On January 10, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that Chief Executive Officer Vlad Vitoc, M.D. will present at the Biotech Showcase 2025 investor conference taking place in San Francisco, California January 13-15, 2025 (Press release, MAIA Biotechnology, JAN 10, 2025, View Source [SID1234649611]). Dr. Vitoc will also host one-on-one meetings with investors throughout the 3-day event. The live event will be followed by a virtual 2-day event on January 21-22, 2025.

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At the conference, Dr. Vitoc will discuss MAIA’s recent clinical developments and targeted value-driving milestones for 2025 and beyond, including:

Expansion of MAIA’s THIO-101 pivotal Phase 2 clinical trial to further assess the efficacy of telomere-targeting agent THIO in advanced non-small cell lung cancer (NSCLC) patients receiving third line (3L) therapy.
Multiple THIO trials planned for additional cancer indications.
Significant market opportunity for THIO in the top tumor types globally.
Biotech Showcase conference details:

Dates:

Live event January 13-15, 2025; Digital event January 21-22, 2025

MAIA presentation:

03:00PM PST on Monday, January 13, 2025*

Conference registration:

All-access and Digital passes available on the conference website

One-on-One Meetings:

Bookings available on the conference website

Webcast:

Join here for live presentation and virtual event streaming

On-demand playback:

Available here 2 hours after the presentation, accessible for 6 months

*Please note that the presentation date and time are subject to change. Attendees can refer to the program agenda for conference updates.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a third line of treatment for NSCLC for patients that are resistant to checkpoint inhibitors and chemotherapy.

On January 10, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing novel KIR-CAR platform technology, reported that it has dosed the first patient in its CELESTIAL-301 Phase 1 clinical trial (Press release, Verismo Therapeutics, JAN 10, 2025, View Source [SID1234649610]). The patient was infused at Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado.

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CELESTIAL-301 aims to assess safety, tolerability, and preliminary efficacy of SynKIR-310 in patients with relapsed/refractory (r/r) B cell Non-Hodgkin Lymphomas (B cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL). The Phase 1 multicenter clinical trial is enrolling patients who previously received CAR T therapy but who have since relapsed or become refractory to it as well as patients who never received CAR T therapy.

CELESTIAL-301 trial seeks to address several areas of high unmet medical need. Commercially approved CAR T cell therapies have shown impressive high initial response rates in blood cancers. Over time, however, these therapies result in relapse in an estimated 40-50% of patients1. Such relapses are due in part to lack of long-term T cell effector function and persistence. There are currently very limited treatment options for patients with r/r DLBCL who relapse following treatment with commercial CAR T cell therapies.

SynKIR-310 relies on Verismo’s unique KIR-CAR platform and proprietary CD19 binder (DS191). SynKIR-310 targets CD19, similarly to the commercially approved CAR T therapies, with the added potential of prolonged anti-tumor T cell function and persistence. These KIR-CAR improvements may prevent early disease relapse in patients with advanced B cell lymphomas.

"The initiation of patient dosing in the CELESTIAL-301 trial marks an exciting milestone for Verismo Therapeutics as we advance our mission to develop transformative therapies for patients facing advanced lymphomas. CBCI’s commitment to patients and to conducting novel early-stage clinical trials has allowed us to reach this milestone earlier than expected," according to Dr. Laura Johnson, Chief Operations Officer and Chief Scientific Officer at Verismo Therapeutics. "SynKIR-310 is uniquely designed to prolong T cell functional persistence and combat the challenges of disease relapse, offering a potentially life-saving option for these patients."

"We are thrilled to administer this promising therapy," said Michael Tees, MD, the principal investigator at SCRI at Colorado Blood Cancer Institute (CBCI), where the first patient was dosed. "Emerging treatments like SynKIR-310 have potential to reshape care for patients with advanced lymphomas, offering new hope. This milestone showcases the impact of CBCI and other expert research centers in advancing early-stage clinical trials."

Verismo achieved IND clearance from the FDA in May 2024 to proceed with this multicenter Phase 1 clinical trial investigating SynKIR-310. SynKIR-310 is Verismo’s second clinical pipeline following SynKIR-110 targeting aggressive mesothelin-expressing solid tumors. For more information about the CELESTIAL-301 clinical trial, please visit ClinicalTrials.gov: NCT06544265.

On January 10, 2025 Diakonos Oncology, a clinical-stage biotechnology company leveraging proprietary dendritic cell technology to address critical and unmet therapeutic needs in late-stage and aggressive cancers, reported that it will present its latest developments at the Biotech Showcase in San Francisco, CA from January 13-15, 2025 (Press release, Diakonos Oncology, JAN 10, 2025, View Source [SID1234649609]). Biotech Showcase is a premier event for private and micro-mid-cap biotechnology companies to highlight their innovation and connect with global investors and engage with executives from prominent biopharmaceutical interests.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Diakonos Oncology will be represented by President and Chief Operating Officer Jay Hartenbach, who will be presenting on recent corporate milestones and research developments, including lead product DOC1021, a unique autologous dendritic cell vaccine (DCV), which will begin enrolling patients in its Phase 2 clinical trial for glioblastoma (GBM) in H1 2025 at leading treatment centers across the US.

Details of the presentation are as follows:

Event: Biotech Showcase 2025
Date: January 15, 2025, at 11:15 a.m. Pacific Standard Time
Location: Hilton San Francisco – Union Square, San Francisco, CA
Track: Yosemite C (Ballroom Level)

"Our unique cellular vaccine product targets the complete tumor antigen profile and induces powerful memory T cell responses against some of the most aggressive cancers," said Mr. Hartenbach. "We are excited to share the latest clinical data, which continues to exceed expectations with ongoing patient survival, and to present our plans for future trials in new indications."

To learn more about the event, please visit https://informaconnect.com/biotech-showcase/ or to schedule one-on-one meetings, please email [email protected].

About DOC1021

DOC1021 is a novel autologous dendritic cell vaccine (DCV) that initiates a potent cytotoxic TH1 immune response against a patient’s cancer through the company’s proprietary double loading technology. This unique approach unlocks a synergistic tumor killing response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen profile. This approach has demonstrated an excellent safety profile and does not require myelosuppressive preconditioning chemotherapy or high dose IL-2 administration.

In addition to the lead GBM study, DOC1021 is being studied in an ongoing Phase 1 clinical trial for pancreatic ductal adenocarcinoma (PDAC) that will complete enrollment later this year. Diakonos has received Fast Track designations from the FDA for both the GBM and PDAC programs. The company has also received Orphan Drug Designation for the GBM program.

On January 10, 2025 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused drug development company, reported that it has entered into a definitive agreement for the purchase and sale of up to an aggregate of 1,333,333 of the Company’s American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing 100 ordinary shares of the Company, at a purchase price of $1.50 per ADS (or ADS equivalent in lieu thereof), in a registered direct offering (Press release, Kazia Therapeutics, JAN 10, 2025, View Source [SID1234649608]). The Company has also agreed to issue, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 1,333,333 ADSs. The warrants will have an exercise price of $1.50 per ADS, will be immediately exercisable upon issuance, and will expire five and one-half years from the date of issuance. The closing of the offering is expected to occur on or about January 13, 2025, subject to the satisfaction of customary closing conditions.

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Maxim Group LLC is acting as the exclusive placement agent for the registered direct offering and concurrent private placement.

The gross proceeds to the Company from the offering are expected to be approximately $2.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include working capital, expenses related to research, clinical development and commercial efforts, and general and administrative expenses.

The securities described above (excluding the warrants and ADSs underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form F-3 (File No. 333-281937) that was originally filed with the Securities and Exchange Commission (the "SEC") on September 5, 2024, and declared effective on September 12, 2024. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from Maxim Group LLC at 300 Park Avenue, New York, NY 10022, by phone at (212) 895-3500 or e-mail at [email protected].

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs representing ordinary shares underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying ADSs may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 10, 2025 The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, and Insilico Medicine ("Insilico"), a clinical stage generative artificial intelligence (AI)-driven biotechnology company, reported that the companies have entered into an exclusive licensing agreement granting Stemline the global rights to develop and commercialize a preclinical small molecule targeting high unmet needs in oncology (Press release, Menarini, JAN 10, 2025, View Source [SID1234649607]).

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The asset is a highly selective and potentially best-in-class small molecule inhibitor targeting a broad range of solid tumor cancers, devel oped with the help of Chemistry42, Insilico’s generative chemistry engine, and Insilico’s drug discovery team. The asset has successfully completed preclinical development and has demonstrated broad anti-tumor activity in selected cancers.

"We are thrilled to enter our second collaboration with Insilico Medicine, a leader in the field of generative AI, for a highly selective and potentially best-in-class small molecule targeting a broad range of cancers," said Elcin Barker Ergun, CEO of the Menarini Group. "This asset will help us enter into new areas of high unmet need, expanding the tumor areas where we can help cancer patients with ground-breaking therapies."

"Our previous experience with Menarini Stemline proved that the company is efficient, agile, strategic, and committed to rapidly delivering the best novel therapeutic solutions to patients with cancer, maximizing the probability of success of the program," said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine. "Menarini Stemline’s strategic visionary management is rapidly re-shaping the field of oncology, and we are very happy to take part in their quest to extend patients’ lives around the world."

Under the terms of the agreement, Stemline will provide a $20 million upfront payment to Insilico. The combined value of the deal, including all development, regulatory, and commercial milestones, is over $550 million, followed by tiered royalties.

Prior to this collaboration, the Menarini Group and Insilico entered an exclusive licensing agreement in January 2024 for MEN2312, an innovative small molecule for breast cancer treatment and other oncology indications.

About MEN2312

MEN2312 was designed by Insilico’s R&D team with the help of its end-to-end Pharma Generative AI platform to inhibit KAT6 and block endocrine receptor (ER) at the transcriptional level, giving it the potential to overcome resistance to endocrine therapies due to mutation or ligand-independent constitutive activation of ER. In preclinical studies, the molecule has demonstrated potent inhibition against KAT6 in multiple CDX and PDX models with good efficacy and safety.