On October 22, 2024 AbCellera (Nasdaq: ABCL) reported that executives from the Company will be presenting at the following investor conferences (Press release, AbCellera, OCT 22, 2024, View Source [SID1234647319]):

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Stifel Healthcare Conference on Monday, November 18, 2024, at 8:30 a.m. Pacific Time (11:30 a.m. Eastern Time)
Jefferies London Healthcare Conference on Tuesday, November 19, 2024, at 10:00 a.m. Pacific Time (5:00 p.m. Greenwich Mean Time)

Live audio webcasts of each presentation may be accessed through links that will be posted on AbCellera’s Investor Relations website. Replays of each webcast will be available through the same links following the presentations.

On October 22, 2024 AvenCell Therapeutics, Inc. ("AvenCell"), a leading clinical-stage cell therapy company focused on advancing both autologous and allogeneic switchable CAR-T cell therapies, reported that it has raised $112 million in Series B financing. The financing was led by global life sciences investor Novo Holdings (Press release, AvenCell Therapeutics, OCT 22, 2024, View Source [SID1234647318]). New investors F-Prime Capital, Eight Roads Ventures Japan, Piper Heartland Healthcare Capital and NYBC Ventures also participated in the round alongside founding investor Blackstone Life Sciences. As part of this financing, Michael Bauer, Ph.D., Partner, Venture Investments, Novo Holdings, and Nihal Sinha, MB BChir, Partner, F-Prime Capital will join AvenCell’s Board of Directors.

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This latest financing will support ongoing clinical validation of AvenCell’s proprietary, switchable universal CAR-T cell therapy platform that generates CAR-T cells that can rapidly be turned "Off" and "On" even after they are administered to a patient. The universal platform was developed to more safely and effectively treat a wide range of hematologic malignancies compared to conventional cell therapies. Current clinical assets utilizing AvenCell’s universal platform include AVC-101, a highly-differentiated autologous CAR-T cell candidate, and AVC-201, a CRISPR-engineered allogeneic CAR-T cell candidate. Both products target the antigen CD123 found on most Acute Myeloid Leukemia (AML) cells. The ongoing trials are investigating both products for the treatment of relapsed/refractory AML, which has a high unmet medical need, and very limited treatment options for patients. In addition, AvenCell has several pipeline candidates entering the clinic over the next two years.

"We are excited by the progress of our pipeline and believe our next-generation immunotherapies have the power to address significant unmet patient needs," said Andrew Schiermeier, Ph.D., Chief Executive Officer, AvenCell Therapeutics. "AvenCell is working to transform the standard of care through switchable, adaptable and readily available cell therapy treatments that can better treat a wide range of difficult-to-treat cancer and autoimmune diseases. The support of Novo Holdings and this leading group of new investors will be integral to our ability to progress and bring these therapies to patients."

"AvenCell’s universal switchable technology and CRISPR-engineered allogeneic platforms are first-of-its-kind and represent a step change in the field of cell therapy. Both AVC-101 and AVC-201 have already yielded encouraging safety and efficacy results in early clinical trials in a very difficult to treat disease like AML. Our investment reflects our confidence in these assets and the future of cell therapy, as well as our long-held strategy to support companies transforming care solutions to enhance patient outcomes," said Michael Bauer, Partner, Venture Investments, Novo Holdings.

"AvenCell’s switchable CAR-T platform represents a paradigm shift in cell therapy, offering unprecedented control over treatment dynamics," said Nihal Sinha, MB BChir, Partner at F-Prime Capital. "The ability to modulate CAR-T cell activity post-infusion could address critical safety and efficacy challenges in current therapies. We look forward to supporting AvenCell’s journey in advancing these promising cell therapies through clinical development, with the potential to address significant unmet needs in the treatment landscape."

On October 22, 2024 SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing oral small-molecule biosynthetic compounds for the treatment of inflammatory diseases, reported the expansion of its intellectual property in autoimmune disease and hepatocellular carcinoma (Press release, SFA Therapeutics, OCT 22, 2024, View Source [SID1234647317]). SFA Therapeutics has been issued a new patent in the United States (11963938) and has been allowed two patent applications in Canada (2,974,510) and in Korea (10-2017-7023391) with patent coverage through 2036. SFA Therapeutics has also been issued one new patent in Korea (10-2646764) with patent coverage through 2038.

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The United States patent and the allowed Canadian and Korean patent applications protect the short chain fatty acid composition that comprises SFA’s proprietary oral small-molecule biosynthetic compound SFA-001. SFA-001 is a potent immunomodulator being evaluated for the prevention, delay of onset, and treatment of hepatocellular carcinoma. In preclinical studies, SFA-001 demonstrated cytotoxicity against two common human liver cancer cell lines expressing the hepatitis B oncoprotein, HBx. Huh7x and Hep3BX are highly sensitive to SFA-001 without damage to normal liver cells. In 2019, the United States Food and Drug Administration granted an Orphan Drug Designation (ODD) to SFA-001 for the treatment of hepatocellular carcinoma.

The Korean patent protects the short chain fatty acid composition that comprises SFA-002, SFA Therapeutics’ lead candidate and Phase-2 ready potent immunomodulator being evaluated for the treatment of psoriasis. SFA-002 acts on multiple therapeutic pathways with the aim of restoring balance to the immune system. While SFA-002 inhibits pathways of pro-inflammatory cytokines such as IL-17, IL-23, TNF-α, and IFN-y, it also increases Treg differentiation and upregulates the anti-inflammatory cytokine IL-10.

"As SFA’s clinical development progresses, we understand the importance of strengthening our intellectual property portfolio to protect SFA Therapeutics’ proprietary therapeutic candidates," said Dr. Ira Spector, Chief Executive Officer of SFA Therapeutics. "The expansion of our patent portfolio allows us to continue the research and development necessary to bring drug candidates like SFA-001 and SFA-002 through the clinic to patients of autoimmune and inflammatory diseases. This brings the total number of issued and allowed SFA Therapeutics patents to 15, with 33 additional patents pending."

"These patents demonstrate the novel nature of SFA Therapeutics’ platform and drug candidates which are developed by adding disease-specific adjuvants to compounds that are naturally found in the human body," said Dr. Mark Feitelson, Chief Scientific Officer of SFA Therapeutics. "Our therapeutic candidates target multiple pathways in autoimmune and inflammatory conditions, working to inhibit pro-inflammatory cytokines, up-regulate anti-inflammatory targets, and suppress autoimmunity. We believe the intellectual property protected by these patents has the potential to not only manage symptoms from diseases, but to also address the underlying cause of these conditions and prevent or delay their onset."

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 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.