1stOncology™: Cancer Intelligence Service – Page 10432 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

INmune Bio, Inc. Announces First Quarter 2021 Results and Provides Business Update

On May 6, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease reported its financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, INmune Bio, MAY 6, 2021, View Source [SID1234579352]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

"We continued to treat patients in the Phase I XPro1595 Alzheimer’s disease trial and expand the extensive biomarker data," stated RJ Tesi, M.D., chief executive officer of INmune Bio. "The interim data that we reported in January confirms that XPro1595 decreases neuroinflammation in patients with Alzheimer’s disease and supports transitioning to a blinded randomized placebo-controlled Phase II trial later this year. We regard these results as extremely promising and look forward to further confirmation of XPro1595’s potential benefit to these patients in a rigorously designed Phase 2 study. We will report the additional biomarker data later this Summer."

"We have started screening patients in the Phase I INKmune NK cell priming platform trial in patients with high-risk myelodysplastic syndrome (MDS). MDS is a serious hematopoietic stem cell disorder in which patients have functionally defective NK cells, and approximately one-third of cases progress to AML. We created a short 5-minute video that we believe does a wonderful job explaining why NK cells fail to clear cancer and how the cellular and molecular interactions by INKmune activate NK cells to kill resistant tumors. The video can be found by clicking here."

"Finally, in our Phase 2 trial of Quellor in hospitalized COVID-19 patients with pulmonary complications, we continue to enroll patients. We expect to receive a ‘go/no-go’ decision by the independent Data Safety Monitoring Board following the analysis of the first 100 patients. We believe Quellor will neutralize soluble TNF, the ‘master cytokine’ of the cytokine storm to decrease progressive respiratory symptoms in these hospitalized patients."

"In summary, notwithstanding the ongoing pandemic that continues to disrupt drug development timelines around the world, we believe that we are well positioned to make meaningful advancements across all of our key programs this year," Dr. Tesi concluded.

Q1 2021 and Recent Corporate Highlights

DN-TNF Platform Highlights:

Announced interim Phase 1b data demonstrating that XPro1595 decreased neuroinflammation measured by CSF cytokines correlated with decreases in white matter free water, a validated non-invasive biomarker of neuroinflammation. The data showed the benefits of decreased neuroinflammation with decreased neurodegeneration and improved synaptic function as measured by CSF proteomics and remodeling and repair in the brain due to improvements in white and gray matter quality as measured by MRI.
Data strongly support initiation of a blinded, randomized, placebo-controlled Phase 2 study in 2021 to explore the clinical impact of long-term control of neuroinflammation with XPro1595 in patients with Alzheimer’s disease.
Presented detailed biomarker data during a Key Opinion Leader webinar on January 21, 2021, a replay of which can be accessed here.
Continued to advance its Phase 2 trial of Quellor in hospitalized COVID-19 patients suffering from pulmonary complications toward a "go/no-go" decision by the DSMB around mid-year.
Financial Highlights:

During the first quarter, the Company raised approximately $29 million from the sale of its common shares through a pre-existing open sale market agreement (At-the-Market, or ATM).
Upcoming Milestones:

Report on the first 100 patients enrolled in the company’s Quellor trial in COVID-19 which will provide proof-of-concept and inform a "go/no go" decision by the Data Safety Monitoring Board (DSMB).
Initiate XPro1595 Phase 2 program for treatment resistant depression, funded in part by a $2.9 million NIH grant in the second half of 2021.
Initiate XPro1595 Phase 2 program for Alzheimer’s disease in patients with neuro-inflammation in the second half of 2021.
Initiation of INKmune high-risk MDS trial.
The company plans additional clinical trials after the COVID-19 pandemic has been controlled. The exact timing of these trials cannot be predicted at this time. These trials include:
INKmune Phase 1 program for ovarian cancer.
LIVNate Phase 2 program for NASH.
INB03 Phase 2 program for MUC4 expressing cancer.
Financial Results for the First Quarter Ended March 31, 2021:

Net loss attributable to common stockholders for the quarter ended March 31, 2021 was approximately $4.6 million, compared to approximately $2.1 million for the quarter ended March 31, 2020.

Research and development expense totaled approximately $2.5 million for the quarter ended March 31, 2021, compared to approximately $0.8 million during the quarter ended March 31, 2020.

General and administrative expense was approximately $2.1 million for the quarter ended March 31, 2021, compared to approximately $1.3 million during the quarter ended March 31, 2020.

As of March 31, 2021, the Company had cash and cash equivalents of approximately $45.3 million and no debt.

As of May 5, 2021, the Company had approximately 14.9 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Date: Wednesday, May 5, 2021
Time: 4:30 PM Eastern Time
Participant Dial-in: 877-407-0784
Participant Dial-in (international): 201-689-8560

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through May 12, 2021 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13718747.

About XPro1595

XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro1595 could have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

ORIC Pharmaceuticals Reports First Quarter 2021 Financial Results and Operational Update

On May 6, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended March 31, 2021 (Press release, ORIC Pharmaceuticals, MAY 6, 2021, View Source [SID1234579351]).

"We continue to make steady progress in advancing our robust pipeline of novel oncology candidates," said Jacob Chacko, M.D., president and chief executive officer. "As planned, we will present preliminary safety, pharmacokinetic, and translational data, as well as early efficacy data from our ongoing Phase 1 trial of ORIC-101 in combination with nab-paclitaxel in solid tumors at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting. In addition, we expect to achieve multiple other milestones throughout the remainder of 2021, including reporting preliminary data from our second trial for ORIC-101 in combination with enzalutamide in prostate cancer, and IND/CTA filings for ORIC-533, our oral small molecule CD73 inhibitor, ORIC-944, our allosteric PRC2 inhibitor, and ORIC-114, our brain penetrant EGFR/HER2 exon 20 inhibitor."

First Quarter 2021 and Other Recent Highlights

Acceptance of Two Abstracts at ASCO (Free ASCO Whitepaper): Two abstracts highlighting preliminary results from the Phase 1b study of ORIC-101 in combination with nab-paclitaxel have been accepted for poster presentations during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4 – 8, 2021. The ASCO (Free ASCO Whitepaper) presentations will highlight interim safety, pharmacokinetic, efficacy, and translational data from the ongoing Phase 1b study of ORIC-101 in combination with nab-paclitaxel.
Preclinical Data Presented at AACR (Free AACR Whitepaper): In April 2021, ORIC presented posters on four programs at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) virtual annual meeting. Key findings of the presentations included:
ORIC-101: Glucocorticoid Receptor (GR) Antagonist

GR upregulation and activation, an established preclinical resistance mechanism for antiandrogens, may drive resistance when antiandrogens are combined with AKT inhibitors.
ORIC-101 was able to overcome this resistance and restore antitumor activity in preclinical prostate cancer cell lines.
ORIC-533: Oral Small Molecule CD73 Inhibitor

Nanomolar concentrations of ORIC-533 efficiently rescued cytotoxic T-cell function in the presence of high AMP concentrations, reflective of AMP levels observed in tumors.
Inhibitors of adenosine receptors were only able to rescue CD8+ T-cell function in the context of low AMP, and were ineffective in moderate or high AMP levels.
ORIC-533 has potential best-in-class properties in inhibiting adenosine production and reversing immunosuppression in tumors.
ORIC-944: Allosteric PRC2 Inhibitor

ORIC-944 has potential best-in-class drug properties compared to first generation PRC2 inhibitors, including a clean CYP profile.
ORIC-944 demonstrated superior activity compared to an EZH2 inhibitor in an in vivo DLBCL model.
ORIC-944 demonstrated strong tumor growth inhibition as a single agent with once daily oral dosing in both enzalutamide-responsive and enzalutamide-resistant in vivo prostate cancer models.
ORIC-114: Brain Penetrant EGFR/HER2 exon 20 Inhibitor

ORIC-114 is highly selective for the EGFR family of receptors with superior kinome selectivity compared to other exon 20 inhibitors.
ORIC-114 demonstrated low nanomolar potency across exon 20 insertion variants in biochemical and cell-based assays.
Significant tumor regression was observed in multiple EGFR exon 20 patient-derived xenograft models using once daily oral administration of ORIC-114.
ORIC-114 displayed superior brain exposure relative to other compounds targeting exon 20 insertion mutations, and greater activity compared to other EGFR inhibitors in an intracranial NSCLC EGFR mutant xenograft model.
Anticipated Milestones

ORIC anticipates the following milestones in 2021:
ORIC-101: Report interim safety, efficacy, and translational data from ongoing combination trial with nab-paclitaxel at ASCO (Free ASCO Whitepaper)
ORIC-101: Report interim safety, efficacy, and translational data from ongoing combination trial with enzalutamide in the second half of 2021
ORIC-533: File an IND in the second quarter of 2021
ORIC-944: File an IND in the second half of 2021
ORIC-114: File a CTA in the second half of 2021
Present additional preclinical data at scientific conferences in 2021
First Quarter 2021 Financial Results

Cash, Cash Equivalents and Short-term Investments: Cash, cash equivalents, and short-term investments totaled $278.1 million as of March 31, 2021. The company expects its current cash, cash equivalents, and short-term investments will be sufficient to fund its current operating plan into the second half of 2023.
R&D Expenses: Research and development expenses were $11.7 million for the three months ended March 31, 2021, compared to $7.3 million for the three months ended March 31, 2020, an increase of $4.4 million. The increase was primarily driven by an increase in external expenses related to the advancement of ORIC-101 and our other product candidates of $3.6 million, as well as higher personnel costs, including additional non-cash stock-based compensation of $0.8 million for the three months ended March 31, 2021, as compared to the same period in 2020.
G&A Expenses: General and administrative expenses were $4.9 million for the three months ended March 31, 2021, compared to $1.9 million for the three months ended March 31, 2020, an increase of $3.0 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $1.4 million for the three months ended March 31, 2021, as compared to the same period in 2020, and higher professional services and related costs to operate as a public company.

MEI Pharma Reports Third Quarter Fiscal 2021 Results and Operational Highlights

On May 6, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended March 31, 2021 and highlighted recent corporate progress (Press release, MEI Pharma, MAY 6, 2021, View Source [SID1234579350]).

"The first several months of 2021 have been very eventful for MEI, highlighted by the completion of enrollment in the follicular lymphoma efficacy population arm of the zandelisib TIDAL study. In addition, we recently reported preclinical data at AACR (Free AACR Whitepaper) 2021, demonstrating the ability of voruciclib to downregulate MYC and synergize with KRAS inhibitors in KRAS mutant cancers," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "While we continue to work diligently to advance the clinical development of voruciclib and ME-344, we anticipate additional important milestones from the zandelisib program this calendar year, including top-line TIDAL data by the end of 2021, the initiation of our Phase 3 COASTAL study evaluating zandelisib in combination with rituximab in patients with second line follicular or marginal zone lymphomas expected to start around mid-year, and clinical data updates from the ongoing Phase 1b study at the ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper) and ICML annual meetings."

Anticipated Calendar Year 2021 Drug Candidate Pipeline Developments

Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies

Reporting of topline data from the Phase 2 TIDAL study in the fourth quarter from the follicular lymphoma primary efficacy population. The complete data from the follicular lymphoma arm of the Phase 2 TIDAL study data are intended to be submitted to FDA to support an accelerated approval application.
Initiation around mid-2021 of enrollment in COASTAL, a Phase 3 study evaluating zandelisib in combination with rituximab in follicular and marginal zone lymphoma patients who received one or more prior lines of treatment. This study is intended to support FDA approval for additional indications and act as the required confirmatory study for the potential accelerated approval of zandelisib in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma.
Clinical data updates from the Phase 1b study of zandelisib at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings, including the combination with zanubrutinib.
Voruciclib – CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia

Program updates, including data from the Phase 1 program evaluating voruciclib in patients with acute myeloid leukemia and B-cell malignancies.
ME-344 – Tumor selective mitochondrial inhibitor

Initiation of a Phase 2 pilot study of ME-344 in solid tumors in the first half of calendar 2022.
Recent and Third Quarter Fiscal Year 2021 Corporate Highlights

In April 2021, MEI completed enrollment in the follicular lymphoma primary efficacy population of the global Phase 2 TIDAL study evaluating zandelisib. Topline data from the study is on track to be reported in the fourth quarter. The complete Phase 2 TIDAL study data are intended to be submitted to FDA to support accelerated approval applications.

In April 2021, MEI reported preclinical data demonstrating that voruciclib, an orally administered cyclin-dependent kinase (CDK) inhibitor that is potent against CDK9, downregulates MYC by inhibiting MYC transcription and stabilization, and synergizes with KRAS inhibitors in KRAS mutant cancers. The research was featured as an E-Poster Session presentation titled, "Voruciclib, a CDK9 inhibitor, downregulates MYC and inhibits proliferation of KRAS mutant cancers in preclinical models" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021.

In January 2021, MEI announced that the Phase 1b trial arm exploring zandelisib in combination with zanubrutinib in collaboration with BeiGene, Ltd. completed the dose optimization stage in patients with B-cell malignancies and is expanding into disease specific B-cell malignancy cohorts. The Safety Review Committee recommended moving forward with a dosing regimen found to be generally well tolerated and active following a planned safety analysis.
Third Quarter Fiscal Year 2021 Financial Results

As of March 31, 2021, MEI had $164.6 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended March 31, 2021, cash used in operations was $15.6 million, compared to $10.3 million for the same period in 2020. The increase in cash used in operations primarily relates to costs associated with our clinical development programs. For the nine months ended March 31, 2021, cash used in operations was $20.7 million, compared to $34.9 million for the same period in 2020. The year-to-date decrease in cash used in operations reflects $20.9 million of cash received from the Japanese taxing authorities as a refund of withholding tax associated with the Kyowa Kirin commercialization agreement signed in April 2019, offset by increased costs associated with our clinical development programs.
Research and development expenses were $17.9 million for the quarter ended March 31, 2021, compared to $9.0 million for the quarter ended March 31, 2020. The increase was primarily related to increased development costs associated with zandelisib, including increased activity in the TIDAL study and start-up costs related to the Phase 3 study, as well as increased personnel costs to support clinical trial activities.
General and administrative expenses were $6.2 million for the quarter ended March 31, 2021, compared to $3.9 million for the quarter ended March 31, 2020. The increase primarily relates to personnel costs and general corporate expenses incurred during the quarter ended March 31, 2021.
MEI recognized revenues of $2.4 million for the quarter ended March 31, 2021, compared to $1.2 million for the quarter ended March 31, 2020. The increase in revenue primarily related to the license agreement with Kyowa Kirin and included the recognition of fees allocated to research and development obligations.
Net loss was $31.3 million, or $0.28 per share, for the quarter ended March 31, 2021, compared to net loss of $4.3 million, or $0.04 per share for the quarter ended March 31, 2020. The Company had 112,591,778 shares of common stock outstanding as of March 31, 2021, compared with 105,998,677 shares as of March 31, 2020.
The adjusted net loss for the quarter ended March 31, 2021, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $22.0 million, compared to an adjusted net loss of $12.1 million for the quarter ended March 31, 2020.

Calithera Biosciences Reports First Quarter 2021 Financial Results and Recent Highlights

On May 6, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel, small molecule drugs for the treatment of cancer and other life-threatening diseases, reported its financial results for the first quarter ended March 31, 2021 (Press release, Calithera Biosciences, MAY 6, 2021, View Source [SID1234579349]).

"In the first quarter, we continued to enroll patients in each of our two key clinical development programs. These include the randomized KEAPSAKE trial evaluating telaglenastat in combination with standard-of-care chemoimmunotherapy for non-small cell lung cancer patients with KEAP1/NRF2 genetic mutations and the Phase 1b clinical trial evaluating CB-280 for the treatment of cystic fibrosis," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "We look forward to maintaining our focus on these key programs and plan to release interim data from CB-280 in cystic fibrosis in the second half, and from KEAPSAKE in the fourth quarter of this year".

First Quarter 2021 and Recent Highlights

Continued enrollment of the Phase 2 randomized KEAPSAKE trial in non-small cell lung cancer (NSCLC) patients with genetic mutation KEAP1/NRF2. The double-blind KEAPSAKE trial will enroll approximately 120 patients with stage IV non-squamous NSCLC with tumors that have the KEAP1 or NRF2 mutation. Patients will be randomized to receive telaglenastat or placebo, in combination with pembrolizumab, carboplatin and pemetrexed. The study will evaluate the safety and investigator-assessed progression-free survival (PFS) of telaglenastat plus this standard-of-care chemoimmunotherapy regimen. Calithera anticipates releasing interim data from the KEAPSAKE trial in the fourth quarter of 2021.
Ongoing enrollment of the Phase 1b clinical trial of CB-280 in patients with cystic fibrosis (CF). CB-280 is an oral inhibitor of arginase, an enzyme that depletes the amino acid arginine. The randomized, double blind, placebo-controlled, dose escalation trial is evaluating multiple ascending doses of CB-280, dosed orally twice daily for 14 days, compared to placebo in up to 32 adult CF patients to determine a safe dose range for CB-280. In October 2020, Calithera was awarded up to $2.4 million from the Cystic Fibrosis Foundation to support clinical development of CB-280. Enrollment in the Phase 1b study is ongoing and Calithera expects to announce data from this study in the second half of 2021.
Final results of the CANTATA trial to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. The Phase 2 CANTATA trial is a global, randomized, double-blind clinical trial of telaglenastat combined with cabozantinib, in patients with advanced or metastatic RCC who have received one or two prior treatments. On January 4, 2021, Calithera announced topline results from the CANTATA clinical study and reported the trial did not meet the primary endpoint of improving PFS in the study population. Data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 7, 2021.
Selected First Quarter 2021 Financial Results

Cash, cash equivalents and investments totaled $102.9 million at March 31, 2021.

Research and development expenses for the first quarter 2021 were $15.3 million, compared to $20.1 million in the same period prior year. The decrease of $4.8 million was primarily due to a $3.3 million decrease in expenses associated with the telaglenastat program, a $1.6 million decrease in the INCB001158 program and a $0.2 million decrease in our early stage research programs, partially offset by an increase of $0.3 million in the CB-280 program.

General and administrative expenses for the first quarter 2021 were $5.4 million, compared to $4.9 million in the same period prior year. The increase of $0.5 million was primarily related to a $0.9 million increase in personnel-related costs, partially offset by a $0.4 million decrease in professional services costs.

Interest and other income, net for the first quarter 2021 was $0.4 million, compared to $0.6 million in the same period prior year.

Net loss for the three months ended March 31, 2021 was $20.4 million.

Conference Call Information

Calithera will host an update conference call today, Thursday, May 6, at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and referring to conference ID 6250035. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

Alector to Present at the BofA Securities 2021 Virtual Health Care Conference

On May 6, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that Shehnaaz Suliman, M.D., MBA, M.Phil., president and chief operating officer of Alector, will participate in a fireside chat at the BofA Securities 2021 Virtual Health Care Conference on Thursday, May 13, 2021, at 11:45 a.m. ET (Press release, Alector, MAY 6, 2021, View Source [SID1234579348]).

A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 30 days following the event.