sale price of the Company’s common shares on June 20, 2023. The private placement is expected to close on or about June 23, 2023, subject to the satisfaction of customary closing conditions.

The Company expects to use the net proceeds from the private placement to continue its clinical and product development activities for DM199, including its pivotal Phase 2/3, ReMEDy2 clinical trial, and for other working capital and general corporate purposes. The Company believes that with the addition of this funding, the Company’s cash resources will be sufficient to fund the Company’s ReMEDy2 trial through the completion of the interim analysis.

Earlier today, DiaMedica also announced that the U.S. Food and Drug Administration ("FDA") has removed the clinical hold on the Company’s Phase 2/3 ReMEDy2 clinical trial studying the use of the Company’s product candidate, DM199, to treat acute ischemic stroke patients.

Craig-Hallum Capital Group LLC acted as the placement agent for the private placement investment by certain of the investors. Lake Street Capital Markets, LLC acted as financial advisor to the Company. Fox Rothschild LLP and Pushor Mitchell LLP acted as counsel to DiaMedica in the private placement and Mintz Levin acted as counsel for certain investors in the private placement.

The offer and sale of the foregoing securities in the private placement have not been registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and 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 applicable state and other securities laws. 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 press release shall not constitute an offer to sell or the solicitation of an offer to buy the foregoing 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.

On June 21, 2023 Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that the Company granted equity awards, previously approved by the Company’s Compensation Committee and the Board of Directors, as a material inducement to employment for two individuals, the Chief Medical Officer, Vojislav Vukovic, and the Principal Accounting Officer and Principal Financial Officer, Sandra Pennell (Press release, Delcath Systems, JUN 21, 2023, View Source [SID1234632819]).

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Mr. Vukovic received a total of 150,000 shares of the Company’s common stock, outside of the Company’s Omnibus 2020 Equity Incentive Plan, as amended ("Plan"). The options were issued upon the employee’s grant date, and all stock options included within the equity inducement award have an exercise price equal to the closing price of Delcath common stock on the grant date with ten-year terms. One-third of the options will vest on the first anniversary of the grant date with the remaining two-thirds of the options vesting in equal monthly installments over the following twenty-four months.

Ms. Pennell received a total of 100,000 shares of the Company’s common stock, outside of the Plan. The options were issued upon the employee’s grant date, and all stock options included within the equity inducement award have an exercise price equal to the closing price of Delcath common stock on the grant date with ten-year terms. One-third of the options will vest on the first anniversary of the grant date with the remaining two-thirds of the options vesting in equal monthly installments over the following twenty-four months.

The above-described awards were each granted in accordance with NASDAQ Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan.