On October 30, 2019 Medigene AG (FSE: MDG1, Prime Standard) reported its participation at the following upcoming scientific and investor conferences (Press release, MediGene, OCT 30, 2019, View Source [SID1234550138]). Medigene’s management and/or scientists will be available for one-on-one meetings at these events.

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SITC (Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)) 34th Annual Meeting
Date: 6 – 10 November 2019
Location: National Harbor, USA

BIO Europe
Date: 11 – 13 November 2019
Location: Hamburg, Germany

Jefferies London Healthcare Conference
Date: 20 – 21 November 2019
Location: London, UK

Cell Therapy Manufacturing & Gene Therapy Congress
Date: 3 – 6 December 2019
Location: Amsterdam, Netherlands

61st ASH (Free ASH Whitepaper) Annual Meeting & Exposition
Date: 7 – 10 December 2019
Location: Orlando, USA

ESMO Immuno-Oncology Congress 2019
Date: 11 – 14 December 2019
Location: Geneva, Switzerland

On October 30, 2019 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that the Company has scheduled the release of its third quarter 2019 financial results after the market closes on Wednesday, November 6, 2019 (Press release, Sangamo Therapeutics, OCT 30, 2019, View Source [SID1234550131]). The press release will be followed by a conference call at 5:00 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a business update.

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The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 7276749. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 7276749.

On October 30, 2019, Protagonist Therapeutics, Inc. (the "Company") entered into a Credit and Security Agreement, dated as of October 30, 2019 (the "Closing Date") by and among the Company, MidCap Financial Trust, as a lender, Silicon Valley Bank, as a lender, the other lenders party thereto from time to time and MidCap Financial Trust, as administrative agent and collateral agent ("Agent") (the "Term Loan Credit Agreement"), which provides for a $50.0 million term loan facility (Filing, 8-K, Protagonist, OCT 30, 2019, View Source [SID1234550125]). The Term Loan Credit Agreement provides for (i) on the Closing Date, $10.0 million aggregate principal amount of term loans, (ii) at the Company’s option, until December 31, 2020, an additional $20.0 million term loan facility subject to the satisfaction of certain conditions and (iii) at the Company’s option, until September 30, 2021, an additional $20.0 million term loan facility subject to the satisfaction of certain conditions (collectively, the "Term Loans"). The Company intends to use the proceeds of the Term Loans for general corporate purposes.

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The obligations under the Term Loan Credit Agreement are secured by a perfected security interest in all of the Company’s assets except for intellectual property and certain other customary excluded property as set forth therein.

The Term Loans are subject to an origination fee of 0.25% of each funded tranche of Term Loans. The Term Loans may be prepaid in full or in part through October 30, 2020 with payment of a 3.0% prepayment premium, after which they may be prepaid in full or in part through October 30, 2021 with payment of a 2.0% prepayment premium, after which they may be prepaid in full or in part with payment of a 1.0% prepayment premium. An additional 2.85% of the amount of Term Loans advanced by the lenders will be due upon prepayment or repayment of the Term Loans.

The interest rate applicable to the Term Loans is the WSJ Prime Rate plus 2.91%, subject to a floor of 4.94%. Commencing November 1, 2019, the Company initially will make interest-only payments for 24 months, followed by 24 months of amortization payments. All unpaid principal and accrued interest is due and payable in full no later than October 1, 2023.

The Term Loan Credit Agreement requires that the Company maintain cash and cash equivalents of at least 35% of the outstanding Term Loans at all times. The Term Loan Credit Agreement also contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness and dividends and other distributions.

Events of default under the Term Loan Credit Agreement include: (i) failure by the Company to timely make payments due under the Term Loan Credit Agreement; (ii) material misrepresentations or misstatements in any representation or warranty by the Company when made; (iii) failure by the Company or its subsidiaries to comply with the covenants under the Term Loan Credit Agreement and other related agreements; (iv) certain defaults under a specified amount of other indebtedness of the Company or its subsidiaries; (v) insolvency or bankruptcy-related events with respect to the Company or any of its subsidiaries; (vi) certain undischarged judgments against the Company or its subsidiaries; (vii) certain ERISA-related events with respect to the Company or its subsidiaries above a specified amount; (viii) certain security interests or liens under the loan documents ceasing to be, or being asserted by the Company not to be, in full force and effect; (ix) the institution of criminal proceedings against the Company; (x) an event of default under the guarantee of the obligations under the Term Loan Credit Agreement; (xi) the prepayment of any subordinated debt other than as specifically permitted by the terms of such subordination; (xii) the occurrence of a Material Adverse Change (as defined in the Term Loan Credit Agreement); (xiii) certain adverse actions by the FDA or DEA with respect to certain products or which could be reasonably expected to result in a Material Adverse Change (as defined in the Term Loan Credit Agreement); (xiv) a default or material breach under certain specified material contracts and (xv) any loan document ceasing to be, or any challenge or assertion by the Company that such loan document is not, in full force and effect. If one or more events of default occurs and continues beyond any applicable cure period, the Agent may, with the consent of the lenders holding a majority of the loans and commitments under the facilities, or will, at the request of such lenders, terminate the commitments of the lenders to make further loans and declare all of the obligations of the Company under the Term Loan Credit Agreement to be immediately due and payable.

On October 30, 2019 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the third quarter that ended September 30, 2019, and provided an update on recent achievements, events, and its ongoing clinical trials in type 1 diabetes and Alzheimer’s disease (Press release, vTv Therapeutics, OCT 30, 2019, View Source [SID1234550092]).

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"We hosted an informative type 1 diabetes key opinion leader event with JDRF this quarter where two prominent KOLs, Drs. John Buse and Kevan Herold, shared important information including that, despite the increasingly widespread use of improved technologies like continuous glucose monitoring, nearly 80% of individuals with type 1 diabetes fail to achieve the American Diabetes Association’s target goals for HbA1c," said Steve Holcombe, chief executive officer, vTv Therapeutics. "Based on the data we’ve seen to date in our trial of TTP399 in patients with type 1 diabetes, we believe our glucokinase activator could eventually provide a meaningful treatment option to patients with type 1 diabetes that would lower A1c, improve glycemic control and reduce daily insulin use, without increasing hypoglycemic events."

"We are also pleased that we are continuing to make progress with the Elevage Study of azeliragon in patients with mild Alzheimer’s disease with type 2 diabetes that is expected to read-out in late 2020 or early 2021."

Recent Achievements and Outlook

Type 1 Diabetes Study

Completed enrollment for Part 2 of the Simplici-T1 Study. In September 2019, we completed enrollment of patients in part 2 of the phase 2 Simplici-T1 Study, a 12-week study to evaluate TTP399 as an adjunct to insulin therapy for patients with type 1 diabetes. We expect to report results in the latter part of the first quarter of 2020.

Presented Additional Positive Data from Part 1 of the Simplici-T1 Study. In September 2019, we presented positive continuous glucose monitor (CGM) and insulin dose data from the patients with complete CGM profiles from part 1 of the Simplici-T1 Study at the 55th Annual Meeting of the European Association for the Study of Diabetes. In addition to the previously presented topline improvement in HbA1c of 0.7% relative to placebo, key results from this presentation included:

Patients taking TTP399 treatment (n=6) had increased "Time in Range" from baseline to end of treatment by 11% (2.7 hours) (p=0.055) per day (24 hours), and by 12% (1.7 hours) (p=0.04) during the critical waking hours (7am-9pm) relative to placebo (n=9).

Patients taking TTP399 treatment reduced the total daily mealtime bolus insulin dose by 23% compared to 4% for placebo while significantly improving glycemic control.

Patients in the TTP399 treatment group experienced fewer Level 1 (≥54-70 mg/dl) and Level 2 (<54 mg/dl) hypoglycemic events than patients in the placebo group.

Alzheimer’s Disease Study

Enrollment continues for Phase 2/3 Elevage Study of azeliragon. We began enrolling patients in the phase 2 part of the Elevage Study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer’s disease (AD) and type 2 diabetes.

The Elevage Study is designed to confirm the positive post-hoc subgroup results from the previous phase 3 study of azeliragon in patients with mild Alzheimer’s disease in which the subgroup of AD patients with type 2 diabetes (defined by an HbA1c of greater than 6.5% at any time in the study) treated with azeliragon demonstrated a potential benefit in both cognition and function relative to those treated with placebo.

The phase 2 part of the Elevage Study will evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer’s disease (screening MMSE 21 to 26, baseline MMSE 19 to 27; and ADAS-cog14 score ≥10) and type 2 diabetes (screening HbA1c 6.5% to 9.5%, inclusive). We expect to report topline results from the phase 2 proof of concept study by late 2020 or early 2021.

Recent Events

Hosted Key Opinion Leader (KOL) Event to Discuss the Type 1 Diabetes Landscape and Emerging Therapies as Adjuncts to Insulin. In October, vTv hosted a KOL event to provide an opportunity to learn more about type 1 diabetes. Dr. John Buse, UNC-CH; Dr. Kevan Herold, Yale University; Dr. Esther Latres, JDRF International; and Dr. Carmen Valcarce, vTv Therapeutics, presented to a diverse audience of analysts, investors, and members of the type 1 diabetes community. The KOLs reported that patients with type 1 diabetes have a serious, unmet need for an adjunct to insulin treatment.

An archived version of the event can be found here.

Second Quarter 2019 Financial Results

Cash Position: Cash and cash equivalents as of September 30, 2019, were $2.4 million compared to $1.5 million as of June 30, 2019.

Revenue: Revenues were not material for the third quarter of 2019 versus $1.8 million in the second quarter of 2019. Revenue recognized in the second quarter of 2019 was due to a milestone recognized under our license agreement with Newsoara and the continued amortization of revenue from our license agreement with Reneo over the transfer services period.

R&D Expenses: Research and development expenses were $3.7 million in the third quarter of 2019 and $4.2 million in the second quarter of 2019. The decrease in these costs

was driven primarily by the decreases in costs for the Elevage Study. Such costs were higher in the second quarter of 2019 as we were performing startup activities related to the sites and initiation of patient enrollment.

G&A Expenses: General and administrative expenses were $1.8 million and $2.4 million in each of the third and second quarters of 2019, respectively. The decrease in these costs is related to the recognition of a gain on the sale of laboratory equipment in the third quarter of 2019 as well as overall lower spending in the quarter.

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $6.0 million for the third quarter of 2019 compared to net loss before non-controlling interest of $5.1 million for the second quarter of 2019.

Net Loss Per Share: GAAP net loss per share was $0.13 and $0.10 for the three months ended September 30, 2019 and June 30, 2019, respectively, based on weighted-average shares of 32.1 million and 28.0 million for the three month periods ended September 30, 2019 and June 30, 2019, respectively. Non-GAAP net loss per fully exchanged share was $0.10 and $0.09 for the three months ended September 30, 2019 and June 30, 2019, respectively, based on non-GAAP fully exchanged weighted-average shares of 55.2 million and 51.1 million for the three months ended September 30, 2019 and June 30, 2019, respectively.

On October 31, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Sarah Cannon Research Institute (Sarah Cannon) reported that the first patient has been dosed in a first-in-human phase 1/2 study evaluating DS-7300, an investigational B7-H3 targeting antibody drug conjugate (ADC), in patients with various advanced solid tumors that have progressed on standard treatments or for whom no standard treatment exists (Press release, Daiichi Sankyo, OCT 31, 2019, View Source [SID1234550087]).

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The study is the first in the strategic oncology partnership announced between Daiichi Sankyo and Sarah Cannon, designed to expedite and optimize global clinical development of Daiichi Sankyo’s novel ADCs and other targeted cancer therapies by combining the operational and scientific expertise of both organizations.

DS-7300 is the fourth ADC in clinical development utilizing Daiichi Sankyo’s proprietary DXd technology and was designed to target and deliver chemotherapy inside cancer cells that express the B7-H3 protein. B7-H3 is frequently overexpressed in various types of cancers and has been associated with disease progression and poor prognosis in many tumor types.[1] No B7-H3 targeting therapies are currently approved for treatment of any cancer.

"This first-in-human phase 1/2 trial will evaluate the potential for DS-7300 to serve as a new mode of targeted therapy for patients with several types of advanced cancers where the B7-H3 protein is overexpressed," said Antoine Yver, MD, MSc, EVP & Global Head of Oncology Research and Development, Daiichi Sankyo. "Based on our preclinical assessments, the trial will focus initially on patients with non-small cell lung, head and neck, esophageal, and other cancers. We also will continue to conduct important biomarker and translational research to further assess the role this promising therapeutic target may play in treatment of various cancers."

"Given the prevalence of B7-H3 in certain tumors, we hope this unique approach will help us to more effectively target a number of cancer types," said Johanna Bendell, MD, Chief Development Officer, Sarah Cannon. "By combining Sarah Cannon’s expertise in developing novel therapies and Daiichi Sankyo’s capabilities in compound development, we have been able to expand our reach to patients across the U.S. and Japan who vitally need advanced treatment options."

B7-H3 (B7 homologue 3) is a transmembrane protein belonging to the B7 family. B7-H3 plays a role in tumor growth as well as in immune response.1,[2] B7-H3 is highly expressed on various types of tumors including lung, head and neck, esophageal, prostate, endometrial and breast cancers.1 In preclinical studies, DS-7300 demonstrated activity in B7-H3 expressing tumors, and activity was associated with target expression levels.

Based on initial preclinical research into the construct necessary for optimized safety and efficacy in B7-H3 expressing tumors, DS-7300 was engineered with a new proprietary Daiichi Sankyo technology, DAR-controlled conjugation, to create a drug-to-antibody ratio (DAR) of four. The technology has been used also to prepare DS-1062, Daiichi Sankyo’s TROP2 ADC under clinical development in patients with NSCLC who have failed standard of care, including immune checkpoint inhibitors.

About the Study
The first-in-human, open-label phase 1/2 study will investigate the safety, tolerability and preliminary activity of DS-7300 in adult patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists.

The first part of the study (dose escalation) will assess the safety and tolerability of increasing doses of DS-7300 to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE). This portion of the trial will enroll approximately 40 patients with advanced/unresectable or metastatic squamous cell head and neck cancers, squamous cell esophageal cancer, squamous and adenocarcinoma cell non-small cell lung cancer (NSCLC), and other tumor types (ten total). The second part of the study (dose expansion) will evaluate the safety, tolerability and preliminary activity of DS-7300 at the RDE and assess overall survival. This portion of the trial will include three cohorts of 40 patients each, potentially including patients with advanced/unresectable or metastatic squamous cell head and neck cancers, squamous cell esophageal cancer, and squamous NSCLC. Additional or alternative indications may be added to expansion cohorts based on preliminary signals of activity.

The study will evaluate safety endpoints including adverse events and efficacy endpoints including objective-response rate, duration of response, disease control rate, time to response, progression-free survival, and overall survival. Pharmacokinetic endpoints and exploratory biomarker and immunogenicity endpoints will also be assessed.

A total of approximately 160 patients are expected to be enrolled in this study in the U.S. and Japan. For more information, please visit ClinicalTrials.gov

About DS-7300
DS-7300 is an investigational B7-H3 targeting ADC and one of four ADCs under clinical development in Daiichi Sankyo’s Cancer Enterprise pipeline. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, DS-7300 is comprised of a humanized anti-B7-H3 monoclonal antibody, which is attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

DS-7300 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.