On November 12, 2021 OncoMyx Therapeutics, a privately-held oncolytic immunotherapy company, reported the presentation of new preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-Conference Programs (SITC 2021) being held November 10-14, 2021, both virtually and in Washington, D.C (Press release, OncoMyx Therapeutics, NOV 12, 2021, View Source [SID1234595341]). The data demonstrate the potential of a multi-armed myxoma virotherapy for the treatment of solid tumors and heme malignancies. In addition to direct oncolytic effects on cancer cells, OncoMyx’s multi-armed myxoma platform show additional anti-tumor activity through immune activation and tumor microenvironment modulation. Furthermore, OncoMyx has previously established in a preclinical model of cancer that myxoma virus has anti-tumor efficacy following intravenous (IV) or intratumoral (IT) dosing (data presented at AACR (Free AACR Whitepaper) 2021).

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"Myxoma is a unique virus in that it naturally infects and kills cancer cells, but it is a nonhuman pathogen, so there’s no preexisting immunity, which allows for systemic dosing, a longer dosing window, and multi-dosing," said Steve Potts, Ph.D., MBA, cofounder and CEO of OncoMyx. "Furthermore, the large size of the myxoma genome allows for the insertion of multiple genes to arm the virus with immune modulators that can orchestrate the cancer-immunity cycle for optimal viral-mediated cancer-killing activity. These data show the unmatched potential of our myxoma platform to be effective across a broad range of cancers, from hematological malignancies to solid tumors. The data, along with previously published studies, support the advancement of these therapies into clinical development as a monotherapy and in combination with many cancer therapeutics and immunotherapies, including checkpoint inhibitors and chemotherapies."

Immune modulation is a key component of the anti-tumor activity of multi-armed myxoma virus in vivo. The data presented show myxoma multi-armed with decorin and IL-12 infects and kills primary human multiple myeloma cells in vitro and demonstrates efficacy in a mouse model of multiple myeloma. Additional data presented show multi-armed myxoma virus demonstrates efficacy in syngeneic and xenograft tumor models following IT or IV delivery and combinatorial efficacy with immune checkpoint inhibitors.

Titles of the presentations are as follows:

(742) Multi-armed myxoma virus induces potent anti-tumor responses in vitro and in vivo
(744) Multi-armed myxoma virus has therapeutic potential for treatment of multiple myeloma
Onsite posters will be presented in the Poster Hall at the Walter E. Washington Convention Center. The posters will be available for onsite viewing November 12-14 from 7am to 5pm EST. Even numbered posters will be presented Saturday, November 13. ePosters will be on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform from 7am EST on Friday, November 12 until the virtual meeting platform is closed on January 9, 2022.

Posters for both presentations are available to view and download here (under publications).

About Oncolytic Immunotherapy and Myxoma Virus

Oncolytic viruses (OV) selectively replicate in and lyse tumor cells and provide stimulation to the immune system, representing a promising therapeutic option in development to treat cancers that do not respond well to treatment with immune checkpoint inhibitors. Myxoma virus (MYXV) is a member of the Pox family of double-stranded DNA viruses. The natural host of MYXV is a subset of rabbits and hares, but MYXV is able to infect cancer cell lines of humans and other species. The genome of MYXV is relatively large and is amenable to engineering for expression of transgenic proteins, making it an excellent oncolytic virus for introduction of immunomodulatory proteins.

On November 12, 2021 BeyondSpring (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported that management will present at and host one-on-one investor meetings during the virtual portion of the Jefferies London Healthcare Conference, taking place November 18-19, 2021 (Press release, BeyondSpring Pharmaceuticals, NOV 12, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-to-present-at-the-2021-jefferies-london-healthcare-conference [SID1234595381]).

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The presentation will be available on-demand for attendees during the virtual conference beginning on November 18, 2021. Investors who would like to view the presentation or request a meeting with management may do so by clicking on the link and registering for the event HERE.

A replay of the presentation will also be available on BeyondSpring’s website on the Events & Presentations page for 30 days following the conclusion of the conference.

On November 12, 2021 Keros Therapeutics, Inc. ("Keros") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, reported that Keros’ President and Chief Executive Officer Jasbir S. Seehra, Ph.D. will present at the Jefferies Virtual London Healthcare Conference (Press release, Keros Therapeutics, NOV 12, 2021, View Source [SID1234595398]).

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The presentation will be available on Thursday, November 18 starting at 3:00 a.m. ET at View Source and archived in the Investors section of the Keros website at View Source A replay will be available for 90 days following the conclusion of the event.

On November 12, 2021 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported its financial results for the third quarter of 2021 and provided a corporate update (Press release, Xenetic Biosciences, NOV 12, 2021, View Source [SID1234595451]).

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"Our team continues to advance the XCART program and validate key workflow and manufacturing components which move us closer to conducting IND-enabling studies. Building on the proven success of CAR T therapy, we believe that Xenetic’s approach is innovative and is well-positioned to have a meaningful impact by addressing the significant unmet needs in certain hematological malignancies. As we continue to advance this important program and witness the potential of the XCART platform, our confidence holds strong in its ability to target cancers with a patient- and tumor-specific approach," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

XCART Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific neoantigens that target independently of CD19 or other surface antigens that are common to both normal and malignant B-cells. Lead program for Non-Hodgkin lymphoma, an area of significant unmet need, with the potential to address an initial global market opportunity of over $7 billion annually.1

Program Highlights:

Advancing preclinical efforts through ongoing research and development collaborations including with Scripps Research and other institutions covering design and implementation of the pre-clinical development program, as well as activities supporting process development for clinical manufacturing.
The exploratory biopsy study in Eastern Europe achieved its initial objective of supporting further XCART platform development, including that of downstream XCART processes, and has provided materials and methods needed to proceed with IND-enabling studies.
Bolstered intellectual property portfolio with issuance of a U.S. patent covering the co-administration of XCART-derived CAR T cells, together with a personalized vaccine designed to enhance the effectiveness of the CAR T therapy.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlights:

Royalty payments of approximately $0.3 million were received in the quarter ended September 30, 2021, from the Company’s sublicense with Takeda. Takeda’s sublicensee has now launched the relevant product in multiple global markets.
Company’s partner, Pharmsynthez, has filed a registration dossier in Russia to obtain approval of Epolong, a polysialylated form of human erythropoietin as a treatment for anemia in patients with chronic kidney disease.
Summary of Financial Results for Third Quarter 2021
Net loss for the quarter ended September 30, 2021, was approximately $1.4 million. Research and development expenses for the three months ended September 30, 2021, increased by approximately $0.2 million, or 36.1%, to $0.8 million from $0.6 million in the comparable quarter in 2020. The increase was due to the Company’s increased spending on the XCART platform technology. General and administrative expenses for the three months ended September 30, 2021, was $0.9 million, increasing $0.1 million, or 17.5%, compared to the same period in the prior year. The increase was primarily due to increases in employee related, legal and consulting costs during the three months ended September 30, 2021, compared to the same period in 2020. In July 2021, the Company completed a $12.5 million private placement of common stock and warrants to purchase common stock resulting in approximately $11.5 million of net proceeds to the Company. At September 30, 2021, the Company reported working capital was approximately $19.5 million. The Company ended the quarter with approximately $19.7 million of cash.

On November 12, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported data from its Phase 1 study evaluating vudalimab (XmAb717), a PD-1 x CTLA-4 bispecific antibody, in patients with advanced solid tumors (DUET-2) (Press release, Xencor, NOV 12, 2021, View Source [SID1234595468]). The updated results, predominantly from the study’s expansion cohorts, are presented in a poster titled, "Preliminary clinical experience with XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in patients with advanced solid tumors" at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

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"Data from early-stage studies suggest that PD-1 and CTLA-4 inhibition has promise in prostate cancer, an area with high unmet need and without much checkpoint use. Dual targeting of these checkpoints through a bispecific antibody with a differentiated tolerability profile could meet an important unmet clinical need. In our Phase 1 study, we have observed vudalimab to be generally well tolerated, with lower rates of some types of immunotherapy-related adverse events, and to have encouraging clinical activity," said Allen Yang, M.D., Ph.D., senior vice president and chief medical officer at Xencor. "We are now enrolling a Phase 2 study of vudalimab for patients with metastatic castration-resistant prostate cancer, as a monotherapy or in combination, depending on molecular subtype. In addition, we are initiating a second Phase 2 study in patients with advanced pelvic tumors, including clinically defined high risk mCRPC and certain gynecologic malignancies, which represent another opportunity for vudalimab’s dual targeting of PD-1 and CTLA-4 to address an unmet need."

At the data cut off, 110 patients had been treated at the 10 mg/kg recommended dose level in dose-escalation (n=7) and in five dose expansion cohorts: melanoma (n=20), renal cell carcinoma (RCC, n=21), non-small cell lung cancer (NSCLC, n=20), castration-resistant prostate cancer (CRPC, n=21) and other cancers without approved checkpoint therapies (n=21). 10 mg/kg was identified as the recommended dose for the multi-cohort, parallel-group expansion phase, based on an observation of consistent proliferation of both CD8+ and CD4+ T cells, indicative of dual checkpoint blockade, and a complete response (CR) in one patient with melanoma.

The safety analysis includes all 110 patients, who were a median of 65 years old and were heavily pretreated, having a median of four prior systemic therapies. 65% of patients had received at least one prior checkpoint therapy, and 25% had received at least two prior checkpoint therapies.

Vudalimab was generally well-tolerated, and the most common treatment-related adverse events were immune-related adverse events (irAEs). The most common irAEs of any grade were rash (45.5%), pruritus (30.9%), transaminase increases (23.6%), diarrhea (11.8%), hypothyroidism (9.1%), infusion related reaction (8.2%) and myalgia (8.2%).
As previously reported, immune-mediated pancreatitis (Grade 5) was reported for one patient with RCC, whose cancer had already metastasized to the pancreas at baseline and progressed on study, and Grade 5 myocarditis and respiratory failure were reported for a patient with NSCLC who had a history of significant cardiac events, including atrial fibrillation and the insertion of a dual-chamber pacemaker.
The efficacy analysis included 78 evaluable patients receiving any amount of vudalimab, who had been followed for at least two cycles prior to data cut.

A complete response was observed in a patient with BRCA1+ high-grade serous ovarian cancer, who had received multiple prior treatments, including olaparib and nivolumab in the metastatic setting. The patient had a partial response after Cycle 4, and by Cycle 18 of treatment all lesions had resolved except a lesion in the abdominal wall, which later showed no cancer cells upon biopsy.
A confirmed complete response was observed in a patient with melanoma during dose-escalation at the 10 mg/kg dose level, as previously reported.
Partial responses were observed in patients with melanoma (n=2), RCC (n=3), NSCLC (n=2) and CRPC (n=2). The objective response rate across cohorts was 14.1% (11/78). All responses in patients with melanoma and CRPC and two responses in patients with RCC were confirmed. All responders, except those with CRPC, had received prior checkpoint inhibitor therapy.

Of the 12 efficacy-evaluable patients with CRPC, four had measurable disease and follow-up RECIST assessments, including the two CRPC responders.
Six additional patients with CRPC, but without measurable disease, experienced a best overall response of non-CR/non-PD, as stable disease cannot be determined without measurable disease.
The two CRPC responders had visceral and nodal metastases, had response durations of 41.3 and 27.0 weeks, were without progression on bone scans and had confirmed prostate-specific antigen (PSA) reductions of more than 50% from baseline. Among twelve patients with baseline and follow-up PSA assessments, including the two responders, 33% (4/12) had PSA reductions greater than 50%.
The median duration of response, unadjusted, for all responders was 18.3 weeks. The median duration of response, unadjusted, for patients with RCC was 24.1 weeks, and two patients remained on treatment.

Pharmacodynamic analysis indicated that activation and proliferation of both CD8+ cytotoxic T cells and CD4+ helper T cells was observed, which is consistent with dual PD-1 and CTLA-4 checkpoint inhibition. Baseline serum levels of the cytokines IL-6, IL-8 and IL-10 trended lower in patients who achieved a response on study. Low baseline tumor expression of myeloid recruitment genes (CXCL3 and CXCL8) was also associated with clinical benefit.

The poster will be archived under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com.

About Vudalimab (XmAb717)

Vudalimab (XmAb717) is an XmAb bispecific antibody that simultaneously targets immune checkpoint receptors PD-1 and CTLA-4 and is designed to promote tumor-selective T-cell activation. Xencor’s approach to dual checkpoint/co-stimulation reduces the need for the multiple antibodies and allows for more selective targeting of T cells with high checkpoint expression, which may potentially improve the therapeutic index of combination immunotherapies. In preclinical studies, dual blockade of PD-1 and CTLA-4 with vudalimab significantly enhanced T cell proliferation and activation, and anti-tumor activity in vivo. Xencor has initiated a Phase 2 clinical study of vudalimab in patients with metastatic castration resistant prostate cancer (mCRPC), as a monotherapy or in combination depending on subtype, and a Phase 2 clinical study in patients with advanced gynecologic and genitourinary malignancies, as well as clinically defined high-risk mCRPC.