On October 30, 2023 Volastra Therapeutics, a discovery and clinical-stage cancer biotechnology company, reported the dosing of the first patient in a Phase I/II clinical trial evaluating VLS-1488 (Press release, Volastra Therapeutics, OCT 30, 2023, View Source [SID1234636451]). VLS-1488 and sovilnesib (formally AMG650) make up Volastra’s innovative clinical portfolio of differentiated KIF18A inhibitors specifically designed for the treatment of solid tumors characterized by high levels of chromosomal instability (CIN).

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The Phase I/II trial (NCT05902988) evaluates safety, tolerability and preliminary efficacy of VLS-1488 in patients with advanced tumors. The trial is a significant milestone in Volastra’s mission to help patients with these hard-to-treat cancers.

"In 2019, our team set out to understand the biology of chromosomal instability and discover new treatment approaches," said Charles Hugh-Jones M.D., FRCP, CEO at Volastra. "The ground-breaking work leading to this study has the potential to define the first-ever CIN-directed therapy."

KIF18A is a protein required by many tumor cells to divide and grow efficiently. It is not required by normal healthy cells to divide, allowing the selective killing of cancer cells. Volastra will deploy multiple exploratory biomarkers that measure CIN, including AI-based tissue imaging developed in partnership with Microsoft.

Dr. Pat LoRusso, D.O., Director of the Phase I Clinical Trial Unit at Yale commented, "Targeting chromosomal instability is a major opportunity for cancer therapy. Inhibiting KIF18A shows impressive data in pre-clinical models with high levels of CIN. We look forward to contributing to the clinical trial of this promising molecule."

Dr. Alexander Starodub, M.D., Ph.D., at The Christ Hospital Cancer Center in Cincinnati, Ohio dosed the first patient in this Phase 1 trial.

On October 30, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SLS009, its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) Peripheral T-cell Lymphomas (PTCL) (Press release, Sellas Life Sciences, OCT 30, 2023, View Source [SID1234636450]). The Fast Track designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.

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"The FDA’s decision to grant SLS009 Fast Track designation signifies an important milestone towards developing a safe and effective treatment for PTCL, a group of aggressive and rare non-Hodgkin lymphomas, and underscores the urgent need for innovative therapies such as SLS009 that can significantly improve the outcome of PTCL patients," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "SLS009 has demonstrated very promising clinical responses in PTCL patients in the recently completed dose-escalation portion of the Phase 1 trial in relapsed/refractory hematological malignancies and with the Fast Track designation we are poised to accelerate its development. We are committed to working closely with the FDA and our partner GenFleet Therapeutics to develop this promising treatment for patients in need."

SLS009 demonstrated favorable safety/tolerability and promising clinical efficacy in the recently completed dose-escalation portion of the Phase 1 trial in r/r hematological malignancies. Complete or partial responses were observed in acute myeloid leukemia and lymphoma patients among which four out of eleven patients with PTCL (36.4%) achieved clinical responses including one in continuous treatment for over 56 weeks. The current standard of care for PTCL, belinostat, approved for r/r PTCL, showed in its pivotal Phase 2 study a 25.8% response rate in a similar patient population to that in the SLS009 Phase 1 clinical trial. An open-label, single-arm Phase 1b/2 trial of SLS009 (known as GFH009 in China) to evaluate safety and efficacy in r/r PTCL, at the recommended phase 2 dose of 100 mg once per week, is ongoing in China and, based on the results, may serve as a registrational study.

This initial PTCL study, which will enroll up to 95 patients, is fully funded by GenFleet Therapeutics (Shanghai) Inc. The Company is also actively pursuing potential Breakthrough Therapy designation from the FDA for SLS009 for the treatment of r/r PTCL and has a scheduled meeting in the fourth quarter of 2023 to discuss with the FDA.

Fast Track is a process designed by the FDA to facilitate and expedite the development of investigational treatments that demonstrate a potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and more frequent interactions with the FDA to discuss the candidate’s development plan in addition to a rolling submission of the marketing application. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.

On October 30, 2023 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported the pricing of a public offering of $750 million aggregate principal amount of its 6.400% senior notes due 2033 under Quest Diagnostics’ shelf registration statement (Press release, Quest Diagnostics, OCT 30, 2023, View Source [SID1234636449]).

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Quest Diagnostics expects to receive the net offering proceeds upon closing on November 1, 2023, subject to customary closing conditions. The company intends to use the net proceeds from the offering for general corporate purposes, which may include the redemption or repayment of indebtedness. The indebtedness the company may redeem or repay with the net proceeds of the offering includes the company’s $300 million aggregate principal amount of 4.25% senior notes due 2024 and any outstanding borrowings under the company’s senior unsecured revolving credit facility and secured receivables credit facility.

This press release shall not constitute an offer to sell or a solicitation of an offer to purchase any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. This offering may be made only by means of a prospectus supplement and accompanying base prospectus, copies of which or information concerning this offering may be obtained by calling Goldman Sachs & Co. LLC, toll free at 1 (866) 471-2526, Mizuho Securities USA LLC, toll-free at 1 (866) 271-7403 or Morgan Stanley & Co. LLC, toll-free at 1 (866) 718-1649.

On October 30, 2023 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results for the third quarter and first nine months of 2023 (Press release, Qiagen, OCT 30, 2023, View Source;non-COVID-products-and-adjusted-EPS-of-0.50-CER/default.aspx [SID1234636448]).

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Net sales results of $470 million at constant exchange rates (CER) for Q3 2023 were above the outlook for at least $465 million CER, driven by 5% CER growth in the non-COVID-19 portfolio. Overall sales results for Q3 2023 declined 5% (-6% CER) to $476 million from Q3 2022, a period marked by significant COVID-19 sales contributions. Adjusted diluted earnings per share (EPS) were $0.50, and results of $0.50 CER were above the outlook for at least $0.48 CER.

QIAGEN has reaffirmed its full-year 2023 outlook for net sales of at least $1.97 billion, driven by ongoing solid consumables demand that accounted for 88% of total sales in the first nine months of the year, while larger-scale instrument sales remain challenging. QIAGEN also continues to closely monitor fast‑changing geopolitical and macro trends around the world. Adjusted diluted EPS are reaffirmed to be at least $2.07 CER.

"We delivered another quarter of solid results that exceeded our outlook, driven by our strategic focus on our Pillars of Growth and the benefits of balance in serving over 500,000 Life Sciences and Molecular Diagnostics customers, along with our broad geographic presence," said Thierry Bernard, Chief Executive Officer of QIAGEN.

"This resilient performance was important as we work through the final quarters of COVID-19 testing headwinds from 2022, and also address an increasingly challenging macro environment. Against this backdrop, our teams executed on goals to generate sales gains across many portfolio areas and key regions. We are well-positioned to finish this year in a stronger position, committed to delivering solid sales growth and improved earnings in the fourth quarter of 2023 as we prepare for more growth and expansion in 2024 and the years ahead."

Roland Sackers, Chief Financial Officer of QIAGEN, said: "QIAGEN is investing into the business, particularly in R&D that accounted for 10% of sales, while maintaining industry-leading margins and a high level of profitability that helped us to exceed our outlook for adjusted earnings per share in the third quarter of 2023. These results again demonstrate our capacity to support our growth prospects while ensuring effective cost management. As we review options to deploy capital, we are committed to creating greater value by enhancing our business portfolio and increasing returns."

Please find a PDF of the full press release incl. tables here.

Investor presentation an conference call

A conference call is planned for Tuesday, October 31, 2023 at 14:00 Frankfurt Time / 13:00 London Time / 9:00 New York Time. A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a recording will also be made available after the event. A presentation is planned to be available before the conference call at View Source

On October 30, 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 Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in three upcoming investor conferences (Press release, Kura Oncology, OCT 30, 2023, View Source [SID1234636445]).

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A virtual fireside chat at the TD Cowen Fall Oncology Innovation Summit: Insights for SITC (Free SITC Whitepaper) and ASH (Free ASH Whitepaper) event at 12:00 p.m. ET / 9:00 a.m. PT on November 3, 2023;
A fireside chat at the Stifel 2023 Healthcare Conference in New York at 11:30 a.m. ET / 8:30 a.m. PT on November 14, 2023; and
A fireside chat at the Jefferies London Healthcare Conference in London at 9:30 a.m. GMT / 5:30 a.m. ET / 2:30 a.m. PT on November 16, 2023.

Live audio webcasts will be available in the Investors section of Kura’s website at www.kuraoncology.com, with archived replays available following all three events.