On May 15, 2019 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the first quarter ended March 31, 2019 (Press release, Cleveland BioLabs, MAY 15, 2019, View Source [SID1234536339]).

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Cleveland BioLabs reported a net loss of $(0.9) million, excluding minority interests, for the first quarter of 2019, or $(0.08) per share, compared to a net loss, excluding minority interests, of $(1.2) million, or $(0.11) per share, for the same period in 2018. The decrease in net loss was primarily due to reduced research and development activity due to previously disclosed vendor delays in in the analytical analyses required to complete the biocomparability study and a decrease in General and Administrative costs partially offset by an increase in the non-cash adjustment to our warrant liabilities. The biocomparability study was completed during the first quarter.

As of March 31, 2019, the Company had $3.3 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations into December 2019.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The development, pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our top priority.

Further Financial Results

Revenue for the first quarter of 2019 decreased to $0.20 million compared to $0.23 million for the first quarter of 2018. The net decrease was primarily attributable to decreased revenue from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure partially offset by increased revenue from our service contract with Incuron.

Research and development costs for the first quarter of 2019 decreased to $0.5 million compared to $1.3 million for the first quarter of 2018. The reduction in research and development costs is due to a $0.57 million reduction in spending for biodefense applications of entolimod, $0.26 million decrease in expenses related to the oncology applications of the entolimod family of compounds, and a $0.04 million reduction in spending on Panacela’s product candidates partially offset by a $0.05 million increase in expenses related to the Curaxins.

General and administrative costs for the first quarter of 2019 decreased to $0.47 million compared to $0.73 million for the first quarter of 2018. This decrease was primarily attributable to $0.15 million decrease in property tax expense, $0.06 million decrease in expense relating to a one-time settlement for the previously completed research contracts with the Russian Ministry of Trade, and $0.05 million decrease in legal and professional fees.

On May 15, 2019 Pfizer Inc. (NYSE:PFE) reported that it will present data across its industry-leading oncology portfolio, covering multiple tumor types and mechanisms of action at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago from May 31-June 4, 2019 (Press release, Pfizer, MAY 15, 2019, View Source [SID1234536356]). Data will highlight Pfizer’s cutting-edge approach, expertise in precision medicine and work in immunotherapy combinations, including company-sponsored and collaborative research studies.

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"The data presented at this year’s ASCO (Free ASCO Whitepaper) showcase our continued commitment to follow the science, whether it’s expanding our approved medicines for breast and prostate cancers into new populations and lines of therapy, or exploring the important role of biomarkers and immunotherapy combinations," said Dany Habr, M.D., Chief Medical Officer, Pfizer Oncology. "We look forward to both sharing our exciting data in these and other tumor types, as well as connecting with our research partners to determine how we can continue to work collaboratively to bring transformative therapies to our cancer patients."

The research to be presented includes new insights on Pfizer’s marketed therapies, including IBRANCE (palbociclib), XTANDI (enzalutamide), TALZENNA (talazoparib), BOSULIF (bosutinib), INLYTA (axitinib) and BAVENCIO (avelumab), which represent Pfizer Oncology’s long-standing legacy of developing innovative therapies for patients in need, as well as its ongoing commitment to addressing the needs of cancer patients across gender, ethnicity and tumor type. For example, Pfizer will present real-world data on the use of IBRANCE for the treatment of men with metastatic breast cancer (MBC).

"At this year’s ASCO (Free ASCO Whitepaper), I am particularly excited that we’ll share data from new initiatives such as the oral presentation of talazoparib in breast cancer or other solid tumors. This builds on a productive year with the approval of four new oncology treatments, three biosimilars and three new indications, including one based on real-world evidence," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "We are proud to have one of the broadest oncology portfolios in the industry, and a research philosophy that puts patients first, embraces new approaches and showcases innovative thinking."

Key Pfizer-sponsored, investigator-sponsored and collaborative research abstracts leveraging the depth of Pfizer’s scientific advances include:

A poster presentation on real-world evidence of male breast cancer patients treated with IBRANCE in combination with endocrine therapy (Abstract 1055).
An external investigator-sponsored oral presentation on a Phase 2 trial examining TALZENNA beyond BRCA, specifically as monotherapy in BRCA1 and BRCA2 wild-type patients with advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous recombination (HR) pathway genes (Investigator-sponsored abstract 3006).
Biomarker analyses from JAVELIN Renal 101 that studied BAVENCIO plus INLYTA vs. sunitinib in advanced renal cell carcinoma (aRCC) (Abstract 101).
An external collaborative research presentation on genomic markers of early progression on fulvestrant with or without IBRANCE for ER+ advanced breast cancer in the PALOMA-3 trial (Collaborative research abstract 1010).

Details for the Pfizer-sponsored, investigator-sponsored and collaborative research oral presentations are below:

Title/Abstract Number Date/Time (CDT) Location
(Abstract 101)
Biomarker Analyses from JAVELIN Renal 101: Avelumab + Axitinib (A + Ax) vs Sunitinib (S) in Advanced Renal Cell Carcinoma (aRCC)

Choueiri TK

Saturday, June 1
8:12 AM – 8:24 AM

Hall D1
(Abstract 1010)
Genomic Markers of Early Progression on Fulvestrant with or without Palbociclib for ER+ Advanced Breast Cancer in the PALOMA-3 Trial

O’Leary B

Saturday, June 1
3:12 PM – 3:24 PM

Hall D1
(Abstract 3006)
Talazoparib Beyond BRCA: A Phase II Trial of Talazoparib Monotherapy in BRCA1 and BRCA2 Wild-Type Patients with Advanced HER2-Negative Breast Cancer or Other Solid Tumors with a Mutation in Homologous Recombination (HR) Pathway Genes

Gruber J

Monday, June 3
10:00 AM – 10:12 AM

S406
(Abstract 5502)
Phase 2, Two-Group, Two-Stage Study of Avelumab in Patients (Pts) with Microsatellite Stable (MSS), Microsatellite Instable (MSI) and Polymerase Epsilon (POLE) Mutated Recurrent/Persistent Endometrial Cancer (EC)

Konstantinopoulos PA

Monday, June 3
1:39 PM – 1:51 PM

S406
(Abstract 1007)
A Randomized Phase II Study of Palbociclib plus Exemestane with GNRH Agonist versus Capecitabine in Premenopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer (KCSG-BR 15-10, NCT02592746)

Park YH

Tuesday, June 4
11:45 AM – 11:57 AM

Hall D1

Please see a complete list of Pfizer-sponsored abstracts featuring data on our broad pipeline of biologics and small molecules at View Source

Learn more about how developing new medicines and supporting people with cancer is personal for Pfizer Oncology at View Source

Please see full US Prescribing Information and Medication Guide for BAVENCIO (avelumab) available at View Source

Please see full Prescribing Information for INLYTA (axitinib) at www.Inlyta.com.

Please see full Prescribing Information for BOSULIF (bosutinib) at www.Bosulif.com.

Please see full Prescribing Information for IBRANCE (palbociclib) at www.Ibrance.com.

Please see full Prescribing Information for TALZENNA (talazoparib) at www.Talzenna.com.

Please see full Prescribing Information for XTANDI (enzalutamide) at www.Xtandi.com.

On May 15, 2019 Sierra Oncology, Inc. (SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that it will report preliminary clinical data from its Phase 1/2 SRA737 monotherapy study and its Phase 1/2 study of SRA737 in combination with low dose gemcitabine (SRA737+LDG) in two posters being presented on June 1st at the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, Illinois (Press release, Sierra Oncology, MAY 15, 2019, View Source [SID1234536372]).

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In addition, the company will be hosting an Analyst and Investor Event on Monday, June 3rd, to discuss these clinical findings and potential next steps in the development strategy for SRA737.

The event will feature presentations by two distinguished oncologists:

Professor Johann de Bono, Regius Professor of Cancer Research, Head of the Division of Clinical Studies and Professor in Experimental Cancer Medicine at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, will discuss the critical role of Chk1 in tumor cell survival during replication stress (RS), as well as describe potential opportunities to combine SRA737 with other therapeutic modalities including PARP inhibitors and immunotherapy agents.
Dr. Rebecca Kristeleit, Clinical Senior Lecturer and Honorary Consultant Medical Oncologist at University College London (UCL) Cancer Institute & UCLH Dept. of Oncology, a leading expert in gynecological malignancies, will discuss her clinical experience with SRA737+LDG, and potential development opportunities for this novel combination in the treatment of anogenital cancers.
"We look forward to presenting preliminary data for these first-in-human studies of SRA737 and SRA737+LDG at ASCO (Free ASCO Whitepaper), and to discussing the potential opportunities for further advancement of our differentiated Chk1 inhibitor that these clinical data provide," said Dr. Nick Glover, President and CEO of Sierra Oncology. "The two studies have enrolled patients across a range of tumor indications including a variety of prospectively selected genetic contexts, allowing us to broadly survey the cancer landscape for activity signals in response to administration of SRA737 alone and in combination with non-cytotoxic low dose gemcitabine. These preliminary data have also enabled us to correlate clinical findings with tumor origin and genetic signature, ascertain whether the exogenous induction of replication stress via low dose gemcitabine can enhance SRA737’s activity, and determine potential next steps in the development path for SRA737."

SRA737 Analyst & Investor Event
Date and Time: June 3rd, 6:00 – 7:00 am CT
Location: History event room, Marriot Marquis Hotel, 2121 S Prairie Ave, Chicago, Illinois.

Event registration and webcast information are available through the Sierra Oncology website at www.sierraoncology.com. An archive of the presentation will be accessible after the event through the Sierra Oncology website.

ASCO 2019 Poster Presentations
Title: A first-in-human phase I/II trial of SRA737 (a Chk1 Inhibitor) in subjects with advanced cancer.
Abstract: 3094
Poster #: 86
Poster Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)
Date and Time: Saturday, June 1, 2019, 8:00 – 11:00 am CT
Location: McCormick Place, Event room: Hall A, 2301 S King Dr, Chicago, Illinois

Title: A phase I/II first-in-human trial of oral SRA737 (a Chk1 inhibitor) given in combination with low-dose gemcitabine in subjects with advanced cancer.
Abstract: 3095
Poster #: 87
Poster Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)
Date and Time: Saturday, June 1, 2019, 8:00 – 11:00 am CT
Location: McCormick Place, Event room: Hall A, 2301 S King Dr, Chicago, Illinois

The posters will be available on June 1, 2019 on the company’s website at www.sierraoncology.com

About SRA737 and SRA737+LDG
SRA737 is a potent, highly selective, orally bioavailable small molecule inhibitor of Checkpoint kinase 1 (Chk1), a key regulator of cell cycle progression and the DNA Damage Response (DDR). Tumors with high levels of replication stress become reliant on Chk1 to mitigate the potentially catastrophic consequences of excess genomic instability.

Intrinsic sources of replication stress can include genetic alterations in tumor suppressors, oncogenes or DNA Damage Repair genes. Tumors harboring defects in these gene classes are hypothesized to have higher levels of intrinsic replication stress due to dysregulated cell cycle control, increased proliferation demands and increased genomic instability.

SRA737+LDG is a novel drug combination, where non-cytotoxic low dose gemcitabine (LDG) acts as a potent extrinsic inducer of replication stress that potentiates SRA737’s anti-tumor activity. Preclinical models have demonstrated that only subtherapeutic levels of gemcitabine are needed to potentiate SRA737’s anti-tumor effect.

Phase 1/2 clinical trials of SRA737 as monotherapy (NCT02797964) and in combination with low dose gemcitabine (NCT02797977) in multiple solid tumors (ovarian, prostate, non-small cell lung, squamous (head & neck, anal), colorectal, small cell lung, sarcoma, cervical, anogenital) are ongoing. Sierra has also prepared for a potential clinical study of SRA737 in combination with a PARP inhibitor.

Sierra Oncology retains the global commercialization rights to SRA737.

On May 15, 2019 Y-mAbs Therapeutics, Inc., (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the acceptance of three poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held May 31 through June 4, 2019 in Chicago, Illinois (Press release, Y-mAbs Therapeutics, MAY 15, 2019, View Source [SID1234536435]). Two of these presentations were submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York and one was submitted by Hospital Sant Joan de Déu, Barcelona, Spain (HSJ) together with MSK.

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These abstracts are publicly available online at View Source

The omburtamab abstract includes a poster presentation of

"A phase I study of convection-enhanced delivery (CED) of 124I-8H9 radio-labeled monoclonal antibody in children with diffuse intrinsic pontine glioma (DIPG) – An Update with Dose-Response Assessment," submitted by MSK.
The naxitamab abstracts include poster presentations of

"High-dose naxitamab plus stepped-up dosing of GM-CSF for high-risk neuroblastoma (HR-NB): Efficacy against histologically-evident primary refractory metastases in bone marrow (BM)," submitted by MSK.
"Naxitamab-based Chemoimmunotherapy for Resistant High-Risk Neuroblastoma: Preliminary results of HITS Pilot/Phase II Study," submitted by HSJ together with MSK.

On May 15, 2019 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, reported that first quarter 2019 financial results (Press release, OncoGenex Pharmaceuticals, MAY 15, 2019, View Source [SID1234536324]).

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ORCA-1 Trial Status

Achieve’s 254-subject Phase 2b ORCA-1 trial of cytisinicline in U.S. smokers completed enrollment in February. The Company announced recently that the last study visit for the last subject enrolled in the ORCA-1 trial has occurred. The trial is evaluating cytisinicline in both the 1.5 mg and 3.0 mg doses on a declining titration schedule as well as three times daily dosing, both over 25 days. The primary efficacy endpoint is reduction in the number of cigarettes smoked during treatment with secondary analyses to be conducted on smoking cessation rates, safety, and compliance. ORCA-1 topline efficacy and safety data are expected to be announced by the end of the second quarter.

Maximum Tolerated Dose (MTD) Trial Extension

Achieve recently initiated a trial to assess the MTD for a single administered oral dose of cytisinicline in smokers. The starting dosage of cytisinicline was 6 mg and is increased in separate groups of subjects for each escalated dose level until stopping criteria, based on the occurrence of dose-limiting adverse events, are reached. To date, 21 mg cytisinicline has been evaluated without evidence of dose limiting toxicity. The trial’s Data Safety Monitoring Committee has recommended a protocol amendment to evaluate additional higher doses of cytisinicline.

Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences commented, "With the results of the ORCA-1 trial expected by the end of the second quarter, we are rapidly approaching another critical milestone for the cytisinicline development program. Importantly, as confirmed by the tolerability of high dose levels in our MTD study, we believe cytisinicline may offer a differentiated and new treatment option for the millions of people who are battling nicotine addiction."

Financial Results

As of March 31, 2019, the company’s cash, cash equivalents, short-term investments and restricted cash were $9.7 million. Each of total operating expenses and net loss for the first quarter of 2019 were $5.9 million.

As of May 15, 2019 Achieve had 6,865,950 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30 p.m. Eastern time today, Wednesday, May 15, 2019. To access the webcast, log on to the investor relations page of the Achieve website at View Source Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 6973659. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.