A Multi-Center Phase I Study of Codrituzumab in Pediatric Patients With Relapsed or Refractory Glypican 3 (GPC3) Expressing Extra-cranial Solid Tumors

The purpose of this study to find out whether codrituzumab is a safe treatment that causes few or mild side effects in children and young adults who have solid tumors that express the protein GPC3. The researchers also want to study the way codrituzumab is absorbed, distributed, and cleared from the body.

Start Date09 Jun 2021

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

NCT03681483 / CompletedPhase 1IIT

A Phase 1 Trial of RO5126766 (CH5126766) in Patients With Advanced KRAS-Mutant Lung Adenocarcinomas

The purpose of this study is to test the safety of RO5126766 at different doses to find out what effects, if any, it has on people with advanced lung cancer who have previously received treatment with a PD-1 or PD-L1 inhibitor.

Start Date31 Oct 2018

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+2]

NCT01901458 / CompletedNot ApplicableIIT

Prospective Randomized Trial Comparing Efficiency of Peripheral Blood Progenitor Cell Collection in Allogeneic Donors Using the Spectra Optia® IDL Set in Comparison With the Spectra Optia® MNC Collection Set

The study will determine the advantage of the Spectra Optia® IDL set compared to the standard collection set for collection of peripheral blood progenitor cells using the Spectra Optia® apheresis system. The study will assess the reduction of apheresis time to obtain the required amount of hematopoietic progenitor cells.

Start Date01 Mar 2014

Sponsor / Collaborator

Heinrich-Heine-Universität Düsseldorf

[+2]

100 Clinical Results associated with Chugai Pharma USA LLC

0 Patents (Medical) associated with Chugai Pharma USA LLC

Literatures (Medical) associated with Chugai Pharma USA LLC

01 Jul 2021·Cancer Research

Abstract CT111: Results of a phase 1 dose escalation study of ERY974, an anti-glypican 3 (GPC3)/CD3 bispecific antibody, in patients with advanced solid tumors

Author: Nakamura, Mikiko ; Almhanna, Khaldoun ; Matsushima, Junnosuke ; Ogita, Yoshitaka ; Druta, Mihaela ; Morley, Roland ; Morse, Michael ; Safran, Howard ; Pintova, Sofya ; Weiss, Daniel ; Gianella-Borradori, Athos ; Ishiguro, Takahiro ; Lynce, Filipa

AbstractBackground: ERY974, a bispecific T cell-redirecting antibody, redirects T cells to tumor cells by engaging the CD3 antigen on T cells and the glypican 3 (GPC3) antigen selectively expressed on tumors. ERY974 demonstrates T cell-dependent cellular cytotoxicity in vitro and transient cytokine elevations in preclinical toxicology studies (Ishiguro et al. 2017). The primary objective of this dose escalation (DE) study was to determine ERY974's maximum tolerated dose in patients with locally advanced or metastatic solid tumors expressing GPC3. Methods: The study included adult patients with advanced or metastatic solid tumors not amenable to standard therapy, histologically confirmed, with measurable disease and a life expectancy ≥ 3 months, including patients with ≤ 1cm and ≤ 1 brain metastasis. Patients with interstitial lung disease, or acute/active chronic infection were excluded. ERY974 was administered IV and dosed weekly. DE was initiated with an accelerated titration design of single patient cohorts followed by three patient cohorts. To mitigate for the toxicity of cytokine release syndrome (CRS), steroid prophylaxis and a flexible study design was implemented which included a two-step intra-patient escalation (regimen A), and a three-step intra-patient escalation (regimen B). Results: 29 patients were enrolled in dose levels ranging from 0.003 μg/kg to 0.81 μg/kg. Treatment-related adverse events that occurred in greater than 20% of patients included CRS and pyrexia. Dose level 0.81 μg/kg (regimen A) was confirmed not tolerable due to DLTs of Grade 3 CRS and Grade 2 CRS in two out of three patients (assessed according to Lee, et al. 2014). The Grade 3 CRS was associated with Grade 3 transaminitis and a Grade 3 elevation of bilirubin. Both CRS events led to dose delay and dose reduction. Increases in IL-6, IL-8 and IL-10 were observed in patients with the CRS. The severity and frequency of CRS in regimen B were similar to those observed in regimen A at the same dose level. One partial response (per modified RECIST criteria) was observed in a patient with esophageal cancer treated with 0.54 μg/kg (regimen B) and having 40% of the tumor tissue staining positive for GPC3 via immunohistochemistry. Stable disease lasting 3 months or longer was observed in four patients. Conclusions: The observed responses and CRS side effects are markers of ERY974 biologic activity. At doses below 0.81 μg/kg (regimen A), ERY974 was generally well tolerated with a manageable toxicity profile, including ERY-induced CRS which was manageable with steroid administration and anti-IL6R therapy. Further research is required to determine if combined prophylactic anti-IL6R and steroid therapy is a more effective strategy for managing CRS. References: 1. Ishiguro, Takahiro, et al. Science translational medicine, 2017, 9.410: eaal4291. 2. Lee, Daniel W., et al. Blood, 2014, 124.2: 188-195.Citation Format: Howard Safran, Mihaela Druta, Michael Morse, Filipa Lynce, Sofya Pintova, Khaldoun Almhanna, Daniel Weiss, Athos Gianella-Borradori, Yoshitaka Ogita, Roland Morley, Mikiko Nakamura, Junnosuke Matsushima, Takahiro Ishiguro. Results of a phase 1 dose escalation study of ERY974, an anti-glypican 3 (GPC3)/CD3 bispecific antibody, in patients with advanced solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr CT111.

09 Oct 2018·Proceedings of the National Academy of SciencesQ1 · CROSS-FIELD

ZFAND5/ZNF216 is an activator of the 26S proteasome that stimulates overall protein degradation

Q1 · CROSS-FIELD

Article

Author: Lee, Donghoon ; Goldberg, Alfred L. ; Takayama, Shinichi

SignificanceZFAND5/ZNF216, a member of the ubiquitous ZFAND protein family, contains two zinc finger domains. It is induced in skeletal muscle during atrophy and was shown to be essential for the resulting large loss of muscle mass. We show here that purified ZFAND5 stimulates the 26S proteasomes’ capacity to degrade peptides and ubiquitinated proteins. In cells, it promotes the degradation of endogenous cell proteins through its ubiquitin-binding zinc finger domain (A20). Unlike several ZFAND proteins, it is not induced in proteotoxic stresses. Unlike other proteasome activators, ZFAND5 actually stimulates overall protein breakdown by the ubiquitin proteasome pathway.

01 Jul 2018·Cancer Research

Abstract 3028: PET imaging with the bispecific 89Zr-antibody ERY974 targeting CD3 and glypican 3 in tumor-bearing mouse models

Author: Waaijer, Stijn J. ; Hooge, Marjolijn N. Lub-de ; Ohishi, Norihisa ; Gianella-Borradori, Athos ; Sano, Yuji ; Vries, Elisabeth G. de ; Schröder, Carolien P. ; Giesen, Danique ; Ishiguro, Takahiro

AbstractBACKGROUND: ERY974, a modified monoclonal IgG4 bispecific antibody directed against human CD3 on T cells and glypican 3 (GPC3) on tumor cell, is currently in phase I clinical trial. The oncofetal protein GPC3 is overexpressed in several tumor types. Radiolabeling ERY974 with positron emission tomography (PET) isotope zirconium-89 (89Zr) enables non-invasive molecular imaging of tumor targeting and whole-body distribution. We aimed to evaluate 89Zr-ERY974 tumor targeting and effect of T cells on tumor uptake in mouse models, including a humanized mouse model.METHODS: ERY974 and two control molecules namely bispecific CD3xkeyhole limpet hemocyanin (KLH) and KLHxKLH antibodies were radiolabeled with 89Zr. Studies were performed in immunodeficient NOD/Shi-SCID/IL-2Rgnull (NOG) as well as human CD34+ hematopoietic stem cell engrafted NOG mice (huNOG), all subcutaneously inoculated with GPC3 overexpressing human hepatocellular carcinoma HepG2 cells. Mice received 10 µg 89Zr-ERY974, 89Zr-CD3xKLH or 89Zr-KLHxKLH intravenously, with subsequent µPET scanning at 24, 72, 120 and 168 h followed by ex vivo biodistribution. Organs of interest were quantified on µPET scans as mean standardized uptake value (SUVmean) and with ex vivo biodistribution as % injected dose/gram of tissue (%ID/g). Tumor, spleen and lymph nodes were analyzed with autoradiography and immunohistochemical CD3 staining.RESULTS: µPET imaging revealed increased tumor-to-blood ratio (TBR) of 89Zr-ERY974 in NOG over time with maximal TBR of 2.2±0.3 at 168 h post tracer injection (pi). At 168 h, tumor uptake was specific as 89Zr-CD3xKLH and 89Zr-KLHxKLH showed a TBR of only 0.6±0.2 and 0.8±0.3, respectively. In huNOG mice human CD3+ T cells were present in tumor, spleen and lymph nodes. In huNOG mice tumor uptake of 89Zr-ERY974 was higher than in NOG mice as measured on µPET scans (SUVmean at 168 h pi 6.9±2.6 vs 2.9±0.2; P<0.01) and with ex vivo biodistribution (60.9±26.2 %ID/g vs 16.7±2.3 %ID/g; P<0.001), whereas 89Zr-CD3xKLH tumor uptake in both mouse models was lower (P<0.05) but were similar in these mouse models. Autoradiography 168 h following 89Zr-ERY974 administration to huNOG mice showed 89Zr in extensive T cell infiltrate areas in the tumors of huNOG mice, whereas T cell infiltrate was lower in tumors of 89Zr-CD3xKLH and 89Zr-KLHxKLH injected huNOG mice. Spleens of huNOG mice showed CD3+ specific uptake as 89Zr-ERY974 and 89Zr-CD3xKLH uptake were higher than 89Zr-KLHxKLH uptake(P<0.05), whereas spleen uptake in NOG mice of the 3 tracers was similar. Moreover, in huNOG CD3+ mesenteric lymph nodes 89Zr-ERY974 uptake was higher than 89Zr-KLHxKLH uptake (P<0.05)CONCLUSION: 89Zr-ERY974 demonstrates specific tumor uptake in NOG and huNOG mice, while in huNOG mice tumor uptake colocalized with T cell rich infiltrate and also uptake in in spleen and lymph nodes was observed.Citation Format: Stijn J. Waaijer, Danique Giesen, Takahiro Ishiguro, Yuji Sano, Norihisa Ohishi, Athos Gianella-Borradori, Carolien P. Schröder, Elisabeth G. de Vries, Marjolijn N. Lub-de Hooge. PET imaging with the bispecific 89Zr-antibody ERY974 targeting CD3 and glypican 3 in tumor-bearing mouse models [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 3028.

News (Medical) associated with Chugai Pharma USA LLC

15 Dec 2022

·www.biospace.com

Endonovo Announces Plans for Spin-off of Medical IP and Assets

New Company To Be Formed for SofPulse® Medical Device Line Los Angeles, CA, Dec. 15, 2022 (GLOBE NEWSWIRE) -- Endonovo Therapeutics, Inc. (OTCQB: ENDV) today announced plans to affect a spin-off of its medical device assets to a new company (“NewCo”) being formed by its current President and Chief Commercial Officer of its Medical Division, Ira Weisberg. Weisberg will be responsible for running NewCo independently from Endonovo and will develop commercialization initiatives through sales and marketing channels for NewCo utilizing the SofPulse® medical assets. Endonovo’s recently announced telehealth initiative will be included in the spin-off of NewCo. NewCo shall pay such amount to Endonovo as determined by a third-party fairness opinion report. The payment may be in stock or note convertible into NewCo common stock. Endonovo intends to make such filings as will allow it to make special dividends of NewCo stock to its shareholders or to structure the transaction so that the stock is received contemporaneously with the spin-off. Endonovo intends to apply a portion of the shares available through the spin-off to satisfy its present debt holders. While no firm arrangements have been made, Endonovo believes that approximately 20% of the shares received in the spin-off will be paid to satisfy its existing debtholders with the balance principally available to existing shareholders. The structure of the eventual spin-off is subject to agreements with NewCo and the existing noteholders as well as other conditions. $50 Million Projected Pre-Money Valuation Management believes that upon completion of the spin-off, NewCo will have a pre-money valuation in excess of $50 million. Additionally, Weisberg has detailed sales and marketing plans to raise working capital through equity financing to continue the commercialization of SofPulse®. All shares distributed to ENDV shareholders shall be issued on a pro rata basis. NewCo’s management believes it can take NewCo to more than $100 million in sales by 2024. NewCo will assemble an outside Board of Directors and appoint the appropriate committee members and necessary infrastructure requirements to prepare itself to become a NASDAQ listed company. Current Endonovo CEO Alan Collier said in making the announcement: “We want to make sure that all present and future stockholders will benefit fairly with the spin-off of IP and medical device assets. Having Ira Weisberg heading the direction and development of SofPulse® is a huge benefit. “Ira is a proven medical company executive and business development specialist and has multiple success stories in working with similar types of medical companies and devices. I believe with Weisberg running the ship, SofPulse® devices will finally be able to reach the potential that the Pulsed Electro Magnetic Frequency (PEMF) technology can provide to the medical community.” To evaluate the fairness of a proposed transaction from a financial point of view, Endonovo will seek out an independent financial advisor and a respected medical device valuation firm. They will be tasked to develop a valuation of medical Intellectual Property (IP) assets through a fairness opinion report. The last valuation report issued for SofPulse® IP and assets stated that these assets were worth $75 million in 2018. Fairness Opinion to be Provided The fairness opinion report will be prepared for Endonovo Therapeutics, Inc. and referenced in filings with the Securities and Exchange Commission (SEC). Once the proposed spin-off is fully structured and the necessary agreements competed, Endonovo shall prepare a 14C filing with the SEC and distribute information statements to the shareholders whereby the Chairman of the Board and the majority voting shareholders plan to have prior approval of the spin-off of the medical device assets to NewCo. Weisberg to be NewCoCEO/President Ira Weisberg has been designated as the CEO/President of NewCo. Weisberg has previous successes in growing multiple medical devices and pharmaceutical companies to profitability and increasing valuations of medical assets in excess of $750 million. He has headed the development of an aggressive “go to market” business plan to commercialize the SofPulse® medical device assets to generate sales in excess of $100 million in revenue in 2024. NewCo will retain an auditor to provide an inception audit on the company Weisberg has more than four decades of experience in healthcare and pharmaceutical management: President and CEO of Amherst Pharmaceuticals; Senior VP and Corporate Development Officer at Neurotrope Bioscience; Negotiated out-licensing, supply, distribution and development agreements in excess of $100 million with major pharmaceutical companies; Contributed to revenues for a company’s specialty product valued at $500 million while assisting building its valuation to more than $750 million; Other medical administrative experience at: Allphavax, Inc., Lifecycle Pharma, Chugai Pharma USA, Haemacure Corporation and Aventis Behring; Led negotiations and signed licensing agreements for strategic acquisitions, distribution and development deals for multiple companies in the medical device and pharmaceutical industry; Positioned a company globally through negotiations and signing of multinational licensing and joint venture agreements; Developed strategies to guide emerging medical companies in fast-growing emerging medical device and pharmaceutical markets; Guided growth and generated revenue of more than $30 million for an IPO. Weisberg stated: “Having SofPulse® and the opportunity to expand the commercialization of PEMF technology globally is an opportunity of a lifetime. Our plan is to position SofPulse® as the standard of care for the mitigation of pain and for the treatment of the associated edema and swelling. We are excited about the future of the SofPulse® devices as well as NewCo.” About Endonovo Therapeutics, Inc. Endonovo Therapeutics is currently structured into two divisions: Legacy – a commercial-stage developer primarily of noninvasive wearable Electroceuticals® therapeutic devices for pain relief, general wellness and wound curatives with many of its products marketed under the SofPulse® brand name; and its Build Up Strategy – acquiring complementary specialty service providers in the construction industry. Safe Harbor Statement This press release contains information that constitutes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, trends, analysis, and other information contained in this press release including words such as "anticipate", "believe", "plan", "estimate", "expect", "intend" and other similar expressions of opinion, constitute forward-looking statements. Any such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any future results described within the forward-looking statements. Risk factors that could contribute to such differences include those matters more fully disclosed in the Company's reports filed with the Securities and Exchange Commission. The forward-looking information provided herein represents the Company's estimates as of the date of the press release, and subsequent events and developments may cause the Company's estimates to change. The Company specifically disclaims any obligation to update the forward-looking information in the future. Therefore, this forward-looking information should not be relied upon as representing the Company's estimates of its future financial performance as of any date subsequent to the date of this press release. Investor Relations Contact: Endonovo Therapeutics, Inc. Steve Barnes (800) 701-1223 Ext. 108 sbarnes@endonovo.com Media Contact: Gregory A. McAndrews Greg McAndrews & Associates (310) 804-7037 greg@gregmcandrews.com

AcquisitionExecutive ChangeLicense out/in

28 Jun 2021

·www.biospace.com

Chugai’s Enspryng (Satralizumab) Approved by European Commission as First At-home Subcutaneous Treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD)

June 28, 2021 06:11 UTC Enspryng is a new treatment approved for both adults and adolescents with AQP4-IgG seropositive NMOSD in the EU. It is the first treatment approved in the EU for adolescents from 12 years of age with NMOSD. Enspryng is the first approved medicine applying Chugai’s proprietary recycling antibody technology. It can be self-administered* subcutaneously at home every four weeks** Enspryng significantly reduced risk of relapse in people with AQP4-IgG seropositive NMOSD in two global phase III studies. The medicine has been approved in 54 countries including Japan, the United States and the EU. TOKYO--(BUSINESS WIRE)-- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Roche has been granted Marketing Authorization from the European Commission for the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody Enspryng® (satralizumab), created by Chugai, as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). Enspryng is the first treatment approved in the EU for adolescents from 12 years of age with NMOSD. “We are very pleased that Enspryng is now approved in the EU as the first subcutaneous treatment for people with AQP4-IgG seropositive NMOSD, with the option to be treated at home,” said Chugai’s President and CEO, Dr. Osamu Okuda. “Enspryng is the first approved therapeutic antibody for which our proprietary recycling antibody technology was applied. We are confident that Enspryng will meaningfully contribute to improving the treatment of people with NMOSD, by fitting into their day-to-day lives.” The efficacy and safety of Enspryng has been evaluated in large clinical trials representative of the real-world population of people with NMOSD, including those who have only experienced a single NMOSD attack and adolescents. The approval by the European Commission is based on the results from two global phase III clinical studies in people with NMOSD: SAkuraSky Study (NCT02028884) and SAkuraStar Study (NCT02073279). SAkuraSky evaluated Enspryng in combination with baseline immunosuppressive treatment, and SAkuraStar assessed monotherapy. Enspryng is designed to prevent NMOSD relapses by inhibiting IL-6 signal signaling, which is a key driver in NMOSD. Enspryng is currently approved in 54 countries including Japan, the United States and EU countries. The impact on the consolidated financials for the fiscal year ending December 2021 of Chugai is expected to be negligible. *Self-administration is not covered in Japan at this time **Subcutaneous administration at 2-week intervals up to the fourth week of treatment and at 4-week intervals thereafter [Reference] New Data of Chugai’s Enspryng (Satralizumab) on Risk and Severity of Relapse in Neuromyelitis Optica Spectrum Disorder (NMOSD) (September 10, 2020) SAkuraSky study Results from Phase III SAkuraSky Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online (November 29, 2019) SAkuraStar study Positive Results from the Second Phase III SAkuraStar Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in The Lancet Neurology (April 24, 2020) About neuromyelitis optica spectrum disorder (NMOSD)1 NMOSD is an autoimmune disease of the central nervous system characterized by inflammatory lesions in the optic nerves and spinal cord, and causes a continual and significant decrease in quality of life due to permanent neurological disability. Patients with NMOSD frequently experience a relapsing disease course with repeated attacks leading to accumulating neurological damage and disability. Symptoms may include visual impairment, motor disability, pain leading to decreased quality of life. In some cases, attacks of NMOSD result in death. Aquaporin-4 antibodies (AQP4-IgG), pathogenic antibodies, are detected in around 70-80% of NMOSD people. AQP4-IgG is known to target and damage a specific central nervous cell type called astrocytes, resulting in inflammatory demyelinating lesions of the optic nerve(s), spinal cord and brain 2-5. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis 6-10. Trademarks used or mentioned in this release are protected by law. Sources 1. Neuromyelitis optica spectrum disorder (NMOSD) Online. Accessed June 2021. (Japanese only) 2. Jarius S, Ruprecht K, Wildemann B et al. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: A multicentre study of 175 patients. J Neuroinflammation 2012;9:14. 3. Lennon VA, Wingerchuk DM, Kryzer TJ et al. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet 2004;364:2106-12. 4. Marignier R, Bernard-Valnet R, Giraudon P et al. Aquaporin-4 antibody-negative neuromyelitis optica: Distinct assay sensitivity-dependent entity. Neurology 2013;80:2194-200. 5. Takahashi T, Fujihara K, Nakashima I et al. Anti-aquaporin-4 antibody is involved in the pathogenesis of NMO: a study on antibody titre. Brain 2007;130:1235-43. 6. Chihara N, Aranami T, Sato W et al. Interleukin 6 signaling promotes anti-aquaporin 4 autoantibody production from plasmablasts in neuromyelitis optica. Proc Natl Acad Sci USA 2011;108:3701-6. 7. Kimura A, Kishimoto T. IL-6: regulator of Treg/Th17 balance. Eur J Immunol 2010;40:1830-5. 8. Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review. Int J Neurosci2016;126:1051-60. 9. Takeshita Y, Obermeier B, Cotleur AC, et al. Effects of neuromyelitis optica-IgG at the blood-brain barrier in vitro. Neurol Neuroimmunol Neuroinflamm. 2016;4(1):e311. 10. Obermeier B, Daneman R, Ransohoff RM. Development, maintenance and disruption of the blood-brain barrier. Nat Med 2013;19:1584-96. View source version on businesswire.com: Contacts For Media Chugai Pharmaceutical Co., Ltd. Media Relations Group, Corporate Communications Dept., Tomoko Shimizu Tel: +81-3-3273-0881 E-mail: pr@chugai-pharm.co.jp For US media Chugai Pharma USA Inc. Casey Astringer Tel: +1-908-516-1350 E-mail: pr@chugai-pharm.com For European media Chugai Pharma U.K. Ltd. Tania Richards Tel: +44-20-8987-5680 E-mail: pr@chugai.eu For Taiwanese media Chugai Pharma Taiwan Ltd. Susan Chou Tel: +886-2-2715-2000 E-mail: pr@chugai.com.tw For Investors Chugai Pharmaceutical Co., Ltd. Investor Relations Group, Corporate Communications Dept., Takayuki Sakurai Tel: +81-3-3273-0554 E-mail: ir@chugai-pharm.co.jp Source: Chugai Pharmaceutical Co., Ltd. View this news release online at:

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Codrituzumab ( GPC3 )	GPC3 Positive Neoplasms More	Phase 1
Avutometinib ( BRAF x CRAF x MEK )	KRAS mutant Non-small Cell Lung Cancer More	Phase 1
Mitemcinal Fumarate ( GPR38 )	Gastroparesis More	Discontinued
CAL-1-transduced hematopoietic stem cell gene therapy(Calimmune, Inc.) ( CCR5 )	Breast Cancer More	Discontinued
BO-653	Graft Occlusion, Vascular More	Discontinued

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