On May 16, 2022 Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for patients with cancer, reported on recent and upcoming business highlights and announced its financial results for the first quarter ended March 31, 2022 (Press release, Cullinan Oncology, MAY 16, 2022, View Source [SID1234614649]).

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"We made excellent progress in the first quarter of 2022, substantially advancing our lead asset, CLN-081, and continuing to progress our diversified pipeline," said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. "Our March clinical and regulatory update for CLN-081 further affirmed its differentiated profile, and we are looking forward to sharing an additional clinical update in an oral presentation at the upcoming ASCO (Free ASCO Whitepaper) meeting. We also announced a U.S. co-development and co-commercialization agreement for CLN-081 with Taiho, the original innovators of the molecule, and an ideal partner with whom to advance this asset into later stage development and commercialization. The proceeds from this transaction will also allow us to accelerate and expand the development of our diverse pipeline as well as discover and obtain promising new oncology therapeutic candidates."

Mr. Ahmed continued, "We are also pleased to continue the progression of our pipeline programs. Dosing in the Phase I trials of CLN-619 and CLN-049 was initiated in December 2021 and the studies are continuing on track to deliver initial data readouts by mid-2023. We are also on track to file INDs for two additional programs, CLN-617 and CLN-978, in the first half of next year. Importantly, we are in an even stronger financial position to continue advancing our strategically built pipeline of diversified assets, each with the potential to be the first or best in their class. We ended the first quarter of 2022 with approximately $410 million in cash and investments2, which, when added to proceeds from the Taiho deal, aggregates to $685 million, and extends our cash runway through 2026."

Portfolio Highlights

CLN-081 (Pearl): Cullinan announced the simultaneous sale of Cullinan Pearl and a U.S. co-development and co-commercialization collaboration of CLN-081 with Taiho Pharmaceutical Co., Ltd. (Taiho). Cullinan will receive $275 million upfront and is eligible for an additional $130 million tied to EGFR exon20 NSCLC regulatory milestones, in addition to sharing 50/50 in the future potential U.S. profits and losses for CLN-081. In January, Cullinan announced that CLN-081 was granted Breakthrough Therapy Designation (BTD) for the treatment of non-small cell lung cancer (NSCLC) patients harboring epidermal growth factor (EGFR) exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy. In March, Cullinan reported a clinical and regulatory update for CLN-081, which included an improved 41% confirmed overall response rate at 100mg BID and a continued favorable safety and tolerability profile.
CLN-049 (Florentine): In December 2021, patient dosing was initiated in a first-in-human clinical trial evaluating CLN-049 in patients with relapsed/refractory AML and MDS. Initial clinical data are expected by mid-2023. CLN-049 is a FLT3/CD3-bispecific T cell-engaging antibody in an IgG format for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 targets the extracellular domain of FLT3, regardless of mutant or wild type expression.
CLN-619 (MICA): In December 2021, patient dosing was initiated in a first-in-human clinical trial evaluating CLN-619 alone and in combination with pembrolizumab in patients with advanced tumors. Initial clinical data are expected by mid-2023. CLN-619 is a first-in-class monoclonal antibody that stabilizes MICA/MICB on the tumor cell surface to promote an antitumor response via activation of both natural killer (NK) cells and certain T cells, with broad therapeutic potential across multiple cancer indications.
Preclinical Portfolio: Continued advancement of five additional oncology programs with the following highlights:
Preclinical data across five distinct programs were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting in April, including CLN-049, CLN-619, CLN-617 (Amber), CLN-978 (NexGem) and Opal.
Cullinan Oncology continues to advance two programs through Investigational New Drug (IND)-enabling studies: CLN-617, a cytokine fusion protein uniquely combining IL-12 and IL-2 with a collagen binding domain for retention in the tumor microenvironment (TME), and CLN-978, a novel CD19/CD3-bispecific construct with extended serum half-life and high potency against target cells expressing very low levels of CD19. Cullinan expects to submit INDs for both programs by the end of the first half of 2023.
First Quarter 2022 Financial Results

Cash Position: Cash and investments2 were $410 million as of March 31, 2022. Including the $275 million upfront payment related to the Taiho transaction, we expect to have $685 million in cash and investments2. As a result of the transaction and based on current operating plans, we expect to have cash runway through 2026, compared to our previous guidance of through 2024.
R&D Expenses: Research and development (R&D) expenses were $24.5 million for the first quarter of 2022, compared to $20.9 million for the fourth quarter of 2021. R&D expenses for each of the first quarter of 2022 and fourth quarter of 2021 included $2.6 million of equity-based compensation expenses. The increase in R&D expenses is primarily related to expanded clinical and chemistry, manufacturing, and controls (CMC) activity for CLN-081 and CLN-619, IND-enabling activities for CLN-617, and discovery and development of our preclinical programs.
G&A Expenses: General and administrative (G&A) expenses were $8.1 million for the first quarter of 2022, compared to $13.5 million for the fourth quarter of 2021. G&A expenses in the first quarter of 2022 and fourth quarter of 2021 included $3.8 million and $9.6 million of equity-based compensation expenses, respectively. The decrease in G&A expenses was primarily driven by a decrease in equity-based compensation expenses, partially offset by a $0.3 million increase in professional services.
Net Loss: The Company’s net loss (before items attributable to noncontrolling interest) was $12.9 million for the first quarter of 2022 compared to $34.2 million for the fourth quarter of 2021. The decrease in net loss was primarily related income tax benefits recorded for the expected utilization of current quarter losses and the release of valuation allowance of certain historical tax losses against the expected gain on the sale of Cullinan Pearl, as well as a decrease in equity-based compensation expenses, which were partially offset by increases in R&D costs to advance our portfolio.

On May 16, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on advanced therapies for autoimmune and inflammatory diseases, reported financial results for the full year ended December 31, 2021, as well as recent pipeline progress (Press release, Akari Therapeutics, MAY 16, 2022, View Source [SID1234614648]).

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"During the last twelve months, Akari has advanced nomacopan pre-clinical and clinical development programs, including three focus areas of autoimmune skin diseases, thrombotic microangiopathies, and progressive retinal diseases," said Rachelle Jacques, President and CEO of Akari Therapeutics. "Broad and deep research and development work is producing compelling science in diseases with complex pathologies and is providing the foundation for next steps in the development of bispecific recombinant nomacopan. Late-stage programs in pediatric HSCT-TMA and BP are active and advancing in Part A clinical studies, which will inform the pivotal Part B studies that will be the basis for potential regulatory submissions in the U.S. and Europe."

Full Year 2021 and Recent Clinical Highlights

Late-Stage Program Studying Investigational Nomacopan in Pediatric HSCT-TMA

Phase III Part A clinical trial sites are open and recruiting in the U.S. and Europe for investigation of nomacopan in pediatric HSCT-TMA.
Urgent unmet need exists in pediatric HSCT-TMA with no approved treatment options in the U.S. or Europe; currently the subset of patients Akari is studying are facing a mortality rate of ~80%
Nomacopan was granted Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for pediatric HSCT-TMA
Patient dosing is underway in the Part A study that has a recruitment goal of approximately seven patients, with a minimum of two patients in each of three age cohorts
Late-Stage Program Studying Investigational Nomacopan in Bullous Pemphigoid (BP)

FDA and European Medicines Agency (EMA) registration-directed Phase III Part A study of nomacopan in moderate and severe BP patients is open for enrollment following resolution of third-party supply chain partner issues that resulted in delays. Data from the Part A study will inform the pivotal Part B study that will be the basis for potential regulatory submissions in the U.S. and Europe
There are no approved therapies; superpotent topical steroid and high dose oral corticosteroid (OCS) are the current standards of care
The mortality rate in BP is approximately three-fold higher than the general population due to the disease itself, and infections and cardiovascular conditions that are more common in older patients and are exacerbated by treatment with high dose OCS.1
There is significant unmet need for an effective steroid-sparing therapy.
Nomacopan was granted Orphan Drug and Fast Track designations by the FDA and Orpan Drug designation from the EMA for the treatment of BP
Results from the completed Phase II study of subcutaneous nomacopan in patients with mild to moderate BP were published online in JAMA Dermatology in May 2022
The Phase II study advanced understanding of the nomacopan safety profile and informed duration of treatment in the ARREST-BP Phase III Part A clinical trial, which is currently open for enrollment
The multi-center, single arm nonrandomized controlled Phase II study included nine patients newly diagnosed or recurrent patients with mild to moderate active BP
Patients received subcutaneous nomacopan (30 mg once daily) with lesional mometasone from Day 1 to 21 of treatment and nomacopan only from Day 21 to Day 42
Seven of nine patients responded to nomacopan with three, regarded as complete responders, showing >80% reduction in BPDAI (BP disease activity index) activity and four patients showing >70% reduction in pruritis by day 42; two of nine patients were non-responders
None of the nine patients reported Common Terminology Criteria for Adverse Events (CTCAE) grade three, four or five treatment-related adverse events
A poster outlining the design of the Phase III study of nomacopan in patients with moderate to severe BP was presented at the 2021 International Pemphigus & Pemphigoid Foundation (IPPF) Scientific Symposium
Pre-Clinical Program Studying Investigational Long-Acting PAS-Nomacopan for Geographic Atrophy/Dry Age-Related Macular Degeneration (GA/dAMD)

Akari has conducted pre-clinical studies that explore the importance of the leukotriene B4 (LTB4)-VEGF axis and the potential role of nomacopan’s bispecific inhibition of both C5 and LTB4 in treating GA/dAMD
Studies have indicated that while certain complement inhibitors slow the progression of GA, they may also promote choroidal neovascularisation (CNV), which can harm the macula, damage vision,2,3 and require VEGF rescue therapy
LTB4 is a potent leukotactic agent that can increase retinal vascular endothelial growth factor (VEGF) a key driver of CNV. Inhibition of LTB4 may decrease the risk of CNV.4
Akari has conducted pre-clinical studies that explore the importance of the LTB4-VEGF axis and the potential role of nomacopan’s bispecific inhibition of both C5 and LTB4 in treating GA/dAMD
In a non-infectious allergic uveitis animal model, PAS-nomacopan reduced VEGF by more than 50% compared to saline control, equivalent to the inhibition caused by an anti-VEGF antibody. In addition, PAS-nomacopan was significantly more effective in reducing retinal inflammation than the anti-VEGF antibody.
A pre-clinical study presented at ARVO 2022 used an industry standard model of laser induced CNV. Intravitreal (IVT) PAS-nomacopan injected once during a 16-day treatment period was compared to an FDA-approved VEGF inhibitor for impact on neo-vascularization. The IVT single dose of PAS-nomacopan significantly reduced CNV (p=0.022) as compared to saline and was as effective as multiple IVT injections of the VEGF inhibitor (p=0.019.) Single IVT injection of PAS-nomacopan showed a trend towards reduced leakage on Day 14 (p = 0.097).
Currently approved therapies for retinal diseases injected directly into the vitreous cavity are typically administered monthly. Studies have shown that due to adverse effects (such as an increase in intraocular pressure [IOP]), discomfort and anxiety, IVT injection presents a heavy burden on patients
PASylation of nomacopan has the potential to make it long-lasting in the back of the eye and may provide a dosing interval that is more attractive to patients
Akari is continuing pharmacokinetic (PK) and pharmacodynamic (PD) work to optimize PAS-nomacopan with the aim of achieving safety and efficacy in GA, and meeting patient preferences for less frequent injections
Studies of Investigational Nomacopan in Inflammation-Implicated Lung Conditions

Advanced the study of investigational nomacopan in the treatment of inflammation-implicated lung conditions
The CORONET study evaluated compassionate use of investigational nomacopan in the treatment of hospitalized COVID-19 pneumonia patients in the U.S.
The CASCADE study in the U.K. explored correlations between biomarkers and risk stratification categories to help predict the subsets of COVID-19 pneumonia patients who have a higher propensity to deteriorate clinically to more severe disease
Nomacopan Manufacturing

Significantly increased the total yield of nomacopan (more than five-fold) with a new manufacturing process
References:

Tedbirt B, et al., JAMA Dermatol. 2021 Apr 1;157(4)
Liao DS, et al. Ophthalmology. 2020 Feb;127(2)
Jaffe GJ et al. Ophthalmology. 2021 Apr;128(4)
Sasaki F et al. JCI Insight. 2018 Sep 20;3(18)
Full Year 2021 Financial Results

At December 31, 2021, the Company had cash of approximately $9.4 million, compared to cash of approximately $14.1 million at December 31, 2020.
In March 2022, Akari entered into an agreement with Paulson Investment Company, LLC to serve as placement agent in connection with a registered direct offering and sold approximately 7.4 million of the Company’s ADSs for gross proceeds of approximately $8.9 million.
In July 2021, Akari closed a private placement of approximately $12.3 million in gross proceeds by issuing approximately 7.9 million of the Company’s ADSs.
Research and development (R&D) expenses for full year 2021 were approximately $9.1 million, as compared to approximately $8.8 million for full year 2020.
General and administrative expenses for full year 2021 were approximately $8.1 million, as compared to approximately $9.2 million for full year 2020. This decrease was primarily due to a one-time non-cash financing expense of approximately $900,000 in 2020 related to the 2020 Purchase Agreement with Aspire Capital.
For full year 2021, total other loss was approximately $210,000 as compared to total other income of approximately $899,000 for full year 2020. This change was primarily due to the accounting reclassification of warrant liabilities to shareholders’ equity as of December 2020.
Net loss for the full year 2021 was approximately $17.4 million, as compared to net loss of approximately $17.1 million for full year 2020.

On May 16, 2022 Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the first quarter ended March 31, 2022 (Press release, Celcuity, MAY 16, 2022, View Source [SID1234614647]).

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"We are off to a strong start in 2022, which we expect will be a transformational year for Century as we transition into a clinical-stage organization," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "Looking ahead, we remain on track to submit our first IND application for our lead program, CNTY-101, mid-year, with the Phase 1 ELiPSE-1 trial for CNTY-101 in relapsed/refractory lymphoma expected to commence in the second half of 2022. We are continuing to invest in our comprehensive, next-generation iPSC-based cell therapy platform, and believe we are well positioned to advance multiple product candidates into the clinic over the next several years. We look forward to providing updates at scientific congresses this year and our upcoming virtual R&D Day next month"

Business Highlights & Upcoming Milestones

Earlier this month, the Company presented preclinical data at the 18th Annual PEGS Boston Conference & Exposition, on the discovery and optimization of CD22 VHH antibodies for CAR T cell therapy.
The Company plans to present preclinical data on MAD7, a novel CRISPR nuclease used to enable the genetic engineering of iPSC-derived NK and T cell product candidates, during a poster presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting being held May 16-19, 2022 in Washington, D.C. Full abstracts are currently available through the ASGCT (Free ASGCT Whitepaper) conference website.
Virtual research and development update to be held June 13, 2022, at 4:30 PM ET. Century’s management team will discuss CNTY-103 and progress on the next-generation platform. Dr Sheila Singh, Professor of Surgery and Biochemistry, Chief Pediatric Neurosurgeon at McMaster Children’s Hospital, the Division Head of Neurosurgery at Hamilton Health Sciences, and the inaugural Director of McMaster’s new Cancer Research Centre will discuss the current treatment paradigm in GBM.
The Company remains on track to initiate ELiPSE-1, its Phase 1 clinical trial to assess CNTY-101 in patients with relapsed/refractory CD19 positive aggressive lymphoma or indolent lymphoma after at least two prior lines of therapy, including patients who have received prior CAR-T cell therapy, in the second half of 2022 subject to U.S. Food and Drug Administration acceptance of its Investigational New Drug (IND) application, which is expected to be submitted in mid-2022.
The Company’s current Good Manufacturing Practice (cGMP) manufacturing facility in Branchburg, New Jersey is expected to be operational in 2022.
Century expects to submit an IND application for CNTY-103 in 2023. CNTY-103 is the Company’s first solid tumor candidate for glioblastoma.
First Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents, and investments were $466.4 million as of March 31, 2022, as compared to $358.8 million as of December 31, 2021. Net cash provided by operations was $86.8 million for the three months ended March 31, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $122.1M) compared to net cash used in operations of $22.2 million for the three months ended March 31, 2021.
Collaboration Revenue: Collaboration revenue was $1.1 million for the three months ended March 31, 2022, generated through the Company’s collaboration, option and license agreement with BMS.
Research and Development (R&D) expenses: R&D expenses were $21.2 million for the three months ended March 31, 2022, compared to $15.4 million for the same period in 2021. The increase in R&D expenses was primarily due to an increase in personnel expenses related to increased headcount to expand the Company’s R&D capabilities, costs for pre-clinical studies, costs for laboratory supplies and facility costs.
General and Administrative (G&A) expenses: G&A expenses were $7.3 million for the three months ended March 31, 2022, compared to $2.7 million for the same period in 2021. The increase was primarily due to an increase in personnel related expense due to an increase in employee headcount, an increase in directors’ and officers’ insurance expense, and an increase in the Company’s professional fees as a result of expanded operations to support the Company’s infrastructure as well as additional costs to operate as a public company.
In-process research and development (IPR&D) expenses: One-time IPR&D expenses were $10.0 million for the three months ended March 31, 2022, in order to amend the FCDI agreement to gain access to the territory rights of Japan as a result of the Collaboration Agreement with BMS.
Net loss: Net loss was $37.5 million for the three months ended March 31, 2022, compared to $18.3 million for the same period in 2021.
Financial Guidance

The Company expects full year GAAP Operating Expenses to be between $155 million and $165 million including non-cash stock-based compensation expense of $10 million to $15 million.
The Company expects its cash, cash equivalents, and marketable securities will support operations into 2025.

On May 16, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported financial results for the first quarter ended March 31, 2022 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAY 16, 2022, View Source [SID1234614646]).

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"As we kicked off 2022, we have worked diligently to advance our clinical and preclinical programs as well as extend our thought leadership in Parkinson’s disease. This past month we brought together leading key opinion leaders in the field of movement disorders to host an educational event highlighting the current unmet need, competitive and regulatory landscape in Parkinson’s disease as well as delineated our development strategy for IkT-148009 as a potential therapeutic option for patients," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "As we look ahead, we anticipate dosing the first patients in our Phase 2a study for IkT-148009 in Parkinson’s disease this quarter. This study will allow us to evaluate our selective c-Abl kinase inhibitor in Parkinson’s patients dosed for a 12-week period. In addition, we anticipate submitting our IND application for IkT-001Pro for stable phase Chronic Myelogenous Leukemia as well as report preclinical data from at least one study of IkT-148009 in Multiple Systems Atrophy in the second quarter. As we advance these programs forward, we will continue to be good stewards of capital to maximize shareholder value. We expect our current cash on hand to be sufficient to fund our operations into the third quarter of 2023."

Recent Developments and Upcoming Milestones:
Phase 2a clinical study for IkT-148009: Inhibikase anticipates dosing the first patients in its Phase 2a study of IkT-148009, known as the "201 Trial," in the second quarter. The trial will be a 3:1 randomized, double-blind, twelve-week dosing trial and will evaluate the safety and tolerability of three doses of IkT-148009 in up to 120 patients diagnosed with Parkinson’s disease who have not yet progressed to the need for symptomatic therapy. The trial will also measure a hierarchy of motor and non-motor function inside and outside of the brain as secondary endpoints and will evaluate whether treatment with IkT-148009 leads to a reduction or clearance of pathogenic alpha-synuclein aggregates as exploratory endpoints.

Hosted virtual investor event featuring Key Opinion Leaders in Parkinson’s disease: In April 2022, Inhibikase held a virtual investor event highlighting the Company’s clinical progress of IkT-148009, provided an overview of the current Phase 2 program and described the current unmet need and competitive landscape in Parkinson’s disease. A replay of the event can be accessed here.

Phase 1b study in clinical trial of IkT-148009: In March 2022, Inhibikase presented data from the first cohort of its Phase 1b study for IkT-148009 at the Alzheimer’s & Parkinson’s Diseases Conference (AD/PD). Data suggested that the safety and tolerability profile in patients closely matched that of older healthy volunteers. Pharmacokinetics of IkT-148009 in volunteers and subjects was also similar, further suggesting that the pharmacology of IkT-148009 is consistent across patient groups and penetrates the Central Nervous System. The Company expects to complete dosing of the second cohort of the Phase 1b study in the second quarter of 2022 and present additional data at a medical meeting later this year.

Investigational New Drug application (IND) for IkT-001Pro for stable-phase Chronic Myelogenous Leukemia (CML): In the first quarter of 2022, Inhibikase completed clinical batch manufacturing of its pill formulated IkT-001Pro, a prodrug formulation of imatinib mesylate. The Company is conducting the necessary stability studies for the IND submission package and expects to submit the IND application in the second quarter of 2022. Following clearance by the FDA, the Company expects to initiate bioequivalence studies in accordance with the 505(b)(2) regulatory pathway.

Preclinical studies evaluating IkT-148009 in animal models of Multiple System Atrophy (MSA): Inhibikase expects to report preclinical data evaluating IkT-148009 in at least one of two animal models of MSA in the second quarter of 2022. Depending on the preclinical results in animal models of MSA and subject to agreement with the FDA and equivalent regulatory bodies in the European Union, Inhibikase may advance IkT-148009 into a Phase 2a clinical study in the fourth quarter of 2022.
First Quarter 2022 Financial Results
Net Loss: Net loss for the quarter ended March 31, 2022, was $4.7 million, or $0.18 per share, compared to a net loss of $2.6 million, or $0.26 per share for the first quarter in 2021.

R&D Expenses: Research and development expenses were $3.0 million for the quarter ended March 31, 2022, compared to $2.4 million in the quarter ended March 31, 2021. The increase was driven by a $2.1 million increase in non-grant related research offset by a decrease of $1.2 million in grant related research expenditures and a decrease of $0.4 million in non-cash stock compensation expense. The non-grant related research was expended primarily in connection with the Company’s Phase I PD clinical trial.

SG&A Expenses Selling, general and administrative expenses for the quarter ended March 31, 2022 were $1.7 million compared to $1.6 million for the first quarter in 2021. The increase was primarily due to increased headcount resulting in increased compensation expense of $.2 million, increased legal fees, board fees, investor relation and consulting fees of $0.1 million and a net increase of $0.2 million for other normal operating expenses offset by decreased non-cash stock-based compensation expense of $0.4 million.

Cash Position: Cash and cash equivalents were $36.6 million as of March 31, 2022. The Company expects that existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the third quarter of 2023.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00am ET Tuesday, May 17, 2022. Participants should dial 877-407-4018 (United States) or 201-689-8471 (International) with the conference code 13729218. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On May 16, 2022 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that the first patient has been dosed in its Phase 1/2 clinical trial of CFT8634, an orally bioavailable BiDAC degrader targeting BRD9 for the treatment of SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors (Press release, C4 Therapeutics, MAY 16, 2022, View Source [SID1234614645]).

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"The initiation of our first clinical trial of CFT8634 is a significant milestone for C4 Therapeutics as we apply our TORPEDO platform to an oncology target currently considered ‘undruggable’ and work to provide a new treatment option for patients living with synovial sarcoma and SMARCB1-null tumors," said Adam Crystal, M.D., Ph.D., chief medical officer of C4 Therapeutics. "Based on our pre-clinical research showing that the BRD9 degrader CFT8634 is potent, selective and efficacious in models of synovial sarcoma and malignant rhabdoid tumors, we believe CFT8634 may offer an effective targeted treatment for patients who currently have limited therapeutic options."

The Phase 1/2 trial will primarily investigate safety, tolerability and anti-tumor activity with secondary and exploratory objectives to characterize the pharmacokinetic and pharmacodynamic profile of CFT8634. The Phase 1 portion of the study will evaluate CFT8634 as an oral, single agent therapy for patients with synovial sarcoma and SMARCB1-null tumors to identify a recommended Phase 2 dose. Following identification of recommended dosage, the Phase 2 portion of the trial is expected to expand to the following investigational arms: one in synovial sarcoma, and one in SMARCB1-null tumors. Across the Phase 1/2 trial, C4T plans to enroll approximately 90 patients.

CFT8634 is C4T’s second oncology program to enter clinical studies from its internally developed research pipeline. CFT8634 is C4T’s first BiDAC degrader candidate to be evaluated in the clinic.

To learn more about the CFT8634 clinical trial, visit clinicaltrials.gov (identifier: NCT 05355753).

About CFT8634
CFT8634 is a BiDAC degrader targeting BRD9 for the treatment of cancers that are dependent on BRD9, including synovial sarcoma and SMARCB1-null cancers. BRD9 has been considered an "undruggable" target due to the inability of bromodomain inhibitors to effectively treat these cancers. Unlike BRD9 inhibition, BRD9 degradation has been shown to be efficacious in pre-clinical models of synovial sarcoma. By leveraging C4T’s TORPEDO platform, C4T developed CFT8634, an orally bioavailable, selective degrader of BRD9. In March 2022, C4T announced

the U.S. Food and Drug Administration had granted orphan drug designation (ODD) to CFT8634.

About Synovial Sarcoma and SMARCB1-null Tumors
Synovial sarcoma is a rare and aggressive subtype of soft tissue sarcoma. It accounts for approximately 10 percent of all sarcoma diagnoses. An estimated 900 people are diagnosed with synovial sarcoma in the U.S. each year. Approximately one-third of patients are diagnosed under the age of 30.

SMARCB1-null tumors include malignant rhabdoid tumor, poorly differentiated chordoma, epithelioid sarcoma and other rare cancers; some subtypes are most commonly diagnosed in children and young adults.

Both synovial sarcoma and SMARCB1-null tumors are believed to be dependent on BRD9 and, as a result, CFT8634 may be an effective treatment.