On April 1, 2025 enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that Ron Cooper, Chief Executive Officer, will present at the Stifel 2025 Virtual Targeted Oncology Forum, on Tuesday, April 8, 2025, at 4:00 p.m. ET (Press release, enGene, APR 1, 2025, View Source [SID1234651738]).

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A live webcast of the presentation can be accessed under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.

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.

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 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported its financial results and business updates for the fourth quarter and full year ended December 31, 2024 (Press release, Renovorx, APR 1, 2025, View Source [SID1234651735]).

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"The fourth quarter of 2024 marks a significant milestone in our company history as we have generated our first revenue from sales of our proprietary RenovoCath device on a standalone basis, with expectations for meaningful revenue growth going forward. Importantly, we believe our current commercial strategy can be accomplished without a material increase in our capital expenditures, regardless of whether we self-commercialize or choose to partner with a larger organization and use their existing sales force and channels. Further, we believe that the gross proceeds from our February 2025 public offering of $12.1 million together with our cash on hand of $7.2 million at year end fully funds our current operational plan as we look to scale RenovoCath revenues and progress our Phase III TIGeR-PaC clinical trial towards key milestones. Moreover, we expect that growing RenovoCath revenues will reduce our burn rate as we prudently deploy our cash on hand to drive shareholder value," said Shaun Bagai, CEO of RenovoRx.

"Based on our internal analysis with current clinical applications, we believe that our initial total addressable market (TAM) for RenovoCath represents an estimated $400 million peak annual U.S. sales opportunity. Beyond this, there are expansion opportunities across other indications that could create the potential for a several billion-dollar U.S. TAM for RenovoCath over time," continued Mr. Bagai. "We expect revenue to increase to the low six figure range for the first quarter of 2025 followed by sequential quarter-over-quarter increases for the remainder of the year."

RenovoCath Commercialization Update

In December 2024, RenovoRx received first commercial purchase orders for its RenovoCath device, which resulted in revenue generation of approximately $43,000 for the fourth quarter of 2024.

RenovoRx is seeing strong organic demand for RenovoCath. More than ten medical institutions have initiated the process for RenovoCath purchase orders, and purchase orders have already been received from several esteemed, high volume National Cancer Institute-designated centers. Additionally, utilization of RenovoCath devices by initial customers has led to repeat purchase orders. Moreover, RenovoRx believes the twenty cancer centers that have used RenovoCath as part of its TIGeR-PaC trial could also be potential customers for RenovoCath after completion of TIGeR-PaC enrollment later this year.

RenovoRx has identified its initial target market for RenovoCath to be approximately $400 million in peak annual U.S. sales, based on the Company’s internal assumptions1. Moreover, expansion opportunities across other clinical indications could create a several billion-dollar total addressable market potential for RenovoCath over time. It’s management’s belief that the Company can achieve meaningful market penetration with a small commercial team targeting the top 200 high-volume treatment centers.

Importantly, there is a current reimbursement code with the Centers for Medicare and Medicaid Services covering procedures utilizing specialty pressure-mediated delivery catheters, which creates incentives for hospitals to adopt more advanced technology, like RenovoCath.

Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial Update

During the fourth quarter 2024, RenovoRx added several additional renowned clinical oncology sites to participate in the TIGeR-PaC study. The initiation of these sites allows for new patient enrollment at the Sarah Cannon Research Institute Oncology Partners in Nashville, TN and at the Northwell Health Cancer Institute Clinical Site in New Hyde Park, NY which are key additions to the number of clinical sites to support RenovoRx’s path to completing patient enrollment for the trial. RenovoRx is continuing to target additional clinical oncology sites, with the expectation that the study will achieve full enrollment during 2025.

The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 28, 2025, 90 patients have been randomized with 50 events having occurred. A second interim analysis will be triggered by the 52nd event.

The timing required to analyze the data after the 52nd event is expected to take several months and includes a full review with recommendations by the TIGeR-PaC Data Monitoring Committee. RenovoRx currently anticipates the 52nd event to occur during the second quarter of 2025. The key recommendation from the Data Monitoring Committee on whether or not to continue the study based on the data reviewed is expected to be announced in the second half of 2025.

Fireside Chat Strategic Update

RenovoRx will host a fireside chat with Shaun Bagai, Chief Executive Officer, on Thursday, April 3, 2025, at 12:00 p.m. ET. During the event, Mr. Bagai will discuss the momentum of RenovoRx’s commercialization efforts for its RenovoCath device, including an update on initial revenues generated, and continued progress on the ongoing Phase III TIGeR-PaC clinical trial. Additionally, one of RenovoCath’s initial customers, Gregory Tiesi, MD, FACS, FSSO, Medical Director of Hepatobiliary Surgery, Division of Surgical Oncology, Hackensack Meridian Jersey Shore University Medical Center, will join Mr. Bagai. He will share his insights on the Trans-Arterial Micro-Perfusion (TAMP) therapy platform and its impact on patient care. Hackensack Meridian Jersey Shore University Medical Center began using the RenovoCath device with oncology patients in December 2024.

Fireside Chat Details:
Date: Thursday, April 3, 2025
Time: 12:00 p.m. ET
Webcast: View Source

A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

On April 1, 2025 Hengrui Pharmaceuticals reported the 5-year long-term follow-up data from the CameL-sq study-a randomized, double-blind, multicenter, phase III trial that evaluated the efficacy and safety of camrelizumab vs. placebo in combination with carboplatin and paclitaxel as first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) with negative driver genes (Press release, Hengrui Pharmaceuticals, APR 1, 2025, View Source;year-survival-of-patients-with-advanced-squamous-lung-cancer—a-potential–paradigm-shift-in-clinical-outcome-for-this-difficult-to-treat-population-302416809.html [SID1234651734]). The results show that the 5-year overall survival (OS) rate for patients treated with camrelizumab plus chemotherapy was 27.8%, indicating that more than one-quarter of the patients survived beyond five years., and a 15.3% improvement over the placebo-chemotherapy group (12.5%). Additionally, camrelizumab significantly reduced the risk of mortality by 43%, enabling more patients to achieve long-term survival.

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The five-year survival rate serves as a critical indicator for assessing potential clinical cure in oncology. China’s Healthy China 2030 initiative has established an ambitious target to increase the overall five-year survival rate for cancer patients by 15%. Epidemiologic data from the National Cancer Center consistently identify lung cancer as the malignancy with the highest incidence and mortality rates across both genders. However, early symptoms of lung cancer are frequently overlooked, resulting in most patients being diagnosed at an advanced stage. In the era dominated by traditional chemotherapy, the five-year survival rate for patients with advanced lung cancer was below 10%. Among histologic subtypes, squamous NSCLC presents unique challenges as it does not benefit from targeted therapies, leading to relatively poor survival outcomes. With the advent of immunotherapy drugs, the prognosis for squamous NSCLC has significantly improved; however, numerous unmet clinical needs remain.

Camrelizumab is a humanized IgG4 monoclonal antibody independently developed by Hengrui Pharmaceuticals. With high binding affinity to PD-1, it has been shown to significantly improve the overall survival of patients with various solid tumors, including lung cancer, liver cancer, esophageal cancer, and nasopharyngeal cancer. At the 2024 ELCC, the long-term follow-up data from the CameL study were presented, highlighting the efficacy of camrelizumab in combination with chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer. The findings revealed that approximately one-third of the patients achieved a survival duration exceeding five years.

The significant clinical benefits of camrelizumab plus chemotherapy as demonstrated by the CameL-sq study ( an increase of 15.3% in the five year survival rate compared to the control group), represent a meaningful advancement toward the goals outlined in the Healthy China 2030 blueprint for cancer prevention and control. This breakthrough represents another significant contribution from Hengrui Pharmaceuticals, a leading innovator in China’s pharmaceutical sector, to prolong and improve the lives of cancer patients worldwide.