On November 5, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported its financial results and development highlights for the quarter ended September 30, 2021 (Press release, Oncolytics Biotech, NOV 5, 2021, View Source [SID1234594604]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"Over the past few months, we achieved key milestones that have advanced pelareorep’s development programs and further highlighted the advantages of its broadly applicable mechanism of action," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "These milestones include the reporting of new clinical biomarker data from our AWARE-1 breast cancer study, which we are pleased to be announcing today. These data further demonstrate pelareorep’s immunotherapeutic effects and its ability to synergize with checkpoint inhibition. It also indicates that changes in peripheral blood T cell populations may be predictive of patient response. This exciting finding could improve our chances of success in subsequent studies by allowing for early identification of patients most likely to benefit from pelareorep therapy. We are evaluating this hypothesis as part of our BRACELET-1 breast cancer trial, which is assessing the safety, efficacy, and pharmacodynamic effects of pelareorep with and without checkpoint inhibition to support the advancement of our lead program to a registrational study."

Dr. Coffey continued, "Beyond our lead program, we also advanced our collaboration with Roche and AIO with the initiation of dosing in our phase 1/2 GOBLET trial. This trial addresses a pressing unmet need in gastrointestinal cancer by leveraging pelareorep’s immunotherapeutic effects to overcome checkpoint inhibitor resistance and then increase the proportion of patients responding to checkpoint inhibition therapies. Looking forward, we will continue to strategically leverage collaborations and partnerships to drive pelareorep’s development as an enabling technology for various immuno-oncology agents across multiple indications with high unmet needs. We believe this will allow us to maximally benefit from pelareorep’s value-creating potential while maintaining focus on our lead breast cancer program."

Third Quarter and Subsequent Highlights

Breast Cancer Program

AWARE-1 data indicate that changes in peripheral blood T cell populations may be a predictive biomarker of pelareorep therapy

Additional analyses from AWARE-1’s first two cohorts being announced today focus on changes in the peripheral blood and tumors’ T cell populations of HR+/HER2- early-stage breast cancer patients following treatment with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 inhibitor atezolizumab. These changes were compared to assessments of CelTIL score (a measure of tumor cellularity and inflammation) and tumor-infiltrating CD8+ T cells, two metrics that are associated with favorable clinical outcomes. Highlights from the analyses using Spearman’s Rank-Order Correlation not adjusted for multiplicity are shown below:

Pooled analysis across cohorts showed:
A statistically significant decrease in peripheral blood T cell diversity post-treatment, explained by the expansion and generation of new middle frequency anti-viral and anti-tumor T cell clones.
A statistically significant association between pre- vs. post-treatment decreases in peripheral blood T cell diversity and increased post-treatment CelTIL score.
A statistically significant association between increased peripheral blood T cell fraction pre-treatment and tumor-infiltrating CD8+ T cells post-treatment.
Comparative analysis of cohort 1 vs. cohort 2 showed:
The addition of atezolizumab enhanced pelareorep’s ability to generate and expand new anti-viral and anti-tumor T cell clones.
A greater decrease in pre- vs. post-treatment changes in peripheral blood T cell diversity in cohort 2 compared to cohort 1.
A numerical association between decreased post-treatment T cell diversity in the peripheral blood and pre- vs. post-treatment increases in tumor-infiltrating CD8+ T cells in cohort 1. This association reached statistical significance in cohort 2 with the addition of atezolizumab.
Collectively, these analyses further demonstrate pelareorep’s immunotherapeutic mechanism of action and its ability to synergize with checkpoint inhibitors such as atezolizumab. They also suggest that changes in peripheral blood T cell populations are predictive of response to pelareorep therapy and could potentially serve as the basis for a blood-based biomarker to inform the design of subsequent studies.

Oncolytics has completed its planned analyses of AWARE-1’s first two cohorts, which enrolled patients with HR+/HER2- breast cancer. Evaluation of these cohorts was the core objective of AWARE-1, as HR+/HER2- is the breast cancer subtype Oncolytics intends to examine in a future registrational study. Following the completion of these cohorts, Oncolytics amended the protocol of the trial so that all remaining cohorts focus exclusively on patients with the HER2+ breast cancer subtype. Together with AWARE-1’s first two cohorts and the ongoing IRENE trial in triple-negative breast cancer, these cohorts will facilitate the evaluation of pelareorep in all breast cancer subtypes.

Partner Adlai Nortye dosed first patient in Chinese bridging trial evaluating pelareorep-paclitaxel combination treatment in breast cancer

The bridging clinical trial is evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Results are expected to allow Adlai Nortye to include data from Oncolytics’ North American IND-213 and BRACELET-1 trials in a future submission to Chinese regulators. This may accelerate pelareorep’s clinical development path in China, which has a rapidly growing pharmaceutical market that is currently the second largest in the world.

Gastrointestinal Cancers Program

Dosed first patient in the phase 1/2 GOBLET trial in collaboration with Roche and AIO

GOBLET is a phase 1/2 multi-center trial designed to evaluate the use of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The trial is being managed by AIO, a leading academic cooperative medical oncology group based in Germany. In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to validate CEACAM6 and T cell clonality as predictive biomarkers, which may improve the patient selection process in future registration studies and increase their likelihood of success. The trial builds off previously reported phase 2 data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (link to PR, link to poster), as well as prior early clinical data showing that pelareorep-based combinations stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS mutated colorectal cancer patients (link to PR, link to study), and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster).

Additional Immunotherapeutic Combinations and Opportunities

Announced preclinical data demonstrating the synergistic immunotherapeutic effects of pelareorep combined with radiotherapy

Preclinical data presented in a poster at The International Conference on Immunotherapy Radiotherapy Combinations showed that combination treatment with pelareorep and radiotherapy promoted the tumor infiltration of anti-cancer T cells and prolonged survival in a murine cancer model. Increased infiltration of anti-cancer T cells was observed both in tumors exposed to local treatment with radiation and pelareorep, and in tumors located away from the treatment site. Collectively, these data are indicative of the synergistic immunotherapeutic effects of the pelareorep-radiotherapy combination (link to PR, link to poster).

Financial Highlights

As of September 30, 2021, the Company reported $48.1 million in cash and cash equivalents.
Operating expense for the third quarter of 2021 was $2.9 million, compared to $2.5 million in the third quarter of 2020.
R&D expense for the third quarter of 2021 was $3.3 million, compared to $3.9 million in the third quarter of 2020.
Net cash used in operating activities for the third quarter of 2021 was $3.7 million, compared to $6.1 million for the third quarter of 2020.
The net loss for the third quarter of 2021 was $4.9 million, compared to a net loss of $6.7 million in the third quarter of 2020. The basic and diluted loss per share was $0.09 in the third quarter of 2021, compared to a basic and diluted loss per share of $0.16 in the third quarter of 2020.
Anticipated Milestones and Catalysts

Completion of enrollment in phase 2 BRACELET-1 metastatic breast cancer study: Q4 2021/Q1 2022
Interim safety update from phase 2 IRENE study in triple-negative breast cancer: Q4 2021
Multiple myeloma study data: Q4 2021
Oncolytics expects to provide updates on the timing of the following milestones:

Interim safety update from BRACELET-1 metastatic breast cancer study
Phase 2 BRACELET-1 metastatic breast cancer study: final data
Webcast and Conference Call
Management will host a conference call for analysts and institutional investors at 8:00 a.m. ET today, November 5, 2021. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 7285-9440. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 859-440#.

On November 5, 2021 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported financial results and a corporate update for the third quarter ended September 30, 2021 (Press release, Neoleukin Therapeutics, NOV 5, 2021, View Source [SID1234594597]).

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"During the third quarter, we made progress with our NL-201 phase 1 clinical trial, initiating multiple additional sites in the United States, Australia, and Canada; we look forward to providing interim data in 2022," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "In addition, we and our collaborators continue to generate preclinical data, demonstrating the potential for NL-201 in additional indications and novel regimens. Based on these data, we plan to initiate a second NL-201 clinical trial in patients with hematology malignancies next year."

"Furthermore, our presentation next week at the American College of Rheumatology Annual Meeting will highlight a de novo IL-2/IL-15 inhibitor we have developed that could have applications in inflammatory and autoimmune disorders."

Recent Updates

NL-201

NL-201 is a de novo protein therapeutic candidate, designed to mimic the therapeutic activity of natural cytokines IL-2 and IL-15, while potentially reducing the toxicities associated with high-dose IL-2. NL-201 is currently in a phase 1 clinical trial for patients with relapsed and refractory solid tumors. A second trial for patients with hematologic malignancies is expected to begin next year.

Executive Appointment

In September, Neoleukin announced the appointment of Bill Arthur, Ph.D., as Vice President and Head of Research. Dr. Arthur joins Neoleukin after a decade at Seagen Inc., where he served most recently as Senior Director & Head of Cancer Biology. Prior to Seagen, Dr. Arthur worked at Merck & Co. and Rosetta Inpharmatics.

Scientific Conference Presentations

In September, an oral presentation at IDWeek by Neoleukin scientists and collaborators demonstrated the potential of NL-CVX1 to prevent or treat SAR-CoV-2 related disease, including new variants of concern.

At the upcoming American College of Rheumatology Annual Meeting (taking place virtually November 5-9, 2021), Neoleukin will have an oral presentation, titled "Development of a Computationally Designed, Hyperstable Dual Inhibitor of the IL-2 and IL-15 Receptors: A Novel Therapeutic Candidate for Inflammatory Conditions" (Monday, Nov. 8 at 2 p.m.). The abstract highlights development of a potent and hyperstable protein that blocks signaling by endogenous IL-2 and IL-15.

Neoleukin and collaborators will present four abstracts at SITC (Free SITC Whitepaper) 2021:

Title: NL-201 Induces Inflammation in a ‘Cold’ Tumor Microenvironment through Upregulation of MHC-I, Expansion of the TCR Repertoire, and Potent Antitumor Activity when Combined with PD-1 Inhibition

Poster/Abstract Number: 716,
Date/Time: Saturday, November 13, 7 a.m. to 8:30 p.m., ET

Title: Intratumoral Administration of NL-201, an Alpha-Independent IL-2/15 Receptor Agonist, Inhibits the Growth of Both Injected and Uninjected Tumors in Preclinical Models

Poster/Abstract Number: 898,
Date/Time: Saturday, November 13, 7 a.m. to 8:30 p.m., ET

Title: A First-in-Human Phase 1 Study of NL-201 in Patients with Relapsed or Refractory Cancer (Trials in Progress)

Poster/Abstract Number: 509,
Date/Time: Friday, November 12, 7 a.m. to 8:30 p.m. ET

Title: ICT01, an Anti-BTN3A Monoclonal Antibody, and NL-201, an Alpha-Independent IL-2/IL-15 Agonist, Combine to Elicit a Potent Anti-Tumor Response by Synergistically Stimulating Vγ9Vδ2 T Cell Activation and Proliferation

Poster/Abstract Number: 563
Date/Time: Friday, November 12, 7 a.m. to 8:30 p.m. ET

Two abstracts have been submitted regarding NL-201 for the upcoming 63RD American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2021) taking place virtually and in person December 11-14, 2021, and one will be presented as a poster:

Title: The IL-2/IL-15 Mimetic NL-201 Prevents Myeloma Relapse after ASCT by Expanding Highly Cytolytic T Cells in the Bone Marrow that are Resistant to Exhaustion

Abstract number: 1609

Title: NL-201, a De Novo Agonist of IL-2 and IL-15 Receptors, Demonstrates Synergistic Antitumor Activity with Anti-PD-1 Checkpoint Inhibitor Therapy in a Preclinical Non-Hodgkin Lymphoma Model

Abstract number: 4560

To be published in the November supplemental issue of Blood.

Summary of Financial Results

Cash Position: Cash and cash equivalents totaled $154.9 million as of September 30, 2021, compared to $192.6 million as of December 31, 2020.

Based upon current internal infrastructure and pipeline initiatives, Neoleukin believes it has sufficient cash to fund operations into the second half of 2023.

R&D Expenses: Research and development expenses for the third quarter of 2021 increased to $9.9 million from $6.2 million for the third quarter of 2020. The increase was primarily due to increased expenses incurred from clinical trial activities related to Neoleukin’s lead product candidate, NL-201, personnel-related costs, and in connection with the advancement of other Neoleukin technologies.

G&A Expenses: General and administrative expenses for the third quarter of 2021 increased to $5.6 million from $3.9 million for the third quarter of 2020. The increase in general and administrative expenses was primarily due to increases in personnel-related costs and professional service fees as Neoleukin continues to grow its operations.

Gain on Sale of Aquinox Canada: The gain in the third quarter of 2020 relates to the sale of Aquinox Canada, a wholly owned subsidiary of Neoleukin. The gain of $7.8 million recognized was the total consideration of $8.2 million, less transaction costs of $0.4 million.

Net Loss: Net loss for the third quarter of 2021 was $15.4 million compared to a net loss of $2.2 million in the third quarter of 2020.

On November 5, 2021 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company introducing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported that members of management will present at the Stifel 2021 Virtual Healthcare Conference on Wednesday, November 17, 2021 at 1:40pm PT / 4:40pm ET (Press release, Pulse Biosciences, NOV 5, 2021, View Source [SID1234594596]).

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Interested parties may access the on-demand webcast at the same time on the "Investors" section of the Company’s website at www.pulsebiosciences.com.

On November 5, 2021 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, reported the pricing of its follow-on public offering of 3,428,571 American Depositary Shares ("ADSs"), at a public offering price of $7.00 per ADS, with each such ADS representing one ordinary share, DKK 1 nominal value per share, of Evaxion (the "Ordinary Shares") (Press release, Evaxion Biotech, NOV 5, 2021, View Source [SID1234594593]). The gross proceeds from the offering are expected to be approximately $24.0 million before deducting underwriting fees, commissions and other offering expenses. Evaxion has granted the underwriters an option for a period of 30 days from the date of the final prospectus to purchase an additional 514,285 ADSs at the follow-on public offering price.

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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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The Company is listed on the Nasdaq Capital Market in the United States and the ADSs trade under the symbol "EVAX". The offering is expected to close on November 9, 2021, subject to the satisfaction of customary closing conditions.

Oppenheimer & Co. Inc. is acting as sole book-running manager for the offering. Ladenburg Thalmann & Co. Inc. is acting as lead manager for the offering and Lake Street Capital Markets, LLC is acting as co-manager for the offering.

The Form F-1 registration statement (the "Registration Statement") was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on November 4, 2021. The offering is being made only by means of a prospectus forming part of the effective Registration Statement. The prospectus will be filed with the SEC and will be available on the SEC’s website at: View Source When available, copies of the final prospectus related to the offering may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at 212-667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release.

On November 5, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that its Immunoscore Colon Cancer test has been included in the Pan-Asian adapted ESMO (Free ESMO Whitepaper)1 Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with localized colon cancer (Press release, Veracyte, NOV 5, 2021, View Source [SID1234594592]). The new guidelines appear online in Annals of Oncology and will be highlighted at the ESMO (Free ESMO Whitepaper) Asia Virtual Oncology Week 2021 meeting, being held November 17-23, 2021.

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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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Veracyte acquired the Immunoscore Colon Cancer test through its acquisition of HalioDx in August 2021. The test measures patient immune response at the tumor site and is used to inform chemotherapy decision-making for patients with Stage II and III colon cancer.

The Immunoscore Colon Cancer test was included in the 2020 ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Colon Cancer. The new Pan-Asian guidelines take into account ethnic differences associated with the treatment of localized colon cancer in Asian patients. They comprise the consensus opinions reached by 14 experts representing the oncological societies of Japan, China, India, Korea, Malaysia, Singapore and Taiwan.

The 2020 ESMO (Free ESMO Whitepaper) guidelines and the new Pan-Asian adapted version both emphasize that tumor recurrence risk-assessment and expected benefit from chemotherapy are key to the evaluation of adjuvant therapy options. In this context, the Immunoscore Colon Cancer test is recommended for its ability to refine the prognosis of stage II and stage III colon cancer patients, in conjunction with standard cancer staging known as TNM (Tumor, Node, Metastasis).

"There is a need for standardization of approaches with the aim of optimizing clinical outcomes. The Immunoscore test is introduced in these guidelines in the Risk Assessment chapter as it provides a reliable estimate of risk of recurrence, when used in adjunct to standard TNM classification," said Dr. Josep Tabernero, of the Vall d’Hebron Institute of Oncology in Barcelona, Spain. "We are happy to have 100 percent consensus in these up-to-date pan-Asian guidelines for considering the use of the test in stage II and stage III disease."

"We are pleased that Pan-Asian experts recognize the utility of the Immunoscore test in localized colon cancer," said Stephane Debono, general manager, Immunoscore and International Diagnostics Operations at Veracyte. "We consider this a significant milestone in our efforts to facilitate reimbursement for the test so that more patients may benefit from its ability to provide important information that may help guide treatment decisions."

According to the new ESMO (Free ESMO Whitepaper) Pan-Asian guidelines, recent estimates show Asia to account for half of the new cases, deaths and 5-year prevalence for colorectal cancer (CRC). Asian studies suggesting that individuals of Chinese, Japanese and Korean ethnicity might be more susceptible to CRC. CRC represents a major healthcare challenge across Asia, with the incidence predicted to increase sharply over the next decade.

About Immunoscore

The Immunoscore Colon Cancer test accurately measures patient immune response at the tumor site by providing a robust, precise, quantitative, and consensus assessment of lymphocytic infiltration in human tumors and has been shown to predict patient outcome in several indications. The test has been validated in an international study conducted on more than 2,500 Stage I-III colon cancer patients2. This study showed that Immunoscore is a powerful and independent prognostic factor for patient survival which provided the greatest contribution to patient prognostication of all assessed factors. In validation studies of stage III colon cancers, the Immunoscore test provides information that may help physicians determine the optimal duration of FOLFOX treatment. In 2020, the test was included in the ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Colon Cancer and the World Health Organization (WHO), in its latest edition of the Digestive System Tumours, cited immune response as an essential and desirable diagnostic criterion for colorectal cancer, in addition to traditional histological parameters3. Immunoscore is commercially available in more than 20 countries. Immunoscore is CE-IVD marked. The test’s results are delivered worldwide from Veracyte’s CLIA laboratories.