On October 3, 2022 SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported the publication of preclinical research on the SQZ Activating Antigen Carrier (AAC) platform (Press release, SQZ Biotech, OCT 3, 2022, View Source [SID1234621644]). The data, published in Frontiers in Immunology, demonstrated that the company’s Cell Squeeze platform can be used to generate AACs by engineering red blood cells (RBCs) with antigen and adjuvant that can drive antigen-specific activation of T cells both in mouse in vivo and human in vitro systems. The study also used a mouse tumor model to show that the efficacy of the AAC therapy could be further enhanced by combining with the chemotherapeutic agent, Cisplatin.

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 paper demonstrates the potential of our technology to generate an effective red blood cell-derived cancer immunotherapy," said Howard Bernstein, M.D., Ph.D., Chief Scientific Officer at SQZ Biotechnologies. "The ability of the Cell Squeeze platform to engineer RBCs to leverage the natural process of RBC clearance for T cell activation represents a promising new therapeutic approach to cancer treatment. We look forward to building on these preclinical results in our ongoing Phase 1/2 clinical trial."

The company’s engineered RBCs are designed to transport their cargo of antigen and adjuvant to professional antigen presenting cells (APCs) in the body. The published data demonstrate that when these professional APCs process the engineered RBC, they present the desired antigen to endogenous T cells and drive their activation. This approach to generate RBC therapeutics could be tailored to deliver a variety of antigen and adjuvant materials, and other possible agents, to potentially enhance different aspects of anti-tumor immunity.

"We are excited about the preclinical findings of our AAC program, which has shown potential in both monotherapy settings and in combination with chemotherapy," said Scott Loughhead, Ph.D., VP of Translational Research at SQZ Biotechnologies. "AACs represent a truly differentiated approach that offers the opportunity for broad applicability across solid tumor types."

Study Findings:

Generation of AACs: Investigators used the Cell Squeeze technology to engineer RBCs with E6 and E7 antigens and the adjuvant, poly I:C. This process generates AACs that resemble aged RBCs which triggers rapid clearance by professional APCs.
Effective Delivery to APCs: The method leverages the natural process of RBC clearance to deliver tumor antigens to endogenous professional APCs without the use of chemical or viral vectors.
Antigen-Specific Activation of T cells: AAC uptake, antigen processing, and presentation by APCs drove antigen-specific activation of T cells in mouse in vivo and human in vitro systems. In a mouse model of HPV16+ tumors, AAC therapy demonstrated significant anti-tumor effects including 12-fold improvement in CD8+ T cell infiltration and 900-fold improvement in E7 antigen-specific CD8+ T cell infiltration compared to untreated animals.
Enhanced Efficacy with Addition of Cisplatin: The combination of AAC therapy and the chemotherapeutic agent Cisplatin, a common treatment for HPV-driven tumors, increased the efficacy of the treatment in a preclinical tumor model.
About SQZ-AAC-HPV
SQZ AACs are generated by squeezing red blood cells (RBCs) with antigens and activating adjuvant. The process is tuned to make the engineered RBCs appear aged. Once administered to patients, SQZ AACs aim to be rapidly taken up by professional antigen presenting cells through a natural process to destroy aged RBCs in the body known as eryptosis. After being taken up, the encapsulated antigen and adjuvant within SQZ AACs is released, allowing for antigen processing and maturation of professional, endogenous antigen presenting cells in the lymphoid organs, and drives subsequent activation of HPV-specific T cells. SQZ-AAC-HPV is the first product candidate from the SQZ AAC platform.

About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years, often leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer, HPV+ tumors account for 4.5% of all cancers worldwide resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

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.

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 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.

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.

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!

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.

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!

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.

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.

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!

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.