On October 19, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova", the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that one of the Company’s scientific collaborators, Gaël Roué, Ph.D., from the Josep Carreras Leukaemia Research Institute, Spain, made a podium presentation during the European MCL Network Annual Meeting in Dublin, Ireland on October 7, 2023 regarding promising ongoing preclinical studies of narazaciclib, in combination with ibrutinib and other targeted therapies used in the treatment for mantle cell lymphoma (Press release, Onconova, OCT 19, 2023, View Source [SID1234636148]).

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"Mantle cell lymphoma (MCL) is an aggressive and devastating disease, marked by frequent relapses and poor prognosis. The biology of MCL is very interesting to Onconova because of the link to cyclin D1 (CD1) overexpression. Onconova’s proprietary multi-kinase inhibitor, narazaciclib, has nanomolar potency across a range of targets including CD1. We believe this molecular feature could make MCL amenable to treatment combinations that include narazaciclib," said Steven Fruchtman, M.D., President and CEO of Onconova. "Dr. Roué’s recent work expands the dataset regarding the potential use of narazaciclib in combination with ibrutinib and other targeted therapies in sensitive and resistant MCL cell lines. Together, these data provide a foundation of support for using narazaciclib in MCL and other cyclin-dependent indications. We look forward to incorporating these important findings into the development plan for narazaciclib as we advance the clinical program, led by the Phase 1/2a study in patients with LGEEC."

Onconova plans to provide an update on the Phase 1/2a clinical program with narazaciclib in patients with low grade endometriod endometrial cancer (LGEEC), including topline safety, pharmacology data, and selection of a recommended Phase 2 dose, in Q4 2023.

Data featured in the presentation in Dublin and in a prior presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April of 2023 outlined promising results from preclinical studies that compared combinations of narazaciclib and other approved CDK4/6 inhibitors with ibrutinib and other next-generation BTK inhibitors to assess potential treatment synergies. Data from the combination of narazaciclib and ibrutinib showed significant synergistic anti-tumor activity in both sensitive and ibrutinib-resistant MCL models.

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