On January 5, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported a portfolio update including initiating development of its wholly owned best-in-class immune cell modulating antibodies in autoimmune and inflammatory diseases with large and significantly underserved patient populations (Press release, AnaptysBio, JAN 5, 2023, View Source [SID1234625956]). With cash, cash equivalents and investments greater than $575 million as of December 31, 2022, the company anticipates having approximately 4 years of capital to execute against its non-risk adjusted research and development plan, excluding potential future royalties from its GSK immuno-oncology financial collaboration.

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"We have continued to progress our strategic portfolio review and are excited to announce the near-term initiation of two global Phase 2b trials across rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ANB032, our BTLA agonist, in atopic dermatitis. We believe their mechanisms of action, with the potential to restore immune balance by acting directly on cell types mediating disease pathology, have the potential to meaningfully impact large and significantly underserved patient populations," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "We’re well capitalized to deliver on multiple Phase 2b readouts across our wholly owned checkpoint agonists as well as to advance ANB033, our anti-CD122 antagonist, through clinical proof-of-concept."

Rosnilimab (PD-1 agonist antibody)

Rosnilimab, its investigational wholly owned PD-1 agonist, demonstrates best-in-class activity in vitro with superior inhibition of T cell proliferation, reduction in inflammatory cytokine secretion (Th1, Th2, Th17) and depletion of PD-1+ T cells via effector function compared to Lilly PD-1 agonist
PD-1+ T cells are clinically validated drivers of disease in rheumatoid arthritis (RA)
RA patient synovial biopsies have dense T cell infiltrates, with >80% of T cells expressing PD-1 and insufficient PD-L1 expression to down-regulate T cell activity
Rosnilimab targets multiple distinct inflammatory mechanisms addressed by approved therapies to treat RA
Initiation in Q3 2023 of a global Phase 2b trial in moderate-to-severe RA
Multi-hundred patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab for approximately 6 months on well-established endpoints including ACR20/50/70 and DAS28
Top-line interim data anticipated by mid-year 2025
Second global Phase 2 trial, in an indication to be announced, with study initiation anticipated by year-end 2023
Conducted a blinded interim review of alopecia areata Phase 2a data in December 2022
Enrolled 51 patients in a placebo-controlled trial assessing a single 400mg Q4W dosage of subcutaneously administered rosnilimab (randomized 2:1)
Study remains blinded with 100% of patients (n=38) through both week 20 dosing period and week 24 primary endpoint and 61% of patients (n=18) through week 32 follow-up period
Demonstrated rosnilimab "proof of mechanism" with robust reductions in peripheral PD-1+ T cells, including PD-1 high T cell reduction of >80%, across blinded pooled rosnilimab treated and placebo patients, which is consistent with observations in the healthy volunteer Phase 1 trial of >90% in rosnilimab treated patients
Suggests rosnilimab administration was generally safe and well tolerated
Severity of Alopecia Tool (SALT) scores were not supportive of achieving the target product profile and further development in alopecia areata will not be pursued
While select patients observed changes from baseline SALT scores at week 24, no patients achieved an absolute SALT score <20
Interim results suggest that target efficacy was not achieved potentially due to an inadequate tested dose level, limited duration of treatment, and/or complexity of disease biology including the hair growth cycle
Unblinded week 32 results, tissue biopsies and additional translational data defining the extent of PD-1 modulation in the periphery and hair follicle will be available in H2 2023

ANB032 (BTLA agonist antibody)

ANB032, its investigational wholly owned BTLA agonist, demonstrates best-in-class activity in vitro with superior inhibition of T cell proliferation and reduction in inflammatory cytokine secretion (Th1, Th2, Th17) compared to Lilly BTLA agonist
While Th2 targeted therapies provide benefit to patients with chronic moderate-to-severe atopic dermatitis (AD), there is compelling evidence that AD is broader than a Th2 driven disease, as Th1, Th17 and other cell types, including dendritic cells, may contribute significantly to its pathogenesis
ANB032 inhibits inflammatory activity of Th1, Th2 and Th17 and modulates additional cell types such as B cells and dendritic cells, with the potential for broader, deeper and more durable responses than more narrowly targeted interventions
Initiation in Q2 2023 of a global Phase 2b trial in moderate-to-severe AD
IND cleared by the FDA in December 2022
160 patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for 12 weeks on well-established endpoints, including EASI75 and IGA 0/1
Top-line interim data anticipated by year-end 2024

ANB033 (anti-CD122 antagonist antibody)

ANB033, its investigational wholly owned anti-CD122 antagonist antibody, targets the common beta subunit shared by the IL-15 and IL-2 receptors
IL-15 signaling mediates the survival and maintenance of tissue resident memory T cells (TRM)
The presence of long-lived and persistent TRM have been shown to drive tissue-specific immune-mediated inflammation
IND anticipated H1 2024

Legacy clinical-stage cytokine antagonist programs available for outlicensing

Imsidolimab, its investigational wholly owned anti-IL-36r antagonist antibody, is in Phase 3 trials for generalized pustular psoriasis (GPP)
Top-line data from the GEMINI-1 Phase 3 trial anticipated Q4 2023
Plan to outlicense imsidolimab prior to potential FDA approval
Etokimab, its investigational wholly owned anti-IL-33 antagonist antibody, is Phase 2/3-ready for the treatment of respiratory disorders
No further internal investment in etokimab is being pursued

GSK immuno-oncology financial collaboration

Dostarlimab, an anti-PD-1 antagonist antibody, cobolimab, an anti-TIM-3 antagonist antibody, and GSK4074386, an anti-LAG-3 antagonist antibody, were discovered at AnaptysBio and licensed by GSK
JEMPERLI (dostarlimab-gxly) has the potential for a first-in-class approval in primary advanced or recurrent endometrial cancer after meeting the primary endpoint in the pivotal RUBY Phase 3 trial demonstrating JEMPERLI plus chemotherapy significantly improved PFS versus chemotherapy plus placebo
Regulatory submissions anticipated H1 2023
GSK expects to publish full results in a medical journal and present at an upcoming scientific meeting
Dostarlimab plus ZEJULA in the pivotal FIRST Phase 3 trial in 1st line ovarian cancer is ongoing with an interim analysis expected in H2 2023
Dostarlimab plus cobolimab plus chemotherapy vs. dostarlimab plus chemotherapy is in the pivotal COSTAR Lung Phase 3 trial in advanced non-small cell lung cancer in patients who have progressed on prior anti-PD-(L)1 therapy

On January 05, 2023 Tavanta Therapeutics, a clinical-stage specialty pharmaceutical company developing a diverse pipeline of specialty drugs that bring clinically meaningful benefits to patients with serious or debilitating diseases, reported positive top-line results from its pivotal, global Phase 3 clinical trial, evaluating the safety and efficacy of TAVT-45 (abiraterone acetate) Granules for Oral Suspension ("TAVT-45"), an investigational enhanced formulation of abiraterone acetate for the treatment of metastatic prostate cancer (Press release, Tavanta Therapeutics, JAN 5, 2023, View Source [SID1234625932]). The trial met its primary objective of establishing therapeutic equivalence of TAVT-45 to Zytiga in patients with metastatic castrate-resistant prostate cancer (mCRPC) and metastatic high-risk castrate-sensitive prostate cancer (mCSPC), in addition to demonstrating a comparable safety profile.

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The primary endpoint comparing serum testosterone levels at Days 9 and 10 was met, demonstrating therapeutic equivalence between TAVT-45 and Zytiga. The key secondary endpoint (a decrease of ≥ 50% in prostate-specific antigen [PSA] levels from baseline at any time over the 84-day treatment period) showed no statistical difference between treatment arms. The safety profile of TAVT-45 in the trial was in line with that of Zytiga.

"The positive results from the TAVT45C02 trial demonstrate that TAVT-45 may provide an easy-to-swallow alternative to Zytiga, benefitting many patients with dysphagia or difficulty swallowing large tablets," said Andreas Maetzel, M.D. Ph.D., chief medical officer of Tavanta Therapeutics. "Approximately 20 to 30 percent of cancer patients, including many patients with prostate cancer, have difficulty swallowing pills and capsules.i,ii We believe these patients may benefit from an alternate formulation like TAVT-45 that would allow them to take their much-needed medications in an easier-to-take formulation."

The Phase 3 registrational trial (Study TAVT45C02; NCT04887506) is a global, randomized, multi-center, open-label trial designed to evaluate the pharmacodynamic effect and safety profile of TAVT-45 compared to Zytiga tablets, in combination with prednisone, in patients with mCRPC and high-risk mCSPC. In addition to establishing therapeutic equivalence between TAVT-45 and Zytiga tablets, the study aims to characterize the multiple-dose pharmacokinetic profile of TAVT-45.

"It is encouraging to see a familiar efficacy and safety profile for TAVT-45, which is consistent with data established for abiraterone acetate as a standard of care in the treatment of metastatic prostate cancer," said Kenneth M. Kernen, M.D., study investigator and partner in the Michigan Institute of Urology. "The positive results from this clinical study further support and validate the use of TAVT-45 as a novel, oral, easy-to-drink formulation of abiraterone acetate. As a physician, this would be a welcome potential treatment alternative that may also help patients adhere to their medication regimens and may ultimately improve clinical outcomes."

"We would like to thank the clinical study site investigators and the patients who participated in this pivotal trial," said Lynne Powell, chief executive officer of Tavanta Therapeutics. "Tavanta intends to submit our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), while also evaluating strategic options for the commercialization of TAVT-45."

Tavanta intends to present detailed results from this Phase 3 registrational study, TAVT45C02, at an upcoming medical meeting, as well as submit for publication.

About TAVT-45 Granules
TAVT-45 (abiraterone acetate) Granules for Oral Suspension ("TAVT-45"), is an enhanced formulation of abiraterone acetate for the treatment of metastatic prostate cancer. When reconstituted with water or juice to yield an oral suspension, TAVT-45 may provide an alternative for the 20 to 30 percent of patients who suffer from dysphagia or have difficulty swallowing tablets and may increase the bioavailability of abiraterone and therefore allow a lower dose to be administered. In addition to the multiple large tablets required daily, other limitations of Zytiga include the requirement to be taken on an empty stomach and the high variability in systemic exposure. This high variability in systemic exposure has been shown to result in patients with low abiraterone plasma concentrations and exposure, which can lead to suboptimal clinical outcomes.iii,iv It is anticipated that TAVT-45 may be taken regardless of food consumption and may result in fewer patients having sub-optimal abiraterone trough plasma concentrations.

on January 5, 2023 -Pheast Therapeutics, a private biotechnology company developing novel innate immune checkpoint inhibitors to unleash the power of macrophages on aggressive, difficult-to-treat cancers, reported the appointment of Jacopo Leonardi as Chief Executive Officer. Mr. Leonardi brings more than 25 years of executive leadership spanning commercial and research and development (R&D) sectors for global pharmaceutical companies as well as experience in building new companies focused on developing novel therapeutics for high unmet medical needs (Press release, Pheast Therapeutics, JAN 5, 2023, View Source [SID1234625948]).

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Amira Barkal, M.D., Ph.D., principal founder and founding CEO of Pheast Therapeutics, will now serve as Chief Development Officer. Dr. Barkal said, "Pheast will benefit from Jacopo’s expertise in building inclusive, inspired teams that reach the ultimate goal of delivering meaningful therapeutics to patients."

"Jacopo’s proven leadership from biopharmaceutical R&D and commercial strategy to early-stage company creation, as well as his experience in advancing new therapeutics in immunology and oncology, will be instrumental in building the team and translating the breakthrough discovery of CD24 blockade into new immunotherapies," added Irving Weissman, M.D., cofounder of Pheast Therapeutics.

"I am excited to join this team of scientific experts and leaders in the field of cancer immunotherapy and innate immunity responsible for several foundational discoveries of novel, tumor-specific macrophage-activating pathways," said Mr. Leonardi. "I look forward to building a purpose-inspired, high-performing team at Pheast to deliver the next generation of innate immunotherapies and provide better treatment options for patients with aggressive, difficult-to-treat cancers."

Mr. Leonardi serves as a Venture Advisor to Agent Capital and on the Board of Directors of AIS Healthcare and recently served on the Boards of Carbon Biosciences and Pyxis Oncology. Previously, he served in key development and global leadership roles in general management, R&D, new product planning, marketing, and sales at Horizon Therapeutics, Baxalta, Baxter Healthcare, Eli Lilly, and Johnson & Johnson. At Baxalta, Mr. Leonardi was Executive Vice President and President of Immunology and was a member of the Executive Leadership Team that spun Baxalta out of Baxter Healthcare, which was subsequently acquired by Shire PLC.

Pheast completed its Series A financing of $76M in April 2022, led by high profile investors, Catalio Capital Management and Arch Venture Partners. Dr. Jacob Vogelstein, Managing Partner of Catalio and Board Director of Pheast, said, "We have been impressed with the power of Pheast’s discovery platform and the early progress being made to elucidate drug candidates that promote anti-tumor responses via interference with CD24 signaling. We look forward to helping the company take maximum advantage of its discoveries to enable the development of new and powerful approaches to the treatment of cancer."

On January 5, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Company will present the latest clinical data of FGFR inhibitor gunagratinib (ICP-192) for the treatment of cholangiocarcinoma at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium on January 19-21, 2023, which will be held online and offline in San Francisco, U.S (Press release, InnoCare Pharma, JAN 5, 2023, View Source [SID1234625947]).

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The 2023 ASCO (Free ASCO Whitepaper) GI Cancers Symposium is an influential academic exchange event in the gastrointestinal cancer in the world, offering the latest innovative science, solution-focused strategies, and multidisciplinary approaches in GI cancer treatment, research, and care.

Poster Presentation

Title: Gunagratinib, a highly selective irreversible FGFR inhibitor, in patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR pathway alterations: A phase IIa dose-expansion study

Abstract Number: 572
Session Title: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Presentation Time: 12:00 PM -1:30 PM, Jan. 20, U.S. Time
Presenter: Professor Ye Guo

On January 5, 2023 -Novocure (NASDAQ: NVCR) reported the LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival over standard therapies alone (Press release, NovoCure, JAN 5, 2023, View Source [SID1234625945]). The LUNAR study is a pivotal, open-label, randomized study evaluating the safety and efficacy of Tumor Treating Fields (TTFields) together with standard therapies for stage 4 non-small cell lung cancer (NSCLC) following progression while on or after treatment with platinum-based therapy.

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The LUNAR study also showed a statistically significant and clinically meaningful improvement in overall survival when patients were treated with TTFields and immune checkpoint inhibitors (ICI), as compared to those treated with immune checkpoint inhibitors alone, and a positive trend in overall survival when patients were treated with TTFields and docetaxel versus docetaxel alone. Patient enrollment was well balanced between the ICI and docetaxel cohorts of the experimental and control arms, and control arms performed in line with prior studies. TTFields therapy was well tolerated by patients enrolled in the experimental arm of the study.

"We are pleased with the positive readout of the LUNAR study. Prior to LUNAR, the last phase 3 trial to lead to significant improvement in overall survival in late-stage, platinum-resistant non-small cell lung cancer was six years ago, underlining the difficulty in treating this disease," said William Doyle, Novocure’s Executive Chairman. "We are also pleased by the profound performance of the TTFields together with immunotherapy, which has the potential to meaningfully extend patient survival beyond what was previously possible. I would like to thank our patients and investigators for their courage and dedication in completing LUNAR. And, I would like to thank Novocure’s employees for their unrelenting commitment to patients and their perseverance in propelling Novocure to this major milestone."

Novocure plans to release the full results of the LUNAR study at a future medical conference. Novocure expects to file a Premarket Approval application with the U.S. Food and Drug Administration (FDA) in the second half of 2023. Novocure also expects to file for a CE Mark in the European Union concurrently with the FDA submission.