On January 5, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported its 2023 company priorities and provided a pipeline update which included anticipated milestones for 2023, recent progress and achievements in its wholly owned and collaboration pipeline, and a data update for the Phase 2, CX-2029 cohort expansion study (Press release, CytomX Therapeutics, JAN 5, 2023, View Source [SID1234625961]). The company will host a call with investors today to review the CX-2029 cohort expansion study data and potential key pipeline events for 2023.

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"We are delighted to enter 2023 with strong momentum across all areas of our business. CytomX’s scientific depth and leadership in pioneering the field of conditionally activated, localized biologics has enabled us to build a robust therapeutic pipeline and continue to attract elite partners with a shared vision of pursuing bold science to positively impact the lives of people with cancer," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics. "For CX-2029 specifically, we have pushed the boundaries of biologics localization with our Probody technology to create a therapeutic window for the previously undruggable target, CD71. The full CX-2029 Phase 2 cohort expansion data continues to demonstrate encouraging clinical activity in unselected, heavily pre-treated patients with tumors of squamous histology and we look forward to working with our partner AbbVie to determine the next steps for this program," continued Dr. McCarthy.

"We also start 2023 with an exciting new collaboration with Moderna that combines the power of our respective technologies to break new ground in oncology and other areas of unmet medical need. This latest alliance comes just weeks after our announcement of a major new collaboration with Regeneron. These collaborations underscore CytomX’s innovation and leadership and further strengthen our organizational foundation as we build for the future. Looking further out into 2023, we expect to make meaningful progress with AbbVie and BMS, to continue Phase 1 investigation of our first T-cell engaging therapy (CX-904) and to file INDs for two new wholly owned programs," continued Dr. McCarthy.

CX-2029 PHASE 2 COHORT EXPANSION DATA UPDATE

Study Highlights and Next Steps:

The updated study results reflect an August 5, 2022, full data cut and an October 4, 2022, data snapshot for efficacy.
The data demonstrate encouraging clinical activity in unselected, heavily pre-treated patients with tumors of squamous histology including a 21% objective response rate (ORR) in squamous esophageal cancer and a 10% ORR in squamous non-small cell lung cancer (sqNSCLC).
The adverse event (AE) profile was consistent with Phase 1 observations with anemia (82.6%) being the most common treatment related adverse event (TRAE). Anemia was managed with transfusions, dose delays, and reductions.
Treatment discontinuation rate due to AEs was 3.3% as a result of anemia.
CytomX and AbbVie will determine potential next steps for CX-2029 in 2023.

Study Background:

The enrolled study cohorts included advanced esophageal/gastro-esophageal junction cancer (E/GEJ), squamous non-small cell lung cancer (sqNSCLC), and head and neck squamous cell carcinoma (HNSCC). The efficacy-evaluable study population included 29 patients with E/GEJ, 30 patients with sqNSCLC, and 28 patients with HNSCC. These patients had received at least one dose of CX-2029 at 3 mg/kg and had at least one post baseline assessment, including, per protocol, 5 patients (2 sqNSCLC and 3 HNSCC) enrolled in the previously reported dose escalation phase. Patients were not selected for CD71 expression.
Data Highlights:

In the 29 efficacy evaluable patients with E/GEJ, 14 patients had squamous esophageal cancer.
In the 14 patients with squamous esophageal cancer, the ORR was 21.4% (3 patients) and 35.7% (5 patients) had a best response of stable disease (SD). As of the Oct 4th data snapshot, 5 patients remained on study (3 confirmed partial responses (cPRs) and 2 SD), 3 of whom had already been on study for 24 weeks, suggesting promising durability of response.
There were no confirmed responses in E/GEJ patients with non-squamous tumors. 4 patients had a best response of stable disease with two on study greater than 6 months.
In the 30 efficacy evaluable patients with sqNSCLC, objective response rate (ORR) by local investigator was 10.0%. 56.7% (17 sqNSCLC patients) of patients had a best response of stable disease.
In 28 patients with HNSCC, the confirmed ORR was 4% (1 patient with duration of response of approximately 12 months) and 46.4% (13 patients) had a best response of SD, including one with duration of response of approximately 10 months, and one unconfirmed PR.
Summary table of the efficacy results: (For Discussion on Conference Call)

Efficacy Evaluable Population a Esophageal Squamous
n=14** Esophageal Adeno/GEJ/Other
n=15 SqNSCLC
n=30 HNSCC
n=28**
Complete Response (CR) 0 0 0 0
Partial Response (PR) 3 (21.4) 0 (0.0) 3 (10.0) 2 (7.1)
Confirmed PR (%) 3 (21.4) 0 (0.0) 3 (10.0) 1 (3.6)
Unconfirmed PR (%) 0 (0.0) 0 (0.0) 0 (0.0) 1 (3.6)
Stable Disease 5 (35.7) 4 (26.7) 17 (56.7) 13 (46.4)
Disease Control Rate* 8 (57.1) 4 (26.7) 20 (66.7) 15 (53.6)
Progressive Disease 5 (50.0) 11 (73.3) 10 (33.3) 12 (42.9)
aIncludes patients who received at least one post-baseline assessment and includes 5 patients from Part B dosed at 3 mg/kg Q3W
* A best response of CR, PR, or SD at the first post-baseline assessment
**1 patient not evaluable

Safety:

Safety analysis was conducted on all patients who received at least one dose of CX-2029 at 3 mg/kg (N=92). The median number of prior therapies in the metastatic setting was three (range, 1-12) for sqNSCLC, four (range, 1-9) for HNSCC, and three (range, 1-6) for Esophageal. All patients with sqNSCLC had received prior platinum and prior checkpoint inhibition; in HNSCC, all but one patient received prior platinum and all but two, prior checkpoint inhibition; in G/EJ, 100% of patients received prior platinum; in squamous esophageal, 60% of patients received prior checkpoint inhibition, and in non-squamous esophageal 20% of patients received prior checkpoint inhibition therapy.

The safety profile was consistent with previous observations, with no new safety signals identified. The most common treatment-related adverse events (TRAEs) in 10% or more of patients (All Grade, Grade 3+) were anemia (82.6%, 76.1%), infusion related reactions (70.7%, 3.3%), neutropenia (23.9%, 17.4%), fatigue (17.4%, 1.1%), nausea (13.0%, 1.1%), and diarrhea (10.9%, 0%). There was 1 febrile neutropenia event (Grade 3) reported.
The most common reason for treatment discontinuation was disease progression (77.1%), three patients (3.3%) discontinued due to treatment-related anemia.
Five squamous esophageal patients were still on treatment as of the October 4th, 2022, data snapshot.
EXPANDING R&D ACTIVITIES IN FIELD OF T-CELL ENGAGING BISPECIFICS (TCBS)

The localization of the potent activity of T-cell engagers in solid tumors is a major opportunity in cancer research and development and the Probody platform may be ideally suited to unlock this important modality. In addition to CX-904, CytomX has developed significant expertise and capabilities in TCB discovery and clinical candidate optimization through its biologic masking strategies which has resulted in meaningful pre-clinically pipeline opportunities in both its wholly owned and collaboration pipeline.

CX-904 (EGFRxCD3 bispecific) Phase 1 Clinical Study Ongoing

The first patient in the CX-904-101 Phase 1 study was dosed in May 2022. The trial continues to enroll patients with advanced solid tumors and has successfully advanced through the single-patient cohort phase of dose escalation. The trial has now entered the "3+3" stage of dose escalation and continues to enroll patients. The continued progression of CX-904 is a key priority for the company in 2023 with the primary goal of assessing safety and determining a recommended dose, or doses, for subsequent expansions in select tumor types. This program is partnered with Amgen in a global co-development alliance.

Progress in Astellas TCB Collaboration

Under the agreement with Astellas, the companies are collaborating on conditionally activated TCB programs with CytomX eligible to receive future preclinical, clinical and commercial milestones. CytomX retains a cost share and co-commercialization option on a select number of targets. The progress in the collaboration demonstrates Astellas’ and CytomX’s commitment to leveraging T-cell engaging bispecifics for cancer immunotherapy.

Regeneron Bispecific Collaboration Initiated

In November 2022, CytomX announced its collaboration with Regeneron to enable the development of investigational next-generation bispecific immunotherapies using CytomX’s Probody and Regeneron’s Veloci-Bi platforms. The Probody platform has the potential to widen the therapeutic window and help minimize off-target effects for these next-generation T-cell engaging therapies, potentially addressing tumor types that have historically been unresponsive to immunotherapy. CytomX received a $30 million upfront payment in December 2022 and is eligible for up to approximately $2 billion in research, development, regulatory and sales-based milestones.

EMERGING NEXT-GENERATION WHOLLY OWNED PIPELINE: TWO INDS TARGETED FOR 2023

CytomX’s continued investment in cutting-edge science and leadership in the field of biologics localization has resulted in a depth of understanding in protease biology and the tumor microenvironment that enables the company to pursue a broad range of pipeline opportunities and continuously raise the bar for investigational medicines that enter the clinic. For CytomX’s next generation molecules, the company has selected the previously validated anti-cancer targets, EpCAM and IFNa2b, respectively, that have been limited in their potential due to systemic toxicities. In the molecular design of CX-2051 and CX-801, we have incorporated our platform expertise and clinical learnings to optimize predicted therapeutic index in order to potentially broaden the clinical utility of these promising targets through tumor localized conditional activation.

CX-801, Interferon-alpha 2b (IFNa2b)

Interferon-alpha 2 beta is an approved immunotherapeutic that has demonstrated clinical activity in multiple cancer types, including in combination with checkpoint inhibitors. IFNa2b provides a potentially superior approach to activating anti-tumor immune responses than other cytokines. CX-801 is a dually masked, conditionally activated version of IFNa2b that has the potential to become a unique centerpiece of combination therapy for a wide range of tumor types. The company plans to rapidly advance this potentially best-in-class program towards clinical evaluation with an IND filing targeted for the second half of 2023.

CX-2051, Antibody Drug Conjugate (ADC) targeting EpCAM

EpCAM is a high potential oncology target that has been clinically validated with locally administered, approved cancer therapies. However, efforts to generate systemic anti-EpCAM therapeutics have, to date, not been successful due to toxicities in epithelial tissues. CX-2051, a conditionally activated ADC, is tailored to optimize the therapeutic index for EpCAM-expressing epithelial cancers. CX-2051’s payload is camptothecin, a topoisomerase-1 inhibitor, that has a well characterized profile base on the strong clinical activity observed with other topoisomerase-1 inhibiting ADCs. CX-2051 has demonstrated a wide predicted therapeutic index and strong preclinical activity and tolerability in multiple preclinical models, including colorectal cancer. The company anticipates filing an IND for this novel ADC in the second half of 2023.

BMS ANTI-CTLA-4 PROBODY PROGRAMS

Bristol Myers Squibb (BMS) continues to make important progress in its next-generation CTLA-4 programs, including with BMS-986249, the Probody version of ipilimumab and BMS-986288, a non-fucosylated CTLA-4 targeting Probody.

CytomX anticipates continued progress from Bristol Myers Squibb on these programs in 2023.

BMS-986249 (Masked version of ipilimumab)

BMS is evaluating BMS-986249 in a randomized Phase 2 study in combination with nivolumab, versus ipilimumab plus nivolumab, in patients with advanced melanoma. The combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer. At ESMO (Free ESMO Whitepaper) 2022, BMS presented promising updated Phase 1 data for BMS-986249 from an ongoing Phase 1/2 study in patients with advanced cancers. These data demonstrated that as a monotherapy and in combination with nivolumab, BMS-986249 may be tolerated at higher doses than standard ipilimumab clinical dosing. Clinical activity was also demonstrated in multiple tumor types, including melanoma and a particularly encouraging case study of a response in microsatellite-stable colorectal cancer.

BMS-986288 (Non-fucosylated CTLA-4 targeting Probody)

BMS also continues to study the non-fucosylated CTLA-4-targeting Probody, BMS-986288, in a Phase 1 / 2 study, both as monotherapy and also in combination with nivolumab, in patients with advanced solid tumors. This strategy is aimed at enhancing the clinical benefit of ipilimumab by superior antigen presenting cell (APC)-mediated T cell priming.

MODERNA ALLIANCE

The new collaboration, announced today, will combine CytomX’s Probody Platform with Moderna’s mRNA technologies to generate and develop therapeutics for oncology and non-oncology conditions. CytomX will receive a $35 million upfront payment with the potential for up to approximately $1.2 billion in research, development, regulatory and sales-based milestones. 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.

2023 KEY MILESTONES AND OUTLOOK

CytomX enters 2023 in a strong strategic position and with significant momentum in its pipeline. In 2023, the company expects to see the continued realization of our vision for conditionally activated, localized therapies through key pipeline milestones including:

CX-904 (EGFRxCD3): Continue patient enrollment and dose escalation in ongoing Phase 1 study
File 2 New INDs: CX-801 (IFNa2b) and CX-2051 (EpCAM) projected in 2H 2023
CX-2029 (CD71): Determine next steps with AbbVie
BMS CTLA-4: Continued clinical progress on BMS-986249 and BMS-986288
Collaborations: Initiation of R&D activities with our newest collaborators, Regeneron and Moderna
The company also remains in a strong financial position with cash into 2025 and a capital allocation, financing and business development strategy focused on both managing variable financial market conditions and delivering meaningful long-term value for patients and stakeholders.

Conference Call & Webcast
CytomX management will host a conference call and a simultaneous webcast today, January 5th 2023 at 5 p.m. ET (2 p.m. PT). A live webcast of the call can be accessed via the Events and Presentations page of CytomX’s website at View Source A replay of the webcast will also be available for 30 days following the call.

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