On January 22, 2024 Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company and developer of best-in-class personalized MRD technology (Haystack MRD), reported that it has entered a research collaboration with TriSalus Life Sciences to evaluate therapeutic response and provide molecular insights in connection with the clinical development of TriSalus’ SD-101, an investigational class C toll-like receptor-9 (TLR9) agonist (Press release, Quest Diagnostics, JAN 22, 2024, View Source,-developer-of-Haystack-MRD-TM-,-and-TriSalus-Life-Sciences-collaborate-in-connection-with-the-clinical-development-of-TriSalus-TLR9-agonist-in-hepatocellular-carcinoma,-intrahepatic-cholangiocarcinoma,-and-pancreatic-adenocarc [SID1234639410]). SD-101 is delivered via hepatic arterial infusion or pancreatic retrograde venous infusion in their phase 1 and 1b clinical trials using their proprietary Pressure-Enabled Drug Delivery (PEDD) to overcome the challenges associated with intratumoral pressure for patients diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and pancreatic adenocarcinoma.

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"Haystack MRD is specifically designed and developed to accurately detect circulating tumor DNA (ctDNA) with unparalleled sensitivity in patients with low tumor burden and in clinically challenging cancer types," said Dan Edelstein, Vice President and General Manager, Haystack Oncology. "Haystack MRD’s sensitivity enables clinical investigators to closely follow molecular response and measure early evidence of treatment efficacy. We’re excited to collaborate with TriSalus to support the clinical development of SD-101 in combination with their unique therapy delivery technology, which aims to overcome challenges associated with treating liver and pancreatic tumors."

Hepatocellular carcinoma is the most common form of liver cancer. Intrahepatic cholangiocarcinoma is cancer that occurs in the parts of the bile ducts that are within the liver. Pancreatic adenocarcinoma is the most common form of pancreatic cancer.

"A significant challenge in the development of immunotherapies for liver and pancreatic tumors is early measurement of response to treatment. Conventional imaging response assessment methods may be misleading in certain situations, and accurate ctDNA assays offer the potential to identify meaningful biologic activity in difficult to treat cancers," says Steven Katz, MD, Chief Medical Officer of TriSalus Life Sciences. "We are thrilled to work with Haystack in pursuit of our mission to develop better therapeutic options for patients with liver and pancreatic tumors."

On January 22, 2024 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that it has agreed to sell approximately 12.5 million shares of its common stock to a select group of institutional and accredited healthcare specialist investors in a private placement, at a price per share of $10.00, representing a premium of approximately 10% to ORIC’s 5-day trailing average price (Press release, ORIC Pharmaceuticals, JAN 22, 2024, View Source [SID1234639409]). The financing is expected to close on January 23, 2024, subject to customary closing conditions. ORIC anticipates the gross proceeds from the private placement to be approximately $125 million, before deducting any offering related expenses.

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The financing includes participation from new and existing institutional investors, including Viking Global Investors, Commodore Capital, Frazier Life Sciences, Venrock Healthcare Capital Partners, NEA, and Nextech1.

ORIC intends to use the net proceeds from the proposed financing to fund research and development of its clinical-stage product candidates and research programs and for working capital and general corporate purposes. The proceeds from this financing, combined with current cash, cash equivalents and marketable securities, is expected to be sufficient to fund the current operating plan into late 2026.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. ORIC has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock issued in this private placement. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On January 22, 2024 Dianthus Therapeutics, Inc. ("Dianthus" or the "Company") (NASDAQ: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, reported that it has entered into a securities purchase agreement for a private investment in public equity ("PIPE") financing that is expected to result in gross proceeds of approximately $230 million to the Company, before deducting placement agent fees and offering expenses (Press release, Magenta Therapeutics, JAN 22, 2024, View Source [SID1234639408]). The PIPE financing included participation from both new and existing investors, including Bain Capital Life Sciences, RA Capital Management, Avidity Partners, Fairmount, Venrock Healthcare Capital Partners, RTW Investments, Great Point Partners LLC, Octagon Capital, Janus Henderson Investors, Vestal Point Capital, Logos Capital, Catalio Capital Management, Woodline Partners LP, Ally Bridge Group, Tellus BioVentures, StemPoint Capital LP and a large investment management firm.

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Pursuant to the terms of the securities purchase agreement, Dianthus is selling an aggregate of 14,500,500 shares of its common stock at a price of $12.00 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 4,666,332 shares of common stock at a purchase price of $11.999 per pre-funded warrant, which represents the per share purchase price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. The PIPE financing is expected to close on or about January 24, 2024, subject to satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the PIPE financing, together with the Company’s existing cash, cash equivalents, and marketable securities, for research and development expenditures focused on product development and for general corporate purposes, including capital expenditures, working capital and potential business development activities.

Jefferies, Evercore ISI, Stifel, Guggenheim Securities, and Raymond James are acting as placement agents for the PIPE financing.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the securities purchase agreement, Dianthus and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock sold in the PIPE financing, as well as the shares of common stock underlying the pre-funded warrants sold in the PIPE financing.

On January 22, 2024 Ipsen (Euronext: IPN; ADR: IPSEY) reported new data to be presented for Cabometyx (cabozantinib) in combination with immunotherapy across indications at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Symposium (ASCO GU) taking place on 25-27 January 2024 in San Francisco, U.S (Press release, Ipsen, JAN 22, 2024, View Source [SID1234639407]).

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Detailed top-line results from the Phase III CONTACT-02 trial of the combination of Cabometyx and atezolizumab versus a second novel hormone therapy (NHT) in people living with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who have progressed on one prior NHT, are to be presented as an oral presentation (Abstract #18).

With a median follow-up of 14.3 months, data from the primary analysis of progression-free survival (PFS) from the CONTACT-02 trial demonstrated a statistically significant PFS benefit for the combination of Cabometyx and atezolizumab of 6.3 months versus 4.2 months for a second NHT (hazard ratio [HR]: 0.65, 95% confidence interval [CI]: 0.50-0.84; p=0.0007). At an interim analysis for the other primary endpoint of overall survival (OS), the data demonstrated a trend toward improvement for the combination, however, these data were immature, and the trial will continue to the next planned analysis, anticipated in 2024. Safety for the combination appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified.

Prostate cancer is the second most common cancer in men1 and for those living with advanced metastatic castration-resistant disease, the prognosis is poor, with an estimated survival of 1-2 years2.

"At the advanced metastatic castration-resistant stage of disease, the prognosis is poor, with a median survival of two years and limited available treatment options," said Stéphane Oudard, Professor of Oncology and Chief of the Oncology Clinical and Translational Research Unit at Georges Pompidou Hospital in Paris, France. "These results from the CONTACT-02 trial represent a positive step in the context of the current treatment landscape, contributing the first positive Phase III data of its kind for the benefit of patients, as we await further data from the overall survival analysis."

Also, four-year extended follow-up data from the landmark Phase III CheckMate -9ER trial investigating the combination of Cabometyx and nivolumab versus sunitinib in people living with previously untreated advanced renal cell carcinoma (aRCC) will be presented (Abstract #362).

With a median follow-up of 55.6 months for OS, the combination of Cabometyx and nivolumab demonstrated a sustained and clinically meaningful OS benefit versus sunitinib, with an absolute median OS gain of 10.5 months (46.5 months for the combination vs 36.0 months for sunitinib, HR 0.77, 95% CI: 0.63-0.95). Additionally, median PFS remained almost double that for the combination versus sunitinib, at 16.4 vs 8.4 months respectively (HR 0.58, 95% CI: 0.49-0.70). The safety profile was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified.

Renal cell carcinoma is the most common form of kidney cancer3, 4 and for the 30% of people diagnosed with an advanced form of the disease, the 5-year survival rate is low at 12%, with no identified cure for this disease.5,6

"Data from our ongoing trials continue to reinforce the value of Cabometyx for patients across a number of challenging tumor types," said Christelle Huguet, EVP and Head of Research and Development, Ipsen. "In combination with immunotherapy, Cabometyx is delivering long-term survival benefits today for people living with renal cell carcinoma worldwide, while also showcasing future potential in metastatic castration-resistant prostate cancer, an area of significant unmet need where no other trials of this modality have proven successful in recent decades."

Additionally, health-related quality of life (HRQoL) data from a modelling analysis based on the CheckMate 9ER trial explored the link between HRQoL and clinical outcomes at a median follow-up of 32.9 months (Abstract #384). These data provide further patient-focused context to the benefits of the combination of Cabometyx and nivolumab, whilst also reinforcing the association of the combination with an increased chance of tumor shrinkage, survival and progression-free survival, independent of early HRQoL deterioration.

On January 22, 2024 Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ: EXEL) reported four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo (nivolumab) in combination with CABOMETYX (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) (Press release, Exelixis, JAN 22, 2024, View Source [SID1234639406]). Results continued to show superior progression-free survival (PFS) and objective response rates (ORR) in patients treated with Opdivoplus CABOMETYXover sunitinib, regardless of risk classification based on International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) scores. Superior overall survival (OS) was also observed in patients treated with the combination. These updated results, including data showing health-related quality-of-life benefits with Opdivo in combination with CABOMETYX vs. sunitinib, will be featured in an oral presentation (Abstract #362) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Genitourinary Cancers Symposium from January 25-27, 2024.

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"Renal cell carcinoma can be very challenging to treat and patients who are diagnosed with advanced disease or develop metastasis often face poor outcomes," said Maria Teresa Bourlon, Urologic Oncology Clinic, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico. "These updated results from the CheckMate -9ER trial continue to support the role of nivolumab in combination with cabozantinib as an important first-line treatment option for this devastating disease, demonstrating durable efficacy across its multiple study endpoints, including a 23% reduction in the risk of death."

At a median follow-up of 55.6 months (48.1 months minimum), all patients randomized to the Opdivo plus CABOMETYX treatment arm (n=323) continued to experience benefits over those who received sunitinib (n=328) across efficacy endpoints:

PFS (primary endpoint): PFS continued to favor Opdivo plus CABOMETYX, with median PFS nearly doubled with the combination regimen at 16.4 months vs. 8.4 months with sunitinib (Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]: 0.49 to 0.70).
OS (secondary endpoint): Treatment with Opdivo in combination with CABOMETYX elicited durable survival benefit over sunitinib, with a median OS of 46.5 months compared to 36.0 months with sunitinib (HR 0.77; 95% CI: 0.63 to 0.95).
ORR (secondary endpoint): The combination regimen showed durable response improvements, doubling the ORR compared to sunitinib (55.7% vs. 27.7%, respectively).
Complete response (CR): Patients who received Opdivo plus CABOMETYX continued to show CR benefit, with triple the number of patients achieving CR vs. sunitinib (13.6% vs. 4.6%).
Duration of response (DOR): Opdivo plus CABOMETYX was associated with a longer median DOR of 22.0 months vs. 15.2 months in the sunitinib group.
Safety: No new safety concerns were identified in this follow-up analysis. Among all treated patients, any-grade treatment-related adverse events (TRAEs) occurred in 97.5% in the Opdivo plus CABOMETYX group compared to 93.1% in the sunitinib group. Grade ≥3 TRAEs occurred in 67.5% of Opdivo plus CABOMETYX-treated patients vs. 55.3% in sunitinib-treated patients.
Additionally, in exploratory analyses, durable and clinically meaningful benefits were observed in patient subgroups across risk groups, including within the favorable-risk and intermediate- and poor-risk groups:

OS: Among patients with intermediate-/poor-risk, median OS was 43.9 months for those treated with Opdivo plus CABOMETYX vs. 29.3 months with sunitinib (HR 0.73; 95% CI: 0.58 to 0.91). In patients with favorable risk, median OS was similar across treatment arms at 52.9 months with the combination regimen and 58.9 months with sunitinib (HR 1.10; 95% CI: 0.69 to 1.75).
PFS: PFS was improved with the combination regimen in patients with intermediate-/poor-risk with a median PFS of 15.4 months compared to 7.1 months with sunitinib (HR 0.56; 95% CI: 0.45 to 0.68), as well as in those with favorable risk at 21.4 months vs. 12.8 months (HR 0.69; 95% CI: 0.48 to 1.00).
ORR: In patients with intermediate-/ poor-risk, ORR was more than doubled at 52.6% with Opdivo and CABOMETYX vs. 23.0% with sunitinib. In those with favorable risk, ORR was 66.2% vs. 44.4%, respectively.
CR: Among those with intermediate-/poor-risk profiles, the number of patients who achieved CR more than tripled (12.9% vs. 3.5%) with the combination regimen compared to sunitinib. In those with favorable risk profiles, the number of patients who achieved CR was doubled (16.2% vs. 8.3%) with the combination regimen.
DOR: Median DOR was also improved with Opdivo and CABOMETYX across both groups. Among the intermediate- and poor-risk group, those treated with the combination regimen had a median DOR of 23.1 months vs. 13.8 months with sunitinib. Among the favorable risk group, median DOR was 18.7 months vs. 17.8 months, respectively.
"There has been an ongoing need for therapeutic options that can provide patients with previously untreated advanced or metastatic renal cell carcinoma with the potential for disease control and extended survival. By combining the power of these two unique modalities, we established a new standard of care with Opdivo and CABOMETYX, building on our commitment to improving outcomes for patients with advanced cancers, including but not limited to genitourinary cancers," said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. "Now, after more than four years of follow up, the data continue to underscore the value of Opdivo-based combinations in the GU cancer treatment paradigm with the potential to help patients diagnosed with advanced RCC live longer, regardless of risk classification."

"These results from CheckMate -9ER provide hope that patients with previously untreated advanced kidney cancer may experience a long-term survival benefit. We are pleased to see that the combination of CABOMETYX and Opdivo continues to demonstrate durable and clinically meaningful efficacy after four years of follow-up in this patient population across risk groups, reinforcing the value of this regimen as a standard of care in this setting," said Amy Peterson, M.D., executive vice president, product development & medical affairs, and chief medical officer, Exelixis. "It is also encouraging that CABOMETYX in combination with Opdivo demonstrated superior PFS and OS benefits in patients who had disease burdens in often challenging-to-treat areas, including bone, liver and lung metastases. The totality of these encouraging findings, achieved in partnership with Bristol Myers Squibb, underscore our commitment to collaborating with the scientific community to advance treatment regimens for patients with advanced cancers."

Bristol Myers Squibb and Exelixis thank the patients and investigators involved in the CheckMate -9ER clinical trial.

About CheckMate -9ER

CheckMate -9ER is an open-label, randomized, multi-national Phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L1≥1%) were randomized to receive Opdivo plus CABOMETYX (n=323) vs. sunitinib (n=328). The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS) and objective response rate (ORR). The primary efficacy analysis is comparing the doublet combination vs. sunitinib in all randomized patients. The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co. and co-funded by Exelixis, Inc., Ipsen Pharma SAS and Takeda Pharmaceutical Company Limited.

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. At diagnosis, up to 30% of patients present with advanced or metastatic RCC.