On October 22, 2024 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, and TerSera Therapeutics LLC, a privately-held biopharmaceutical company with a focus in oncology and non-opioid pain management, reported that they have entered into an agreement in which TerSera will acquire global rights to MARGENZA (margetuximab-cmkb) (Press release, MacroGenics, OCT 22, 2024, View Source [SID1234647315]).

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MARGENZA was approved by the U.S. Food and Drug Administration (FDA) in December 2020 in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. The approval was based on results from the pivotal Phase 3 head-to-head clinical trial (SOPHIA) evaluating the safety and efficacy of MARGENZA vs. Herceptin (trastuzumab), both combined with chemotherapy.

Pursuant to the terms of the agreement, TerSera will pay MacroGenics $40 million at closing. MacroGenics may receive additional sales milestone payments of up to an aggregate of $35 million. The transaction is expected to close in the fourth quarter of 2024, subject to customary closing conditions.

"This transaction will enable us to focus our efforts on advancing our pipeline of novel and differentiated oncology product candidates," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "We believe TerSera’s established and complementary U.S. commercial infrastructure has the potential to broaden patient access to MARGENZA."

"MARGENZA is an important treatment option for patients with metastatic HER2+ breast cancer," said Edward Donovan, Chief Executive Officer of TerSera. "We are very excited to add MARGENZA to our existing oncology portfolio, deepening our commitment to the treatment of patients with breast cancer."

IMPORTANT SAFETY INFORMATION

BOXED WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY

Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function.
Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.
WARNINGS & PRECAUTIONS:

Left Ventricular Dysfunction

Left ventricular cardiac dysfunction can occur with MARGENZA.
In SOPHIA, left ventricular dysfunction occurred in 1.9% of patients treated with MARGENZA.
MARGENZA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of myocardial infarction or unstable angina within 6 months, or congestive heart failure NYHA class II-IV.
Withhold MARGENZA for ≥16% absolute decrease in LVEF from pretreatment values or LVEF below institutional limits of normal (or 50% if no limits available) and ≥10% absolute decrease in LVEF from pretreatment values.
Permanently discontinue MARGENZA if LVEF decline persists greater than 8 weeks, or dosing is interrupted more than 3 times due to LVEF decline.
Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment. Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.
Monitor cardiac function every 4 weeks if MARGENZA is withheld for significant left ventricular cardiac dysfunction.
Embryo-Fetal Toxicity

Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman. Post-marketing studies of other HER2 directed antibodies during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.
Advise pregnant women and women of reproductive potential that exposure to MARGENZA during pregnancy or within 4 months prior to conception can result in fetal harm.
Advise women of reproductive potential to use effective contraception during treatment and for 4 months following the last dose of MARGENZA.
Infusion-Related Reactions (IRRs)

MARGENZA can cause IRRs. Symptoms may include fever, chills, arthralgia, cough, dizziness, fatigue, nausea, vomiting, headache, diaphoresis, tachycardia, hypotension, pruritus, rash, urticaria, and dyspnea.
In SOPHIA, IRRs were reported by 13% of patients on MARGENZA plus chemotherapy. Most of the IRRs occur during Cycle 1. Grade 3 IRRs were reported in 1.5% of MARGENZA-treated patients.
Monitor patients during and after MARGENZA infusion. Have medications and emergency equipment to treat IRRs available for immediate use.
In patients experiencing mild or moderate IRRs, decrease rate of infusion and consider premedications, including antihistamines, corticosteroids, and antipyretics. Monitor patients until symptoms completely resolve.
Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with supportive medical therapy as needed. Permanently discontinue MARGENZA in all patients with severe or life-threatening IRRs.
MOST COMMON ADVERSE REACTIONS:

The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia (57%), nausea (33%), diarrhea (25%), vomiting (21%), constipation (19%), headache (19%), pyrexia (19%), alopecia (18%), abdominal pain (17%), peripheral neuropathy (16%), arthralgia/myalgia (14%), cough (14%), decreased appetite (14%), dyspnea (13%), infusion-related reactions (13%), palmar-plantar erythrodysesthesia (13%), and extremity pain (11%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).

INDICATION

MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

Please see full Prescribing Information, including Boxed Warning.

About HER2-positive Breast Cancer

Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Monoclonal antibodies targeting HER2 have greatly improved outcomes; however, a significant number of patients progress to later lines of therapy. Effective treatments for metastatic HER2-positive breast cancer continue to remain an unmet need.

About MARGENZA

MARGENZA (margetuximab-cmkb) is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Similar to trastuzumab, margetuximab-cmkb inhibits tumor cell proliferation, reduces shedding of the HER2 extracellular domain and mediates antibody-dependent cellular cytotoxicity (ADCC). However, through MacroGenics’ Fc Optimization technology, margetuximab-cmkb has been engineered to enhance the engagement of the immune system. In vitro, the modified Fc region of margetuximab-cmkb increases binding to the activating Fc receptor FCGR3A (CD16A) and decreases binding to inhibitor Fc receptor FCGR2B (CD32B). These changes lead to greater in vitro ADCC and NK cell activation. The clinical significance of in vitro data is unknown.

On October 22, 2024 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments using its proprietary, drug-specific patient selection technology, reported that the European Patent Office (EPO) has issued a formal notice of its intention to grant a patent for Allarity’s Drug Response Predictor (DRP) companion diagnostic specific to stenoparib, the Company’s dual-targeted PARP/Tankyrase inhibitor (Press release, Allarity Therapeutics, OCT 22, 2024, View Source [SID1234647316]).

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This patent represents a significant step forward in securing Allarity’s market position for stenoparib and the Stenoparib DRP companion diagnostic, which identifies patients most likely to derive clinical benefit from stenoparib treatment.

Thomas Jensen, CEO of Allarity Therapeutics, commented, "As we advance our clinical program for stenoparib, we are also focused on securing patents in key markets to pave the way for potential future commercialization. Though our main focus is to first achieve regulatory approval in the US for both stenoparib and its DRP companion diagnostic, we strongly believe stenoparib has the potential to help ovarian cancer patients worldwide. Therefore, knowing that the EPO intends to grant us a European patent for the Stenoparib DRP is an important step towards securing the foundation for an international market position for stenoparib and its companion diagnostic."

Patent applications for the Stenoparib DRP companion diagnostic are also pending in the United States, Japan, China, Australia, and India. Allarity has previously been granted 17 patents for drug-specific DRPs, including eight in the United States.

About Stenoparib
Stenoparib is an orally available, small-molecule, dual-targeted inhibitor of PARP1/2 and Tankyrase 1 and 2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the Wnt signaling pathway. Aberrant Wnt/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and also blocking Wnt pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic. Allarity has exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, are found to have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients dozens of clinical studies (both retrospective and prospective). The DRP platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in the peer-reviewed literature.

On October 22, 2024 (the "Closing Date"), MEI Pharma, Inc., a Delaware corporation (the "Company"), and Aardvark Therapeutics, Inc., a Delaware corporation (the "Purchaser"), reported to have entered into an Asset Purchase Agreement (the "Asset Purchase Agreement"), pursuant to which the Company sold its rights, title and interest in and to certain assets related to ME-344 (the "Program Candidate"), including relevant intellectual property rights, technology and contracts (Filing, 8-K, MEI Pharma, OCT 22, 2024, View Source [SID1234647440]). Pursuant to the Asset Purchase Agreement, the Purchaser paid the Company an initial payment of $500,000 in cash plus the Reimbursement Amount (as defined in the Asset Purchase Agreement) at the closing of the transactions contemplated by the Asset Purchase Agreement (the "Closing") and may make payments up to $62 million after the Closing (the "Milestone Payments"), payable upon the achievement of certain milestones regulatory approval and sales related to the Program Candidate (the "Milestone Events"). The Purchaser also assumed certain liabilities of the Company arising after the Closing, including liabilities arising under the transferred contracts.

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The Asset Purchase Agreement and the transactions contemplated therein were approved by the board of directors of the Company. The Asset Purchase Agreement contains customary representations, warranties and covenants of each of the Company and the Purchaser. Subject to specified survival limitations, the representations and warranties contained in the Asset Purchase Agreement terminated immediately following the Closing.

Other than the Asset Purchase Agreement, there exists no material relationship between the Company, its affiliates or any of the Company’s directors and officers, on the one hand, and the Purchaser, on the other. The terms of the transaction were negotiated between the Company and the Purchaser on an arms-length basis.

The foregoing description of the Asset Purchase Agreement is qualified in its entirety by reference to the complete text of the Asset Purchase Agreement, which is attached as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.

The Asset Purchase Agreement contains representations and warranties that the parties made to, and are solely for the benefit of, each other. Investors and security holders should not rely on the representations and warranties as characterizations of the actual state of facts since they were made only as of the date of the Asset Purchase Agreement. Moreover, information concerning the subject matter of such representations and warranties might change after the date of the Asset Purchase Agreement, which subsequent information might or might not be fully reflected in public disclosures.

On October 21, 2024 Astex Pharmaceuticals, a pharmaceutical company based in Cambridge, UK, dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, reported that it will make five key data presentations at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on molecular targets and cancer therapeutics, 23rd-25th October 2024, Barcelona, Spain (Press release, Astex Pharmaceuticals, OCT 21, 2024, View Source [SID1234647280]). The Astex presentations will focus on its novel small-molecule CBP/p300 HAT domain inhibitor, ASTX528 in preclinical development and its Phase II-ready MDM2 antagonist, ASTX295.

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Astex data presentations at 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium, 23rd-25th October 2024, Barcelona

Title Presentation Date/Time/Session Title/Presenter Presentation number
A Novel Small-Molecule CBP/p300 HAT Domain Inhibitor Demonstrates Potent In Vivo Activity and a Favourable Safety Profile in Preclinical Species Poster Date: Wed, 23rd Oct 2024
Time: 12:00 – 19:00

Session Title: Molecular Targeted Agents

Presenter: Gianni Chessari, Astex Pharmaceuticals, UK

Catalog #42
Presentation #PB030

Targeting the Catalytic HAT Domain of CBP/p300 for the Treatment of Hormone-Dependent Breast and Prostate Cancers Poster Date: Wed, 23rd Oct 2024
Time: 12:00 – 19:00

Session Title: Molecular Targeted Agents

Presenter: John Lyons, Astex Pharmaceuticals, UK

Catalog #73
Presentation #PB061

From a Preclinical Therapeutic Concept to the Clinic. ASTX295: Discovery of a bone marrow sparing MDM2 antagonist Oral Date: Wed, 23rd Oct 2024
Time: 16:55 -17:15

Session Title: Optimising of preclinical models for drug development

Presenter: Maria Ahn, Astex Pharmaceuticals, UK

Workshop 2
Room 113+114

Identification of Biomarkers Predictive of Response to ASTX295, a Next-Generation MDM2 Antagonist, in Solid Tumors Carrying Wild-type p53 Poster Date: Wed, 23rd Oct 2024
Time: 12:00 – 19:00

Session Title: Molecular Targeted Agents

Presenter: Maria Ahn, Astex Pharmaceuticals, UK

Catalog #28
Presentation #PB016

Pulsatile Induction of the p53 Pathway by MDM2 Antagonist ASTX295 Shows an Enhanced Therapeutic Index in vivo Poster Date: Thu, 24th Oct 2024
Time: 9:00 – 17:30

Session Title: Translational Studies

Presenter: Andrea Biondo, Astex Pharmaceuticals, UK

Catalog #289
Presentation #PB277

ASTX528 – CBP/p300 HAT Domain Inhibitor – Preclinical

ASTX528 is a novel small molecule CBP/p300 HAT domain inhibitor with potent in vivo activity and a favourable safety profile in preclinical species that was discovered by Astex using its proprietary fragment-based drug discovery approach. CREB binding protein (CBP) and its paralog, EP300 (p300), are lysine acetyltransferases and transcriptional cofactors implicated in human cancers. Dose-limiting tolerability issues have been observed with dual CBP/p300 bromodomain (BRD) inhibitors, which may limit their clinical utility. We hypothesised that a dual inhibitor targeting the histone acetyltransferase (HAT) domain may improve the therapeutic window. Our presentations will describe the effects of CBP/p300 HAT domain inhibition in preclinical models of AR- and ER-driven cancers and the characterisation of ASTX528, a potent, fragment-derived CBP/p300 HAT domain inhibitor with a low predicted human dose and promising preliminary toxicity evaluation. Astex is interested in discussing the further development of ASTX528 with potential partners.

ASTX295 – Bone Marrow-Sparing MDM2 Antagonist, Phase II-ready

ASTX295 is an oral, potent inhibitor of the p53-MDM2 protein-protein interaction that was discovered by Astex using its proprietary structure-based drug design approach. The compound was specifically designed to overcome the on-target toxicity seen in the first generation MDM2 antagonist compounds which have shown dose-limiting haematological toxicities in the clinic. In contrast, ASTX295 is a potent MDM2 antagonist with a clean CYP/hERG profile and a shorter human half-life allowing for pulsatile pathway modulation while avoiding myelosuppression. ASTX295 therefore has bone-marrow sparing characteristics which permit a differentiated safety profile. ASTX295 was discovered by Astex in collaboration with the Cancer Research UK Drug Discovery Unit at Newcastle University. Astex has an exclusive license to research, develop and commercialise ASTX295 under its drug discovery alliance agreement with Newcastle University and Cancer Research Technology Limited.

On October 21, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued positive opinions recommending an extended authorization for TEVIMBRA (tislelizumab) in gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC) (Press release, BeiGene, OCT 21, 2024, View Source [SID1234647281]).

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In G/GEJ adenocarcinoma, the CHMP positive opinion is for TEVIMBRA in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic G/GEJ cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score ≥ 5%. In ESCC, the CHMP positive opinion is for TEVIMBRA in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic ESCC whose tumors express PD-L1 with a TAP score ≥ 5%.

"Survival rates in the advanced stages of gastric/gastroesophageal and esophageal cancers are among the lowest of all cancer types despite recent advances, and new treatment options are needed," said Prof. Florian Lordick, Director and Professor of Oncology of the University Cancer Center Leipzig, Germany. "The RATIONALE-305 and 306 trials showed that tislelizumab plus chemotherapy improved survival compared to treatment with placebo plus chemotherapy, highlighting its potential to deliver better outcomes for eligible patients."

"TEVIMBRA is foundational for BeiGene’s solid tumor portfolio. In line with our commitment to help patients affected by cancer in Europe and across the globe, we recently launched TEVIMBRA in the EU for eligible patients in both the first- and second-line NSCLC settings and second-line ESCC," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "With these CHMP opinions, we are one step closer to bringing this innovative therapy to eligible patients with untreated G/GEJ cancer and ESCC , who face a poor prognosis and limited treatment options."

The extension of indication application for first-line G/GEJ cancer is based on results from BeiGene’s RATIONALE-305 (NCT03777657), a randomized, double-blind, placebo-controlled, global Phase 3 trial to evaluate the efficacy and safety of TEVIMBRA in combination with chemotherapy as a first-line treatment for patients with advanced unresectable or metastatic G/GEJ cancer. The study enrolled 997 patients at research centers across Europe, North America and Asia-Pacific. The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of 15.0 months for patients treated with TEVIMBRA in combination with investigator’s choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy (n=997; HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011), resulting in a 20% reduction in the risk of death. In the PD-L1 ≥ 5% population, the median OS was 16.4 months for TEVIMBRA plus chemotherapy compared to 12.8 months for the placebo arm (HR: 0.71 [95% CI, 0.58-0.86]), which represents a 29% reduction in the risk of death.

The extension of indication application for first-line ESCC is based on results from BeiGene’s RATIONALE-306 (NCT03783442), a randomized, placebo-controlled, double-blind, global Phase 3 study to evaluate the efficacy and safety of TEVIMBRA in combination with chemotherapy as a first-line treatment in patients with unresectable, locally advanced recurrent or metastatic ESCC. The study enrolled 649 patients at research centers across Europe, North America and Asia-Pacific. The study met its primary endpoint, with first-line TEVIMBRA in combination with chemotherapy resulting in statistically significant and clinically meaningful OS benefit compared with placebo plus chemotherapy in the intent-to-treat population. The median OS was 17.2 months for TEVIMBRA with chemotherapy versus 10.6 months for placebo plus chemotherapy (HR: 0.66 [95% CI, 0.54-0.80, 1-sided p-value of < 0.0001]), a 34% reduction in the risk of death. Three-year OS in the PD-L1 ≥ 5% population was also substantially improved in favor of the TEVIMBRA arm (median 19.1 versus 10.0 months, respectively; HR: 0.62 [95% CI, 0.49-0.79]), demonstrating a 38% reduction in the risk of death.

The safety data in the applications included 1,534 patients who received TEVIMBRA monotherapy at the approved dosing regimen, and 1,319 patients with G/GEJ cancer, ESCC or NSCLC who received TEVIMBRA at the approved dosing regimen (200 mg every 3 weeks) in combination with various chemotherapies. The most common Grade 3 or 4 adverse reactions for TEVIMBRA given in combination with chemotherapy were neutropenia, thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia, pneumonia, decreased appetite, rash, lymphopenia, alanine aminotransferase increased, aspartate aminotransferase increased, diarrhea, pneumonitis, and hepatitis.

TEVIMBRA is approved in the EU for eligible patients with advanced or metastatic ESCC after prior platinum-based chemotherapy and for three non-small cell lung cancer (NSCLC) indications covering both the first- and second-line settings.

About Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma

Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth highest leading cause of cancer mortality.1 Nearly 1 million new patients were diagnosed with gastric cancer in 2022, and 660,000 deaths were reported globally. Gastroesophageal junction adenocarcinoma occurs at the area where the esophagus joins the stomach, which is just beneath the diaphragm (the thin sheet of breathing muscle under the lungs).2

About Esophageal Squamous Cell Carcinoma (ESCC)

Globally, esophageal cancer (EC) is the sixth most common cause of cancer-related deaths, and ESCC is the most common histologic subtype, accounting for nearly 90% of ECs. An estimated 957,000 new EC cases are projected in 2040, an increase of nearly 60% from 2020, underscoring the need for additional effective treatments.3 EC is a rapidly fatal disease, and more than two-thirds of patients have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases.4

About TEVIMBRA (Tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

This information is intended for a global audience. Product indications vary by region.