On March 10, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Omega Therapeutics, MAR 10, 2022, View Source [SID1234609903]).

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"In 2021, we made significant strides across all aspects of our business highlighted by the successful completion of our initial public offering, the nomination of OTX-2002 as the industry’s first programmable epigenetic medicine to be developed for the treatment of c-Myc (MYC)-driven hepatocellular carcinoma (HCC), and the continued development of our groundbreaking platform and pipeline," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "With our funding in 2021 and recent key additions to our team, we are well positioned to steadily advance a broad portfolio of Omega Epigenomic Controllers (OECs). Looking ahead, we are targeting to submit an Investigational New Drug application (IND) for OTX-2002 and nominate two OEC candidates in the first half of 2022. We are also planning for an additional IND in the second half of 2022 or early 2023 and several scientific presentations and publications throughout the year."

Recent Business Highlights and Corporate Update

Development Pipeline and Platform

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022: An abstract titled, "Epigenetic Modulation of the MYC oncogene as a potential novel therapy for HCC" was selected for a poster presentation at the upcoming AACR (Free AACR Whitepaper) 2022 Annual Meeting. The presentation will highlight the mechanism of action of OTX-2002 and its potential as a differentiated and viable approach to the treatment of HCC.
OTX-2002: IND-enabling studies are ongoing for Omega’s lead OEC candidate OTX-2002, a novel, engineered, and programmable mRNA therapeutic targeting the MYC oncogene in patients with HCC. In preclinical studies, OTX-2002 demonstrated its ability to potently downregulate MYC oncogene expression. The Company continues to be on track to file an IND for OTX-2002 in the first half of 2022.
Additional OEC Development: The Company is working on multiple programs in pre-clinical studies, including acute respiratory distress syndrome (ARDS) with CXCL1-3/IL8, non-small cell lung cancer (NSCLC) with MYC, alopecia with SFRP1, and liver disease with HNF4a.
OMEGA Epigenomic Programming Platform: Omega is creating a new generation of programmable epigenetic mRNA medicines that are designed to control the fundamental epigenetic processes to correct the root cause of disease by restoring aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega has developed a highly rational and deterministic approach to drug design that enables the Company to rapidly develop and optimize novel OECs with high target specificity to durably tune the expression of single or multiple genes. Omega is advancing multiple pre-clinical development programs in oncology, multigenic diseases including immunology, regenerative medicine, and select monogenic diseases.
Corporate

In January 2022, Yan Moore, M.D., was appointed Chief Medical Officer of Omega. Dr. Moore has extensive management, research, translational drug development and medical affairs experience across various pharmaceutical and biotechnology companies.
Anticipated Milestones and Key Priorities for 2022

Complete IND-enabling studies for OTX-2002 and file the Company’s first IND to the U.S. Food and Drug Administration (FDA) during the first half of 2022.
Declare two OEC development candidates in the first half of 2022.
Target submission of an additional IND application in the second half of 2022 or early 2023.
Continue to develop the OMEGA Epigenomic Programming platform and investigate additional development programs to expand pipeline.
Publish and present relevant preclinical and early clinical data supporting programs and platform development.
Fourth Quarter and Full Year 2021 Financial Results

As of December 31, 2021, the Company had cash, cash equivalents and marketable securities totaling $225.3 million.

Research and development (R&D) expenses for the fourth quarter of 2021 were $14.7 million, compared with $7.1 million for the fourth quarter of 2020. R&D expenses for 2021 were $47.9 million, compared to $21.1 million in 2020. The $26.8 million increase in R&D expenses in 2021 compared to 2020 was primarily due to an increase in discovery and preclinical development costs and personnel and related expenses as the Company continues to advance its pipeline and discovery portfolio.

General and administrative expenses (G&A) for the fourth quarter of 2021 were $5.7 million, compared with $1.9 million for the fourth quarter of 2020. G&A expenses for 2021 were $16.6 million, compared to $6.2 million in 2020. The $10.4 million increase in G&A expenses in 2021 compared to 2020 was primarily due to higher personnel and related expense and increased costs to operate as a public company, in addition to the higher professional fees to support business growth.

Net loss for the fourth quarter of 2021 was $20.9 million, compared with $9.5 million for the fourth quarter of 2020. Net loss for the year ended December 31, 2021 was $68.3 million, compared to a net loss of $29.4 million for the year ended December 31, 2020. The increase in net loss for 2021 compared to 2020 was primarily due to increased R&D and G&A expenses to support the Company’s growth and operations as a public company.

On March 10, 2022 Exscientia (Nasdaq: EXAI) and the University of Oxford Target Discovery Institute (Oxford TDI) reported the formation of Xcellomics – a program designed to source cellular functional assays from the global academic community to develop novel screens and identify targets and therapeutic candidates for unmet medical needs (Press release, Exscientia, MAR 10, 2022, View Source [SID1234609920]).

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The Xcellomics program was created by the two Oxford-based institutions to expedite early-stage drug discovery research – primarily conducted within academic labs – and potentially leverage those outputs to bring therapies to patients sooner. The program offers applicants resources to explore, identify and rapidly advance novel drug targets by leveraging Oxford TDI’s expertise in developing robust, disease-relevant, predictive screening assays and Exscientia’s AI personalised medicine design capabilities.

"Academic research has and will continue to play a critical role in the development and advancement of medicine, and this partnership is a shining example of how industry and academia can come together to bridge a traditional gap in the drug development cycle," said Sir Peter Ratcliffe, FRS, FMedSci, Director of the Oxford TDI within the Nuffield Department of Medicine and winner of the 2019 Nobel Prize in Medicine. "Despite the multitude of advancements in using genetics, genomics, cell and chemical biology to improve target discovery, we believe we’ve only scratched the surface in terms of available assays that could be translated into meaningful therapies for patients."

Assay submissions will be evaluated and selected by the Xcellomics Scientific Committee and will be developed, produced and validated within Oxford TDI’s advanced cell screening facility using a range of phenotypic and functional genomic outputs that leverage Exscientia’s technology platform. The Xcellomics Board provides oversight and is comprised of members from Exscientia and Oxford TDI, and is chaired by Exscientia’s founder and CEO, Andrew Hopkins, DPhil.

Successful projects will be progressed using Exscientia’s proprietary AI-driven platform with the aim of rapidly identifying potential targets for potential new medicine programmes. Therapeutic area focus will rotate every six months, beginning with a focus on oncology and immuno-oncology, although "blue sky" submissions will be accepted on a rolling basis. Data and intellectual property will be co-owned by the researcher and the Xcellomics program.

"Exscientia’s roots started in academia, and we remain committed to supporting and advancing the innovative research happening at these institutions around the world," said Denise Barrault, Director, Portfolio Management at Exscientia. "We believe that our partnership with the University of Oxford Target Discovery Institute will help unearth new science and potentially translate and advance the most promising ideas into tomorrow’s new medicines."

An online informational event will be held Wednesday, March 23 at 1:00 p.m. GMT. More information on the event can be found at : View Source

On March 10, 2022 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported that management will be presenting a corporate overview and participating in 1-on-1 meetings on March 15, 2022, at the 32nd Annual Oppenheimer Healthcare Conference (Press release, Chemomab, MAR 10, 2022, View Source [SID1234609849]).

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32nd Annual Oppenheimer Healthcare Conference (virtual)

Date: March 15, 2022
Time: 10:00am – 10:30am ET
Registration: Webcast Registration Link

To request a virtual 1-on-1 meeting with Chemomab management, investors should speak with an Oppenheimer representative.

An archived version of the presentation webcast will also be available at the Investor Relations section of the company’s website at investors.chemomab.com/events

On March 10, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that management will participate in a fireside chat at the 34th Annual Roth Conference on March 14, 2022, at 11:30AM PT (Press release, Panbela Therapeutics, MAR 10, 2022, View Source [SID1234609872]). The webcast will be available at: View Source

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To learn more or to schedule a one-on-one meeting with management, please contact your conference representative or [email protected].

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.0 months which is not yet final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit
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On March 10, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Corvus Pharmaceuticals, MAR 10, 2022, View Source [SID1234609888]).

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"We continue to advance three clinical programs for novel product candidates targeting CD73, the adenosine 2A receptor, and ITK, which are involved in immune response to cancers and other diseases," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We have established sound scientific foundations for our product candidates, which give us confidence as we initiate mid-stage clinical trials in front-line treatment of lung cancer and renal cell cancer. In addition, our partnership with Angel Pharmaceuticals has expanded the clinical development of CPI-818 for T cell lymphomas into China and is accelerating global development of this product candidate."

Mupadolimab (anti-CD73)

The Company plans to initiate a randomized Phase 2 clinical trial evaluating mupadolimab as a front-line therapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC). The randomized, blinded trial will compare standard chemotherapy plus pembrolizumab (anti-PDL-1) with or without mupadolimab. The Company intends to enroll approximately 150 patients with any tumor PDL-1 expression in the clinical trial, potentially addressing a large patient population. The primary endpoint for the study will be progression free survival and secondary endpoints will evaluate objective response rate and overall survival.
The Company continues to enroll its two Phase 1b/2 clinical trial expansion cohorts of patients with (1) head and neck cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy and (2) relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-1 therapy and chemotherapy. Up to 15 patients will be enrolled in each expansion cohort and initial results are anticipated to be presented in the second half of 2022.
In November 2021, the Company presented results from its Phase 1/1b clinical trial that, along with pre-clinical data, provided further evidence regarding mupadolimab’s mechanism of action and its potential anti-tumor activity in cancer patients. The data showed that mupadolimab doses of 12mg/kg or greater, resulted in complete occupancy of the CD73 target and B cell activation. In the assessment of anti-tumor activity in sixteen evaluable patients receiving the 12mg/kg or greater doses of mupadolimab, tumor regression (not meeting the threshold for partial response by RECIST) was seen in five patients who had progressive disease as the best response to most recent prior therapy, which included anti-PD(L)1. We believe these interim findings support mupadolimab’s potential to cause tumor regression in patients with tumors refractory to anti-PD(L)1.
CPI-818 (selective ITK inhibitor)

The Company’s partner in China, Angel Pharmaceuticals, initiated patient enrollment in a Phase 1/1b clinical trial of CPI-818 for the treatment of refractory T cell lymphomas. Angel Pharmaceuticals is responsible for all expenses related to conducting the clinical trial in China.
The Company continues to enroll patients in its Phase 1/1b clinical trial, which was expanded to include patients with certain types of T cell leukemias in addition to T cell lymphomas.
Based on interim results observed in patients with peripheral T cell lymphoma (PTCL) in these Phase 1/1b clinical trials, the Company believes such results could provide the foundation for a potential global phase 2 clinical trial in advanced PTCL.
Ciforadenant (adenosine 2a receptor antagonist)

The Company plans to collaborate with the Kidney Cancer Clinical Trials Consortium to initiate an open-label Phase 2 clinical trial evaluating ciforadenant as a first-line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-PD-1) and nivolumab (anti-CTLA-4). The clinical trial will enroll up to 60 patients and is intended to evaluate the potential for ciforadenant to generate increased complete responses and deep responses in the front-line setting. The Kidney Cancer Clinical Trials Consortium is comprised of a group of leading cancer centers in the United States led by investigators at MD Anderson. The trial design is based on Corvus’ preclinical research published in 2018 in Cancer Immunology Research that demonstrated impressive antitumor control and cures in several animal models using ciforadenant in combination with anti-CTLA4 and anti-PD1.
The Company continues to advance its understanding of the Adenosine Gene Signature biomarker, which has been confirmed by other groups as a means to identify an unfavorable group of renal cell cancer patients. Tumor biopsies from the Phase 2 clinical trial will be evaluated for expression of the Adenosine Gene Signature.
Financial Results
As of December 31, 2021, Corvus had cash, cash equivalents and marketable securities totaling $69.5 million compared to $44.3 million as of December 31, 2020. Corvus expects full year 2022 net cash used in operating activities to be between $34 million and $36 million.

Research and development expenses for the three months and full year ended December 31, 2021 totaled $4.8 million and $29.1 million, respectively, compared to $7.2 million and $31.8 million for the same periods in 2020. In the fourth quarter of 2021, the decrease of $2.4 million was primarily due to a decrease in clinical trial and personnel costs.

Net loss for the three months and full year ended December 31, 2021 was $9.2 million and $43.2 million, respectively, compared to net income of $27.3 million and a net loss of $6.0 million for the same periods in 2020. Results for the year ended December 31, 2020 included a $37.5 million gain from the deconsolidation of Angel Pharmaceuticals. Total stock compensation expense for the three months and year ended December 31, 2021 was $0.7 million and $4.2 million, respectively, compared to $1.2 million and $5.7 million for the same periods in 2020.

Conference Call and Webcast
Corvus will host a conference call and webcast today, March 10, 2022, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2021 financial results. The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) and using the conference ID 13727689. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.