On May 7, 2024 Flagship Pioneering, the bioplatform innovation company, reported Prologue Medicines, a company unlocking the therapeutic potential of the viral proteome for the creation of powerful new medicines (Press release, Prologue Medicines, MAY 7, 2024, View Source [SID1234643565]). Flagship has initially committed $50 million to advance the company’s Decoding Evolutionary Logic of Variant Ensembles (DELVE) Platform and harness its power to develop a pipeline of medicines fora wide range of diseases, with an initial focus in immunological, oncology and metabolic indications.

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"We asked, what if we could expand beyond the functional boundaries of the human proteome by harnessing viral evolution," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering and Co-Founder and Chairman of the Strategic Oversight Board of Prologue. "By exploring the viral proteome, we can discover novel proteins with enhanced or completely unique therapeutic properties to develop medicines for optimal patient outcomes."

Prologue is unlocking viral proteome-assisted drug discovery with its novel DELVE Platform. DELVE combines computation and high-throughput biology to continually mine the expanding viral proteome to uncover viral proteins and their unique features and evaluate their potential to modulate human physiology for the treatment of disease. The platform contains the largest known database of viral protein structures layered both with detailed data from known human proteins and annotations of previously uncharacterized viral proteins predicted through Prologue’s proprietary computational frameworks. By applying the learned rules of natural viral evolution, Prologue creates enhanced therapeutic proteins programmed to have properties, some previously unique to viruses, that expand the functional boundaries of human proteins.

"The viral proteome dwarfs the human proteome by orders of magnitude, enabling us to reveal a trove of powerful new proteins that can be used as medicines across nearly any therapeutic area," said Lovisa Afzelius, Ph.D., MBA, Co-Founder and CEO of Prologue and Origination Partner at Flagship Pioneering. "Nature has evolved proteins with unique characteristics across the viral proteome. Advances in machine learning are enabling us to quickly characterize and select those that can precisely regulate human physiology to create powerful new medicines with impeccable precision."

In addition to Afeyan and Afzelius, Prologue is led by Theonie Anastassiadis, Ph.D., Founding President of Prologue and Senior Principal at Flagship Pioneering, and Hozefa Bandukwala, Ph.D., Founding Chief Scientific Officer of Prologue and Science Partner at Flagship Pioneering.

On May 7, 2024 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the first quarter ended March 31, 2024 and provided a business update (Press release, Janux Therapeutics, MAY 7, 2024, View Source [SID1234642882]).

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"We continue to focus on enrollment in the two clinical studies for PSMA-TRACTr JANX007 and EGFR-TRACTr JANX008, and we are pleased with the progress," said David Campbell, Ph.D., President and CEO of Janux. "As we advance our clinical programs and gather additional clinical data, we are also expanding our pipeline so that we can create further value from our technology platforms and, most importantly, accelerate the development of new meaningful therapies for cancer patients."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

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JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).

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JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).

An update on JANX007 data and doses selected for expansion cohorts is anticipated in the second half of 2024. An update on JANX008 data is expected in 2025.

FIRST QUARTER 2024 FINANCIAL RESULTS:

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Cash and cash equivalents and short-term investments: As of March 31, 2024, Janux reported cash and cash equivalents and short-term investments of $651.8 million compared to $344.0 million at December 31, 2023.

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Research and development expenses: For the quarter ended March 31, 2024, Janux reported research and development expenses of $14.1 million compared to $15.9 million for the comparable period in 2023.

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General and administrative expenses: For the quarter ended March 31, 2024, Janux reported general and administrative expenses of $7.3 million compared to $6.5 million for the comparable period in 2023.

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Net loss: For the quarter ended March 31, 2024, Janux reported a net loss of $14.8 million compared to $17.5 million for the comparable period in 2023.

Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s second clinical candidate, JANX008, is a TRACTr that targets EGFR and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline.

On May 7, 2024 BPGbio, Inc., a leading biology-first AI-powered biopharma that focuses on oncology, neurology, and rare diseases, reported its participation in both the US Pharma Partnering Summit, scheduled for May 14-15, 2024, in San Diego and the EU Pharma Partnering Summit taking place May 22-23, 2024 in Basel, Switzerland (Press release, BPGbio, MAY 7, 2024, View Source [SID1234642825]).

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BPGbio’s executives, including Daniel Elliott, Board Member and Chief Commercial Advisor, plan to share details of the company’s commercial ready assets. Of particular note is progress in advancing BPM31510-IV, their lead drug candidate, which is currently enrolling in Phase 2b trial for glioblastoma multiforme (GBM) and in Phase 2b trial design for pancreatic cancer as well as being studied for a range of other aggressive cancers. BPM31510 acts by targeting the mitochondrial machinery and tumor microenvironment (TME) to create a metabolic shift in cancer cells, leading to cancer cell death. BPM31510 has already received Orphan Drug designations from the U.S. FDA for both GBM and pancreatic cancer. BPGbio is also exploring a late stage trial with BPM31510-IV/oral for primary coenzyme Q10 deficiency, an ultra-rare, potentially life threatening disease that affects the brain, muscles, and kidneys in afflicted patients.

"The clinical trial success of our lead candidate, BPM31510, underscores the value of our biology-first approach and the decade plus we have spent refining our approach to AI-powered drug discovery," said Niven Narain, PhD, CEO of BPGbio. "Our team is looking forward to meeting with potential partners in the biopharma industry who want to join us in bringing our novel therapeutics to patients in need or leveraging our AI-capabilities to support their development activities."

The executives will also provide insights into the company’s growing portfolio of therapeutic targets and candidates, including their novel E2 Degrader Platform, which have been identified through BPGBio’s proprietary AI-powered NAi Interrogative Biology Platform. This platform identifies targets, biomarkers, and drugs and assists the development team through both the development and clinical trial stages. The NAi Platform is now commercially available to pharma, academic, and government organizations. The platform operates a clinically annotated, longitudinal 100,000+ patient/sample biobank, uses domain specific AI models to analyze multi-omics data with the world’s current fastest supercomputer, Frontier, at Oak Ridge National Laboratory (ORNL), making it the only fully integrated high-performance computing (HPC) platform in the biopharmaceutical industry for AI-driven target nomination, discovery, and molecule design.

BPGbio’s therapeutic pipeline also includes drug candidates for epidermolysis bullosa (EB, orphan drug), squamous cell carcinoma (SCC, orphan drug), sarcopenia, solid and liquid tumors, Huntington’s disease (orphan drug) and Parkinson’s disease.

The company’s diagnostic pipeline includes its prostate diagnostic test pstateDx, as well as tests being developed and validated for the detection of Parkinson’s disease (ParkinsonDx), pancreatic cancer (PancDx), breast cancer, and liver disease.

On May 7, 2024 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) and Agenus Inc. (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, reported that the companies have entered into a royalty financing agreement to support Agenus’ key development initiatives in the ongoing BOT/BAL clinical development program, including its planned confirmatory Phase 3 trial in its lead indication of patients with metastatic, relapsed/refractory colorectal cancer not microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR), who are without active liver metastases (r/r MSS CRC NLM), along with other launch readiness activities (Press release, Ligand, MAY 7, 2024, View Source [SID1234642824]).

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Under the terms of the agreement, Ligand will pay $75 million to Agenus at closing. In addition, Ligand has the option to invest an additional $25 million on the same terms on a pro rata basis. In return for the initial $75 million payment, Ligand will receive 18.75% of the future royalties and 31.875% of the future milestone payments related to six of Agenus’ clinical-stage partnered oncology programs, including BMS-986442 (Bristol Myers Squibb), AGEN2373 (Gilead Sciences), INCAGN2385 and INCAGN2390 (Incyte), MK-4830 (Merck), and UGN-301 (UroGen Pharma). Ligand’s portion of the milestones related to these six programs has the potential to exceed $400 million, with royalties in the low single digits. In addition, Ligand will also receive a 2.625% royalty on future global net sales generated by BOT/BAL. The royalties and milestone payments owed to Ligand could be adjusted up or down based upon pre-determined future events and achievements of certain milestones.

"This partnership with Agenus gives us an interest in multiple oncology products diversified across targets and indications, including royalties on BOT/BAL and several partnered oncology programs being developed by experienced biopharmaceutical companies," commented Todd Davis, CEO of Ligand. "We are encouraged by Agenus’ progress to move BOT/BAL forward in the metastatic, relapsed/refractory colorectal cancer setting, in addition to other major indications, including pancreatic cancer, lung cancer, and melanoma. This demonstrates the potential value BOT/BAL could deliver to patients, as well as the significant revenue potential of this broad and highly differentiated program. Our seasoned investment team spent significant time and effort conducting diligence on each of these unique and valuable assets."

As part of the agreement, the companies have also agreed to allow Agenus to syndicate up to an additional $125 million, potentially bringing the total capital infusion up to $200 million. This strategic collaboration will further validate BOT/BAL’s potential as a transformative treatment for patients with solid tumor malignancies and enhances Agenus’ ability to advance this promising therapy.

Garo Armen, Chairman and Chief Executive Officer of Agenus, commented, "We are pleased to partner with Ligand, a company that recognizes the paradigm-shifting potential of BOT/BAL in delivering benefit to patients across the solid tumor landscape. Ligand also recognizes the potential impact of our ongoing partnered programs, many of which are showing promise in the clinic. This collaboration enables both parties to benefit in the future potential success of these assets while simultaneously enabling Agenus to accelerate our efforts to bring BOT/BAL to patients in need."

Over 900 patients have been treated with BOT/BAL in clinical trials across nine different difficult to treat solid tumor cancers. The novel therapeutic regimen has demonstrated the potential to be combined with chemotherapy and other standard of care therapies, and as an immunotherapy-only combo in CRC, one of the most prevalent solid tumors globally. In April 2023, Agenus was granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the investigation of the BOT/BAL combination in patients with r/r MSS CRC NLM. Patients targeted with this designation are heavily pretreated with standard of care chemotherapy, anti-VEGF and anti-EGFR if RAS wild type.

On May 7, 2024 ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ARTs), and Nucleus RadioPharma Inc. (Nucleus), the world’s first fully integrated development, manufacturing, and supply chain organization for radiopharmaceuticals, reported a strategic manufacturing and supply agreement to support ARTBIO’s therapeutic product manufacturing (Press release, ARTBIO, MAY 7, 2024, View Source [SID1234642823]).

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Under the terms of the agreement, Nucleus will manufacture ARTBIO’s 212Pb-radiolabeled therapies for its planned Phase I and II clinical trials of its lead program in prostate cancer, AB001, using ARTBIO’s proprietary AlphaDirectTM 212Pb isolation technology. This agreement will enable the supply and manufacturing of ARTs from Nucleus’ facility in Rochester, Minn., for patients living in the Northern and Midwest U.S.

"As we continue building our distributed manufacturing capabilities in the U.S. and globally, selecting partners who share our patient-centric vision is critical," said Emanuele Ostuni, Ph.D., Chief Executive Officer of ARTBIO. "The Nucleus team shares our passion to make targeted radiopharmaceutical therapies accessible, and together, we commit to bringing a new class of alpha radioligand therapies to hospitals across greater Minnesota and beyond."

"This strategic partnership with ARTBIO underscores our unwavering commitment to transforming the lives of cancer patients through groundbreaking therapies," said Charles S. Conroy, Chief Executive Officer of Nucleus. "We are thrilled to unite in our mission to address the pressing need for innovative radiopharmaceuticals, ensuring that patients have access to potentially life-changing treatments with highest quality and supply chain resilience."

AlphaDirectTM is a first-of-its-kind system that delivers highly pure 212Pb from widely available raw materials. 212Pb is an alpha-emitting radioisotope that has gained attention for its potential applications in therapeutic medicine, particularly in targeted alpha radioligand therapy due to the radioisotope’s attractive short half-life and other properties. Preliminary studies of radiopharmaceuticals labeled with 212Pb have been promising, indicating that 212Pb has the potential to address unmet clinical needs.