ON April 21, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that Dr. Matt Coffey, President and Chief Executive Officer, will be presenting a corporate overview at the Bloom Burton & Co. Healthcare Investor Conference, which is taking place May 2-3, 2022 at the Metro Toronto Convention Centre, North Building in Toronto, Ontario (Press release, Oncolytics Biotech, APR 21, 2022, View Source [SID1234612843]). Additional details on the presentation can be found below.

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Date: Tuesday, May 3, 2022
Time: 11:00 a.m. ET
Location: Metro Toronto Convention Centre, North Building Hall B
Webcast Link: Available by clicking here
Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a meeting request on the conference website, contact your Bloom Burton & Co. representative, or email [email protected].

A live webcast of the Company’s presentation will also be available on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months.

About the Conference
The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from the premier Canadian publicly traded and private companies through presentations and private meetings.

On April 21, 2022 Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, reported that results from the melanoma cohort in the ongoing phase I/II MATINS (Macrophage Antibody to Inhibit Immune Suppression) trial, will be presented at the 18th Congress of the European Association of Dermato-Oncology (EADO), being held in Seville, Spain, April 21 to April 23, 2022 (Press release, Faron Pharmaceuticals, APR 21, 2022, View Source [SID1234612830]).

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The melanoma cohort is one of the ten advanced treatment-resistant solid tumor types included in Part II (110 patients) of the MATINS study, which is investigating the potential of bexmarilimab, Faron’s wholly-owned investigational precision cancer immunotherapy, as a monotherapy. Bexmarilimab targets tumor associated macrophages, which are known to be immunosuppressive, make up nearly 50% of the tumor mass, and limit the efficacy of currently approved cancer immunotherapies, including anti PD-1/L1. As previously communicated, melanoma is among five different tumor types from the original 10 studied to have shown the strongest clinical benefit rate (CBR = partial response or stable disease) – 30% – alongside gastric cancer (30%), cholangiocarcinoma (30%), hepatocellular carcinoma (40%) and breast cancer (40%), following treatment with bexmarilimab.

Data from 11 melanoma patients (including the full cohort of 10 patients in Part II and one additional patient with same dosing regimen from Part I) who were refractory to checkpoint inhibition are being presented at the congress. All patients were treated with 1mg/kg of bexmarilimab monotherapy, every three weeks. The median number of previous treatment lines was three, the median age of patients was 60.

· Of the 11 patients, four experienced clinical benefit – one patient had a partial response after two cycles of bexmarilimab (tumor growth reduced by 40% from baseline) but was discontinued before a confirmatory scan was performed. Three patients had stable disease (i.e., clinical benefit rate of 30% in Part II).

· Current estimates for 12-month survival in Part II melanoma cohort were 100% for the patients who experienced clinical benefit following treatment compared to 33.3% of non-CBR patients.

· A preliminary biomarker analysis including the melanoma cohort showed that patients with higher intra-tumoral Clever-1 positivity and low baseline levels of serum interferon gamma (IFNy) and tumor necrosis factor alpha were more likely to experience clinical benefit following treatment with bexmarilimab. Among those patients who experienced clinical benefit, a marked rise in serum IFNy levels was seen during treatment. IFNy is a necessary pro-inflammatory cytokine for response to checkpoint inhibitors like PD-1/L1, highlighting bexmarilimab’s combination potential.

"This rate of clinical benefit is particularly striking when you consider these are heavily pre-treated patients, all of whom were refractory to currently approved checkpoint inhibitor therapy," said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. "Bexmarilimab’s ability to ignite an immune response in these patients means that it may serve as a catalyst for the immune system allowing initially checkpoint inhibitor resistant patients to become responsive to PD-1/L1 blockade."

"Additionally, the biomarker analysis among melanoma patients is consistent with our broader analyses and suggests that two cytokines, which can be measured by a standard blood test as part of a patient’s routine care, could hold the key to understanding which patients will gain the greatest benefit from this novel immunotherapy. Knowing which patients are most likely to respond to treatment is key to both the development process and the successful roll out of new therapeutic approaches."

On April 21, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that its PLACCINE platform technology at the World Vaccine Congress taking place in Washington D.C (Press release, Celsion, APR 21, 2022, View Source [SID1234612748]). In an oral presentation during a Session on Cancer and Immunotherapy, Dr. Khursheed Anwer, Celsion’s Chief Science Officer, highlighted the Company’s technology platform in his presentation entitled: "Novel DNA Approaches for Cancer Immunotherapies and Multivalent Infectious Disease Vaccines." PLACCINE is one of three platform technologies Celsion has for a range of therapeutics in oncology and immunotherapy. A copy of Dr. Anwer’s presentation is available on the investor portion of the Celsion website under Scientific Presentations.

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"PLACCINE is demonstrating the potential to be a powerful platform that provides for rapid design capability for targeting two or more different variants of a single virus in one vaccine," said Dr. Khursheed Anwer, Chief Science Officer at Celsion. "There is a clear public health need for vaccines today that address more than one strain of viruses, like COVID-19, which have fast evolving variant capability to offer the widest possible protection. Murine model data has thus far been encouraging and suggests our approach provides not only flexibility, but also the potential for efficacy comparable to benchmark COVID-19 commercial vaccines with durability to protect for more than 6 months."

Dr. Anwer continued, "In the murine model, our multivalent vaccine targeted against two different variants showed to be immunogenic as determined by the levels of IgG, neutralizing antibodies, and T-cell responses. Additionally, our multivalent vaccine was equally effective against two different variants of the COVID-19 virus while the commercial mRNA vaccine appeared to have lost some activity against the newer variant. We are continuing to evaluate our technology and look forward to the results from our ongoing proof-of-concept non-human primate study evaluating our PLACCINE vaccine against the challenge from live SARS-CoV-2 virus in the second quarter, with durability results available in the second half of this year."

PLACCINE is the company’s first-in-class nucleic-acid vaccine platform used to design its next-generation vaccine technology against multiple antigens. PLACCINE was derived from the Company’s TheraPlas platform and was designed to develop vaccines against infectious diseases that are administered by intramuscular (IM) injection. The platform allows for straightforward adoption of the vaccines to additional applications such as cancer vaccines. PLACCINE demonstrates Celsion’s deep scientific know-how and extensive expertise in the design of novel delivery formulations as well as novel DNA constructs.

Michael H. Tardugno, chairman, president and chief executive officer of Celsion, noted "We are pleased to have our PLACCINE platform and technology highlighted at this prestigious conference. A vaccine that targets multiple strains at once, which could also provide longer lasting immunity, is a logical next step in the COVID-19 vaccination strategy. With our proof-of-concept studies underway, we are optimistic our approach will prove to offer meaningful benefits over current vaccines targeting the SARS-CoV-2 virus."

On April 21, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported that Dr. Milton Werner, Ph.D., the Company’s President & Chief Executive Officer will participate in a fireside chat at the B. Riley Securities’ 2022 Virtual Neuro & Ophthalmology Conference on April 28, 2022 at 2:30pm ET (Press release, Inhibikase Therapeutics, APR 21, 2022, View Source [SID1234612757]).

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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

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A live webcast of the presentation will be available for on-demand viewing under "News & Events" in the Investors section of the Company’s website, www.inhibikase.com. An archived replay of the webcast will be available for approximately 30 days. In addition, the Company recently hosted a virtual Key Opinion Leader investor event on April 20, 2022. A replay of the event can be accessed here.

On April 21, 2022 OncXerna Therapeutics, Inc. ("OncXerna"), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, reported the peer-reviewed publication of results from a Phase 1b trial evaluating navicixizumab, an anti-DLL4/VEGF bispecific antibody, combined with paclitaxel, in patients with platinum-resistant ovarian cancer (PROC) (Press release, OncXerna Therapeutics, APR 21, 2022, View Source [SID1234612760]). The paper, entitled, "Phase Ib Study of Navicixizumab Plus Paclitaxel in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer," was published in Journal of Clinical Oncology and can be found here.

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Featured in the paper are efficacy and safety data from the trial as well as correlative biomarker results generated with OncXerna’s novel RNA gene expression-based diagnostic panel, the Xerna TME Panel. The Xerna TME Panel uses a machine learning-based algorithm to assign scores based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). Given navicixizumab’s anti-angiogenic mechanism of action, patients with high Xerna TME Panel angiogenesis scores were classified as biomarker positive (B+), while those with low angiogenesis scores were classified as biomarker negative (B-).

"This prestigious publication highlights the encouraging, durable clinical activity of navicixizumab in a heavily pretreated platinum resistant ovarian cancer patient population where the treatment options are very limited," said Kathleen Moore, M.D., Professor at The Stephenson Cancer Center, The University of Oklahoma. "In addition to seeing activity regardless of prior treatments, this study showed the potential of the Xerna TME panel to address the unmet need for a predictive biomarker for response to anti-angiogenic treatment."

Key data and conclusions from the paper include:

Navicixizumab plus paclitaxel showed promising and durable clinical activity in a heavily pretreated patient population regardless of prior treatment (median of four prior therapies)
Overall response rate (ORR) across all evaluable patients: 43% (19/44)
ORR in patients previously treated with bevacizumab (Avastin): 33% (10/30)
ORR in patients previously treated with a PARP inhibitor: 45% (9/20)
11 of 19 patients with partial or complete response had progressive disease as best response to immediate prior therapy
Median duration of response: 6 months
B+ classification showed enrichment of patients with tumor response
ORR in B+ vs. B- patients: 62% (8/13) vs. 25% (5/20)
Best response of progressive disease in B+ vs. B- patients: 0% (0/13) vs. 30% (6/20)
Median progression-free survival in B+ vs. B- patients: 9.2 months vs. 3.9 months
The safety profile of navicixizumab plus paclitaxel was consistent with known toxicities with no new safety signals or unexpected safety findings. The monitoring and management plan for hypertension and pulmonary hypertension was effective in reducing risk of severe toxicity and showed recovery upon treatment discontinuation. No grade 3 pulmonary hypertension or grade 4 hypertension reported. Treatment related adverse events led to discontinuation in 9% (4/44) of patients.
Laura Benjamin, Ph.D., Chief Executive Officer of OncXerna Therapeutics, commented, "We are thrilled with both the strength of our data and the external validation that comes from its publication in such a high-impact journal. Biomarkers to improve the selection of patients who are more likely to respond to therapy and prevent those less likely to respond from receiving an ineffective late-stage treatment are an important unmet need for cancer patients. This study provides proof of principle for further development of navicixizumab, a drug designed to address resistance to anti-VEGF and chemotherapies, as well as the potential of the Xerna TME panel to provide a predictive biomarker for anti-angiogenic treatment. To confirm this finding, the Xerna TME Panel will be used to stratify patients enrolled in a planned Phase 3 study."

OncXerna’s planned Phase 3 study, REVELARE, is designed as an open-label, randomized study of navicixizumab ± paclitaxel vs. paclitaxel monotherapy in pretreated PROC patients stratified by Xerna TME Panel biomarker status. Additional information on this planned trial can be found using ClinicalTrials.gov identifier NCT05043402.

About the Phase 1b Trial

The Phase 1b trial was an open-label, non-randomized, dose-escalation and expansion study of the safety, tolerability, and efficacy of navicixizumab plus paclitaxel in patients with platinum-resistant ovarian cancer. The trial enrolled patients who previously received Avastin (bevacizumab) and/or more than two prior lines of therapy. Patients were treated with navicixizumab once every two weeks together with weekly paclitaxel. The primary endpoint of the trial was incidence of dose limiting toxicities. Secondary endpoints included response rate assessed by RECIST criteria 1.1 and progression-free survival. For more information, see ClinicalTrials.gov Identifier: NCT03030287.

About Navicixizumab

Navicixizumab is an anti-DLL4/VEGF bispecific antibody product candidate that demonstrated antitumor activity in patients who were previously treated with Avastin (bevacizumab) in a Phase 1b clinical trial. The U.S. Food and Drug Administration granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal, or fallopian tube cancer in patients who have previously received Avastin and/or more than 2 prior lines of therapy. Navicixizumab is an investigational agent that has not been approved, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced ovarian cancer.

About the Xerna TME Panel

The Xerna TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). The Xerna TME Panel is an investigational assay that has not been approved and has not been demonstrated to be safe or effective for any use.