On January 29, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) reported an amendment to their collaboration agreement and a separate equity investment by Gilead of $320 million in Arcus common stock at $21.00 per share (Press release, Gilead Sciences, JAN 29, 2024, View Source [SID1234639688]). The equity investment and collaboration amendment enable accelerated growth of the companies’ joint development programs that span multiple indications. Additionally, Johanna Mercier, Chief Commercial Officer at Gilead Sciences, will join the Arcus Board, bringing Gilead’s total director designees to three. The amendment also includes governance enhancements enabling streamlined decision-making and reflecting the continued growth of the collaboration.

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"This amendment allows Gilead to accelerate the domvanalimab program and enables Arcus to focus on progressing multiple pipeline assets, including both Gilead-optioned and non-optioned programs," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "We look forward to strengthening our collaboration as we explore the collective power of our cross-portfolio combinations to help transform how cancer is treated."

Gilead and Arcus have reprioritized the joint domvanalimab development program to focus on advancing and potentially accelerating the Phase 3 studies STAR-121 (lung cancer) and STAR-221 (gastrointestinal cancer), which are both expected to be fully enrolled by year-end. This prioritization focuses on domvanalimab-containing regimen research in areas where it may have significant impact in combination with chemotherapy and in settings with high unmet need through all-comer study designs. The companies also plan to initiate STAR-131, a new registrational Phase 3 lung cancer study that includes the domvanalimab plus zimberelimab regimen. This prioritization reflects the companies’ continued conviction in the TIGIT pathway and the Fc-silent design of domvanalimab, which has the potential for differentiation in both efficacy and safety.

"Since the inception of our partnership with Gilead in 2020, the companies have moved increasingly closer in all aspects of our research and development efforts," said Terry Rosen, PhD, Chief Executive Officer, Arcus. "This investment and prioritization enable both companies to leverage their respective strengths and focus on efficiently advancing novel combinations that have the potential to change the landscape of cancer treatment. The additional investment by Gilead, which extends our cash runway into 2027, will enable us to fund our Phase 3 studies of quemliclustat in pancreatic cancer and AB521 in kidney cancer, as well as to begin preparation for our first potential product approvals."

Additional changes during this prioritization will include discontinuing further enrollment in the Phase 3 ARC-10 study evaluating domvanalimab plus zimberelimab compared to pembrolizumab monotherapy in first-line locally advanced or metastatic, PD-L1-high NSCLC. The discontinuation of the ARC-10 study is based on strategic prioritization to advance and potentially accelerate the Phase 3 studies STAR-121 and STAR-221, which have the potential to address a higher unmet need for patients with lung and gastrointestinal cancers.

Gilead and Arcus are grateful to the patients and investigators who have made the choice to participate in ARC-10, which will continue to generate data and insights that will be shared at future scientific conferences. Patients currently enrolled in ARC-10, or who consented prior to January 29, 2024, and choose to enroll in the study, may continue their treatment and be monitored according to the study protocol. No changes to the safety and efficacy profile of domvanalimab and zimberelimab have been observed.

Also, under the terms of the amended collaboration agreement, the planned Phase 3 first-line study in pancreatic cancer evaluating the investigational small molecule CD73 inhibitor quemliclustat will become an Arcus independent study.

Domvanalimab, zimberelimab and quemliclustat are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use of these molecules, and their safety and efficacy for the treatment of lung, gastrointestinal and pancreatic cancers have not been established.

About Domvanalimab

Domvanalimab is the first Fc-silent investigational monoclonal antibody in pivotal trials which was designed to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a protein on immune cells that acts as a brake on the immune response. Cancer cells can exploit TIGIT to avoid detection by the immune system. By binding to TIGIT, domvanalimab is designed to free up immune activating pathways and activate immune cells to attack and kill cancer cells. Domvanalimab has demonstrated complete target coverage on all TIGIT-expressing immune cells in the blood of patients.

Domvanalimab is being evaluated in three registrational Phase 3 studies across lung and gastrointestinal cancers, including: (1) STAR-121, evaluating domvanalimab plus zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy in first-line all-comer NSCLC regardless of PD-L1 expression levels; (2) STAR-221, evaluating domvanalimab plus zimberelimab and chemotherapy versus nivolumab plus chemotherapy in first-line locally advanced, unresectable or metastatic gastric, esophageal and gastro-esophageal junction adenocarcinomas; and (3) PACIFIC-8, being operationalized by AstraZeneca, evaluating domvanalimab plus durvalumab in unresectable Stage 3 NSCLC.

About Zimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. As a differentiated next-generation, fully human antibody, zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types.

Guangzhou Gloria Biosciences Co. Ltd., who holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab as the first and only anti-PD-1 antibody to treat recurrent or metastatic cervical cancer (September 2023). Additionally, in China, zimberelimab is approved to treat relapsed or refractory classical Hodgkin’s lymphoma (August 2021). Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead.

On January 29, 2024 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported key 2024 strategic priorities and upcoming catalysts to support advancement of its clinical programs in RAS pathway-driven cancers (Press release, Verastem, JAN 29, 2024, View Source [SID1234639687]).

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"We have made significant progress in our commitment to advancing new solutions for RAS pathway-driven cancers and look forward to an exciting and catalyst-filled year ahead. With plans to submit an NDA for Accelerated Approval for the combination of avutometinib and defactinib in recurrent low-grade serous ovarian cancer in the first half of this year, we are working rapidly to bring forward the first potential therapy approved by the U.S. Food and Drug Administration for patients with LGSOC in need of better treatment options," said Dan Paterson, President and Chief Executive Officer of Verastem Oncology. "Further, we plan to provide data read-outs with avutometinib and defactinib combinations in KRAS G12C-mutant non-small cell lung cancer and frontline metastatic pancreatic cancer, as well as supporting our collaborator GenFleet in advancing oral KRAS G12D inhibitor GFH375/VS-7375 into a Phase 1 clinical trial this year."

2023 and Recent Accomplishments

· Presented interim results from the Phase 1/2 RAMP 201 trial of avutometinib and defactinib in LGSOC, including an objective response rate (ORR) of 45% (13/29) and disease control in 86% (25/29) of evaluable patients. Safety and tolerability continued to be favorable and consistent with previously reported data.
· Finalized design with the FDA and initiated confirmatory Phase 3 RAMP 301 trial to evaluate the efficacy and safety of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent LGSOC.
· Launched patient and healthcare professional initiatives, including Let’s Talk About LGSOC , designed to support clinicians in the diagnosis and management of LGSOC and to provide information, resources and support to patients. Engaged with more than 25% of the recurrent LGSOC patient population.
· Presented initial results from Phase 1/2 RAMP 203 trial evaluating the efficacy and safety of avutometinib and sotorasib in patients with KRAS G12C-mutant non-small cell lung cancer (NSCLC) who have or have not been previously treated with a KRAS G12C inhibitor. The confirmed ORR was 25% (3/12) across efficacy-evaluable patients and responses observed in both KRAS G12C inhibitor resistant (14.3%; 1/7) and naïve (40%; 2/5) patients. Avutometinib 4.0 mg by mouth biweekly (BIW) 21/28 days and sotorasib 960 mg by mouth once-daily (QD) 28/28 days was selected as the recommended Phase 2 dose based on dose limiting toxicity assessment.
· Received Fast Track designation from the FDA for avutometinib, in combination with Amgen’s G12C inhibitor, LUMAKRAS (sotorasib), for the treatment of patients with KRAS G12C-mutant metastatic NSCLC who have received at least one prior systemic therapy and have not been previously treated with a KRAS G12C inhibitor.
· Entered into a discovery and development collaboration with GenFleet Therapeutics ("GenFleet") to advance three oncology discovery programs targeting RAS pathway-driven cancers. Completed investigational new drug (IND)-enabling GLP toxicology studies for oral KRAS G12D inhibitor GFH375/VS-7375, selected as lead program.

Strategic Priorities and Anticipated 2024 Milestones and Catalysts

LGSOC Program

· Begin submission of an NDA to the FDA for Accelerated Approval for the combination of avutometinib and defactinib in recurrent LGSOC in H1 2024; prepare for potential commercial launch in 2025.
· Present full data from Part A and Part B of RAMP 201 trial in LGSOC at a scientific medical conference in H1 2024.
· Initiate discussions with European and Japanese regulatory authorities for the avutometinib and defactinib regimen in LGSOC to address patient needs outside the U.S.

KRAS G12C-Mutant NSCLC Program

· Based on stronger tumor regressions in KRAS G12C-mutant NSCLC preclinical models when FAKi is added along with G12Ci + avutometinib, add defactinib to the RAMP 203 trial of avutometinib with sotorasib.

· Data updates from RAMP 203 and RAMP 204 trials planned for mid-2024.

Frontline Metastatic Pancreatic Cancer Program

· Present initial safety and efficacy results from RAMP 205 trial of avutometinib and defactinib in combination with standard of care gemcitabine and nab-paclitaxel in frontline metastatic pancreatic cancer in H1 2024.

GenFleet Collaboration

· GenFleet expected to submit an IND for GFH375/VS-7375 in China for patient with KRAS G12D mutations in H1 2024 and begin a Phase 1 trial for GFH375/VS-7375 in China in H2 2024.
· Companies to continue discovery/lead optimization for second and third programs.

About the Avutometinib and Defactinib Combination

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. In contrast to currently available MEK inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent LGSOC regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is currently conducting clinical trials with its RAF/MEK clamp avutometinib in RAS pathway-driven tumors as part of its (Raf And Mek Program). RAMP 301 is a Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent LGSOC. RAMP 201 is a Phase 2 registration-directed trial of avutometinib in combination with defactinib in patients with recurrent LGSOC and has completed enrollment in the dose optimization and expansion phases and is enrolling for low-dose evaluation. Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively. Supported by the "Therapeutic Accelerator Award" Verastem Oncology received from PanCAN, the Company is conducting RAMP 205, a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer.

On January 29, 2024 Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, reported that its sponsor client, CellVax Therapeutics Inc., received clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for FK-PC101 (Press release, Theragent, JAN 29, 2024, https://theragent.com/cellvax-therapeutics-announces-fda-clearance-of-ind-application-for-fk-pc101-a-novel-personalized-cancer-immunotherapy/ [SID1234639686]). Patient recruitment for the randomized Phase II trial will begin in March of 2024, with first patient treatments expected in Q2 2024.

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FK-PC101 is CellVax’s novel personalized cancer immunotherapy intended to treat prostate cancer patients who have a high risk of recurrence after prostatectomy. It consists of patient’s own tumor cells which are collected during surgery, then modified in the laboratory. The modified cells express Major Histocompatibility Complex (MHC) Class II on their surface, which are then irradiated to make them replication incompetent and delivered as an individualized immunotherapy. Fernando Kreutz, CEO at CellVax, stated, "We are thrilled to receive FDA clearance of our FK-PC101 IND. We have worked diligently throughout the pre-IND and IND process with our reliable partner Theragent, as well as our other consultants, who have brought process development expertise, regulatory know-how, and alignment with our core values. As CellVax reaches this important milestone, it represents over 20 years of work from discovery to clinical development, creating a new class of therapy for the most in-need patients."

The trial, CELLVX-230, is a randomized, multicenter, open-label study of irradiated autologous cellular vaccine in men with high-risk prostate cancer post-radical prostatectomy. It will be conducted through a partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), with Scott Eggener, MD (University of Chicago) as Principal Investigator. Patient recruitment will begin in March 2024, with a goal of up to 230 participants sourced from 21 pre-selected sites across the US. Theragent will be responsible for end-to-end manufacturing, release, and disposition of all clinical material out of its purpose-built, state-of-the-art CGMP cell therapy manufacturing facility in Arcadia, CA. "We are tremendously excited to partner with CellVax on this clinical trial. Theragent was founded specifically for this purpose – to bring paradigm-changing treatments to patients in need," said Dr. Yun Yen, President and CEO of Theragent.

Despite recent improvements in radiation, surgeries, and other therapies, up to 30% of patients may still experience recurrent prostate cancer after prostatectomy. After recurrence, the current standard of care is salvage radiotherapy and/or androgen deprivation therapy (ADT). FK-PC101 could delay the necessity for such treatments, if not prevent it entirely. The primary clinical endpoint for CELLVX-230 will be disease free survival (DFS), with the secondary endpoint being increased time to next treatment (TTNT).

CellVax has high ambitions for FK-PC101 as the company gears up for the Phase II clinical trial. Looking forward, CellVax’s corporate strategy has been specifically designed to ensure treatment accessibility. "We have thoughtfully assembled a disruptive corporate structure that could translate into a cost-effective cancer treatment for thousands of patients in the future," says Emerson von der Goltz, CellVax’s Chief Financial Officer.

On January 29, 2024 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, reported that it has closed a private placement (the "private placement" or the "financing") resulting in gross proceeds of approximately $6.1 million, before deducting offering expenses (Press release, Renovorx, JAN 29, 2024, View Source [SID1234639685]).

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The closing of this private placement extends RenovoRx’s cash runway as RenovoRx continues its ongoing pivotal TIGeR-PaC Phase III clinical trial, with a second interim analysis for this study to occur at the 52nd event (death), which is expected in late 2024.

RenovoRx insiders, including members of the management team and Board of Directors, participated in the private placement. Through the execution of this financing, RenovoRx sold an aggregate of 6,133,414 shares of common stock and warrants exercisable for up to an aggregate of 6,133,414 shares of common stock. Investors who are not insiders of RenovoRx paid $0.99 per share for the common stock and associated warrants, but RenovoRx’s management team and directors purchased shares and warrants at the market price for Nasdaq Stock Market purposes at $1.22 per share and associated warrant, reflecting their strong belief in the Company. The warrants are exercisable at a price equal to the per share price paid by the applicable investor and are exercisable for a period of five years following the closing of the private placement.

Shaun Bagai, CEO of RenovoRx, stated, "We are thrilled to start the new year with the closing of this important financing, especially in a challenging market climate. The net proceeds bolster our balance sheet and will allow us to drive our pivotal trial towards what we hope will be another positive interim analysis by the end of this year. We are particularly grateful for the participation in this financing from members of our board and management team as well as existing and new investors. With the net proceeds of this financing, in alignment with our consistent focus on efficient use of capital, we anticipate that we will be able to fund our operations through late 2024, even as we continue to explore additional capital raising opportunities. We are at a critical inflection point, and our efforts are laser focused on advancing multiple late-stage programs, reaching clinical milestones, and helping cancer patients live a longer, fuller life."

"Last year, I joined RenovoRx’s Board as a Director," said Dr. Robert J. Spiegel. "I have now chosen to join as an investor in this private placement financing. RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) platform has the possibility to extend across a variety of high unmet needs by expanding our pipeline into other difficult-to-treat solid tumor cancers with additional therapeutics."

The first interim analysis in RenovoRx’s pivotal Phase III TIGeR-PaC clinical trial at the 26th specified event, was completed in March 2023, and the Data Monitoring Committee (DMC) recommended a continuation of the study. The second interim analysis will occur at the 52nd of the specified events. The 52nd event is estimated to occur in late 2024. TIGeR-PaC is an ongoing randomized multi-center study in locally advanced pancreatic cancer (LAPC) using RenovoRx’s proprietary TAMP therapy platform to evaluate its first product candidate, RenovoGemTM, a novel oncology drug-device combination product. The study is comparing treatment with TAMP to the current standard of care of systemic intravenous chemotherapy.

The TIGeR-PaC study is prespecified to provide a primary endpoint of a 6-month Overall Survival benefit and secondary endpoints including reduced side effects versus standard of care. Interim analysis data was presented at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and as a Late Breaker Oral Presentation at the 2023 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer.

The financing will also allow RenovoRx to begin to engage additional clinical trial sites in preparation for the Company’s Phase III CouGar study in bile duct cancer, which is the second late-stage clinical trial to evaluate RenovoGem in a difficult-to-access solid tumor cancer. RenovoRx has also identified other potential pipeline indication opportunities in non-small cell lung cancer, uterine tumors, glioblastoma, and sarcoma. The Company will require additional funding to fully pursue these opportunities.

Paulson Investment Company, LLC acted as the exclusive placement agent in connection with this financing.

"We are excited to assist RenovoRx in securing funding with Paulson’s high-net-worth clients for the Phase III study on its TAMP therapy for LAPC treatment," said Marta Wypych, Head of Investment Banking at Paulson Investment Company. "By doing so, we aim to facilitate the Company’s journey towards FDA approval, bringing forth this innovative combination therapy to the market for the well-being of pancreatic cancer patients."

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On January 29, 2024 PharmaMar (MSE:PHM) reported that it has presented at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers symposium that has been held from the 25th to 27th of January in San Francisco, USA, two abstracts with Zepzelca (lurbinectedin) in Prostatic Small Cell and Neuroendocrine Carcinoma (SC/NEPC), and Metastatic Neuroendocrine Carcinomas of the genitourinary tract (Press release, PharmaMar, JAN 29, 2024, View Source [SID1234639684]).

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The poster presented by Dr. Haley M. Meyer et al., from Mayo Clinic Arizona is titled "Lurbinectedin in Prostatic Small Cell and Neuroendocrine Carcinoma". SC/NEPC is a high-grade, invasive malignancy that is distinct to Prostatic Adenocarcinoma and behaves similarly to Small Cell Lung Cancer (SCLC), and treatments in second-line and beyond are major clinical challenges. This study was carried out in four academic centers of eighteen highly pretreated metastatic patients with a median number of four prior systemic therapies administered before lurbinectedin. Clinical Benefit Rate was found in 56.3%, with Partial Response in 5 of 16 patients, 31%. The study concluded that lurbinectedin is a well-tolerated and active treatment option for patients with SC/NEPC.

Dr. Alan H. Bryce, M.D., C.P.E., Chief Clinical Officer of City of Hope Cancer Center, Phoenix, commented "the Partial Response rate of 31% and Stable Disease in an additional 25% is quite promising in this highly refractory disease population". Dr. Mohammad Jad Moussa from The University of Texas, MD Anderson Cancer Center, Houston, Texas, presented the poster "Clinical efficacy of lurbinectedin in Metastatic Neuroendocrine Carcinomas of the genitourinary tract: Multi-institutional real-world experience." Neuroendocrine Carcinomas (NEC) of the genitourinary (GU) tract, including Small Cell (SC) metastasic NEC (mNEC) and Large Cell (LC) NEC, are rare aggressive malignancies. The investigator reports the first multi-institutional data with fourteen patients treated with lurbinectedin in GU mNEC with encouraging responses close to those seen in SCLC, in previously treated bladder mNEC. Larger cohorts are needed to confirm the survival benefit and genetic analyses are warranted to identify characteristics of responders; the author concludes.

Highlighted studies at ASCO (Free ASCO Whitepaper) Gu 2024

PRODUCT TITLE LEAD AUTHOR ABSTRACT
Zepzelca (lurbinectedin) Lurbinectedin in Prostatic Small Cell and Neuroendocrine Carcinoma Haley M. Meyer ABSTRACT: 164 SESSION TYPE: Prostate Cancer POSTER: G14 DATE: January 25, 2024 11:30 – 13 :00 GMT-8
Clinical efficacy of lurbinectedin in Metastatic Neuroendocrine Carcinomas of the genitourinary tract: Multi-institutional real-world experience. Mohammad Jad Moussa Cousin ABSTRACT: 601 SESSION TYPE: Urothelial Carcinoma POSTER: G7 DATE: January 26, 2024 11:30 – 13:00 GMT-8