On August 17, 2023 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported the publication of a peer-reviewed research paper in Science (Press release, Revolution Medicines, AUG 17, 2023, View Source [SID1234634484]). This original research was led by scientists at Revolution Medicines and conducted in collaboration with researchers from Memorial Sloan Kettering Cancer Center.

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The paper describes the Revolution Medicines tri-complex inhibitor approach to developing novel small molecules with high affinity and selectivity for the active state of mutant RAS, or RAS(ON), proteins that are common causes of human cancer and were previously considered undruggable. Specifically, it describes the creation of innovative, natural product-inspired, orally bioavailable small molecules, including the tool compound RMC-4998 and the clinical candidate RMC-6291. These compounds are shown to remodel the surface of the cellular chaperone cyclophilin A (CYPA) to create a neomorphic interface with affinity for active KRAS and achieve high selectivity for mutant KRASG12C via covalent, irreversible binding to the cysteine residue in the active state of this variant RAS protein that often drives formation of lung and colorectal cancers. KRASG12C(ON) trapped in these tri-complexes is sterically blocked from interacting with downstream effectors that transmit cancer-causing signals. Both RMC-4998 and RMC-6291 inactivate oncogenic signaling in KRASG12C-dependent tumor cells and drive deep and durable tumor regressions in human xenograft models of these cancers.

"This research serves as preclinical validation of our tri-complex RAS(ON) inhibitor platform and confirms our ability to design potent, selective small molecules that target KRAS mutations in their active or ON state," said Steve Kelsey, M.D., president, research and development at Revolution Medicines. "These data provide the rationale for the RMC-6291 clinical program, our first mutant-selective RAS(ON) inhibitor to enter clinical development, which is currently underway. We look forward to sharing a preliminary report of the clinical profile for RMC-6291 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Triple Meeting) in October 2023."

The investigational agent RMC-6291, an oral, selective, covalent inhibitor of KRASG12C(ON) designed to treat patients with cancers driven by the KRASG12C variant, is the first of the company’s mutant-selective RAS(ON) inhibitors to enter clinical development and the first reported clinical-stage inhibitor of KRASG12C that uses this highly differentiated mechanism of action. Revolution Medicines is currently evaluating RMC-6291 as monotherapy in a Phase 1/1b trial in patients with advanced KRASG12C mutant solid tumors (NCT05462717).

The manuscript published In Science is entitled, "Chemical remodeling of a cellular chaperone to target the active state of mutant KRAS" and can be accessed at View Source

On August 17, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, reported financial results for the second quarter ended June 30, 2023 (Press release, Renovorx, AUG 17, 2023, View Source [SID1234634483]).

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"We made strong progress this quarter and have continued momentum in our commitment to transform the lives of patients by delivering innovative solutions to change the current paradigm of cancer care," said Shaun Bagai, CEO of RenovoRx. "This quarter marked significant milestones including positive interim data presented from our pivotal Phase III TIGeR-PaC study, a strategic collaboration to potentially utilize immunotherapy to expand our platform to help metastatic patients, and key additions to our leadership team, Board of Directors and Scientific Advisory Board. We are also excited for the upcoming year, when we expect our secondary interim analysis data readout."

Key Business Highlights:

● • Presented positive Phase III data demonstrating RenovoGem delays cancer progression by 8-months, while providing a 6-month overall survival benefit and 65% reduction in adverse effects over standard of care in locally advanced pancreatic cancer patients, at 2023 ESMO (Free ESMO Whitepaper) World Congress in Gastrointestinal Cancer and American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
● Initiated patient enrollment at the University of Texas Southwestern Medical Center for pivotal Phase III TIGeR-PaC clinical trial.
● • Launched collaboration with Imugene Ltd (ASX: IMU) to explore a better way to deliver oncolytic immunotherapy in difficult to access to tumors, such as metastatic pancreatic cancer, using RenovoRx’s proprietary TAMP therapy platform. This collaboration potentially expands the market for the TAMP platform beyond locally advanced to metastatic pancreatic cancer.
● Appointed Margaret A. Tempero, M.D., Director, UCSF Pancreas Center and Leader of the UCSF Pancreas Cancer Program, to the Company’s Scientific Advisory Board (SAB).
● Appointed Robert J. Spiegel, MD to the Company’s Board of Directors. Dr. Spiegel is former Chief Medical Officer of Schering-Plough ($41B merger with Merck MSD). His experience includes involvement involved in more than 30 successful New Drug Application (NDA) approvals by the FDA and the development and launch of multiple products with annual sales exceeding $1B.
● Appointed Leesa Gentry as Senior Vice President of Clinical Operations to lead RenovoRx’s expansive clinical programs. Ms. Gentry is an industry expert in clinical trials management with prior senior leadership experience at Evotec, PPD, Quintiles and Otsuka America Pharmaceutical.
● Closed a registered direct offering and a concurrent private placement for aggregate gross proceeds of $5 million.

Second Quarter 2023 Financial Results:

● Cash Position: Cash and cash equivalents as of June 30, 2023, were $6.0 million.
● R&D Expenses: Research and development expenses were $1.9 million for the quarter ended June 30, 2023, compared to $1.4 million for the quarter ended June 30, 2022. The increase was primarily due to our ongoing Phase III clinical trial costs and an increase in employee and related benefits costs. This increase was partially offset by a decrease in costs associated with a secondary manufacturer.
● G&A Expenses: General and administrative expenses were $1.4 million for the second quarter ended June 30, 2023, compared to $1.2 million for the quarter ended June 30, 2022. This increase was primarily due to higher employee and related benefits costs due to an increased in headcount. This increase was partially offset by a decrease in professional and consulting fees compared to the same period last year.
● Net Loss: Net loss was $2.3 million for the quarter ended June 30, 2023, compared to net loss of $2.6 million for the quarter ended June 30, 2022.
● Shares Outstanding: Shares of common stock outstanding, as of June 30, 2023, were 10,693,080.

On August 17, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies (Press release, Regeneron, AUG 17, 2023, View Source [SID1234634482]). The EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

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FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL is a slow-growing subtype, with patients often relapsing within five years. DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment (e.g., relapsing or refractory to treatment). As these blood cancers progress, they become increasingly hard to treat, especially in the third-line setting and beyond, leaving patients with few treatment options.

The MAA is supported by data from a Phase 1 and pivotal Phase 2 trial (ELM-1 and ELM-2) investigating odronextamab in FL and DLBCL, which were last presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

Regeneron is conducting a broad Phase 3 development program to further investigate odronextamab in earlier lines of therapy and additional B-NHLs, representing one of the largest clinical programs in lymphoma. Odronextamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

About the Odronextamab Trials
ELM-2 is an ongoing, open-label, multicenter Phase 2 trial investigating odronextamab in more than 500 patients across five independent disease-specific cohorts, including DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-NHL. The primary endpoint is objective response rate according to the Lugano Classification, and secondary endpoints include complete response, progression-free survival, overall survival, duration of response, disease control rate, safety and quality of life.

ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to investigate the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy.

On August 17, 2023 Processa pharmaceuticals presented its corporate presentation (Presentation, Processa Pharmaceuticals, AUG 17, 2023, View Source [SID1234634481]).

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On August 17, 2023 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company focused on novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases and cancer, reported that the Company has achieved an undisclosed milestone payment from Boston Pharmaceuticals (Press release, Pieris Pharmaceuticals, AUG 17, 2023, View Source [SID1234634480]). The milestone is based on dosing the first patient in a Boston Pharmaceutical-sponsored phase 1/2 study of BOS-342 (formerly PRS-342), a 4-1BB/GPC3 immuno-oncology antibody-Anticalin fusion (Mabcalin) bispecific protein, which was discovered by Pieris and licensed to Boston Pharmaceuticals and designed to provide a potent costimulatory bridge to exert tumor killing activity through the recruitment of T-cells.

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The open-label phase 1/2 study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BOS-342. The Phase 1 dose escalation portion of the study is expected to enroll adults with hepatocellular carcinoma (HCC) that progressed on at least one prior treatment and establish a recommended Phase 2 dose. If pursued, the Phase 2 portion of the study will evaluate efficacy, as measured by overall response rate.

The study is funded and conducted by Boston Pharmaceuticals, who exclusively licensed worldwide rights to BOS-342 in April 2021. In addition to the milestone announced today, Pieris could potentially be entitled to receive up to approximately $350 million in development, regulatory and sales-based milestone payments, and tiered royalties on sales of BOS-342.

"We are delighted with Boston Pharmaceuticals’ commitment to BOS-342, now having initiated clinical development of yet another promising 4-1BB bispecific Mabcalin program originating from our platform and representing the fourth 4-1BB-targeted therapy that has entered clinical stage development," said Stephen S. Yoder, President and CEO of Pieris. "4-1BB is a highly promising target for cancer immunotherapy, and our multiple partnerships in this area validate the potential that 4-1BB-based bispecific therapies may play in advancing cancer therapeutics."

"Dosing of the first patient with BOS-342 represents an important milestone for the BOS-342 program and, more importantly, for patients with HCC, many of whom often do not achieve durable benefit from current available treatment regimens," said Sophie Kornowski, CEO of Boston Pharmaceuticals. "Preclinical data strongly support our belief that BOS-342 has the potential to address a significant unmet need as a treatment for patients with GPC3+ HCC."