On June 21, 2023 IGM Biosciences, Inc. (NASDAQ: IGMS) reported that it intends to offer and sell an aggregate of $100.0 million of shares of its common stock and, in lieu of common stock to certain investors that so choose, non-voting common stock, in an underwritten public offering and concurrent private placement (Press release, IGM Biosciences, JUN 21, 2023, View Source [SID1234632847]). In addition, IGM intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares offered in the public offering at the public offering price, less underwriting discounts and commissions. All of the securities offered in the proposed public offering will be sold by IGM.

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Concurrent with the proposed public offering, IGM intends to sell, subject to the consummation of the proposed public offering and other customary conditions, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the Securities Act), shares of non-voting common stock to certain institutional and other accredited investors affiliated with or managed by Redmile Group, LLC at a sale price equal to the price to the public in the public offering. However, the consummation of the public offering is not contingent on the consummation of this concurrent private placement.

The proposed public offering and concurrent private placement are subject to market and other conditions, and there can be no assurance as to whether or when the proposed public offering and concurrent private placement may be completed, or as to the actual size or terms of the proposed public offering and concurrent private placement.

BofA Securities, Jefferies, Stifel, and Guggenheim Securities are acting as joint book-running managers for the proposed public offering.

The securities are being offered by IGM in the proposed public offering pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on November 3, 2022 and declared effective on November 14, 2022. IGM will file a preliminary prospectus supplement and accompanying prospectus relating to the proposed public offering with the SEC, copies of which can be accessed for free through the SEC’s website at www.sec.gov. The final terms of the proposed public offering will be disclosed in a final prospectus supplement to be filed with the SEC. When available, copies of the preliminary prospectus supplement, the final prospectus supplement and the accompanying prospectuses relating to the proposed public offering may also be obtained from: BofA Securities, Attention: Prospectus Department, NC1-0220-02-24, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, or via email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

The shares of non-voting common stock to be sold in the concurrent private placement have not been registered under the Securities Act or under any state securities laws and, unless so registered may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

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

On June 21, 2023 Ozette Technologies, Inc., a technology-driven life sciences company, reported its collaboration with Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers (Press release, Umoja Biopharma, JUN 21, 2023, View Source [SID1234632837]). Umoja will use Ozette’s AI-powered single-cell technology for their preclinical studies.

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As part of this work, the Ozette Platform will be used to provide research and development (R&D) support and evaluate biomarker endpoints from preclinical tumor-bearing, humanized mouse models. Humanized mouse models are often deployed in preclinical studies as a tool for modeling human immune responses in the evaluation of potential therapeutics and treatment effects before first-in-human studies. The goal of this collaboration is to help derive insights that have the potential to catalyze Umoja’s therapeutic program development.

"Our mission is to unlock the power of the immune system using computation and machine learning. As a result, we can quickly understand how the immune system is evolving and what that means for a therapy and a patient at the single-cell level," said Dr. Ali Ansary, CEO and Co-founder of Ozette. "This collaboration with Umoja is an important opportunity to continue showcasing Ozette’s technology and innovative impact on the vast variety of therapeutic indications, including cutting-edge T-cell treatments."

Umoja and Ozette share a common mission to increase the efficiency of drug development and expand access to transformative immunotherapies through technology innovation. The partnership will leverage Ozette Endpoints and Ozette Discovery to enable both companies’ multidisciplinary scientific and bioinformatic teams to collaborate and expand the benefits of CAR T-cell immunotherapy to patients in need.

"Our collaboration with Ozette is the next step in expanding the value of our preclinical data by leveraging their advanced single-cell technology," said Ryan Larson, Ph.D., Senior Vice President of Translational Science at Umoja. "The Ozette Platform will allow us to efficiently distill complex biology, that traditionally relies on manual analysis, into actionable insights rapidly. Together, we’re able to gather a deeper and wider set of preclinical insights from our data which, in turn, allows us to increase the efficiency of developing our transformative therapeutics. We’re excited to expand our R&D efforts with Ozette on broader applications at Umoja."

On June 21, 2023 Molecular Targeting Technologies, Inc. (MTTI) announced promising results from a 1-year follow-up on EBTATE (2 cycles, 3.7 GBq/cycle) treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) without amino acid pretreatment. EBTATE’s safety, biodistribution, and dosimetry in a crossover randomized protocol in patients (N=10) with and without amino acids were published in Clinical Nuclear Medicine (Press release, Molecular Targeting Technologies, JUN 21, 2023, View Source [SID1234632835]).

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The kidney is sensitive to radiation. Peptide receptor radionuclide therapy (PRRT) dosing is constrained by potential kidney toxicity. A 4-hour long amino acid cocktail infusion reduces renal absorbed radiation dose, with significant side effects like nausea, vomiting and hyperkalemia. The Evans blue moiety in EBTATE binds to serum albumin, extending in vivo circulatory half-life and residence time, reducing renal uptake and hence making amino acid infusion unnecessary.

Professor Zhaohui Zhu, MD, principal investigator, commented, "Our results showed that administration of EBTATE without amino acid infusion had acceptable kidney radiation absorbed dose and residence time. One month after EBTATE, there were no significant changes in creatinine, blood urea nitrogen (BUN), and glomerular filtration rate (GFR). None of the patients had nephrotoxicity of any grade. Furthermore, a recent one-year follow-up showed creatine and BUN of all patients stayed within normal limits. EBTATE administration appears to be safe without amino acid infusion."

Chris Pak, President & CEO of MTTI commented, "Amino acid infusion impacts quality of life, access to care, patient compliance to treatment and overall treatment costs. The benefits of EBTATE treatment without amino acids are clear. We expect EBTATE trials in small cell lung cancer, NET, and nasopharyngeal cancers to show the same benefit."

Molecular Targeting Technologies, Inc. (MTTI). MTTI is a privately held, venture-backed, clinical-stage biotech company developing next-generation targeted radiotherapeutics for rare cancers with high unmet needs. MTTI is committed to building value by translating innovative radiopharmaceuticals to improve human health and reduce healthcare costs. MTTI is orchestrating multiple clinical trials. For more information: www.evathera.com; Contact: Chris Pak, Email: [email protected]

* Jiang Y, Liu Q, Wang G, et al. . Evaluation of Safety, Biodistribution and Dosimetry of a Long-Acting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE (EBTATE) with and without Amino Acid Infusion. Clin Nucl Med 18 Apr 2023, 48(6):e289-e293

On June 21, 2023 Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, reported that the fifth dose escalation cohort in the ALS-6000-101 dose escalation Phase 1 clinical trial to evaluate the safety and tolerability of AVA6000 has been completed successfully (Press release, Avacta, JUN 21, 2023, View Source [SID1234632834]). The data continue to show a very favourable safety profile for the tumour targeted chemotherapy and several patients in cohort 5 and earlier cohorts remain on treatment as their disease has not progressed.

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AVA6000 is a form of doxorubicin that has been chemically modified with Avacta’s pre|CISION platform designed to reduce systemic side effects by targeting the release of active chemotherapy in tumour tissue. Despite the high dose level in the fifth cohort which is approximately 2.25 times a typical dose of doxorubicin, AVA6000 has continued to be well tolerated by patients with a marked reduction in the incidence and severity of the typical toxicities associated with the standard doxorubicin chemotherapy administration.

The emerging positive safety and pharmacokinetic data from the study support the potential clinical differentiation of AVA6000 over doxorubicin. This includes: (i) higher dosing of AVA6000 compared to standard doxorubicin, (ii) more frequent dosing of AVA6000 compared to doxorubicin – doxorubicin is typically dosed every three weeks in order for patients to recover from the side effects of treatment, (iii) the ability to administer many more cycles of AVA6000 compared to doxorubicin.

A total of 29 patients with a range of advanced and/or metastatic solid tumours have now been dosed at the clinical trial in sites in the UK and United States. On the basis of the very favourable safety profile of AVA6000 in the study to date, the Safety Data Monitoring Committee (SDMC) has recommended continuation to the sixth dose cohort at 310 mg/m2, which is equivalent to 2.7 times the standard dose of doxorubicin. This continued dose escalation is aimed at identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the Phase 1b and future studies.

Dr Alastair Smith, Chief Executive of Avacta Group plc commented: "The continued positive safety profile of AVA6000 at these dose levels compared with standard doxorubicin is remarkable. We are seeing a significant reduction in the incidence and severity of all doxorubicin side effects. Analysis of the tumour biopsies to date also confirms that enough doxorubicin is being released in the tumour to have a therapeutic effect. If even higher doses of AVA6000 are tolerated then this may make a significant difference to the outcomes for patients in the upcoming efficacy study.

"We are keen to progress onto the Phase 1b efficacy study as soon as possible following completion of the dose finding Phase 1a study. The dose expansion Phase 1b study will provide an initial evaluation of efficacy and of the relative improvement in patient outcomes and quality of life of different dosing regimens of AVA6000 compared with the standard doxorubicin regimen."

On June 21, 2023 Quest Diagnostics (NYSE:DGX), the nation’s leading provider of diagnostic information services, reported that it has completed its previously announced acquisition of Haystack Oncology (Press release, Quest Diagnostics, JUN 21, 2023, View Source [SID1234632832]).

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Haystack Oncology has developed a highly sensitive minimal-residual disease (MRD) testing technology, based on circulating tumor DNA (ctDNA), to aid in the early detection of residual or recurring cancer and better inform therapy decisions. Quest expects to incorporate this MRD technology into the development of new blood-based clinical lab services for solid tumor cancers available beginning in 2024.