On October 19, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that the first patient has been dosed in the FIT-001 Phase 1 dose-escalation trial of KO-2806, the Company’s next-generation farnesyl transferase inhibitor (FTI) for the treatment of advanced solid tumors (Press release, Kura Oncology, OCT 19, 2023, View Source [SID1234636144]).

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"We’re excited to advance our next-generation FTI drug candidate into the clinical setting, underscoring our commitment and sense of urgency to develop novel therapies for cancer indications with high unmet medical needs," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Our understanding of how to use FTIs to target farnesylated proteins has matured significantly beyond our initial strategy to target HRAS mutant tumors. With the success of targeted therapies such as KRASG12C inhibitors, tyrosine kinase inhibitors and EGFR inhibitors, there is now considerable focus on the development of companion therapeutics that have potential to drive enhanced antitumor activity and address mechanisms of innate and adaptive resistance. We will focus the development of KO-2806 initially in combinations in the areas of lung cancer and renal cell carcinomas and, if successful, we believe KO-2806 could become the ideal combination partner for a wide range of targeted therapies."

FIT-001 is a Phase 1, first-in-human, multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of KO-2806 when administered as monotherapy and in combination with targeted therapies. Concurrent with the monotherapy dose escalation, the Company plans to evaluate KO-2806 in dose-escalation combination cohorts with other targeted therapies, beginning in KRASG12C-mutant non-small cell lung cancer (NSCLC) and clear cell renal cell carcinoma (ccRCC). For more information regarding FIT-001, please visit www.clinicaltrials.gov (identifier: NCT06026410).

About KO-2806

KO-2806 is a next-generation inhibitor of farnesyl transferase designed to improve upon potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates. Earlier this month 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), Kura presented promising preclinical data supporting the rationale for combining KO-2806 with distinct classes of targeted therapies, including tyrosine kinase inhibitors, KRASG12C inhibitors and KRASG12D inhibitors. Additional information about clinical trials for KO-2806 can be found at View Source

On October 19, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that it has granted non-statutory stock options to purchase an aggregate of 401,220 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company (Press release, Geron, OCT 19, 2023, View Source [SID1234636143]).

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The stock options were granted on October 18, 2023 at an exercise price of $1.77 per share, which is equal to the closing price of Geron common stock on the date of grant. Stock options representing an aggregate of 396,000 shares have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 5,220 shares have a 10-year term and vest in full upon achievement of a certain regulatory milestone, subject to continued employment with Geron through the applicable vesting date. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.

On October 19, 2023 Emergent BioSolutions Inc. (NYSE: EBS) reported that it will host a conference call on Thursday, November 2, 2023, at 5:00 pm eastern time to discuss the financial results for the third quarter of 2023, recent business developments, and financial outlook for full year 2023 (Press release, Emergent BioSolutions, OCT 19, 2023, View Source [SID1234636142]).

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Conference Call Information
Participants can access the conference call live via webcast from the Investors page of Emergent’s website. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.

A replay of the call can be accessed from the Investors page of Emergent’s website.

On October 19, 2023 Circio Holding ASA (OSE: CRNA) reported that an abstract describing its circular RNA technology has been accepted for poster presentation at the 30th i European Society for Gene and Cell Therapy in Brussels, Belgium (Press release, Circio, OCT 19, 2023, View Source [SID1234636141]).

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The poster is scheduled for presentation 25-26 October 2023 and will be available on Circio’s website after the presentation.

Poster title: circVec, a versatile circular RNA vector cassette for enhanced and durable intra-cellular protein expression
Date and time: Wednesday 25 October 2023, 17:00- 18:16 CEST and Thursday 26 October 2023, 20:30-21:30 CEST
Location: Brussels, Belgium
Poster number: P803
Presenter: Thomas Birkballe Hansen, VP and Head of Research, Erik Digman Wiklund, CEO

On October 19, 2023 Bristol Myers Squibb (NYSE: BMY) reported that the Phase 3 CheckMate -67T noninferiority trial evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as "subcutaneous nivolumab") compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy met its co-primary pharmacokinetics endpoints and key secondary endpoint (Press release, Bristol-Myers Squibb, OCT 19, 2023, View Source;67T-Trial-of-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase-Meets-Co-Primary-Endpoints-in-Advanced-or-Metastatic-Clear-Cell-Renal-Cell-Carcinoma/default.aspx [SID1234636139]). Subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo, the study’s co-primary endpoints. Additionally, subcutaneous nivolumab showed a noninferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo, a key secondary endpoint. The safety profile of subcutaneous nivolumab was consistent with the IV formulation.

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"Intravenous Opdivo has helped transform the treatment of several solid tumor types over the past decade, but there remains a need for additional administration options to address treatment burden on patients and improve efficiencies in healthcare systems," said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. "We are delighted that the results of CheckMate -67T demonstrate that subcutaneous nivolumab delivers noninferior pharmacokinetics, in addition to objective response rate and safety data consistent with IV Opdivo. We believe this new option, given as a single injection administered in less than five minutes, could transform the treatment experience for both patients and physicians."

The company will complete a full evaluation of the available CheckMate -67T trial data and work with investigators to present the results at an upcoming medical conference. The company also looks forward to discussing next steps for subcutaneous nivolumab with health authorities across multiple indications. Study follow-up is ongoing to assess additional secondary efficacy and safety endpoints.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -67T clinical trial.

About CheckMate -67T

CheckMate -67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous (IV) Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or IV Opdivo. The co-primary endpoints of the trial are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. IV Opdivo. Objective response rate (ORR) is a key secondary endpoint.

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 431,000 new cases and 179,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. Clear cell renal carcinoma (ccRCC) is the most common form of RCC, affecting about 7 out of 10 people with RCC. The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 14% and five-year disease-free survival (DFS) rates for those with localized disease that can be resected are just over 50%.