On April 1, 2025 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported its participation in the following investor conference (Press release, Nkarta, APR 1, 2025, View Source [SID1234651720]):

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24th Annual Needham Virtual Healthcare Conference
April 8, 2025
11:00 a.m. ET – fireside chat

A simultaneous webcast of the event will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately 90 days.

On April 1, 2025 Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company"), a global biopharmaceutical company, and Shilpa Medicare Limited ("Shilpa") reported the U.S. launch of BORUZU, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration (Press release, Amneal Pharmaceuticals, APR 1, 2025, View Source [SID1234651736]). This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration.

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BORUZU (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade, a lyophilized powder requiring reconstitution before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. BORUZU has a unique J-code.

"As we advance our broader strategy to build a leading injectables portfolio with durable, high-impact complex products, we are excited to announce the U.S. launch of BORUZU in our oncology portfolio. This ready-to-use injectable marks a significant innovation for our customers by streamlining pharmacy preparation steps for clinicians while now carrying a unique J-code to facilitate reimbursement. Our commitment remains steadfast in delivering differentiated oncology products that enhance patient care and access," said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology.

"This second NDA product being launched in the US market from our novel injectable portfolio demonstrates our capabilities and commitment to introduce pharmacy efficient solutions that enhance compliance and have the potential to reduce patient wait times. This development exemplifies Shilpa’s constant endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool," said Vishnukant Bhutada, Managing Director of Shilpa Medicare.

The most commonly reported adverse reactions for BORUZU in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia.

On April 1, 2025 CuraCell reported the company will present clinical outcomes of patients treated with our Tumor Infiltrating Lymphocytes (TIL)-based therapy this spring at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the International Society for Cell & Gene Therapy (ISCT) Annual Meeting, both taking place in the United States. All patients treated, on a patient-named basis, were diagnosed with late-stage solid tumors and refractory to all conventional therapies.

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The presentations mark a significant milestone for our team as we share important data highlighting the potential of our TIL-product CC-38 to address the unmet medical need in cold solid tumors.

"We look forward to connecting with the scientific and clinical community during these events and continuing the conversation on advancing durable, personalized cancer immunotherapy." said Dr. Lucas Arruda, CSO of CuraCell.

(Press release, CuraCell, APR 1, 2025, View Source [SID1234661186])

On April 1, 2025 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies, including gene elimination, gene insertion, and gene excision programs, reported that management will present at the 24th Annual Needham Virtual Healthcare Conference taking place on April 7, 2025 (Press release, Precision Biosciences, APR 1, 2025, View Source [SID1234651721]).

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Presentation Details:

Date: Monday, April 7, 2025
Time: 3:00 PM ET in Track 2
Format: Presentation
Webcast Registration: Link

A live webcast will also be accessible on Precision’s website in the Investors section under Events & Presentations at investor.precisionbiosciences.com. An archived replay of the webcasts will be available for approximately 30 days following the event.

On April 1, 2025 TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics ("BBOT" or the "Company"), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported that the first patient has been dosed with BBO-11818 in the Phase 1 KONQUER-101 trial for advanced solid tumors (Press release, BridgeBio Oncology Therapeutics, APR 1, 2025, View Source [SID1234651737]). BBO-11818 is an orally bioavailable small molecule dual inhibitor that directly binds to both the "ON" and "OFF" states of KRAS. KONQUER-101 will enroll patients globally with certain KRAS mutations.

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"The dosing of the first patient is a major milestone in assessing BBO-11818’s potential benefit for patients with tumors driven by mutant KRAS," said Dr. Ignacio Garrido-Laguna, MD, PhD, Principal Investigator at Huntsman Cancer Institute at the University of Utah. "We are committed to bringing cutting-edge therapies to patients with advanced cancer in the Mountain Region. BBO-11818 has the potential to safely achieve optimal target inhibition and combine with other targeted therapies. We look forward to evaluating it in the KONQUER-101 trial."

BBO-11818 was designed to non-covalently bind both the inactive GDP-bound "OFF" and active GTP-bound "ON" forms of KRASG12D and KRASG12V. In cellular assays, EC50 values for pERK inhibition in selected KRAS G12D and G12V-mutant cell lines range from sub-nanomolar to single-digit nanomolar potency. BBO-11818 is similarly effective in reducing cell viability in KRASG12D, KRASG12V, and KRASG12C-mutant cell lines. Further, NRAS and BRAF mutant cell lines show insensitivity to BBO-11818, and the molecule exhibits more than 500-fold selectivity for KRAS over H- and NRAS.

"There is a great need for new therapies that can safely treat patients with tumors driven by KRAS mutations, as the current standard of care lacks satisfactory options as monotherapy or to enable combinations of KRAS targeted therapies with other targeted agents," said Yong (Ben) Ben, MD, Chief Medical and Development Officer of BBOT. "BBO-11818 marks the third molecule entering the clinic for BBOT, further proving our capability to advance novel programs into the clinic. Of note, our portfolio is uniquely positioned to deliver the combination of MAPK (BBO-8520 and BBO-11818) and PI3Kα/AKT (BBO-10203) co-inhibition, with a therapeutic index. We hope this will bring unprecedented benefit to patients with RAS-driven cancers."

The discovery of BBO-11818 was the result of a collaboration between the RAS Initiative at Frederick National Laboratory, Lawrence Livermore National Laboratory, and BBOT.