On November 5, 2021 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported that it will release third quarter 2021 financial results Friday, Nov. 12, 2021 (Press release, Forma Therapeutics, NOV 5, 2021, View Source [SID1234594608]). Forma management will host an investment community conference call at 8 a.m. Eastern Time, on Nov. 12, 2021 to discuss these financial results and provide a business update.

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Investors may participate by dialing (833) 301-1146 in the U.S. or Canada, or (914) 987-7386 internationally, and by referring to Conference ID 6662686. A live webcast of the conference call will be available in the "News & Investors" section of Forma’s website at www.formatherapeutics.com.

On November 5, 2021 Bavarian Nordic A/S (OMX: BAVA) reported that it will announce its 2021 third quarter results on Friday, November 12, 2021 (Press release, Bavarian Nordic, NOV 5, 2021, View Source [SID1234594606]).

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The management of Bavarian Nordic will host a conference call at 2:00 pm CET (8:00 am ET) on the same day to present the interim results followed by a Q&A session. A live and replay version of the call and relevant slides will be available at https://bit.ly/3q73EvS.

To join the Q&A session dial one of the following numbers and state the participant code 2839609: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495.

On November 5, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported dosing of the first patient in the Company’s multi-cohort Phase 1/2 study of oral fadraciclib in patients with leukemias or myelodysplastic syndromes (MDS) (Press release, Cyclacel, NOV 5, 2021, View Source [SID1234594605]).

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"We are proud to have achieved this second key clinical milestone and corporate objective following the start of the oral fadraciclib Phase 1/2 solid tumor and lymphoma study last quarter," said Spiro Rombotis, Cyclacel’s President and Chief Executive Officer. "After opening these two streamlined, registration-directed Phase 1/2 studies with fadraciclib as planned, we will next evaluate the clinical potential of oral CYC140, our PLK1 inhibitor, first in solid tumors and lymphomas and then in leukemias. We look forward to providing periodic updates on our clinical progress and data from these open-label studies when available."

"We are pleased to have dosed the first patient in this leukemia study and are delighted by the enthusiasm and strong interest from current and prospective investigators," said Mark Kirschbaum M.D., Senior Vice President and Chief Medical Officer of Cyclacel. "The study has initially opened at City of Hope, a world-renowned cancer research and treatment organization, with more sites to join later. We are building a distinguished, global network of participating institutions for this leukemia study, the ongoing solid tumor clinical study and also for preclinical collaborations. We are excited to begin this second mid-stage study of fadraciclib with the objective of registration-enabling outcomes as a single agent and in relevant combinations, potentially offering a new treatment option for patients with leukemias, MDS and related disorders."

"Based upon the mechanism of action and prior clinical activity shown to date, further exploration of this novel CDK2/9 inhibitor, both as a single-agent and in combinations, is warranted across a number of leukemias and MDS," said Brian Ball, M.D., Assistant Professor, Department of Hematology and Hematopoietic Cell Transplantation at City of Hope. "We look forward to enrolling patients in this trial, performing correlative studies, and evaluating potential treatment benefit for this experimental therapy, particularly in novel subsets of AML, which we have recently described and which may respond to inhibition of these targets."

The Phase 1/2 registration-directed trial, designated CYC065-102, uses a streamlined design and will first determine the recommended Phase 2 dose (RP2D) for single-agent, oral fadraciclib. Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design, where fadraciclib, both as a single agent and in combinations, will be administered to patients in up to seven cohorts relevant to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in previous studies.

Single-agent cohorts will include patients with acute myeloid leukemia (AML) or MDS who have an inadequate response or have progressed on venetoclax combinations with hypomethylating agent (HMA) or low dose Ara C; relapsed/refractory AML or MDS patients with FLT3, KIT or MAPK pathways (including N and K RAS, BRAF, PTPN11, NF1). The trial will also include patients with chronic lymphocytic leukemia (CLL) who have progressed after at least two lines of therapy including a BTK inhibitor and venetoclax.

Combination cohorts for patients with AML or MDS are: fadraciclib and azacitidine for patients with AML or MDS who progressed with hypomethylating (HMA) treatments and also fadraciclib and venetoclax for patients that have progressed after venetoclax therapy. A further combination cohort of fadraciclib and venetoclax will enroll patients with CLL or small lymphocytic lymphoma (SLL) who have progressed after venetoclax therapy. An additional basket cohort will evaluate patients with biomarkers relevant to the drug’s mechanism, including MCL1 and MYC.

The protocol allows for expansion of a cohort based on response which may allow acceleration of the clinical development and registration plan for fadraciclib.

About Cyclin-Dependent Kinases and Fadraciclib

Cyclin-dependent kinases (CDKs) are critical for cell cycle control and transcriptional regulation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased cancer cell survival. Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9. CDK2 drives cell cycle transitions and CDK9 regulates transcription of genes through phosphorylation of the carboxy-terminal domain (CTD) of RNA polymerase II (RNAP II). By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death of cancer cells at sub-micromolar concentrations. Published data support the hypothesis that concomitant inhibition of CDK2 and CDK9 yields synergistic anti-tumor activity rather than inhibition of CDK2 or CDK9 alone.

Preclinical and animal model data suggest that fadraciclib may benefit patients with adult and pediatric hematological malignancies, such as ALL, AML, B-cell lymphoma, CLL, and multiple myeloma and certain cyclin E-addicted or MYC-amplified solid tumors, including certain forms of breast cancer, neuroblastoma, ovarian cancer and uterine serous carcinoma. Similarly to FDA-approved CDK4/6 inhibitors, fadraciclib may be useful in combination with other anticancer drugs, including HER2 inhibitors, such as trastuzumab, or BCL2 inhibitors, such as venetoclax.

Venetoclax has modest single-agent activity in AML. MCL1 dependence appears to correlate with resistance to venetoclax. A pre-clinical study confirmed synergy of fadraciclib and venetoclax, suggesting that the suppression of both BCL2 and MCL1 may be more beneficial than inhibiting either protein alone.

Pre-existing or emergent mutations in the MAPK pathway contribute towards resistance to venetoclax, FLT3 inhibitors and mutant IDH inhibitors. These mutations are also frequent in proliferative CMML progressing to AML. Activating mutations in the MAPK pathway upregulates MCL1 and renders AML resistant to apoptosis. CDK9 inhibition downregulates MCL1 transcriptionally and can potentially be effective in the context of MAPK and other receptor tyrosine kinase mutations.

In a prior Phase 1 open-label trial (CYC065-01), patients with high copy CCNE (cyclin E), MYC or MCL1 showed sensitivity to intravenously-administered, single-agent fadraciclib. A heavily pretreated patient with MCL1 amplified endometrial cancer achieved a radiographically confirmed partial response (PR) after a month and a half on fadraciclib. This patient continues on therapy for almost two years and reduction in her target tumor lesions has reached 100%. An additional patient with cyclin E amplified ovarian cancer achieved stable disease with 29% shrinkage in her target tumor lesions.

References: Do, KT, et al., 32nd EORTC/AACR/NCI Virtual Symposium 24-25 Oct. 2020; Frame S et al, PLOS One, 2020; Frame et al, AACR (Free AACR Whitepaper), 2010, Abs 3886; Poon E et al, JCI 2020; Scaltriti M et al, PNAS, 2011.

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.