On August 15, 2023 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported that it has initiated patient dosing in the first-in-human Phase 1 clinical trial of WU-NK-101 for patients with relapsed or refractory (r/r) acute myelogenous leukemia (AML) (Press release, Wugen, AUG 15, 2023, View Source [SID1234634431]). Additionally, Wugen announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to WU-NK-101 for the treatment of AML.

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WU-NK-101 is Wugen’s lead memory natural killer (NK) cell therapy product and is comprised of cells optimized for anti-cancer function. WU-NK-101 cells possess a unique cytokine-induced memory-like (CIML) phenotype that supports enhanced anti-tumor activity, robust trafficking, superior proliferation capacity, and metabolic flexibility, all of which contribute to treatment resilience in the adverse tumor microenvironment (TME). WU-NK-101 is produced with the company’s proprietary MonetaTM manufacturing platform, which enables robust generation of off-the-shelf memory NK cell-based therapies.

"The start of this clinical trial is a significant step forward in our memory NK cell program, which we believe offers significant advantages over other NK cell therapy approaches and has the potential to benefit patients with a number of tumor types," said Jan Davidson-Moncada, M.D., Ph.D., chief medical officer of Wugen. "Early clinical studies with memory NK cells demonstrated impressive response rates in patients with AML, even those with a high disease burden. We look forward to building on these data while advancing WU-NK-101 as a readily accessible allogeneic cell product. In tandem, we are proud to announce our Orphan Drug Designation for WU-NK-101, which will enhance our efforts to deliver this therapy to AML patients."

"Today’s news represents a significant milestone for Wugen, as WU-NK-101 is the first therapeutic candidate from our memory NK cell platform to enter the clinic," added Kumar Srinivasan, Ph.D., president and chief executive officer of Wugen. "Beginning in AML, where there remains a high unmet need for new therapeutic options, our goal is to deploy our memory NK cell platform to deliver next-generation, best-in-class allogeneic memory NK cell therapies to transform cancer care, including treatment of solid tumors."

The Phase 1 study is a global, open-label, dose-escalation, and cohort expansion study designed to characterize the safety and tolerability of WU-NK-101 in patients with r/r AML and determine the recommended Phase 2 dose. It will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-leukemic activity of WU-NK-101. WU-NK-101 will be administered as three weekly infusions in a 28-day cycle. Additional information is available on clinicaltrials.gov, identifier NCT05470140.

An abstract on the design of the Phase 1 trial was published in the November 2022 supplemental issue of Blood, the journal of the American Society of Hematology (ASH) (Free ASH Whitepaper).

Memory NK cells have been clinically validated for safety and efficacy in AML. In addition, solid tumor preclinical studies of WU-NK-101 suggest efficacy in solid tumors alone or in combination with monoclonal antibodies.

The FDA Office of Orphan Products Development grants orphan designation for novel drugs or biologics being developed to treat a rare disease or condition affecting fewer than 200,000 patients in the United States. ODD qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including potentially seven years of U.S. marketing exclusivity, tax credits for clinical research costs, clinical research trial design assistance, the ability to apply for annual grant funding and waiver of Prescription Drug User Fee Act filing fees.

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness, making it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML). Wugen is planning to initiate solid tumor studies of WU-NK-101 in combination with cetuximab. Studies of WU-NK-101 to date have shown promising robust in vivo activity in various tumor indications, retention of anti-cancer activity in TME, resistance to immune suppression, and enhanced activity with checkpoint inhibitors.

About the MonetaTM Platform

Wugen’s proprietary MonetaTM manufacturing platform is a robust, efficient, scalable process to generate off-the-shelf memory natural killer (NK) cell therapies with enhanced anti-tumor functionality. The MonetaTM platform uses cytokine fusion complexes for streamlined and consistent manufacturing, is free of feeder cells for enhanced safety, and integrates cryopreservation to allow convenient dosing options for cancer patients.

On August 15, 2023 TAE Life Sciences reported a landmark agreement with Biddle Sawyer to serve as the exclusive supplier of TC220, a novel boronated amino acid analog drug for boron neutron capture therapy (BNCT) (Press release, TAE Life Sciences, AUG 15, 2023, View Source [SID1234634430]). As part of this exclusive agreement, Biddle Sawyer has enlisted contract research and manufacturing organization Kinentia Biosciences to refine and streamline the drug’s manufacturing process, and ultimately produce the drug in their state-of-the-art GMP facility. Kinentia Biosciences will be the exclusive manufacturer of TC220 for the US market.

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Today, TAE Life Sciences is working with several renowned cancer hospitals around the world to deploy its Alphabeam BNCT system to conduct clinical research and begin clinical trials. This collaboration between Biddle Sawyer and Kinentia will help propel TAE Life Sciences’ clinical trials pipeline forward by readying its TC220 boronated drug for the IND application process with the United States Food & Drug Administration.

"As a strategic partner to TAE Life Sciences and Kinentia, our collective mission is to push the boundaries of BNCT by manufacturing groundbreaking boronated drugs that offer many advantages to today’s most common BNCT drugs. Leveraging our strong foothold in the pharmaceutical industry, we are enthusiastic about working with this group to revolutionize radiation oncology and unlock new clinical possibilities," said Lee DeWitt, VP of Business Development, Biddle Sawyer

"We are thrilled to partner with Biddle Sawyer and TAE Life Sciences on this significant long-term supply agreement for TC220. Kinentia’s expertise in process refinement, backed by our comprehensive cGMP manufacturing capabilities, perfectly aligns with TAE Life Sciences’ commitment to innovation and excellence in drug discovery and development," said David Fairfax, President of Kinentia Biosciences.

BNCT stands out as an innovative and distinctive biologically-targeted radiation therapy that employs a non-toxic boron-10 compound and a neutron source. When exposed to a low-energy neutron beam, this boronated compound triggers a targeted reaction, effectively eliminating cancer cells while preserving healthy tissue.

TAE Life Sciences has made a remarkable breakthrough with their exclusive drug, TC220, representing a significant leap forward in BNCT. Notably, TC220 offers several key advantages over conventional boronophenylalanine (BPA) as the boron target drug. Through pre-clinical studies, TC220 has demonstrated its ability to deliver boron more effectively to tumor cells compared to BPA. This is attributed to its enhanced solubility, prolonged retention in tumor tissue, and consistent and superior boron delivery in multiple human tumor xenografts. With these exceptional attributes, TC220 holds the potential to be applied across a broader range of clinical scenarios, thereby expanding the horizons of BNCT as a next-generation cancer treatment.

"We are driven by the mission to bring our biologically targeted radiation therapy to those fighting aggressive and recurrent cancers," said Kendall Morrison, Ph.D., Chief Science Officer at TAE Life Sciences. "This exclusive supplier deal with Biddle Sawyer and Kinentia Biosciences represents a significant milestone in our journey to deliver cutting-edge cancer treatments to patients in need."

BNCT has shown promising outcomes in clinical studies worldwide. With the availability of better boron-10 drugs like TC220 and an in-hospital neutron system like TAE Life Sciences’ Alphabeam, there is a unique opportunity to improve patient care and treatment economics while reducing the burden and stresses of cancer treatment on the body.

Clinical trials for Alphabeam and proprietary boron-containing drugs are expected to commence in the United States and Europe in 2024.

Click here for the press kit

About BNCT
BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT’s potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

About Biddle Sawyer
Biddle Sawyer is a trusted veteran in the field of sourcing, development, and custom manufacturing, supply, marketing, and distribution of specialty and fine chemicals, excipients, and APIs, as well as offering other services to advance drug substance and drug product programs including biology, discovery, medchem, DMPK, ADME, GLP Tox, pre-formulation and formulation development. Headquartered in New York City, they have warehouses, offices, and strategic partners around the world. Their presence in North and South America, Asia, and Europe allows them to serve their many global customers efficiently, delivering high-quality low-cost products to their doors.

Over the course of 70 years, they have developed strong, long-standing relationships with CDMOs, manufacturers, transportation and shipping companies, and government agencies ensuring that transactions proceed quickly and smoothly. From an initial phone call through development, manufacturing, packing, shipping, documentation, and final delivery, they always have every detail—and their customers’ interests—covered.

On August 15, 2023 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company will target the Peter Mac Cancer Center in Melbourne, Australia, as the site for the First-In-Human (FIH) study for PRP in patients with advanced solid tumors (Press release, Propanc, AUG 15, 2023, View Source [SID1234634429]). Initial discussion held previously with the Clinical Investigator confirmed the remaining development activities to be conducted by the Company prior to filing the clinical trial application for the FIH study. This includes the finished drug product manufacture and validation of the bioanalytical method to analyze the pharmacokinetics (movement of drug within the body) of PRP during the study.

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The Peter Mac Cancer Center is a world leading cancer research, education and treatment center and Australia’s only public health service dedicated to caring for people affected by cancer. They have 3,900 employees, including more than 750 laboratory and clinical researchers, all focused on providing better treatments, better care and potential cures for cancer. They are well placed to support the Company’s goals for a world first clinical study of PRP, as a long term, proenzyme therapy for the treatment and prevention of metastatic cancer from solid tumors by targeting and eradicating cancer stem cells, free from side effects normally associated with standard treatment approaches.

"We are pleased to have engaged in positive initial discussion with Professor Mark Rosenthal, Director and FIH Clinical Study Investigator at the Peter Mac Cancer Center," said James Nathanielsz, BAS, MEI, Propanc’s Chief Executive Officer. "We are excited about the opportunity to work with a world class facility like Peter Mac, and it was great to see our mutual excitement about a potential world first study for PRP as a new therapeutic approach to treat and prevent metastatic cancer from solid tumors. Our plan is to undertake the FIH study in Australia, given the favorable R&D cashback benefit where we will receive 43% of our R&D expenditure on local activities, as well as approval from the Australian Government for reimbursement some overseas activities as well. We will then plan to undertake subsequent clinical studies in Europe, as the preeminent region behind the USA, where we will undertake a Pre-IND meeting with the US Food and Drug Administration once we have clinical data from our FIH study. Achieving this exciting development stage in the not-too-distant future could prove transformative for the Company, and its shareholders."

Propanc is set to capitalize on favorable government incentives from the Australian government for future product and clinical development of PRP, receiving a 43.5% cash back benefit on all local R&D activities conducted in Australia. Furthermore, a Certificate for Advance Overseas Finding was received from the Board of Innovation and Science Australia to receive up to a 43.5% "cash back" benefit from overseas R&D expenses. Overseas activities to be undertaken include validation of the pharmacokinetics method for PRP and its manufacture of the finished product for the FIH study.

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (FDA) for treatment of pancreatic cancer.

On August 15, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based in vivo gene editing therapies, reported completion of a strategic transaction with Imugene Limited (ASX: IMU) for global rights to Azercabtagene Zapreleucel (azer-cel), Precision’s lead allogeneic CAR T candidate, for cancer (Press release, Precision Biosciences, AUG 15, 2023, View Source [SID1234634428]). Imugene will assume ongoing clinical execution for azer-cel in the large B-cell lymphoma (LBCL) population who have relapsed following autologous CAR T treatment. The license also includes an option to develop up to three other cancer research programs in the future.

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"We are excited to reach this key inflection point for Precision BioSciences with the achievement of three milestones – first, the completion of a global deal with Imugene for azer-cel in cancer; second, the extension of our expected cash operating runway to greater than two years; and third, our pivot to focus exclusively on in vivo gene editing," said Michael Amoroso, Chief Executive Officer at Precision BioSciences. "We are very pleased to partner with Imugene as they plan to leverage azer-cel’s clinical data package and recent regulatory feedback to continue its path toward a pivotal trial in LBCL and potentially help patients in dire need. Our commercial and scientific interests are closely aligned, and we believe Precision’s allogeneic CAR T technology can complement the novel oncology approaches being pursued by Imugene, especially its OnCARlytics platform for solid tumors."

"After an extensive review of the allogeneic CAR T landscape, we are excited to progress what we believe is the most advanced allogeneic CAR T program – azer-cel, which has regulatory feedback and a broad data set. This is an important opportunity to develop a much-needed treatment for the growing number of lymphoma patients who have relapsed following CAR T treatment and is complementary to our pipeline, which is designed to unleash the immune system to fight cancer, including our OnCARlytics program," said Leslie Chong, Chief Executive Officer and Managing Director at Imugene Limited.

In exchange for global rights to azer-cel for cancer, as well as Precision BioSciences’ CAR T infrastructure and its experienced cell therapy teams, Precision will receive upfront economics valued at $21 million (all figures in USD) consisting of cash and equity. In addition, Precision is eligible for an $8 million near-term payment in cash and equity upon successful completion of the phase 1b dosing in the CAR T relapsed LBCL patient population. For azer-cel, Precision is eligible to receive up to $198 million in additional milestone payments and double-digit royalties on net sales. For each additional research program selected by Imugene, Precision is eligible for up to $145 million in milestone payments and tiered royalties on net sales.

Precision’s PBCAR19B stealth cell and its CAR T assets targeting multiple myeloma, as well as all rights to non-oncology indications for azer-cel, remain available for development through partnership only.

Corporate & Financial Update

As a result of this transaction, Precision expects to reduce its annual operating spend by approximately $20 million from the current base case and has right-sized the company to operate as a single platform company focused on in vivo gene editing. Upfront cash from this transaction, reduced CAR T operating expenses, and continued fiscal discipline are expected to extend Precision’s cash runway through the third quarter of 2025.

"As we pivot our full attention and resources to leveraging the core features of ARCUS for differentiated in vivo gene editing programs, we are prepared to capitalize on the utility of ARCUS to produce a profound impact on diseases in the liver and beyond, including those that are best suited for gene insertion or excision of large defective gene sequences. We look forward to providing additional updates about our in vivo gene editing progress at our upcoming R&D event on September 12, 2023," added Mr. Amoroso.

On August 15, 2023 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 for its previously announced (July 10, 2023) global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV ("Janssen"), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the investigational, potential first-in-class radioenhancer NBTXR3 (Press release, Nanobiotix, AUG 15, 2023, View Source [SID1234634427]).

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With the expiration of the HSR waiting period, the transaction has become effective, and as such, Nanobiotix is eligible to receive payment of the $30 million upfront cash licensing fee.