On October 30, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported the initiation of a Phase 2 trial evaluating poziotinib in non-small cell lung cancer patients with an exon 20 insertion mutation in EGFR or HER2 (Press release, Spectrum Pharmaceuticals, OCT 30, 2017, View Source [SID1234521305]). The first patient has been enrolled and the Company expects to enroll patients at several leading cancer institutions in the United States.

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“Following the promising preliminary data from the University of Texas MD Anderson Cancer Center’s study, we are excited to launch this multicenter trial,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “Earlier this month, results presented at the 18th IASLC World Conference on Lung Cancer showed that poziotinib has the potential to address unmet needs of lung cancer patients with EGFR Exon 20 insertion mutations. The efficacy of first-generation tyrosine-kinase inhibitors has been found to be unsatisfactory in such patients, resulting in single digit response rates and a progression-free survival of around two months. We are grateful for the guidance the Food and Drug Administration has provided in designing this trial.”

The goal of this Phase 2 trial is to evaluate both the efficacy and safety of poziotinib in patients with non-small cell lung cancer (NSCLC) that is locally advanced or metastatic and have an exon 20 insertion mutation in either EGFR or HER2. This trial will enroll up to 87 patients with EGFR exon 20 insertion mutations and up to 87 patients with HER2 exon 20 insertion mutations in several leading cancer institutions. The study will evaluate objective response rate (ORR) as the primary endpoint, and disease control rate (DCR), duration of response (DOR), and safety as secondary endpoints. In addition, progression-free survival (PFS) and quality of life (QoL) will be evaluated.

Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations; this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer.

On October 30, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will host a conference call on Tuesday, November 7, 2017, at 8:30 a.m. ET to review its third quarter 2017 financial results and provide an update on the company (Press release, Infinity Pharmaceuticals, OCT 30, 2017, View Source [SID1234521299]).

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A live webcast of the conference call can be accessed in the Investors/Media section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 97100725. An archived version of the webcast will be available on Infinity’s website for 30 days.

On October 30, 2017 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company pioneering the development of medicines to control the expression of disease-driving genes, reported that new preclinical pharmacodynamic (PD) and pharmacokinetic (PK) data providing a rationale for the twice weekly dosing regimen currently being used in the ongoing Phase 1 clinical trial of SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, in advanced solid tumors were presented at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference in Philadelphia (Press release, Syros Pharmaceuticals, OCT 30, 2017, View Source [SID1234521306]).

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“We are encouraged by the preclinical PK and PD data for SY-1365,” said David A. Roth, M.D., Chief Medical Officer of Syros. “The prolonged PD effect, coupled with the sustained tumor regressions seen in multiple preclinical models of difficult-to-treat cancers using intermittent dosing, support investigation of a twice-a-week dosing regimen for patients. Additionally, based on the correlation between CDK7 target occupancy and the anti-tumor activity of SY-1365, we developed a PD marker for use in our ongoing Phase 1 trial that we believe will help us efficiently identify the optimal dose and regimen for SY-1365.”

Syros scientists evaluated the relationship between SY-1365’s PK, PD and anti-tumor activity in multiple in vivo models, including preclinical models of triple negative breast cancer (TNBC) and acute myeloid leukemia (AML), across a range of doses and regimens from daily to weekly dosing. SY-1365 is a covalent inhibitor that binds irreversibly to CDK7. The data showed:

A prolonged PD effect, as measured by CDK7 target occupancy, with a half-life of about three days, supporting intermittent dosing.
A dose-dependent relationship between CDK7 target occupancy and anti-tumor activity in a preclinical model of AML.
Sustained tumor regressions in multiple in vivo models using a twice weekly dosing regimen consistent with the initial regimen in the ongoing Phase 1 clinical trial.
CDK7 target occupancy in blood cells in preclinical models similar to that seen in tumor cells, supporting the use of an assay measuring target occupancy in patients’ blood samples as a PD marker in the ongoing Phase 1 trial to help guide optimization of the dose and regimen to establish a recommended Phase 2 dose.
The Phase 1 trial of SY-1365 is a multi-center, open-label trial that is expected to enroll approximately 70 patients with advanced solid tumors. The primary objective of the trial is to assess the safety and tolerability of escalating doses of SY-1365, with the goal of establishing a maximum tolerated dose and a recommended Phase 2 dose and regimen. The dose-escalation phase is open to solid tumor patients for whom standard curative or palliative measures do not exist or are no longer effective. Following the dose-escalation phase, expansion cohorts are planned to further evaluate the safety and anti-tumor activity of SY-1365 in patients with triple negative breast, small cell lung and ovarian cancers, to confirm a recommended Phase 2 dose and regimen, and to enroll patients with tumors of any histology in a cohort focused on analyzing biopsied tumor tissue. Additional details about the trial can be found using the identifier NCT03134638 at www.clinicaltrials.gov.

Syros also announced that a publication co-authored by two of its scientific founders Nathanael S. Gray, Ph.D., and Richard A. Young, Ph.D., in the peer-reviewed scientific journal Cancer Discovery (Rusan M., et al., “Suppression of adaptive responses to targeted cancer therapy by transcriptional repression”) highlighted CDK7 inhibition in combination with targeted therapies as a promising new approach for combatting drug resistance. In multiple in vitro and in vivo models of treatment-resistant cancers, a research tool compound, known as THZ1, which inhibits CDK7, enhanced tumor cell killing and impeded the emergence of drug-resistant cell populations when combined with targeted therapies, including MEK, BRAF, EGFR and ALK inhibitors, compared to either THZ1 or the targeted therapy alone. These findings suggest that CDK7 inhibition prevents the formation of active enhancers that drive the increased expression of genes promoting the emergence of drug resistance in response to targeted therapy and blocks transcriptional programs required for the growth and survival of cancer.

Syros has an exclusive, worldwide license from the Dana-Farber Cancer Institute under certain patents relating to CDK7 inhibitors, including THZ1. Using its internal drug discovery capabilities, Syros generated SY-1365 to have better drug-like properties than THZ1, making it suitable for clinical development.

On October 30, 2017 X4 Pharmaceuticals, a clinical stage biotechnology company developing a novel CXCR4 inhibitor to improve immune cell trafficking to treat cancer and rare diseases, reported updated results from the Phase 1 part of an ongoing Phase 1/2 study of X4P-001-IO in combination with Inlyta (axitinib) in patients with clear cell renal cell carcinoma (ccRCC) (Press release, X4 Pharmaceuticals, OCT 30, 2017, View Source [SID1234521340]).

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The results in patients with ccRCC who received the combination treatment of X4P-001-IO, a CXCR4 inhibitor, and Inlyta, Pfizer’s VEGFR kinase inhibitor, showed an objective response rate (ORR) of 29%, including 1 patient achieving a confirmed complete response (CR), with an encouraging disease control rate (DCR) of 93%. 31% of patients entering the study had received one prior line of therapy while the majority of patients (69%) had received at least two prior lines of therapy. The data were presented at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference on October 29 in Philadelphia.

"The combination of CXCR4 inhibition and VEGFR inhibition shows promising clinical results in this very difficult to treat population of patients with ccRCC. These results suggest that X4P-001-IO may address some of the limitations and augment the clinical utility of axitinib, which is a clinically meaningful drug in the treatment of patients with advanced metastatic ccRCC," said Michael Atkins, MD, Deputy Director, Georgetown Lombardi Comprehensive Cancer Center, William M. Scholl Professor of Oncology at Georgetown University School of Medicine, and lead investigator of the study. "These results, while early, are very promising with a strong disease control rate and a manageable safety profile."

Results from the 16 patients with advanced ccRCC enrolled in the dose escalation part of the ongoing Phase 1/2 study as of the data cutoff date of October 2, 2017 were presented and highlights of the poster presentation include:

The combination of X4P-001-IO and Inlyta showed one confirmed complete response (CR) and produced a DCR and ORR of 93 percent (13/14) and 29 percent (4/14), respectively, in the evaluable patient population.
The median duration on treatment at the data cutoff was 22.1 weeks and 44 percent of patients had been exposed to study treatment for at least 24 weeks.
X4P-001-IO in combination with Inlyta was considered to be safe and generally well tolerated. The most frequent treatment-related adverse events (AEs) were hypertension, diarrhea, fatigue, nausea, decreased appetite, headache and dry eye. No grade 4 or 5 AEs were observed.
Pharmacodynamic (PD) measurements demonstrated that the 400 mg dose inhibited the intended target chemokine receptor CXCR4.
Based on the study results, a dose of 400 mg X4P-001-IO once daily with 5 mg Inlyta twice daily has been selected for the Phase 2 portion of the ongoing Phase 1/2 study.
"We are encouraged by the results to date in this first cohort of patients, many of whom have been on study for over six months and have seen early signs of clinical efficacy with manageable side effects," said Sudha Parasuraman, MD, Chief Medical Officer of X4. "We look forward to sharing a comprehensive update on the ongoing Phase 2a clinical trial, as well as the path forward for further development, in 2018."

The Phase 2 portion of the study continues to enroll patients to evaluate the clinical efficacy of X4P-001-IO as measured by objective response rate (ORR), duration of response (DOR), and progression free survival (PFS), as well as explore the correlation of biomarkers with efficacy. (View Source)

About X4P-001-IO in Cancer

X4P-001-IO is an investigational selective, oral, small molecule inhibitor of CXCR4 (C-X-C receptor type 4) that regulates the tumor microenvironment thereby enhancing endogenous anti-tumor responses. CXCR4 is a chemokine receptor that modulates immune function and angiogenesis through the trafficking of key immune cells such as T- cells, dendritic cells, and myeloid derived suppressor cells. CXCR4 signaling is disrupted in a broad range of cancers, facilitating tumor growth by allowing cancer cells to evade immune detection and creating a pro-tumor microenvironment.

About Renal Cell Carcinoma

Kidney cancer is among the ten most common cancers in both men and women with more than 60,000 new diagnoses each year in the United States.1 Clear cell renal cell carcinoma (ccRCC) is the most common form of kidney cancer, and advanced ccRCC accounts for approximately 20% of the patient population. Therapies for advanced ccRCC include immunotherapies, mammalian target of rapamycin (mTOR) kinase inhibitors, and angiogenesis inhibitors, such as vascular endothelial growth factor (VEGF) inhibitors.2 There continue to be unmet medical needs with advanced ccRCC because durable responses remain a serious clinical challenge for patients with advanced disease.

On October 30, 2017 Pfenex Inc. (NYSE MKT: PFNX) reported today that its third quarter 2017 financial results will be released on Thursday, November 9, 2017, after the market close (Press release, Pfenex, OCT 30, 2017, View Source2017-10-30-Pfenex-to-Report-Third-Quarter-2017-Results-and-Provide-Business-Update-on-Thursday-November-9-2017" target="_blank" title="View Source2017-10-30-Pfenex-to-Report-Third-Quarter-2017-Results-and-Provide-Business-Update-on-Thursday-November-9-2017" rel="nofollow">View Source [SID1234521317]). At 4:30 pm Eastern Time, Pfenex management will host a conference call to discuss the financial results and provide a business update. A press release outlining the financial results and business update will be publicly distributed prior to the call.

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Please call 1-866-376-8058 (US) or 1-412-317-6011 (international) and reference Pfenex to access the call. A replay of the conference call will be available approximately one hour after the call until November 16, 2017. To access the teleconference replay please call 1-877-344-7529 (US) or 1-412-317-0088 (international) and enter the passcode 10113809. The conference call will also be available as a webcast. To access the webcast link please log on to www.pfenex.com.

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.