On September 26, 2019, vTv Therapeutics Inc. (the "Company"), reported that it has entered into a letter agreement (the "September 2019 Letter Agreement"), with MacAndrews & Forbes Group LLC (the "Investor"), for the Investor’s commitment to purchase, at the Company’s option, exercisable on demand during a one-year period after the date of the Letter Agreement (the "Investment Period"), the Company’s Class A common stock, par value $0.01 per share ("Common Stock") at a per share price of $1.46, which is equal to the closing price of the Common Stock for the trading day prior to the date of the September 2019 Letter Agreement (Filing, 8-K, vTv Therapeutics, SEP 30, 2019, View Source [SID1234539933]). The September 2019 Letter Agreement also permits the Investor to exercise an option to purchase Common Stock at the same price up to three times during the Investment Period. The aggregate amount of Common Stock that may be purchased by the Investor (whether at its or the Company’s option) pursuant to the September 2019 Letter Agreement is limited to $10.0 million.

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!

In consideration for the commitment of the Investor under the September 2019 Letter Agreement, the Investor will receive warrants (the "Warrants") to purchase 400,990 shares of the Company’s Common Stock, exercisable at a price of $1.68, which is 115% of the option price under the September 2019 Letter Agreement. The Warrants will be exercisable until September 26, 2026.

The obligation of the Investor to fund and the obligation of the Company to issue shares under the September 2019 Letter Agreement is subject to the execution of mutually acceptable definitive documentation at the time of a request for funding.

As of September 26, 2019, subsidiaries and affiliates of the Investor held 23,084,267 shares of the Company’s Class B Common Stock and 23,506,897 shares of the Company’s Class A Common Stock. As a result, the Investor’s holdings represent approximately 81.5% of the combined voting power of the Company’s outstanding common stock. One of the Company’s directors, Paul G. Savas, is also an employee of the Investor. The transactions described above were approved in accordance with the Company’s Related Person Transactions Policy.

The descriptions of the September 2019 Letter Agreement and the Warrants contained herein do not purport to be complete and are qualified in their entirety by reference to the September 2019 Letter Agreement and the Warrants, copies of which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2019.

On September 30, 2019 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing a new class of potent and selective precision oncology medicines for the treatment of patients with a wide range of solid tumor malignancies, reported the presentation of Phase 1 data from an ongoing Phase 1/2a study of PEN-866 at the at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019 (Press release, Tarveda Therapeutics, SEP 30, 2019, View Source [SID1234539951]). The results presented, which are based on a data cutoff date of July 10, 2019, show that PEN-866 was well tolerated and demonstrated preliminary evidence of anti-tumor activity. Three patients remained on study at the time of data cutoff.

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!

"Results of the Phase 1 study in heavily treated, advanced patients show that overall PEN-866 was well tolerated with encouraging, early signs of anti-tumor activity," said Dr. Jeffrey D. Bloss, Chief Medical Officer of Tarveda. "Based on these results, we have progressed to an expansion cohort to determine the recommended Phase 2 dose. We are excited about the profile of PEN-866 for its development in solid tumors where new, effective treatments are truly needed. Further, the attributes of PEN-866 are indicative of the opportunity we have with our HSP90 binding miniature drug conjugate platform to enable a wide range of compelling, anti-cancer payloads that are promising but require enhanced penetration, accumulation and residence time in tumor to be effective."

PEN-866 is a small molecule miniature drug conjugate linked to a potent topoisomerase 1 inhibitor (SN-38) payload which targets and binds to Heat Shock Protein 90 (HSP90). HSP90 is activated and upregulated in tumor cells compared to normal tissue allowing the HSP90 miniature drug conjugate to accumulate and be retained in tumor cells. The HSP90 miniature drug conjugate is designed with a slowly cleaving linker resulting in a sustained release of SN-38 in tumor. The Phase 1 study established a MTD and assessed the safety, tolerability, pharmacokinetics and efficacy of PEN-866.

"Investigating new treatment options for patients who are not responding to standard therapies is central to our research efforts," said Johanna Bendell, M.D., Chief Development Officer and Director of the Drug Development Unit at Sarah Cannon Research Institute in Nashville, Tenn. "With PEN-866’s innovative approach to targeting solid tumors, we observed promising early results with stable disease after treatment for some of the participants and a partial response for one additional participant. These preliminary results support the further investigation of PEN-866 for patients living with these difficult-to-treat cancers."

Phase 1 Trial Design
Patients were enrolled in seven dose escalating cohorts of two to six patients with advanced solid tumor malignancies, the most common of which were pancreatic and colon tumor types. Patients received PEN-866 weekly for three of four weeks in a 28-day cycle, and in cohorts 1-5, patients were initially treated with flat dosing. Cohorts 6 and 7 were switched to body surface area dosing based on emerging data indicating variable exposure.

Safety Data
Results of the study show that PEN-866 was well tolerated with no dose limiting toxicities (DLTs) in the first four cohorts (30-240 mg). One DLT was observed in cohort 5 (360 mg) and was resolved with dose reduction. 2 DLTs were observed in cohort 7 (200 mg/m2). One fatal event of dehydration occurred 11 days following the last dose of PEN-866. The most frequent adverse events observed were nausea, fatigue, diarrhea, vomiting, and alopecia and the most common Grade 3 adverse event was neutropenia. The maximum tolerated dose for PEN-866 monotherapy was determined to be 175 mg/m2.

Efficacy Data
There was preliminary evidence of antitumor activity observed in the trial. One patient (5.9%) of 17 evaluable patients per RECIST v1.1, achieved partial response and remains on therapy. Five patients of the 17 patients (29.4%) experienced stable disease (SD). Of the patients who experienced stable disease:

Two patients with pancreatic cancer had prolonged SD (~4 and 5 months, respectively).
One patient with liposarcoma had prolonged SD (>12 months).
One patient with acinar cell cancer of the pancreas remained on therapy after 6 months with SD.
About PEN-866
PEN-866 is a small molecule miniature drug conjugate that selectively binds to the activated form of the intracellular target Heat Shock Protein 90 (HSP90) linked to a topoisomerase 1 inhibitor (SN-38), a potent anti-cancer payload. HSP90 is activated and upregulated in tumor cells compared to normal tissue allowing the HSP90 miniature drug conjugate to accumulate and be retained in tumor cells. The HSP90 miniature drug conjugate is designed with a slowly cleaving linker resulting in a sustained release of SN-38 in tumor which has been shown to cause prolonged DNA damage and tumor regressions in multiple patient-derived and other xenograft tumor models. PEN-866 is in a Phase 1/2a trial and the first miniature drug conjugate from Tarveda’s HSP90 binding conjugate platform.

On September 30, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that it will release its financial results for the third quarter of 2019 before the market opens on Wednesday, October 23, 2019, and will hold a conference call on the same day at 8:30 a.m. EDT (Press release, Thermo Fisher Scientific, SEP 30, 2019, View Source [SID1234539917]).

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!

During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (877) 273-7122 within the U.S. or (647) 689-5496 outside the U.S. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can be found in that section of our website under "Financial Results." A replay of the call will be available under "Webcasts and Presentations" through Friday, November 8, 2019.

On September 30, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing immune modulators and precision therapies for solid tumor cancers, reported updated data from the Phase 1a/1b clinical trial of FPA150 in patients with advanced solid tumors in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain (Press release, Five Prime Therapeutics, SEP 30, 2019, View Source [SID1234539934]). The poster can be found on the Scientific Publications Page of the Five Prime Therapeutics website.

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!

The FPA150 data presented at ESMO (Free ESMO Whitepaper) included preliminary efficacy results from the Phase 1b monotherapy expansion portion of the study in patients preselected for B7-H4 tumor overexpression across breast, endometrial and ovarian cancers, and early safety results from the Phase 1a Keytruda (pembrolizumab, a PD1 antibody) combination portion of the study in patients preselected for B7-H4 tumor overexpression in ovarian cancer.

"B7-H4 is a novel T cell immune checkpoint and the early results from the phase 1b monotherapy portion of our FPA150 study provide the first clinical demonstration of B7-H4 as a potential therapeutic target," said Helen Collins, Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. "Based on the study results to-date, we continue to believe that the most promising opportunity for FPA150 is in combination with other therapeutic agents."

Key highlights from the presentation include:

Phase 1 FPA150 Monotherapy:

Two patients with B7-H4 positive ovarian cancer experienced a confirmed partial response (one in the dose escalation and one at the recommended dose of 20mg/kg)

10 patients with stable disease remain on therapy as of August 9, 2019

Increased tumor infiltration of T cells and NK cells observed in patients with a partial response or stable disease

Recommended dose of 20 mg/kg was well tolerated in all patients

Phase 1 Safety Lead-in Combination of FPA150 + Pembrolizumab :

Combination was well tolerated in the first four patients treated with FPA150 (20 mg/kg) and pembrolizumab (200 mg)

Expansion initiated in August 2019 in a cohort of ovarian cancer patients with B7-H4 overexpression

About FPA150

FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 overexpression is observed in multiple solid tumors, including breast and gynecologic cancers. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as promoting enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells expressing B7-H4.

On September 30, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported that it will present at the following conference in October (Press release, UroGen Pharma, SEP 30, 2019, View Source [SID1234539952]):

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!

2019 Cantor Global Healthcare Conference

Wednesday, October 2nd
8:20AM Eastern Time
New York, NY
A live audio webcast of the event will be available on the Investors section of UroGen’s website, www.urogen.com. A replay of the webcast will be available on the website for approximately two weeks.