On August 10, 2017 Takeda Pharmaceutical Company Limited (TSE: 4502) and Shattuck Labs, Inc. reported that they have entered into a research collaboration to explore and develop checkpoint fusion proteins that have the potential to become highly differentiated, next-generation immunotherapies (Press release, Shattuck Labs, AUG 10, 2017, View Source [SID1234520210]). Under the terms of the collaboration agreement, Takeda will hold options for exclusive global development and commercialization rights for up to four molecules resulting from the collaboration.

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!

Shattuck Lab’s Agonist Redirected Checkpoint (ARC) platform combines two binding domains to create fusion proteins that potentially restore and enhance immune system function in a single construct. The ARC molecules block checkpoint molecules while simultaneously stimulating TNF superfamily co-stimulatory receptors on T-cells and innate cells, which are targets controlling the immune system and often dysregulated in cancers, thereby enabling combination immunotherapy with a single product.

"Shattuck Labs has pioneered the unique ARC platform, and we are excited about the opportunity this collaboration presents to develop groundbreaking, next-generation immuno-oncology treatments," said Christopher Arendt, Ph.D., Head, Oncology DDU & Immunology Unit, Takeda. "Research partnerships are a key aspect of our continued dedication to oncology innovation, and this collaboration will bring us closer to our goal of discovering, developing and delivering breakthrough oncology therapies."

The collaboration will include two pre-clinical and four discovery stage programs. Takeda will provide funding for pre-clinical and clinical development and will have the option to take an exclusive license to further develop and commercialize up to four ARC molecules resulting from the collaboration. Additional terms of the collaboration are not disclosed.

"Takeda shares our passion and mission to develop and advance novel therapies in oncology, with the goal of achieving better clinical outcomes in patients," said Josiah Hornblower, Chairman and CEO of Shattuck Labs. "We are very excited to work with Takeda, a proven leader in oncology, to continue to validate the ARC technology."

Takeda signed the collaboration agreement through its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc.

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R＆D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R＆D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in Emerging Markets, are currently fueling the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. For more information, visit www.takeda.com/news.

About Shattuck Labs

Headquartered in Austin, Texas, Shattuck Labs, Inc. is a biopharmaceutical company committed to developing biologic medicines for oncology and inflammatory disease. Shattuck Labs developed the Agonist Redirected Checkpoint (ARC) platform to enable immuno-oncology therapeutics capable of simultaneously blocking immune checkpoints and stimulating TNF superfamily receptors. Shattuck Lab’s state-of-the-art research and development organization is currently advancing multiple lead products toward clinical trials.

On August 10, 2017 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, reported its financial results for the second quarter ended June 30, 2017 (Filing, Q2, Syndax, 2017, AUG 10, 2017, View Source [SID1234520162]). In addition, the Company provided a clinical and business update. As of June 30, 2017, Syndax had $130.0 million in cash, cash equivalents and short-term investments.

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!

Enrollment in all cohorts of ENCORE 601 have proceeded rapidly. The second stage of the ENCORE 601 cohort enrolling PD-1 (programmed death receptor-1) refractory melanoma patients has reached its accrual target. Enrollment in the PD-1 refractory non-small cell lung cancer (NSCLC) cohort remains on track, and is expected to be complete in the fourth quarter. The Company also announced that the first patient has been dosed in the ENCORE 601 cohort enrolling microsatellite stable colorectal cancer (CRC) patients.
"The second quarter was marked by continued progress across our clinical pipeline. The initial results from ENCORE 601 provide the first clinical evidence that entinostat may reverse resistance to immune checkpoint therapies," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We had a productive Type B meeting with the FDA in June to discuss potential registration paths for entinostat when used in combination with a PD-1 inhibitor for the treatment of melanoma patients who have progressed on checkpoint therapy. We are now evaluating the options discussed with the FDA and will provide an update by the end of the year.
Pipeline Updates

• ECOG-ACRIN Cancer Research Group, sponsor of E2112, the Phase 3 registration trial of entinostat plus exemestane in advanced HR+, HER2- breast cancer, expects the progression free survival analysis to be available in the first half of 2018 directly following completion of enrollment. As of the end of July, the trial was 78% enrolled.

•
A number of patients enrolled in the ENCORE 601 cohort of NSCLC patients naïve to PD-(L)1 therapy remain on drug, with a determination on whether the cohort has satisfied the pre-specified efficacy criteria for advancement to the second stage of the trial expected by year end. The pre-specified objective response threshold to advance this cohort into the second stage of the Phase 2 trial has been revised to ³ 4 responses out of 17 (versus the previous benchmark of ³ 3 responses out of 13) in order to incorporate Phase 1b patients dosed at the recommended 5 mg dose of entinostat. Similarly, the cohort of PD-(L)1 refractory NSCLC patients, announced in May to have met the pre-specified objective response threshold to advance into the second stage of

the Phase 2 trial, used revised criteria requiring ³3 responses out of 31 (versus the previous benchmark of >2 responses out of 20) in order to incorporate Phase 1b patients dosed at entinostat 5 mg.

• Enrollment in the second stage of the PD-(L)1 refractory melanoma cohort of ENCORE 601 has completed, and the second stage of the PD-(L)1 refractory NSCLC cohort of ENCORE 601 is expected to complete enrollment in the fourth quarter. Syndax expects to present data from stage one of the NSCLC cohorts, as well as biomarker data from the melanoma cohort, at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in the fall, and the full trial data from both the refractory NSCLC and melanoma cohorts at a medical congress in the first half of 2018.

• Dosing has been initiated in the ENCORE 601 cohort of patients with microsatellite stable CRC. This new cohort, announced in April 2017, employs a Simon two-stage design enrolling 13 patients in the first stage, and requires ³ 2 confirmed objective responses to proceed to the second stage. A decision on whether to advance to the second stage of the CRC cohort is expected in the first half of 2018.

• Enrollment is also progressing in the two additional trials aimed at exploring the ability of entinostat to enhance the efficacy of PD-L1 inhibitor therapies, ENCORE 602 and ENCORE 603. ENCORE 602, the Phase 1b/2 clinical trial evaluating the combination of entinostat plus Genentech’s PD-L1 inhibitor, TECENTRIQ, in patients with triple negative breast cancer, is expected to complete enrollment in the Phase 2 portion by the end of the fourth quarter. ENCORE 603, the Phase 1b/2 clinical trial evaluating entinostat in combination with Pfizer/Merck KGaA’s BAVENCIO in patients with ovarian cancer, recently began enrolling patients into the Phase 2 portion and is expected to complete enrollment in the first half of 2018.

• Enrollment is now complete in the Phase 1 single ascending dose (SAD) clinical trial of SNDX-6352 in healthy volunteers to determine the safety, pharmacokinetics and pharmacodynamics of the anti-CSF-1R monoclonal antibody. The Company expects to present data from this study at a scientific congress in the fourth quarter of 2017. Syndax also plans to initiate a multiple ascending dose (MAD) trial in cancer patients in the third quarter of 2017.
Syndax Expects to Participate in the Following Upcoming Investor Conferences

• Citi 12th Annual Biotech Conference, September 6-7, 2017 in Boston

• Morgan Stanley Healthcare Conference, September 11-13, 2017 in New York

• Cantor Fitzgerald 2017 Global Healthcare Conference, September 25-27, 2017 in New York
Second Quarter 2017 Financial Results
As of June 30, 2017, Syndax had cash, cash equivalents and short-term investments of $130.0 million and 22,219,843 shares issued and outstanding. This includes aggregate net proceeds of $48.7 million, raised in a follow-on offering in May 2017 whereby 3,950,190 shares of common stock were sold at an offering price of $13.25 per share.
Second quarter 2017 research and development expenses increased to $9.9 million from $6.1 million for the comparable period in the prior year due to increases in clinical trial activities of $2.3 million, employee compensation expense of $0.8 million, and legal and consultant expenses of $0.6 million. The increase in clinical trial activities was primarily due to increases in spending related to the additional cohorts added to ENCORE 601, increased activities in ENCORE 602 and ENCORE 603, start-up costs related to SNDX-6352, our Phase 1 clinical pharmacology trials and CMC activities. The increase in employee compensation costs was primarily due to increased headcount.
General and administrative expenses totaled $4.3 million during the second quarter of 2017 compared with $2.8 million in the comparable period in the prior year. The increase in general and administrative expenses was primarily due to an increase in employee compensation of $1.0 million combined with increases in consulting expenses of $0.4 million. The increase in employee compensation of $1.0 million was primarily due to increases in non-cash stock-based compensation of $0.6 million, combined with an increase in salary expense of $0.4 million due to increased headcount.
For the three months ended June 30, 2017, Syndax reported a net loss attributable to common stockholders of $13.6 million, or $0.70 per share, compared to $8.4 million, or $0.47 per share, for the comparable prior year period.
Financial Guidance
Today the Company provided operating expense guidance for the third quarter and full year 2017. For the third quarter and full year 2017, research and development expenses are expected to be $12.0 to $14.0 million and $46.0 to $51.0 million, respectively, and total operating expenses are expected to be $16.0 to $18.0 million and $63.0 to $68.0 million, respectively.

On August 10, 2017 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a late stage clinical biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases, today reported financial results for the three and six months ended June 30, 2017 and key corporate highlights (Press release, Sophiris Bio, AUG 10, 2017, View Source [SID1234520160]).

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!

Key Corporate Highlights:

Phase 2b Localized Prostate Cancer Study Underway. On June 8, 2017, the Company announced that the first patient had been dosed in its Phase 2b study to evaluate the safety and tolerability of a single dose of topsalysin in focally treating men with clinically significant localized prostate cancer. Topsalysin (PRX302) is an innovative, first-in-class pore-forming protein engineered to be activated only in the presence of enzymatically-active PSA, which is only found within the prostate. This study is enrolling approximately 40 patients at clinical sites in the UK and US. The Company expects to receive the 24- week biopsy data for all patients from the first dose of topsalysin in the first quarter of 2018 assuming enrollment is completed as expected.

The Phase 2b study includes an option to re-treat patients with a second dose of topsalysin, with a targeted biopsy to occur 24 weeks following the second dose. The Company expects to have complete data on all patients who receive a second dose by the fourth quarter of 2018 assuming enrollment is completed as expected.

Added to Russell Microcap Index. In June 2017, the Company was added to the Russell Microcap Index. Russell indices are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies.
Filing of New Form S-3. In anticipation of the expiration of the company’s existing Form S-3 shelf registration statement filed in September 2014, Sophiris will file a new Form S-3 today with the Securities and Exchange Commission to register securities which could be issued in the future.
"Topsalysin is a highly potent ablative agent, which we administer by an ultrasound-guided injection directly into a tumor, previously confirmed by biopsy. We are using state of the art commercially available software in order to increase the precision by which the physician administers topsalysin into the pre-identified tumor," said Randall E. Woods, president and CEO of Sophiris. "We are working toward completion of enrollment, and we would like to thank the investigators, study coordinators and patients for their participation in this exciting study."

Financial Results:

At June 30, 2017, the Company had cash, cash equivalents and securities available-for-sale of $24.0 million and working capital of $23.4 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations through the end of 2018. The Company is currently not planning on pursuing a second Phase 3 trial in BPH, unless the Company can secure a development partner to fund a new clinical trial or the Company obtains other financing.

For the three months ended June 30, 2017

The Company reported net income of $0.6 million or $0.02 per share for the three months ended June 30, 2017 compared to a net loss of $4.1 million or ($0.21 per share) for the three months ended June 30, 2016. The net income for the three months ended June 30, 2017 was driven by a non-cash gain related to the revaluation of the Company’s warrant liability. See an additional discussion below related to this item.

Research and development expenses

Research and development expenses were $1.4 million for the three months ended June 30, 2017, compared to $1.0 million for the three months ended June 30, 2016. The increase in research and development costs are primarily attributable to increases in the costs associated with the Company’s Phase 2b clinical trial for the focal treatment of localized prostate cancer, costs associated with manufacturing activities for topsalysin and non-cash stock-based compensation expense. These increases are partially offset by decreases in costs associated with our completed Phase 2a proof of concept clinical trial for low to intermediate risk prostate cancer and personnel related costs.

General and administrative expenses

General and administrative expenses were $1.4 million for the three months ended June 30, 2017 and 2016. General and administrative expense included non-cash stock-based compensation expense of $0.3 million for the three months ended June 30, 2017 as compared to $0.1 million for the three months ended June 30, 2016. This increase was offset by decreases for personnel related costs.

Gain (loss) on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $3.3 million for the three months ended June 30, 2017 compared to a loss of $1.6 million for the three months ended June 30, 2016. Because these warrants may require us to pay the warrant holder cash under certain provisions of the warrant, we account for these warrants as a liability and we are required to calculate the fair value of these warrants each reporting date. This non-cash gain is associated with a reduction in the fair value of the Company’s warrant liability which is calculated using a Black-Scholes pricing model. Certain inputs utilized in the Company’s Black-Scholes fair value calculation may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liability, which could also result in material non-cash gain or loss being reported in the Company’s consolidated statement of operations and comprehensive loss.

For the six months ended June 30, 2017

The Company reported a net loss of $2.0 million or ($0.07 per share) for the six months ended June 30, 2017 compared to a net loss of $6.3 million or ($0.35 per share) for the six months ended June 30, 2016.

Research and development expenses

Research and development expenses were $2.6 million for the six months ended June 30, 2017 compared to $1.9 million for the six months ended June 30, 2016. The increase in research and development costs are primarily attributable to increases in the costs associated with the Company’s Phase 2b for the focal treatment of localized prostate cancer, costs associated with the manufacturing activities for topsalysin and the non-cash stock-based compensation expense. These increases are partially offset by decreases in costs associated with our completed Phase 2a proof of concept clinical trial for low to intermediate risk prostate cancer and personnel related costs.

General and administrative expenses

General and administrative expenses were $2.7 million for the six months ended June 30, 2017 compared to $2.5 million for the six months ended June 30, 2016. The increase is primarily due to an increase in professional services and non-cash stock-based compensation expense. These increases are partially offset by the decreases in personnel related costs, legal and closing costs which were expensed as they were allocated to the warrants issued in our completed financing during the six months ended June 30, 2016.

Gain (loss) on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $3.2 million for the six months ended June 30, 2017 as compared to a loss of $1.6 million for the six months ended June 30, 2016. This non-cash gain is associated with a reduction in the fair value of our warrant liability.