On January 5, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), and BWXT Medical Ltd., a subsidiary of BWX Technologies, Inc. (NYSE: BWXT), reported that the companies have entered into a preferred partner agreement for the supply of actinium-225 (Press release, Fusion Pharmaceuticals, JAN 5, 2023, View Source [SID1234625920]). Under the agreement, BWXT Medical will provide predetermined amounts of Fusion’s actinium supply needs at volume-based pricing.

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Actinium-225 is an alpha-emitting isotope used in targeted alpha therapies (TATs) that combine the isotope with specific tumor-seeking targeting vectors to kill cancer cells while minimizing the impact to healthy tissues. There is growing demand for the isotope but a limited number of suppliers who are currently able to produce meaningful quantities of high purity actinium.

Fusion Chief Executive Officer John Valliant, Ph.D., said, "Fusion’s portfolio of clinical-stage targeted alpha therapies is expanding, with three proprietary programs in clinical trials and additional programs advancing under our collaboration with AstraZeneca. Based on emerging clinical data in the literature which show the power of alpha particles over conventional beta emitters, we continue to proactively prioritize access to actinium as a critical component of Fusion’s development plans and we are excited to partner with BWXT Medical. As an established global leader in medical isotope manufacturing and supply with proven ability to produce high purity actinium, BWXT Medical has the necessary infrastructure and shipping logistics capabilities to support both clinical and commercial scale manufacturing and distribution of medical isotopes. This agreement increases our existing actinium supply for both current programs as well as future business development opportunities and partnered programs, diversifies our supply chain, and establishes a relationship to collaborate on longer-term commercial production needs."

BWXT Medical President and Chief Executive Officer Jonathan Cirtain, Ph. D., said, "Excitement for the potential of targeted alpha therapies to treat cancer is growing, and we have made the necessary investments in infrastructure and intellectual property to help meet the increasing global demand for actinium. BWXT Medical is now producing high-purity non-carrier added actinium-225. Fusion is a leading developer of targeted alpha therapies, and we are pleased to work with them as their clinical programs continue to advance."

On January 5, 2023 CytomX Therapeutics, Inc. (NASDAQ: CTMX), a leader in the field of conditionally activated oncology therapeutics and Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported a collaboration and licensing agreement to create investigational mRNA-based conditionally activated therapies utilizing Moderna’s mRNA technologies and CytomX’s Probody therapeutic platform (Press release, CytomX Therapeutics, JAN 5, 2023, View Source [SID1234625919]).

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The research collaboration will leverage core scientific advances at Moderna and CytomX. Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune diseases. CytomX’s Probody technology enables proteins to be activated locally in diseased tissue, while remaining masked in systemic circulation. These advances open up the strategy of encoding potent, masked biologics with mRNA, for the potential treatment of a wide range of diseases.

"We are excited to enter this collaboration with CytomX to combine our technologies and to potentially bring mRNA-based conditionally activated therapies to patients," said Rose Loughlin, Ph.D., Moderna’s Senior Vice President for Research and Early Development. "Moderna and CytomX have a shared vision of investing at the intersection of biology and technology to transform the lives of patients, and this collaboration will expand applications of our growing therapeutics pipeline."

"At CytomX, we have always embraced bold science in building the potential of Probody therapeutics and we are thrilled to be joining forces with Moderna in oncology as well as expanding our technology to areas outside oncology where we believe there is great potential," said Sean McCarthy, D.Phil, CEO and Chairman of CytomX. "Moderna’s global impact has shown the enormous power of mRNA and we look forward to working closely with our newest collaborator to bring novel, mRNA-based conditionally activated therapeutics to patients with unmet medical needs."

About the Alliance

Under the terms of the agreement, CytomX will receive an upfront payment of $35 million, including $5 million of pre-paid research funding. CytomX will continue to receive research funding and is eligible to receive up to approximately $1.2 billion in future development, regulatory, and commercial milestone payments. CytomX is also eligible to receive tiered royalties on global net sales of any products that are commercialized under the agreement. Moderna and CytomX will collaborate on discovery and pre-clinical development and Moderna will lead clinical development and commercialization of therapeutics resulting from the agreement. The agreement additionally provides Moderna with an option to participate in a future equity financing by CytomX subject to certain terms, conditions and regulatory requirements.

On January 5, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the U.S. Food and Drug Administration (FDA) has granted LP-284 Orphan Drug Designation (ODD) for the treatment of mantle cell lymphoma (MCL) (Press release, Lantern Pharma, JAN 5, 2023, View Source [SID1234625918]). MCL is a rare and aggressive form of B-cell non-Hodgkin’s lymphoma (NHL) that is typically diagnosed at advanced stages in elderly patients. As nearly all MCL patients acquire resistance and relapse from treatment with standard-of-care (SOC) agents, there is an urgent and unmet clinical need for new and effective therapies to treat MCL.

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LP-284 is a novel small molecule agent that preferentially damages DNA in cancer cells harboring mutations in DNA damage repair pathways. Lantern is developing LP-284 for several aggressive B-cell NHL’s, including MCL and double hit lymphoma (DHL), where LP-284 has shown potent anti-tumor activity in preclinical models. Lantern has been able to advance LP-284 from initial RADR A.I. insights regarding anti-cancer activity and potential mechanisms of action in hematological cancers, to selection of specific subtypes of lymphomas with superior response, to late stage IND enabling studies and initial design of first in human clinical trials in less than 2 years.

"Receiving Orphan Drug Designation is an important milestone for our latest drug candidate, LP-284, and further validates our data-driven approach to oncology drug discovery and development" stated Panna Sharma, President & CEO of Lantern Pharma. "At ASH (Free ASH Whitepaper), we recently reported positive preclinical data demonstrating LP-284’s potent anti-tumor activity in new MCL tumors and also against tumors that had grown resistant to the MCL standard-of-care agents Ibrutinib and Bortezomib. These findings are critically pertinent due to the high relapse rate, and poor prognosis of the majority of MCL patients," continued Sharma.

"This orphan designation is the fourth overall designation granted to Lantern, with the other three granted for our drug candidate LP-184. Acquiring these orphan designations is a key element of our business model as they provide a number of benefits including seven years of market exclusivity and eligibility for expedited drug development programs. Looking forward, these designations further position Lantern to advance our discussions with biopharma companies for partnering and collaborative development opportunities."

The FDA’s Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. ODD is designed to provide drug developers with various benefits to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of marketing registration application fees, reduced annual product fees, clinical protocol assistance and qualification for expedited development programs.

In addition to the ODD granted for LP-284 in MCL, Lantern was previously granted ODD’s by the FDA for its drug candidate LP-184 for the treatment of malignant gliomas, atypical teratoid rhabdoid tumors (ATRT), and pancreatic cancer. Lantern has also been granted a Rare Pediatric Disease Designation for LP-184 in ATRT.

On January 5, 2023 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported a business update reviewing 2022 achievements and outlining the Company’s key business objectives for 2023 (Press release, Cyclacel, JAN 5, 2023, View Source [SID1234625917]).

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"2022 was a year of solid progress for Cyclacel highlighted by the clinical advancement of our two product candidates in Phase 1/2 clinical studies," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "Both fadraciclib, our CDK2/9 inhibitor, and plogosertib (formerly CYC140), our PLK1 inhibitor, have shown differentiated and competitive profiles in their respective classes. We believe that fadra is the only transcriptionally active CDK inhibitor to have shown single agent responses in both liquid and solid tumors with a good tolerability profile. We are seeing preliminary indications of single-agent activity in the ongoing Phase 1/2 trial of plogosertib in advanced solid tumors and lymphoma. We also estimate that our cash runway will fund operations through the end of 2023, providing sufficient funding over this catalyst-rich period."

"We believe that we are very close to identifying the recommended Phase 2 dose (RP2D) in the ongoing Phase 1/2 study of oral fadra for the treatment of advanced solid tumors and lymphoma," said Dr. Mark Kirschbaum M.D., Chief Medical Officer. "Fadra is showing signs of single agent activity in several tumor types including PRs in 2/3 T cell lymphoma patients and stable disease in certain solid tumors. Oral fadra has also maintained an acceptable safety and tolerability profile across multiple dosing cohorts. We expect to enter the Phase 2 segment of the trial in the first half of 2023, after completing the rapid accrual we have seen in Phase 1, and reviewing the safety, pharmacokinetics and correlative study data. To accelerate Phase 2 enrollment, we have expanded the number of clinical trial sites participating in the trial including certain widely recognized U.S. and international cancer centers. We expect to provide a data update at a major medical meeting in the first half of 2023 and initial data from the Phase 2 in the second half of 2023."

"We have also made encouraging progress with our second candidate, plogosertib," continued Dr. Kirschbaum. "The dose escalation stage of our Phase 1/2 study in advanced solid tumors and lymphoma is enrolling well. Based upon the molecule’s differentiated profile and early observation of efficacy with three patients on treatment for at least 3 cycles, we believe plogosertib has the potential to demonstrate single-agent activity across a broad range of cancers. We anticipate reporting preliminary safety and efficacy data from the dose-escalation stage of the ongoing plogosertib Phase 1/2 study within 2023."

2022 Key Achievements

Fadraciclib

Final dose-escalation level 6a to determine RP2D in the oral fadraciclib 065-101 Phase 1/2 study has enrolled 3 out of 6 patients
Broad activity observed in the first 5 dose levels: 2/3 partial responses (PRs) in patients with T-cell lymphoma; 4 patients with cervical, endometrial, hepatocellular and ovarian cancer showed stable disease with target lesion reductions; and a patient with pancreatic cancer achieved stable disease for 5 cycles
Achieved target engagement levels predicted to inhibit CDK2 and CDK9 for approximately 5 to 7 hours per dose on continuous dosing
At the Company’s R&D Day a principal investigator from Seoul National University Hospital showed preclinical data demonstrating sensitivity to fadra in biliary tract and pancreatic cancer cells obtained from patient specimens
A publication from The University of Texas MD Anderson Cancer Center reported preclinical data against chronic lymphocytic leukemia (CLL) cell lines showing that fadraciclib, as a single agent and in combination with the BCL2 antagonist, venetoclax, depletes anti-apoptotic proteins and synergizes with venetoclax
Reported positive preliminary data from the Phase 1/2 clinical trial of oral fadraciclib in patients with solid tumors and lymphoma at the ENA 2022 meeting

Plogosertib (formerly CYC140)

Announced dosing of first patient in Phase 1/2 study of oral plogosertib in patients with advanced solid tumors and lymphomas
No dose limiting toxicities observed to date in the first 3 dose levels
Stable disease at the first dose level in an ongoing patient with metastatic, KRAS G12V mutated, non-small cell lung cancer for 9 cycles and a patient with metastatic ovarian cancer for 5 cycles

Corporate Highlights

On October 31, 2022 the Company held an R&D Day (Webcast replay) at which updated clinical and preclinical data on fadraciclib and plogosertib were presented
Announced the election by the preferred stockholders of Kenneth M. Ferguson, Ph.D. to the Board of Directors

Key Business Objectives for 2023

1H 2023

First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors and lymphoma
Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma at a major medical meeting
Report interim Phase 1 data from 140-101 study of oral plogosertib in patients with advanced solid tumors and lymphoma
2H 2023

Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma
Report interim data from dose escalation stage of 065-102 study with oral fadraciclib in patients with advanced leukemia
Report final data from dose escalation stage of 140-101 study with oral plogosertib in advanced solid tumors and lymphoma

On January 5, 2023 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat oncology indications, reported that Jeffrey Eisenberg, Chief Executive Officer of Xenetic Biosciences will present at the Virtual Investor 2023 Companies to Watch Event on Tuesday, January 17, 2023 at 10:00 AM ET (Press release, Xenetic Biosciences, JAN 5, 2023, View Source [SID1234625916]).

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A live video webcast of the presentation will be available on the Events page in the Investors section of the Company’s website (www.XeneticBio.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

About Xene