On March 7, 2024 AbbVie (NYSE: ABBV) reported that it will participate in the Barclays 26th Annual Global Healthcare Conference on Thursday, March 14, 2024. Robert A. Michael, president and chief operating officer, Scott T. Reents, executive vice president, chief financial officer, Jeffrey R. Stewart, executive vice president, chief commercial officer and Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, will present at 8:00 a.m. Central time (Press release, AbbVie, FEB 7, 2024, View Source [SID1234640941]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On February 7, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported it has discontinued the Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) and that the U.S. Food and Drug Administration (FDA) placed all magrolimab studies in myelodysplastic syndromes (MDS) and AML, including related expanded access programs, on full clinical hold (Press release, Gilead Sciences, FEB 7, 2024, View Source [SID1234640175]). These decisions follow the recommendation of an independent Data Monitoring Committee which reviewed top-line data from a planned interim analysis of ENHANCE-3 for overall survival (OS). In that analysis, magrolimab in combination with azacitidine plus venetoclax demonstrated futility and an increased risk of death was observed, primarily driven by infections and respiratory failure.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Based on these results, as well as data from two other clinical studies in higher-risk MDS (ENHANCE) and AML with TP53 mutations (ENHANCE-2) where the primary analyses also demonstrated futility with an increased risk of death in the magrolimab-treatment arm, Gilead will not pursue further development of magrolimab in hematologic cancers.

Patients in the ENHANCE-3 study will discontinue treatment with magrolimab and Gilead is communicating with investigators to determine appropriate next steps for patients in the study. Sub-analyses of ENHANCE-3 for efficacy and safety are ongoing and results will be shared with regulatory authorities and will be submitted for presentation at an upcoming medical meeting and/or publication in a peer-reviewed journal.

Gilead will share a top-line, integrated summary of all pivotal magrolimab trials (ENHANCE, ENHANCE-2 and ENHANCE-3) shortly, as well as more detailed results of each trial in upcoming medical conferences. In addition, Gilead is reviewing the safety of magrolimab across all ongoing solid tumor trials and will provide an update on this assessment as soon as possible.

"The complexity of treating blood cancer is highlighted in these results," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "We are incredibly grateful to all the patients and investigators for their participation in the ENHANCE studies."

About ENHANCE-3
ENHANCE-3 is a Phase 3 study evaluating the safety and efficacy of magrolimab versus placebo in combination with venetoclax plus azacitidine in newly diagnosed, previously untreated patients with AML who are ineligible for intensive chemotherapy. More information about ENHANCE-3 (NCT05079230) can be found at ClinicalTrials.gov.

On February 7, 2024 QSAM Biosciences Inc. (OTCQB: QSAM) ("QSAM or the "Company") reported that it has signed a definitive Agreement and Plan of Merger (the "Agreement") providing for the acquisition of the Company by Telix Pharmaceuticals Limited (ASX: TLX) ("Telix") (Press release, QSAM Biosciences, FEB 7, 2024, View Source [SID1234639942]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Pursuant to the Agreement, QSAM stockholders will receive (i) $33.1 million in Telix ordinary shares ("Telix Shares") or cash, less an adjustment amount equal to QSAM’s indebtedness and payables as of the merger closing (the "Closing Consideration"), and (ii) contingent value rights ("CVRs") to receive future payments of up to $90 million upon the achievement of four clinical and commercial milestones within ten years of closing.

Prior to closing the merger, QSAM will effect a reverse stock split of its common stock in a ratio between 1:1000 and 1:2000. Each whole share of QSAM common stock outstanding after the reverse split will receive Telix Shares. Any remaining fractional shares of QSAM common stock resulting from the reverse split will be exchanged for an equivalent value in cash on a per share basis based on the per share price of Telix Shares as of the signing date of the Agreement. All QSAM stockholders will receive one CVR for each QSAM common share held prior to the reverse split.

Telix Shares issued to QSAM stockholders will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), but will be issued pursuant an exemption to the registration requirements thereunder, and more specifically, Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D; and as a result, will be subject to resale restrictions under Rule 144 of the Securities Act.

QSAM stockholders representing greater than a majority of the total voting stock of the Company have already approved the merger. Closing, however, is subject to various conditions set forth in the Agreement including, among others, the filing of a definitive information statement pursuant to Regulation 14C of the Securities Exchange Act of 1934, as amended (the "Information Statement"). The merger cannot be closed until 20 days after the mailing of the Information Statement to QSAM stockholders.

Dr. C. Richard Piazza, QSAM’s Executive Chairman and co-Founder, stated, "The signing of our Merger Agreement with Telix marks a major milestone for QSAM and our shareholders. We are thrilled to advance this transaction to signing and expect to complete the transaction in the first half of 2024, subject to the timing of our Information Statement and the satisfaction of customary closing conditions. We believe strongly that Telix is the right partner to advance Samarium-153-DOTMP through clinical trials and give this important technology the best chance to improve the lives of patients suffering from bone cancer. We are equally excited for our shareholders, as we believe this is a great outcome for their investments."

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix said, "The acquisition of QSAM provides Telix with an additional near-term therapeutic pipeline asset, further differentiating our innovation position in radiopharmaceuticals and building depth in Telix’s key disease focus areas of urological and musculoskeletal oncology. Samarium is a highly optimal radionuclide for treating bone metastases, and the combination of Orphan Drug Designation and Rare Pediatric Disease Designation status with Telix’s demonstrated experience in pharmacy-based cold-kit distribution has strong potential for a rapid pathway to commercialisation of this asset."

Additional details about the Agreement, the CVRs and other material aspects of the merger and agreements and transactions contemplated by the merger will be provided in the Company’s Form 8-K to be filed subsequently with the SEC.

On February 7, 2024 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that it will participate in and present at Oppenheimer’s 34th Annual Healthcare Life Sciences Conference, which will be held virtually. Summit will present on Wednesday, February 14, 2024, at 2:40PM ET (Press release, Summit Therapeutics, FEB 7, 2024, View Source [SID1234639927]). Dr. Maky Zanganeh, Chief Executive Officer and President, and Robert W. Duggan, Chairman and Chief Executive Officer, will present on behalf of our organization and provide details regarding the development of our innovative investigational bispecific antibody, ivonescimab.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The presentation will be available live from our website: www.smmttx.com. An archived version will be available on our website following the presentation.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Summit has begun its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in its two Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies.

On February 7, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the publication of extensive work describing preclinical studies for lead candidate THIO in small cell lung cancer (SCLC) in the peer-reviewed scientific journal Nature Communications (Press release, MAIA Biotechnology, FEB 7, 2024, View Source [SID1234639926]). The reported findings from the research, conducted in collaboration with the University of Texas Southwestern (UTSW) scientists, led by corresponding author Dr. Esra Akbay, demonstrate the immune-enhancing, metastasis-reducing effects of MAIA’s telomere-targeting agent THIO (6TdG) in several well-characterized in vitro and in vivo models of SCLC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"This publication highlights a rather unique dual mechanism of action for THIO as a first-in-clinic telomere-targeted anticancer agent for potential treatment of SCLC," said Sergei M. Gryaznov, PhD., MAIA’s Chief Scientific Officer. "In addition to the direct and potent cancer cell depletion activity, the observed specific interferons stimulation, immune responses-enhancement, and metastasis-reducing effects of THIO provide solid scientific foundation for further advancement of this compound in clinical development."

A prominent characteristic of lung cancer small cells is their reliance on telomerase activity, a key enzyme essential for the continuous proliferation of SCLC. While 85-90% of all human cancers are telomerase positive, SCLCs are nearly all telomerase positive1, suggesting that telomerase targeting may be an effective strategy in the treatment of SCLC.

Key findings in the published paper include:

Human and mouse SCLC lines are sensitive to THIO (6TdG) treatment in vitro and in vivo
THIO decreases cancer initiating cells and diminishes tumor initiation potential in vitro and in vivo
Low doses of THIO are effective in treating metastatic mouse SCLC tumors
THIO activates type-I interferon pathway through cGAS-STING signaling
THIO is highly effective in combination with ionizing radiation treatment regiments
"With few, if any, effective treatments for small cell lung cancer, there is a widespread need for innovative therapeutic strategies. The positive outcomes reported in our publication show THIO’s potential as a new therapeutic approach," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "THIO already holds Orphan Drug Designation for SCLC, underscoring the FDA’s recognition of THIO’s potential to improve outcomes for this highly lethal disease. With the positive preclinical and clinical data we have obtained to date for THIO, we have entered the Phase 2 planning stage for a clinical trial of THIO in SCLC along with two other cancers."

Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.

About the Publication

Nature Communications, volume 15, article number: 672 (2024), "A telomere-targeting drug depletes cancer initiating cells and promotes anti-tumor immunity in small cell lung cancer," published 22 January 2024. Co-author disclosures included in manuscript.

About Small Cell Lung Cancer

Small cell lung cancer (SCLC) accounts for 13% of lung cancers. As the deadliest of all lung cancers, SCLC is one of the leading causes of cancer-related mortality in United States with 30,000 deaths annually. It is less common than non-small cell lung cancer (NSCLC), but is more aggressive and rapidly spreads (metastasizes) throughout the body.

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 nucleoside 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 activating 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 second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.