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Novocure to Report Third Quarter 2022 Financial Results

On October 3, 2022 Novocure (NASDAQ: NVCR) reported that it will report financial results for the third quarter 2022 on Thursday, October 27, 2022, before the U.S. financial markets open (Press release, NovoCure, OCT 3, 2022, View Source [SID1234621643]). Novocure management will host a conference call and webcast to discuss the company’s financial results for the three and nine months ended September 30, 2022, at 8 a.m. EDT on Thursday, October 27, 2022. To access the conference call by phone, use the following registration link, and dial-in details will be provided.

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The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Seneca Therapeutics Receives FDA Clearance to Begin SVV-001 Phase I/II Clinical Study

On October 3, 2022 Seneca Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to the development of novel immunotherapies for difficult to treat solid cancers reported it had received FDA clearance to begin a Phase I/II clinical study utilizing Seneca Valley Virus ("SVV-001") in combination with a checkpoint inhibitor (Press release, Seneca Therapeutics, OCT 3, 2022, View Source [SID1234621642]). This Phase I/II study with SVV-001 is in patients that are TEM8 positive and SVV-001 permissive with neuroendocrine tumors or neuroendocrine carcinomas. The study should begin enrollment early in 2023.

Kite Receives U.S. FDA Approval Of Viral Vector Manufacturing Facility In Southern California To Produce Commercial Product

On October 3, 2022 Kite, a Gilead Company (Nasdaq: GILD), reported the U.S. Food and Drug Administration (FDA) has approved the company’s retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production (Press release, Kite Pharma, OCT 3, 2022, View Source [SID1234621639]). Viral vectors are key components needed to manufacture Kite’s cell therapies to treat certain blood cancers. Kite is the only cell therapy company with in-house commercial and clinical trial viral vector manufacturing capabilities, augmenting its strong external supply partners.

CAR T-cell therapies are one-time treatments individually made starting from a patient’s own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite’s specialized manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR). During this process, a viral vector is used to encode the CAR in the patient’s T-cells so the engineered T-cells can recognize and attack the patient’s cancer cells in certain types of blood cancers. Once an individual therapy is created for a patient, the cells are carefully preserved, packed and sent back to the hospital to be infused back into the patient. Over 10,000 patients have been treated with Kite’s CAR T-cell therapies globally through more than 300 authorized treatment centers around the world, including 117 of the leading cancer hospitals in the U.S.

"The FDA approval of our commercial viral vector manufacturing facility further strengthens our global cell therapy manufacturing network with the addition of an in-house capability to produce a crucial element in the CAR T process, which is especially important as patient demand continues to grow," said Christi Shaw, Chief Executive Officer of Kite. "This milestone is several years in the making and reflects our continued commitment to, and investment in, bringing the curative intent of cell therapy to patients."

The Oceanside site is part of Kite’s global commercial manufacturing network that includes facilities in El Segundo, California, Amsterdam, Netherlands, and a recently FDA-approved Maryland site. This forms the largest dedicated in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. Kite has continued to increase its manufacturing network capacity to meet increasing demand, ensuring scheduling availability to meet the needs of physicians and their patients.

"The cell therapy manufacturing process is complex and requires specific materials, including viral vectors that play a critical role in ‘engineering’ a patient’s own T-cells to recognize and attack their cancer. The certainty of timely and dependable viral vector production supplied by our own facility provides an additional level of control essential for reliably delivering CAR T-cell therapy on a large commercial scale as well as providing supply for clinical trials to develop future treatments," said Chris McDonald, Global Head of Technical Operations, Kite.

The company continues to invest in its cell therapy workforce, employing approximately 100 employees at the 100,000-square-foot space. The capabilities and operations are fully scalable and will allow Kite to accommodate additional vector manufacturing as cell therapy science advances.

AMP886 Activity in Acute Myeloid Leukemia (AML)

On October 3, 2022 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that new data which demonstrates the potential of its second focal adhesion kinase (FAK) inhibitor AMP886 for the treatment of acute myeloid leukemia (AML) (Press release, Amplia Therapeutics, OCT 3, 2022, View Source;[email protected] [SID1234621638]). AML makes up about 1% of all cancer diagnoses and is a heterogeneous cluster of cancers that affect blood and bone marrow, with around 900 new cases diagnosed in Australia each year, about 50 of which are in children. Adults over 60 are the most commonly affected and have the poorest prognosis. Optimal treatment for AML depends on the disease subtype for each patient as well as their age/fitness but typically requires use of relatively toxic chemotherapies. Poorer response rates in older patients and high rates of relapse after treatment are also typical of AML.

Amplia’s drug candidate AMP886 potently inhibits both FAK and Fms-like tyrosine kinase 3 (FLT3). FLT3 is mutated in around a third of AML patients and is a clinically validated target for chemotherapy. There is a poor duration of response to current FLT3 inhibitors which often leads to an aggressive disease relapse and very poor patient outcomes. Emerging research supports combing inhibition of FLT3 and FAK to overcome disease rebound following to FLT3 monotherapy, 1 and that this approach may have a beneficial impact in AML patients.

2 Amplia has now shown that AMP886 inhibits AML in an industry-standard MV4-11 disease model recognised to carry the FLT3 mutation. Figure 1 shows that 21 days after inoculation with MV4-11 cells, oral doses of AMP886 significantly reduced the tumour burden in mice Figure 1: Dose dependent reduction in tumour growth measured via bioluminescence of AML MV4-11 cells following treatment with AMP886 Vehicle (0 mg/kg AMP886) AMP886 37.5 mg/kg AMP886 75 mg/kg 1 Allert, C. et al. Protein tyrosine kinase 2b inhibition reverts niche-associated resistance to tyrosine kinase inhibitors in AML. Leukemia (2022). View Source 2 Carter BZ, et al. Focal Adhesion Kinase as a Potential Target in AML and MDS. Mol Cancer Ther. (2017). View Source

In a second experiment, we measured the efficacy of AMP886 combined with venetoclax, a B-cell lymphoma 2 (BCL-2) inhibitor that is approved as part of combination therapy, typically for older patients with AML. Our rationale for adding AMP886 to venetoclax was based on recent reports showing that combination of FLT3 inhibitors and venetoclax may have clinical potential in patients with relapsed or refractory AML.

3 The data show (Figure 2a) that AMP886 is more effective in reducing AML cell growth than venetoclax alone. Figure 2b shows that while both AMP886 and venetoclax improve survival in the MV4-11 model of AML, the combination of the two drugs tended to further enhance survival. A

B Figure 2: (A) Inhibition of MV4-11 AML in mice treated with AMP886, venetoclax or combined AMP886 and venetoclax; (B) Kaplan-Meier survival curves of mice bearing MV4-11 AML when treated with AMP886, venetoclax or combined AMP886 and venetoclax Amplia’s CEO, Dr John Lambert, commented that "The impressive results we are reporting today tell us that there may be a clinical rationale to include AMP886 as part of new treatment regimens for unmet needs in AML. With an eye to expanding Amplia’s clinical development pipeline, further experiments are already underway with AMP886 to build on this data and establish a scientifically solid foundation for initiation of formal development of AMP886."

This ASX announcement has been approved and authorised for release by the Board of Amplia Therapeutics.

Alexion, AstraZeneca Rare Disease to Acquire LogicBio® Therapeutics to Accelerate Growth in Genomic Medicine

On October 3, 2022 Alexion, AstraZeneca Rare Disease, reported that it has entered a definitive agreement to acquire Lexington, Mass.-based LogicBio Therapeutics, Inc. (NASDAQ: LOGC), a pioneering genomic medicine company (Press release, Alexion, OCT 3, 2022, View Source [SID1234621637]). The proposed acquisition aims to rapidly accelerate Alexion’s growth in genomic medicines through LogicBio’s unique technology, experienced rare disease R&D team, and expertise in pre-clinical development.

"The proposed acquisition of LogicBio is a significant development for our growing research in genomic medicine," said Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease. "LogicBio’s people, experience and platforms provide new scientific capabilities by adding best-in-class technology and expertise to our genomic medicine strategy. The scientific collaboration between Alexion and AstraZeneca has been a substantial area of focus since last year’s acquisition and the addition of LogicBio will expand this foundational work."

LogicBio has developed technology platforms for the delivery and insertion of genes to address genetic diseases, as well as a platform designed to improve viral vector manufacturing processes. These platforms, coupled with LogicBio’s highly experienced team and Alexion’s advancements with AstraZeneca, will drive future scientific possibilities and next generation medicines to treat rare genetic diseases.

Fred Chereau, President and Chief Executive Officer, LogicBio, said: "We are excited about the opportunity to bring our science and expertise in genetic medicine to Alexion, which shares our commitment to discovering treatments for rare conditions and improving the lives of patients. Through this acquisition, we strive to accelerate our research in gene editing and AAV capsid development and together move the field of genomic medicine forward."

Under the terms of the agreement, Alexion, through a subsidiary, will initiate a cash tender offer to acquire all outstanding shares of LogicBio for $2.07 per share. Both boards have unanimously approved the transaction. Alexion plans to close the deal in four to six weeks, subject to the tender of at least a majority of the outstanding shares of LogicBio common stock and satisfaction of other closing conditions, and plans to retain LogicBio employees at their current location.