On May 30, 2024 Day One Biopharmaceuticals (Nasdaq: DAWN) ("Day One" or the "Company"), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported it sold its Priority Review Voucher ("PRV") for $108 million to an undisclosed buyer (Press release, Day One, MAY 30, 2024, View Source [SID1234643852]). The Company was awarded the PRV following the U.S. Food and Drug Administration ("FDA") accelerated approval of OJEMDA (tovorafenib).

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"The sale of the PRV delivers true non-dilutive capital to Day One and further strengthens our balance sheet as we continue executing on the launch of OJEMDA and investing in clinical development opportunities for children and adults living with cancer," said Charles York II, chief operating and financial officer of Day One.

Under the Rare Pediatric Disease Priority Review Voucher Program, FDA awards PRVs to sponsors of rare pediatric disease product applications that meet certain criteria. The program is intended to encourage development of new drugs and biologics for the prevention and treatment of rare diseases. A PRV can be redeemed to receive priority review of a subsequent marketing application for a different product, sold or transferred.

As part of the transaction, $8.1 million of the total consideration received from the sale of the PRV will be paid to Viracta Therapeutics, Inc. ("Viracta") to fully satisfy PRV related obligations of the Company’s license agreement with Viracta, dated December 16, 2019, as amended.

On May 30, 2024 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that Richard A. Miller, M.D., president and chief executive officer, and Jeffrey Arcara, chief business officer, will conduct one-on-one meetings with investors and present a corporate overview at the Jefferies Global Health Conference, which is being held in New York from June 5-7, 2024 (Press release, Corvus Pharmaceuticals, MAY 30, 2024, View Source [SID1234643851]). The Company’s presentation will be on Wednesday, June 5 at 3:00 pm ET.

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A webcast of the presentation will be available live and for 90 days following the event. The webcast may be accessed via the investor relations section of the Corvus website.

On May 30, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported it is entitled to receive a milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN) triggered by the dosing of the first patient in a Phase 3 trial evaluating rilvegostomig, AstraZeneca’s PD-1/TIGIT bispecific antibody (Press release, Compugen, MAY 30, 2024, View Source [SID1234643850]). The TIGIT component of rilvegostomig is derived from Compugen’s clinical-stage anti-TIGIT antibody, COM902. Both rilvegostomig and COM902 are designed to have reduced Fc effector function.

The trial, called TROPION-Lung10, is evaluating the efficacy and safety of rilvegostomig as monotherapy and in combination with datopotamab deruxtecan (Dato-DXd), AstraZeneca and Daiichi Sankyo’s (TSE: 4568) TROP2-directed antibody drug conjugate versus pembrolizumab as first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations. The trial is sponsored by AstraZeneca in collaboration with Daiichi Sankyo and is expected to enrol approximately 675 patients in more than 14 countries. Further details about TROPION-Lung10 are available on ClinicalTrials.gov, identifier: NCT06357533.

"We are very excited to see the advancement of rilvegostomig into its second Phase 3 trial by AstraZeneca in collaboration with Daiichi Sankyo, two global leaders in oncology," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "TROPION-Lung10 follows the start of the ARTEMIDE-Biliary01 Phase 3 trial evaluating rilvegostomig in biliary tract cancer, for which we received a $10 million milestone payment. Now, after dosing the first patient in this lung cancer trial, we are eligible to receive a $5 million milestone payment from AstraZeneca. Broadening the assessment of rilvegostomig reinforces our partnering strategy to expand opportunities for our pipeline and brings us closer to realizing potential future milestone payments and royalties."

The ARTEMIDE-Biliary01 Phase 3 trial is evaluating the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator’s choice of chemotherapy in patients with biliary tract cancer after surgical resection with curative intent. Further details about the ARTEMIDE-Biliary01 trial are available on ClinicalTrials.gov, identifier: NCT06109779.

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On May 30, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that it has entered into a Supply Agreement with SpectronRx for the production of Cu-64 (Press release, Clarity Pharmaceuticals, MAY 30, 2024, View Source [SID1234643849]).

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Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are very excited to bring an additional Cu-64 manufacturer to our extensive and reliable network of copper radioisotope suppliers. SpectronRx will be the first private supplier of Cu-64 to join our network in the US.

"Cu-64, with an ideal 12.7-hour half-life, is able to overcome the overwhelming supply restraints of other diagnostic isotopes, specifically Ga-68 with a half-life of ~1 hour and F-18 with a half-life of ~2 hours. Radiopharmaceutical products using these isotopes are severely limited and are associated with significant manufacturing and supply complications, driven by these very short half-lives. This leaves many patients around the world with no option of positron emission tomography (PET) imaging. This is well documented in the United States, the largest oncology market in the world, and the effects of these hurdles more heavily impact vulnerable populations, including African Americans and Veterans, who already experience much higher incidences of prostate cancer than the general population1, 2.

"Our focus at Clarity is to establish the most reliable, scalable, and logistically seamless supply chain in the radiopharmaceutical field to continue delivering our best-in-class products to patients and their clinicians on time. With our TCTs, we can avoid the myriad of challenges associated with the current generation of diagnostic isotopes, such as Ga-68 and F-18, which require local production due to their short half-lives.

"The unique properties of Cu-64 include the ability to produce commercially relevant volumes of this isotope daily, on centrally located cyclotrons. Cu-64 can then be manufactured into ready-to-use products with a shelf life that is measured in days rather than hours and supply the growing demand for PET imaging agents. Should an imaging site require 1, 10 or 100+ patient doses, we see a future where these quantities can be reliably supplied to any zip code in the United States, removing the burden of the current supply issues with Ga-68 and F-18 based products from practices and their patients.

"We are now actively recruiting and imaging patients for our first Phase III trial with 64Cu-SAR-bisPSMA in a pre-prostatectomy setting and planning our second Phase III trial in biochemically recurrent prostate cancer with this optimised product. With outstanding clinical trial data to date, we continue to implement our strategy for the commercial launch of 64Cu-SAR-bisPSMA, developing a seamless supply chain for this potential best-in-class agent."

The overarching Master Service Agreement and associated Cu-64 supply agreement are effective as of 30 May 2024. The initial supply from SpectronRx is expected to launch before the end of calendar year 2024. The Master Services Agreement is for an initial period of five years and the Cu-64 supply agreement is for an initial period of 3 years. Cancellation and extension provisions are aligned with industry standard rates.

On May 30, 2024 CinRx Pharma, a hub-and-spoke biotech accelerating high-impact medicines, reported the closing of a $73 million financing, bringing the total funds raised to $176 million (Press release, CinRx Pharma, MAY 30, 2024, View Source;utm_medium=rss&utm_campaign=cinrx-pharma-announces-additional-73-million-financing [SID1234643848]). Participants in the round include prior investors comprised of industry insiders and high-net-worth individuals. To date, CinRx has launched five companies ("CinCos") focused primarily on cardiovascular, metabolic and gastrointestinal conditions. In addition to its company creation function, CinRx has forged several CINergy partnerships with existing companies. CinRx plans to use the funds to advance development of its existing portfolio programs and assets to expand in key areas of high unmet medical need.

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"Our early financings totaling $103 million supported the construction and progression of our seven-company portfolio. Notably, this included the formation, advancement and exit of CinCor Pharma ahead of its $1.8 billion acquisition, underscoring the success of our incredibly effective team and validation of our efficient business model," said Dr. Jon Isaacsohn, Founder and Chief Executive Officer at CinRx Pharma. "With this infusion of capital, we will continue rapid advancement of existing programs and replicate our proven asset selection process to identify and accelerate more promising new programs with high potential to impact patients’ quality of life."

CinRx’s portfolio of CinCos are managed by a lean team of scientific, technical and drug development experts with decades of experience treating patients and supporting thousands of clinical development programs. Each CinCo was created through a rigorous asset selection process to identify novel therapies with the potential to address significant unmet medical needs and meaningfully reduce disease burden for patients.

CinCor Pharma was created to advance baxdrostat (CIN-107), a highly selective, oral small molecule inhibitor of aldosterone synthase for the treatment of hypertension and other cardiorenal conditions from a license agreement with Roche in 2019. CinRx led the clinical design and execution of baxdrostat, and was responsible for CinCor’s successful Series A and Series B financings to fund its early development through its $194 million IPO in 2022. In early 2023, CinCor was acquired by AstraZeneca in a deal worth $1.3 billion upfront and an additional $500 million in biobucks.

CinFina Pharma is developing a pipeline of four therapies, in-licensed from Janssen Pharmaceuticals, aimed at providing safe, tolerable and durable options for treating obesity. In March 2024, CinFina announced the dosing of the first patients in a Phase 1 trial of CIN-110, a PYY analog. Upcoming milestones include initiation of a Phase 2 study evaluating CIN-109, a novel GDF-15 molecule focusing on body composition and lean body mass preservation, with and without semaglutide. Additional preclinical development is ongoing to support Investigational New Drug (IND) application submissions for CIN-209 and CIN-210, which are both dual-agonists utilizing GLP-1 therapy in combination with the aforementioned mechanisms of action.

CinDome Pharma is developing deudomperidone (CIN-102) as a potential safe, chronic treatment for gastroparesis. Deudomperidone is a novel formulation of a well-known dopamine D2/D3 agonist, domperidone. In May 2023, CinDome presented encouraging QT study data at the 2023 Digestive Disease Week (DDW) Conference. CinDome recently raised $40 million in a Series B financing from Perceptive Advisors and CinRx, and is actively enrolling the Phase 2 envision3D study for adults with diabetic gastroparesis, expected to read out in 2025.

CinPhloro Pharma is progressing CIN-103, a small molecule for the long-term management of irritable bowel syndrome with diarrhea (IBS-D). CIN-103 is a pulsatile-release formulation of phloroglucinol, an approved therapy in select countries outside of the U.S., modified for sustained exposure and less frequent dosing. In February 2024, CinPhloro dosed the first patients in the Phase 2 enviva study to evaluate the safety, efficacy and tolerability of CIN-103 for IBS-D. CinPhloro is actively enrolling the enviva study, which is expected to complete in 2025.