On February 27, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported significant progress in the advancement of its strategic pipeline of drug assets (Press release, Sierra Oncology, FEB 27, 2018, View Source [SID1234524263]).

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The company announced noteworthy progress in the Dose Escalation Phase 1 portions for both of its ongoing Phase 1/2 clinical trials evaluating its potential best-in-class Chk1 inhibitor, SRA737. The company announced expansion of the efficacy-oriented Phase 2 portions of both trials, which will now target aggregate enrollment of approximately 200 patients across ten cancer indications. The company also announced it is planning to initiate a Phase 1b/2 clinical trial in the fourth quarter of 2018 that will evaluate SRA737 in combination with ZEJULA (niraparib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

In addition, the company announced it is planning to submit an Investigational New Drug (IND) for its Cdc7 inhibitor, SRA141, in the second half of 2018 in order to initiate a Phase 1/2 clinical trial, focused initially on the treatment of colorectal cancer.

Sierra is hosting a Program Update event today at 10:00 am ET in New York where it will provide an update on the progress of its portfolio of assets, with specific reference to its clinical development program for SRA737. The Sierra management team will be joined by Dr. Udai Banerji, Chief Investigator for the company’s ongoing SRA737 Phase 1/2 clinical trials, and Dr. Alan D’Andrea, a member of Sierra’s DDR Advisory Committee. A live webcast of the event will be available at www.sierraoncology.com.

"We are pleased to report encouraging progress in the advancement of both of our next generation DDR assets. In particular, SRA737 has demonstrated an emerging preclinical and clinical profile which appears competitively differentiated in comparison to other clinical stage Chk1 inhibitors, which gives us confidence to significantly expand its development program both as monotherapy and in a variety of combination settings," said Dr. Nick Glover, President and CEO of Sierra Oncology. "In support of this expansion, we are adding further clinical centers in 2018, with the goal of reporting preliminary clinical data in the fourth quarter of 2018."

"The safety profile for SRA737 has been highly promising, both as monotherapy and in combination with low dose gemcitabine. These observations are entirely consistent with the asset’s mechanism-of-action and preclinical toxicology data, supporting a broad potential therapeutic window for SRA737," Dr. Barbara Klencke, Chief Development Officer, Sierra Oncology. "The Phase 2 efficacy-oriented portion of the monotherapy trial is also underway and focuses on cancers that are driven by genetic mutations that result in high replication stress, which have been associated with synthetic lethality to Chk1 inhibition."

"Given our continued understanding of Chk1 biology, we are also adding a CCNE1-driven ovarian cancer cohort to the monotherapy study," added Dr. Mark Kowalski, Chief Medical Officer, Sierra Oncology. "Women with tumors harboring this genetic profile have limited therapeutic options; they typically become resistant to platinum-based chemotherapy and do not commonly harbor mutations in BRCA1/2 genes. However, given the key role of CCNE1 in driving replication stress, SRA737 may be effective in these tumor types. We are encouraged by preclinical data we have generated that reinforce this potential utility."

SRA737-01 Phase 1/2 Monotherapy Trial: Trial Update and Expansion Plans

This trial consists of two phases, a safety-oriented Dose Escalation Phase 1 in unselected ‘all-comer’ patients and an efficacy-oriented Cohort Expansion Phase 2 in patients with genetically-defined tumors that harbor genomic alterations linked to increased replication stress and hypothesized to be more sensitive to Chk1 inhibition. The company will provide an update on the Dose Escalation Phase 1 portion today.

Dose Escalation has proceeded through multiple dose levels and SRA737 has been well-tolerated from 20 mg QD to 1000 mg QD as monotherapy.
The majority of reported adverse events (AEs) have been Grade 1 or Grade 2 in severity.
Most commonly observed AEs (≥ 20%; all reported causalities) were fatigue and GI events (diarrhea, nausea, vomiting).
Grade 3 adverse events have included neutropenia (2 patients), nausea (2 patients), and diarrhea (1 patient).
Serious Adverse Events (at least possibly related by Investigator assessment) included Grade 3 neutropenia (probably related; one patient) and Grade 3 heart failure/cardiomyopathy (possibly related) in a single patient with rapid disease progression.
Two Dose Limiting Toxicities (DLTs) were reported at 1300 mg QD (inability to receive 75% of the planned SRA737 dose due to GI intolerability).
No evidence of emergent or cumulative toxicity and/or declining tolerability was observed with up to 8 cycles of drug administered, supportive of potential for extended dosing.
Dose escalation is now complete; 1000 mg QD & 500 mg BID cohorts are currently being compared in order to optimize the SRA737 dose regimen.

The Cohort Expansion Phase 2 portion of the trial is enrolling genetically-defined patients into indication specific cohorts, including advanced or metastatic:

castration-resistant prostate cancer (mCRPC);
high grade serous ovarian cancer (HGSOC);
non-small cell lung cancer (NSCLC);
head and neck squamous cell carcinoma (HNSCC) or squamous cell carcinoma of the anus (SCCA); and
colorectal cancer (mCRC).

The company announced today the addition of a sixth indication specific cohort, CCNE1-driven HGSOC. During the Program Update, the company will present preclinical data demonstrating that SRA737 has significant anti-tumor activity and a profound survival benefit in CCNE1-driven HGSOC preclinical models.

Sierra is also expanding the number of sites recruiting patients into the trial from three active sites (as of the third quarter of 2017) to a planned fifteen active sites at leading centers across the United Kingdom, to support its increased enrollment to 20 patients in each of the six genetically-defined cohorts. In total, 120 patients are expected to be enrolled into the Phase 2 portion of the trial. The company reported that 20 patients had been enrolled into this portion of the study to date and that enrollment was in line with the anticipated prevalence of the gene mutations targeted. The Cohort Expansion Phase 2 portion of the study is expected to report preliminary clinical data in the fourth quarter of 2018.

SRA737-02 Phase 1/2 Low Dose Gemcitabine Combination Trial: Trial Update and Expansion Plans

This clinical trial consists of three phases:

1. A Standard Dose Triplet Combo Dose Escalation Phase 1 evaluating a combination of SRA737 with standard dose gemcitabine and cisplatin in patients with solid tumors.

The company reported that this phase has concluded.

2. A Low Dose Gemcitabine (LDG) Combo Dose Escalation Phase 1 evaluating safety in ‘all-comer’ non-selected patients, where cohorts of 3 to 6 patients are being administered escalating doses of SRA737 on an intermittent schedule in addition to low dose gemcitabine (5-10% of the standard gemcitabine dose) until the combination maximum tolerated dose (MTD) is reached.

The company reported that significant progress has been made in the LDG Combo Dose Escalation Phase 1, and the combination regimen has been very well-tolerated.

The majority of reported AEs have been Grade 1 or Grade 2 in severity.
Most commonly observed AEs (≥ 20%; all reported causalities) were diarrhea, anemia, thrombocytopenia, fatigue, influenza-like illness, nausea, neutropenia and vomiting.
Only one Grade 3 treatment related AE (neutropenia) was observed, at 40 mg SRA737/300 mg/m2 gemcitabine.
Related SAEs included a Grade 1 fever (possibly related) and a Grade 2 DVT (possibly related).
No evidence of emergent or cumulative toxicity and/or declining tolerability was observed with up to 5 cycles of drug administered, supportive of potential for extended dosing.
No DLTs have been reported in any LDG dose escalation cohort and dose escalation continues.

3. A Low Dose Gemcitabine Combo Cohort Expansion Phase 2, that will explore the preliminary efficacy of SRA737 plus low dose gemcitabine in prospectively enrolled genetically-defined patients with tumors that harbor genomic alterations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality.

The company reported that this phase is anticipated to commence in the second quarter of 2018 and has been expanded to target enrollment of 80 genetically-selected patients across four indications, including advanced or metastatic:

urothelial carcinoma;
small cell lung cancer (SCLC);
soft tissue sarcoma;
cervical/anogenital cancer.

An update on the study is expected to be provided in the fourth quarter of 2018.

SRA737 PARPi Combination Program Initiation and Supply Agreement
The company also announced execution of a supply agreement with Janssen Research & Development, LLC for the supply of TESARO’s ZEJULA (niraparib), an orally administered poly ADP-ribose polymerase (PARP) inhibitor, facilitating the initiation of a combination trial of SRA737 with niraparib in patients with prostate cancer, expected in the fourth quarter of 2018.

The trial is to be led by 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.

During the Program Update today, the company will present preclinical data supporting SRA737’s synergistic activity in combination with PARPi in a model of PARPi acquired resistance. Additional preclinical data supporting this combination will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018.

SRA737 Combination with Immuno-Oncology
During the Program Update today, the company will also present preclinical data providing evidence of biological synergy between SRA737 and immune checkpoint blockade. Sierra is currently designing a clinical study for this combination, which potentially could be submitted to regulatory authorities in the fourth quarter of 2018.

SRA141 Program Update
The company continues to advance SRA141, its potent, selective, orally bioavailable small molecule inhibitor of Cell division cycle 7 kinase (Cdc7), an emerging DDR target with exciting potential in cancer. During the Program Update today, the company will present supportive preclinical research for SRA141 demonstrating noteworthy anti-cancer activity in oncology models, generated in preparation for an IND submission expected in the second half of 2018, with an initial clinical focus on the treatment of colorectal cancer.

On February 27, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, today reported its financial and operational results for the year ended December 31, 2017 (Press release, Sierra Oncology, FEB 27, 2018, View Source [SID1234524262]).

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"During 2017, we made substantial progress advancing our portfolio of promising next generation DDR therapeutics. In particular, emerging preclinical and clinical data continue to reinforce the fundamental biological role of Chk1 in regulating cancer-driven replication stress associated with genomic instability, a hallmark of cancer with potentially broad therapeutic relevance. Accordingly, during the year we significantly advanced and expanded the development program for our potential best-in-class Chk1 inhibitor, SRA737, which will now be evaluated across ten cancer indications in two ongoing Phase 1/2 trials, targeting aggregate enrollment of approximately 200 genetically-selected patients. We look forward to reporting preliminary data from these trials, expected in the fourth quarter of 2018," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We also announced, subsequent to the end of the year, the advancement of a promising third development opportunity for SRA737 with the signing of an agreement with Janssen to supply us with ZEJULA (niraparib). This agreement facilitates the advancement of a novel Chk1i/PARPi combination trial in prostate cancer that we plan to initiate in the fourth quarter of 2018, which will be led by Professor Johann de Bono, Regius Professor of Cancer Research at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust.

2017 Highlights:

In January 2017, we relaunched as Sierra Oncology with a stated focus on developing oncology drugs targeting the DNA Damage Response (DDR) network.
Also in January, we successfully transferred sponsorship of the two ongoing Phase 1/2 clinical trials for our lead DDR drug candidate, SRA737, from the Cancer Research UK Centre for Drug Development, enabling us to submit protocol amendments aimed at enhancing these studies to include cohort expansions of prospectively selected patients with tumors identified to have genetic aberrations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality.
In February, we raised net proceeds of US$27.4 million to further advance our programs.
In April, our collaborator, the Institute of Cancer Research (ICR), London, UK, reported preclinical results for SRA737 in a poster at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, supporting our genetically-driven clinical development strategy for SRA737.
In May, we were issued a patent providing SRA737 with protection in the United States to 2033, before any potential patent term extensions.
In June, having received clearance for our protocol amendments, we presented these innovative SRA737 Phase 1 clinical designs in two Trials in Progress posters at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. We concurrently reported encouraging initial progress from the two ongoing trials; SRA737 was well-tolerated and a maximum tolerated dose (MTD) had not yet been reached in the dose escalation phase of the monotherapy trial.
In August, we established a DDR Advisory Committee composed of leading experts in DDR biology, chemistry and medicine. We also held two Key Opinion Leader (KOL) events, in September and October 2017, which featured members from our Advisory Committee who shared their insights on emerging DDR biology and the potential of Chk1 inhibition in oncology, providing further support for our programs.
In October, we presented a poster at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), reporting on preclinical data demonstrating that sub-therapeutic, non-cytotoxic doses of gemcitabine induce replication stress and hence potentiate the anti-tumor activity of SRA737. These data support the design of our ongoing Phase 1/2 clinical trial which is specifically evaluating this combination.
We appointed Dr. Andrew Allen to our Board of Directors, effective October 23, 2017. Dr. Allen is the co-founder of Gritstone Oncology and was the co-founder of Clovis Oncology (Nasdaq: CLVS).

Subsequent Events:
On February 27, 2018, we provided an update on the SRA737 and SRA141 development programs:

For the SRA737 Monotherapy Phase 1/2 trial, we reported that the Dose Escalation Phase 1 portion of the study was in the final stages of optimizing the SRA737 dose regimen and the Cohort Expansion Phase 2 portion of the study was ongoing. The Cohort Expansion Phase 2 portion of the study was being expanded to include more patients, including a sixth indication (CCNE1-driven ovarian cancer), and would in aggregate target enrollment of 120 patients across six genetically-defined cohorts. We also reported that we plan to expand the number of sites recruiting patients into the trial from three active sites (as of the third quarter of 2017) to fifteen leading centers across the United Kingdom. The Cohort Expansion Phase 2 portion of the study is expected to report preliminary data in the fourth quarter of 2018.
For the SRA737 Low-Dose Gemcitabine Phase 1/2 Combination trial, we reported that the Standard-Dose Triplet Combo Dose Escalation Phase 1 was complete and that the Low-Dose Gemcitabine Combo Dose Escalation Phase 1 had made significant progress. In addition, the Low-Dose Gemcitabine Combo Cohort Expansion Phase 2 was anticipated to commence in the second quarter of 2018 and would be expanded to target enrollment of 80 genetically-selected patients across four indications. An update on the study is expected to be reported in the fourth quarter of 2018.
We reported signing a supply agreement with Janssen Research & Development, LLC where they will supply TESARO’s ZEJULA (niraparib), an orally administered poly ADP-ribose polymerase (PARP) inhibitor, facilitating the initiation of a combination trial of niraparib with SRA737 in patients with prostate cancer in the fourth quarter of 2018. The trial is to be led by 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.
We presented emerging evidence of biological synergy between immune checkpoint blockade and Chk1 inhibition. Sierra is currently designing a clinical study for this combination, which potentially could be submitted to regulatory authorities in the fourth quarter of 2018.
We reported supportive preclinical research for SRA141 demonstrating noteworthy anti-cancer activity in two independent oncology models, generated in preparation for an Investigational New Drug (IND) filing expected in the second half of 2018.

2017 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $30.2 million for the year ended December 31, 2017, compared to $33.9 million for the year ended December 31, 2016. The decrease is primarily due to expenses incurred in 2016, including $9.0 million related to the SRA737 license agreement, a $0.9 million upfront payment for the exclusive license of SRA141, and a $2.3 million restructuring charge related to close-out expenses for PNT2258. These decreases were partially offset by increases of $4.6 million in third-party manufacturing costs, $2.6 million in research and other costs related to SRA737 and SRA141, and $1.0 million in clinical trial costs. Research and development expenses included non-cash stock-based compensation of $4.0 million and $3.6 million for the years ended December 31, 2017 and 2016, respectively.

General and administrative expenses were $12.5 million for the year ended December 31, 2017 compared to $14.2 million for the year ended December 31, 2016. The decrease is primarily due to a $1.1 million decrease in business development expenses and a $0.5 million decrease in restructuring costs as compared to 2016. General and administrative expenses included non-cash stock-based compensation of $1.9 million for both the year ended December 31, 2017 and the year ended December 31, 2016.

For the year ended December 31, 2017, Sierra incurred a net loss of $42.0 million compared to a net loss of $47.9 million for the year ended December 31, 2016.

Cash and cash equivalents totaled $100.3 million as of December 31, 2017, compared to $107.8 million as of September 30, 2017, and $109.0 million as of December 31, 2016. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2019.

At December 31, 2017, there were 52,395,223 shares of common stock issued and outstanding, and stock options to purchase 7,470,601 shares of common stock issued and outstanding.

On February 27, 2018 SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (SELLAS), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, reported that data from the Phase 2 trial of its lead candidate, galinpepimut-S (GPS), in acute myeloid leukemia (AML) have been published in the current issue of Blood Advances (Press release, Sellas Life Sciences, FEB 27, 2018, View Source [SID1234524259]). GPS met its pre-specified primary endpoint of ≥34% actual overall survival (OS) rate at three years with a GPS-induced OS rate of 47.4%. Median disease-free survival (DFS) from first complete response was 16.9 months, while the overall survival (OS) from diagnosis has not yet been reached, but is predicted to be > 67.6 months. GPS targets the antigen, Wilms tumor 1 (WT1) protein, which has been ranked by the National Cancer Institute as the leading target for cancer immunotherapy.

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"These data follow on prior positive data in AML and various cancer indications, supporting the development of GPS as an important potential therapy in the treatment of AML and other cancers," said Angelos Stergiou, MD, ScD h.c., President & Chief Executive Officer of SELLAS. "We are encouraged by the collective supporting evidence generated by our Phase 1 and Phase 2 AML studies. We wholeheartedly appreciate the participation of patients and their families in all our clinical studies, as well as the exceptional physicians and study teams. We look forward to advancing GPS into a Phase 3 trial in AML."

For patients in the older cohort (age >60; n=13), median OS post-diagnosis was 35.8 months. Historical controls for comparable patients over sixty years of age who reach first complete remission (CR1) show median OS since initial diagnosis of 9.5-15.8 months.

"We were especially pleased with the findings in AML patients over sixty years of age, which are important considering the poor prognosis particularly for those patients, even with optimal use of current care standards" stated Peter Maslak, M.D., Chief, Immunology Laboratory Service at Memorial Sloan Kettering Cancer Center and Principal Investigator of the study.

The open-label Phase 2 study evaluated GPS in 22 adult patients with AML (median age – 64 years) in CR1. Patients received 6 vaccinations administered over 10 weeks with the potential to receive 6 additional monthly doses if they remained in CR1. Immune responses (IR’s) were evaluated after the sixth and twelfth vaccinations by CD4+ T-cell proliferation, CD8+ T cell interferon-γ secretion (ELISPOT) or the CD8-relevant WT1 peptide MHC tetramer assay (HLA-A*02 patients only).

"Older adults with AML who achieve complete remission (CR) are in critical need of new treatment options to prevent emerging relapses, especially in cases where allogeneic stem cell transplant is infeasible or is not predicted to improve outcome," stated Gert Ossenkoppele, M.D., Ph.D., professor of Hematology at the VU University Medical Center in Amsterdam, The Netherlands, and chair of the AML working party of HOVON (Dutch-Belgian Hematology Trial Group). "Results from this GPS Phase 2 study reinforce the potential of this innovative WT1-targeting immunotherapy in the post-CR maintenance setting. I look forward to co-leading the Phase 3 study in AML patients older than 60 years, currently being planned by SELLAS." Dr. Ossenkoppele did not participate in the GPS Phase 2 study.

In the study, GPS was well tolerated, with the most common side effects being Grade 1/2 injection site reactions (46%), fatigue (32%), and skin induration (32%). Fourteen patients (64%) completed more than six vaccinations, and nine (41%) received all 12 vaccine doses. Nine of 14 tested patients (64%) had an immune response (IR) in more than one of three assays used (one for CD4 or two for CD8).

The article, "Phase 2 trial of a multivalent WT1 peptide vaccine (galinpepimut-S) in acute myeloid leukemia," is available in the current issue of Blood Advances, a peer-reviewed medical journal published by the American Society of Hematology (ASH) (Free ASH Whitepaper). The complete article can be accessed here (View Source).

On February 27, 2018 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported that it will report its fourth quarter and year end 2017 financial results after market close on Tuesday, March 6, 2018. Rigel senior management will follow the announcement with a live conference call and webcast at 5:00pm Eastern Time (2:00pm Pacific Time) to discuss the financial results and provide a company update (Press release, Rigel, FEB 27, 2018, View Source;p=RssLanding&cat=news&id=2334848 [SID1234524258]).

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Participants can access the live conference call by dialing 855-892-1489 (domestic) or 720-634-2939 (international) and using the Conference ID number 7289803. The conference call will also be webcast live and can be accessed from Rigel’s website at www.rigel.com. The webcast will be archived and available for replay for 30 days after the call via the Rigel Website.

On February 27, 2018 Pfenex Inc. (NYSE AMERICAN: PFNX), reported that the company will present at Barclay’s 2018 Global Healthcare Conference in Miami Beach, Florida (Press release, Pfenex, FEB 27, 2018, View Source2018-02-27-Pfenex-Inc-to-Present-at-Barclays-2018-Global-Healthcare-Conference" target="_blank" title="View Source2018-02-27-Pfenex-Inc-to-Present-at-Barclays-2018-Global-Healthcare-Conference" rel="nofollow">View Source [SID1234524255]).

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President and Chief Executive Officer, Eef Shimmelpennink, is scheduled to present on Tuesday, March 13th at 3:50 pm ET.

Interested parties can access the live audio webcast for this presentation from the Investors Section of Pfenex’s website at www.pfenex.com. The webcast replay will be available after the conclusion of the live presentation for approximately 60 days.

Pfenex investors and others should note that we announce material information to the public about the Company through a variety of means, including our website (View Source), our investor relations website (View Source), press releases, SEC filings, public conference calls, corporate Twitter account (View Source), Facebook page (View Source), and LinkedIn page (View Source) in order to achieve broad, non-exclusionary distribution of information to the public and to comply with our disclosure obligations under Regulation FD. We encourage our investors and others to monitor and review the information we make public in these locations as such information could be deemed to be material information. Please note that this list may be updated from time to time.