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."

On August 17, 2023 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported that NXP800 was granted Orphan Drug Designation by the United States Food and Drug Administration ("FDA") for the treatment of cholangiocarcinoma (Press release, Nuvectis Pharma, AUG 17, 2023, View Source [SID1234634478]).

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "We are pleased to have received this designation from the FDA for NXP800, which emphasizes the need for new, innovative therapies for the treatment of cholangiocarcinoma, a deadly malignancy with only limited treatment options available. NXP800 is an oral small molecule with a novel mechanism of action that has demonstrated robust activity in several preclinical cancer models, including ARID1a-mutated ovarian, endometrial and gastric carcinomas, as well as cholangiocarcinoma. The clinical activity of NXP800 is currently being evaluated in a Phase 1b clinical trial in patients with ARID1a-mutated ovarian carcinoma, with additional diseases planned for clinical investigations. This orphan drug designation is an important milestone in our journey toward our mission of developing NXP800 for the treatment of serious conditions of unmet medical need in oncology."

About Orphan Drug Designation

Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Orphan Drug Designation provides certain financial incentives to support clinical development, and the potential for up to seven years of marketing exclusivity for the product for the designated orphan indication in the United States if the product is approved for its designated indication.

About Cholangiocarcinoma

Cholangiocarcinoma is a cancer of the biliary tract originating in the epithelium of the biliary tree accounting for approximately 3% of all gastrointestinal malignancies, with an annual incidence of approximately 8,000 – 10,000 in the United States. Surgical resection is the only potentially curative treatment for cholangiocarcinoma, but the disease is often diagnosed as unresectable because of local extension and/or metastases. While several targeted therapies have been approved in recent years for subsets of patients with cholangiocarcinoma based on specific tumor genetics, the overall prognosis remains poor with 5-year survival rates of 20-50% after resection and almost 0% in unresectable tumors.