On July 6, 2022 Pyramid Biosciences, Inc., a clinical-stage biotechnology company developing a portfolio of precision therapies targeting a range of serious diseases, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for PBI-200, a next-generation, highly brain penetrant inhibitor of the neurotrophic tyrosine receptor kinase (NTRK) currently in clinical development for the treatment of NTRK fusion-positive solid tumors (Press release, Pyramid Biosciences, JUL 6, 2022, View Source [SID1234616516]).

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"Oncogenic NTRK gene fusions are found in a broad range of cancers," said Pyramid Biosciences CEO Brian Lestini, MD, PhD. "Orphan designation for drugs in development such as PBI-200 are important to ensure continued innovation to address unmet needs for these patients, including primary and metastatic brain tumors."

"We are extremely pleased that the orphan designation was granted, and we look forward to continued enrollment in our global Phase 1/2 clinical trial of PBI-200," said Pyramid Biosciences co-founder and COO Jordan Leef.

The FDA’s Office of Orphan Drug Products grants orphan drug designation to support the development of medicines for underserved patient populations or rare disorders, that affect fewer than 200,000 people in the United States.

About PBI-200

PBI-200 is an oral, highly potent, and selective inhibitor of TRK kinase that is currently in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases. In some patients, the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. PBI-200 was discovered and developed by Pyramid Biosciences to overcome a wide range of on-target resistance mutations that have been described with first-generation TRK inhibitors. In addition, preclinical studies have shown that PBI-200 achieves high levels of penetration into brain, which translated into superior efficacy in intracranial xenograft models compared to other TRK inhibitors, as well as a favorable safety profile.

The global Phase 1/2 trial of PBI-200 (PBI-200-101) is a multicenter, open-label study in subjects with NTRK fusion-positive advanced or metastatic tumors including primary and metastatic CNS tumors. The trial consists of a dose-escalation phase, followed by a multicohort expansion at the recommended Phase 2 dose. Additional information can be found at: View Source (NCT04901806).

On July 6, 2022 Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus") reported that the United States Food and Drug Administration ("FDA") has accepted for review the Biologics License Application ("BLA") resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma ("NPC") and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy (Press release, Shanghai Junshi Bioscience, JUL 6, 2022, View Source [SID1234616501]).

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The FDA has set a Prescription Drug User Fee Act ("PDUFA") action date for December 23, 2022. The Agency earlier communicated that the review timeline for the BLA resubmission would be six months, as onsite inspections in China would be required. Travel restrictions related to the COVID-19 pandemic previously hindered the FDA’s ability to complete required inspections. Coherus plans to launch toripalimab in the United States in the first quarter of 2023, if approved.

"Although the COVID-19 pandemic has created tremendous challenges for everyone, our dedication to bring better treatment options to patients around the world remains steadfast," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "Through our concerted efforts with our partner, Coherus, we have made continual progress towards obtaining toripalimab’s first marketing authorization outside of China. Over the next several months, we will work closely with the FDA to facilitate the review of this novel drug."

"Toripalimab would address a critical unmet medical need for patients with nasopharyngeal carcinoma, an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments. We collaborated closely with our partner, Junshi Biosciences, to complete the quality process changes requested by the FDA and facilitate the rapid resubmission of the toripalimab BLA," said Dr. Theresa LaVallee, Chief Development Officer of Coherus.

"For Coherus, the toripalimab resubmission is one of several key development and commercialization milestones we are sharply focusing on over the next twelve months, and we are pleased with the Company’s execution and progress on all of them," said Denny Lanfear, CEO of Coherus. "We now look forward to the August 2, 2022 target action date for our BLA for CIMERLI, our Lucentis biosimilar, followed by product launch which we are confident will be very successful. The toripalimab December 2022 PDUFA date follows directly, and the projected toripalimab launch in Q1 2023 will formally mark our entry into immuno-oncology, where Coherus will be one of just a handful of companies with a proprietary PD-1 as a foundation stone to build its oncology franchise upon. Lastly, twelve months from now, in July 2023, we expect to begin marketing our Humira biosimilar, YUSIMRY, which was approved by the FDA in December 2021. Preparations for that commercial launch are going very well. Biosimilar market execution is a demonstrated Coherus competency, and we believe that our commercialization strategy provides a robust framework against which we can successfully execute to meet our market expectations and share projections."

Following approval of toripalimab for NPC, Coherus’ strategy in the US includes evaluating toripalimab’s ability to deliver substantial clinical benefit in significant indications, in combination with other cancer drugs and immunotherapies, through co-development agreements.

About Toripalimab in NPC
NPC is a type of aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. In the United States, there are presently no immunotherapies approved for the treatment of NPC.

The toripalimab BLA is supported by the results from JUPITER-02, a randomized, double blind, placebo-controlled, international multi-center Phase 3 clinical trial, as well as POLARIS-02, a multi-center, open-label, pivotal Phase 2 clinical study. The JUPITER-02 results were first presented in June 2021 in a plenary session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") annual meeting (#LBA2) and subsequently published in detail as the cover article of the September 2021 issue of Nature Medicine. The POLARIS-02 results were published online in January 2021 in the Journal of Clinical Oncology.

The FDA has granted Breakthrough Therapy designation ("BTD") for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the 1st line treatment of recurrent, locally advanced or primary metastatic non-keratinizing NPC and for toripalimab monotherapy for patients with recurrent or metastatic non-keratinizing NPC with disease progression on or after platinum-containing chemotherapy. Additionally, the FDA has granted Orphan Drug designation for toripalimab for NPC.

In China, the National Medical Products Administration ("NMPA") in 2021 approved toripalimab for two NPC indications.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are five approved indications for toripalimab in China.

On July 6, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported that the Phase 2 study of praluzatamab ravtansine in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 (HER2)-non-amplified breast cancer (Arm A) met its primary efficacy endpoint of confirmed objective response rate (ORR) of greater than 10 percent by central radiology review (Press release, CytomX Therapeutics, JUL 6, 2022, View Source [SID1234616502]). Praluzatamab ravtansine is a DM4-conjugated, conditionally activated antibody-drug conjugate (ADC) targeting CD166 and is wholly owned by CytomX.

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As of the data cutoff on May 13, 2022, 47 patients unselected for CD166 expression with advanced HR+/HER2-non-amplified breast cancer were evaluable for the primary efficacy endpoint. The ORR by central radiology review was 15 percent. Clinical benefit rate at 24 weeks by investigator (CBR24), as defined in the protocol as any response (confirmed or unconfirmed) or stable disease for 24 weeks, was 40 percent; median progression-free survival was 2.6 months. All patients in Arm A were treated at the initial Phase 2 starting dose of 7 mg/kg administered every three weeks. Arm B did not pass protocol-defined futility boundary (ORR was less than 10%) in patients with advanced triple-negative breast cancer (TNBC) and enrollment into Arms B and C will be discontinued.

As of this data cut, the safety profile of praluzatamab ravtansine in Arm A was generally consistent with toxicities observed in Phase 1 and with the DM4 payload; namely, high-grade toxicities or toxicities resulting in dose modifications were predominantly ocular or neuropathic in nature. Thirty percent of patients discontinued treatment for an adverse event (AE). Grade 3+ ocular and neuropathic toxicities were 15 and 10 percent, respectively. Arm B evaluated both 7 mg/kg and 6 mg/kg in patients with TNBC. The toxicity profile of 7 mg/kg starting dose was consistent with Arm A. In the 6 mg/kg cohort, no patients discontinued treatment for an AE and Grade 3+ ocular or neuropathic related events were lower at 3, and 0 percent, respectively. Biomarker analysis is ongoing. CytomX intends to submit data from this study for presentation at a medical conference in the second half of 2022.

"These results from our Phase 2 evaluation of praluzatamab ravtansine support single-agent activity of this novel drug candidate in hormone receptor-positive breast cancer where significant unmet need remains," said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics. "However, we do not believe the median progression-free survival at 7 mg/kg supports further evaluation at this dose. While we are encouraged by the emerging safety profile of 6 mg/kg, we do not plan to further advance this program alone given current financial market conditions and will be seeking a partnership."

Kathy D. Miller, MD, Ballvé Lantero Professor of Oncology, Indiana University Simon Comprehensive Cancer Center, Indianapolis, Indiana, and lead investigator of the Phase 2 study stated, "In this Phase 2 study, praluzatamab ravtansine showed single-agent activity in an unselected population of patients with advanced HR+/HER2-non-amplified breast cancer; additional clinical studies at 6 mg/kg are warranted."

Conference Call & Webcast
CytomX management will host a conference call and a simultaneous webcast today at 5:00 pm ET (2:00 pm PT) to discuss these results. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. A live webcast of the call can be accessed via the Events and Presentations page of CytomX’s website at View Source

About Praluzatamab Ravtansine
Praluzatamab ravtansine is a conditionally activated antibody-drug conjugate (ADC) comprised of a CD166-directed humanized monoclonal antibody conjugated to the maytansinoid DM4, a tubulin inhibitor. Praluzatamab ravtansine utilizes CytomX Probody platform technology, which incorporates a masking peptide to cover and block the cellular binding region of the antibody. Tethered to the antibody via a protease-cleavable linker, the masking peptide is designed to be removed in a protease-rich tumor microenvironment, enabling the ADC to be unmasked and engage its target to deliver the toxic DM4 payload inside tumor cells. The goal is to have praluzatamab ravtansine remain inert while in circulation to limit binding in healthy tissues until it is activated by tumor-associated proteases. Praluzatamab ravtansine was evaluated in a three-arm Phase 2 study (NCT04596150) in patients with hormone receptor-positive/HER2-non-amplified breast cancer and patients with triple-negative breast cancer.

About the Phase 2 Study of Praluzatamab Ravtansine in Breast Cancer (NCT04596150)
Arm A of the study evaluated praluzatamab ravtansine as monotherapy (7 mg/kg, Q3W) in patients with inoperable, locally advanced or metastatic hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-non-amplified breast cancer. Patients received 0 to 2 prior cytotoxic chemotherapies in the inoperable, locally advanced, or metastatic setting, regardless of the level of CD166 expression.

Arm B assessed praluzatamab ravtansine as a single agent (6 or 7 mg/kg, Q3W) in patients with inoperable, locally advanced or metastatic triple-negative breast cancer (TNBC). Patients received 1 to 3 prior lines of chemotherapy for inoperable, locally advanced, or metastatic disease and had CD166 expression.

Arm C studied praluzatamab ravtansine (6 mg/kg, Q3W) in combination with pacmilimab (1200 mg, Q3W), CytomX’s proprietary conditionally activated anti-PD-L1 antibody, in patients with TNBC. Eligibility was the same as Arm B with the additional requirement that patients’ tumors were programmed death-ligand 1 (PD-L1)-positive by an FDA-approved test.

On July 6, 2022 Elicio Therapeutics, a clinical stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported that it presented preclinical data demonstrating its Amphiphile (AMP) platform adjuvant AMP-CpG combined with cell surface-associated viral protein EBV gp350 and EBVpoly protein, elicits a robust and durable immune response to Epstein-Barr virus (EBV) (Press release, Elicio Therapeutics, JUL 6, 2022, View Source [SID1234616503]). EBV gp350 is expressed on the outside of the virus and on the cells producing the virus, making it a major target for neutralizing antibodies and CD4+ T cells, while EBVpoly protein contains multiple epitopes for CD8+ T cells. The data was presented at the 2022 Keystone Symposia on Viral Immunity Basic Mechanisms and Therapeutic Applications virtually and in-person at the Keystone Resort in Keystone, CO from June 29-July 2, 2022. The electronic poster is accessible here.

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EBV is a herpesvirus responsible for the well-known mononucleosis infections ("mono") and has also been implicated in multiple lymphoid and epithelial cancers. EBV targets both B cells and epithelial cells and utilizes their molecular machinery to replicate the viral genome. The virus causes B cells to differentiate into memory B cells, which then can move into the circulatory system, or become latent until a trigger causes reactivation. Approximately 95%[1] of the adult population worldwide is infected with EBV which persists for the life of the individual, however, there is currently no approved vaccine.

"Vaccines against EBV have historically been difficult to develop because of the associated viral latency, persistence and immune modulation properties which enable it to evade effective antibody targeting," said Lisa McNeil, Ph.D., Head of Translational Medicine at Elicio Therapeutics. "These data reinforce what we’ve seen in previous studies with our AMP platform, demonstrating the potent and durable immune responses elicited by delivering a therapeutic payload direct to the lymph nodes, the control center of the immune system. By targeting the most abundant glycoprotein expressed on the virus with the AMP-CpG adjuvant, in a mouse model mimicking human-specific immune responses to viral infection, we were able to induce neutralizing antibodies and strong T cell responses. This holds great promise for prevention of EBV associated diseases and controlling the spread of latently infected B cells."

The EBV vaccine is based on the research of Dr. Rajiv Khanna, Professor, Senior Scientist and Coordinator of QIMR Berghofer’s Centre for Immunotherapy and Vaccine Development. Professor Khanna said, "I am encouraged by the data demonstrating the potential of the AMP-CpG adjuvant combined with the EBV proteins to not only activate but supercharge the immune system as shown by the high frequencies of polyfunctional gp350-specific CD4+ T cells and EBVpoly-specific CD8+ T cells induced in this model."

Poster Presentation Details

Title: A Lymph Node Targeted Engineered Subunit Antigen and Molecular Adjuvant Vaccine Promotes Potent Cellular and Humoral Immunity to Epstein Barr Virus in HLA-expressing Mice

Highlights from the Poster

EBVpoly is a polyepitope protein developed at QIMR Berghofer Medical Research Institute that includes 20 CD8+ T cell epitopes from EBV latent and lytic antigens with broad coverage against multiple HLA types.
AMP-CpG delivers adjuvant directly to lymph nodes, boosting the immune response to protein antigens.
Vaccination with AMP-CpG combined with EBV gp350 and EBVpoly proteins rapidly induced potent gp350-specific IgG and EBV neutralizing antibody responses in HLA transgenic mice.
AMP-CpG immunization induced high frequencies of polyfunctional gp350-specific CD4+ T cells and EBVpoly-specific CD8+ T cells.
The potent humoral and cellular immunity induced by AMP-CpG was durable, with responses maintained for >7 months.
The broad coverage against multiple viral determinants and the AMP-CpG adjuvant are likely to provide better protection against primary EBV infection while the strong T cell responses will be critical in controlling the spread of latently infected B cells and the development of EBV-associated diseases, such as malignancies and multiple sclerosis.
About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform is thought to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability.

On July 6, 2022 Global Coalition for Adaptive Research (LARKSPUR, CA), Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), and Vigeo Therapeutics — The Global Coalition for Adaptive Research (GCAR) in collaboration with Biohaven and Vigeo Therapeutics, reported the activation of Biohaven’s troriluzole and Vigeo’s VT1021 in GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) (Press release, Biohaven Pharmaceutical, JUL 6, 2022, View Source [SID1234616519]). GBM AGILE is a revolutionary patient-centered, adaptive platform trial for registration that tests multiple therapies for patients with newly-diagnosed and recurrent glioblastoma (GBM) – the deadliest form of brain cancer.

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Biohaven’s troriluzole and Vigeo’s VT1021 are entering the GBM AGILE trial, which initially opened in July 2019 and has screened over 1200 patients to date. Troriluzole and VT1021 will enroll patients with newly-diagnosed and recurrent glioblastoma.

Dr. Michael Lim, Chair of the Department of Neurosurgery at Stanford University and Dr. Michael Weller, Director Department of Neurology, University Hospital Zurich, Switzerland will serve as arm Principal Investigators for troriluzole’s evaluation in GBM AGILE. VT1021 will be led by arm Principal Investigators, Dr. Howard Colman, Professor, Huntsman Cancer Institute and Department of Neurosurgery, University of Utah, and Dr. Tom Mikkelsen, Medical Director, Precision Medicine Program & Clinical Trials Office, Henry Ford Health.

"GBM AGILE is a ground-breaking trial that enables us to simultaneously and dynamically study the effects of multiple new drug candidates in an optimized learning environment. The trial’s nimble model allows us to more efficiently and rapidly identify effective therapies for GBM patients," said Dr. Michael Lim, who also serves as a member of the GBM AGILE Arm Identification and Selection Committee. "We are excited to include troriluzole and VT1021 in GBM AGILE. These investigational drugs have the potential to support improved outcomes for GBM patients, who desperately need more effective treatment options."

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE can be used as the foundation for a new drug application (NDA) and biologics license application (BLA) submissions and registrations to the FDA and other health authorities.

The new interventions are opening first at Henry Ford Health Cancer in Detroit under Henry Ford site Principal Investigator Dr. Tom Mikkelsen and will subsequently open at more than 40 trial sites across the United States with additional global sites to follow.

"Glioblastoma is a devasting disease with few effective treatment options and no cure. Currently the average survival rate is estimated to be only eight months," noted Dr. Mikkelsen. "We are enthusiastic to be the first site to activate troriluzole and VT1021 in the GBM AGILE study. We are committed to finding our patients the best possible treatments."

Biohaven’s troriluzole is a novel, orally administered small molecule that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. Troriluzole is thought to restore glutamate homeostasis by enhancing glutamate cycling, decreasing presynaptic glutamate release, and augmenting the expression and function of excitatory amino acid transporters (i.e., EAAT2) located on glial cells that play a key role in clearing excess glutamate from the synapse. Troriluzole was selected for inclusion in GBM AGILE, based on compelling evidence showing deregulation of glutamate in glioblastoma. The therapeutic potential of troriluzole in glioblastoma and other oncology indications is supported by several recent clinical and translational research studies conducted with troriluzole and its active moiety.

"The initiation of this pivotal trial of troriluzole for glioblastoma is an exciting milestone," commented Dr. Vlad Coric, Chairman and Chief Executive Officer of Biohaven. "We are extremely proud to be joining the highly innovative GBM AGILE trial. We look forward to collaborating with the Principal Investigators, Drs. Lim and Weller, the team at GCAR, and the GBM AGILE trial sites in order to rapidly advance the development of troriluzole in combination with standard of care therapies as a novel treatment for people suffering from glioblastoma, which is amongst the most recalcitrant and lethal of all cancers."

Vigeo’s VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates the apoptotic and macrophage reprogramming activity of CD36. The result of the dual modulating activity is the induction of apoptosis in tumor and endothelial cells, as well as an increase in both CTL:Treg and M1:M2 macrophage ratio. The biological/therapeutic activity of VT1021 is mediated by the stimulation of thrombospondin-1 (Tsp-1). Through these dual-modulating effects VT1021 reprograms the tumor microenvironment from one that is immune suppressive, or "cold," to immune enhanced (or sensitized), or "hot," that are more susceptible to attack from the immune system. With its novel mechanism of action and clinical data from a Phase 2 expansion study in recurrent GBM patients, VT1021 is undergoing further studies to determine its effect in treating the disease, given that CD36 and CD47 are found to be highly expressed in tumor cells compared to normal brain tissue. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.

"VT1021 has seen remarkable patient response, with a great safety profile, in our earlier clinical trials. We are excited that VT1021 is included as part of this global, multi-site effort to treat such a devastating disease," said Jim Mahoney, Chief Executive Officer, Vigeo Therapeutics. "The opportunity to work with these distinguished Principal Investigators and to test our drug in both newly diagnosed and recurrent GBM patient populations are key factors in our decision to join AGILE."