On April 30, 2024 ONO Pharmaceutical, Co., Ltd., (TSE: 4528, Representative Director, Chairman of the Board and Chief Executive Officer: Gyo Sagara, "ONO") and Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH, Chief Executive Officer: Steven L. Hoerter, "Deciphera") reported that on April 29, 2024 (Japan time), ONO and Deciphera entered into a definitive merger agreement under which ONO will acquire all outstanding shares of Deciphera common stock for US $ 25.60 per share in cash through a tender offer followed by a merger of a wholly owned subsidiary of ONO with and into Deciphera with Deciphera surviving as a wholly owned subsidiary of ONO (the "Acquisition") (Press release, Ono, APR 30, 2024, View Source [SID1234642481]). The total equity value of the Acquisition is approximately US $ 2.4 billion, assuming that there are approximately 94.7 million outstanding shares of Deciphera common stock on a fully diluted basis. The purchase price represents a premium of 74.7% to Deciphera’s closing share price of US $14.65 on April 26, 2024, and a premium of 68.8% to Deciphera’s 30 trading day volume weighted average price as of April 26, 2024. The Boards of Directors of both companies have unanimously approved the Acquisition.

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1. Strategic Objectives of the Acquisition

ONO, as a Global Specialty Pharma company, is committed to delivering innovative new drugs to patients around the world. As a part of our medium-term management plan, ONO aims to reinforce our pipeline and accelerate global development, as well as realize direct sales in the United States and Europe. In addition, ONO has designated oncology, immunological diseases, central nervous system diseases, and specialty areas with high medical needs as priority research areas, and we accumulate disease know-how in each area to create new drugs that will bring innovation to medicine on-site. Through this Acquisition, ONO is pleased to welcome Deciphera as a partner with commercial capabilities in the United States and Europe and excellent research and development capabilities in the field of cancer. This combination will further enhance ONO’s pipeline and accelerate its globalization.

Deciphera focuses on the discovery, development, and commercialization of innovative medicines for cancer and has deep expertise in kinase biology (see Table 1 below). QINLOCK (ripretinib), a KIT inhibitor, is approved in over 40 countries and marketed globally, including in the US, Europe, and China, for the treatment of fourth-line gastrointestinal stromal tumor (GIST). Vimseltinib, a CSF-1R inhibitor, demonstrated statistically significant and clinically meaningful efficacy across all primary and secondary endpoints in the Phase III MOTION trial in patients with tenosynovial giant cell tumor (TGCT). Data from the MOTION trial will be used to support marketing applications in the US and EU in Q2 and Q3 2024, respectively. Deciphera has established highly successful commercial operations in the United States and key European countries to support the distribution of QINLOCK directly, which could be immediately leveraged for vimseltinib, if approved.

With this Acquisition, ONO will expand its oncology pipeline with near-term revenue growth, notably through the immediate addition of QINLOCK and potential addition of vimseltinib. Moreover, acquiring Deciphera’s commercial capabilities in United States and Europe will strengthen ONO’s global commercial presence. By leveraging Deciphera’s drug discovery capabilities, ONO will further accelerate its research and development capabilities in the field of oncology.

Gyo Sagara, Representative Director, Chairman of the Board and Chief Executive Officer of ONO, said, "We expect that this acquisition of Deciphera will not only expand ONO’s targeted oncology portfolio, but also accelerate ONO’s business development in the United States and Europe, and strengthen kinase drug discovery research. Deciphera’s mission statement "Inspired by Patients: Defeat Cancer" is aligned with ONO’s corporate philosophy "Dedicated to the Fight against Disease and Pain." We respect the innovative culture of Deciphera and look forward to working together to drive further growth for both ONO and Deciphera."

Steven L. Hoerter, President and Chief Executive Officer of Deciphera, said, "Deciphera and ONO share a deep commitment to improve the lives of people living with cancer, and the transaction announced today enables us to make even greater impact for patients. Together, we expect to advance and accelerate each organization’s important work through combined research and development capabilities and a global commercial footprint. Importantly, this acquisition delivers for all of Deciphera’s stakeholders. We believe that it provides immediate, compelling value for our shareholders, provides greater opportunities for our world-class team, and ultimately, greater hope for patients . I am excited about the future of the combined organizations and we are honored to contribute to the continued growth of ONO in the United States and around the world."

2. Overview of the Acquisition

The Acquisition is structured as a tender offer and subsequent merger of Deciphera with a wholly-owned subsidiary of ONO. Under the terms of the merger agreement, ONO will acquire all outstanding shares of Deciphera at a price of US $25.60 per share in cash, which represents a premium of 68.8% to Deciphera’s volume-weighted average price per share over the 30 days ended April 26, 2024, the day before the transaction was announced. ONO will promptly commence the Tender Offer, which will expire 20 business days after its commencement, unless otherwise extended. If the Tender Offer conditions are not satisfied, ONO may be required to extend the Tender Offer under certain circumstances. Upon the successful completion of the tender offer, Ono’s wholly-owned subsidiary will merge into Deciphera, and any shares of common stock of Deciphera not tendered into the offer will receive the same USD per share price payable in the tender offer in the subsequent merger. The closing of the proposed Acquisition is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of Deciphera’s outstanding shares of common stock. The companies expect to complete the Acquisition in the second quarter of ONO’ fiscal year 2024 (third calendar quarter of 2024). In connection with the execution of the merger agreement, certain stockholders of the company owning approximately 28% of the outstanding shares of Deciphera common stock have entered into tender and support agreements pursuant to which they will tender all of their owned shares in the offer. A copy of the definitive merger agreement regarding the proposed Acquisition will be filed with the U.S. Securities and Exchange Commission ("SEC") and will be publicly available on the SEC’s website at View Source

BofA Securities is serving as ONO’s financial advisor, Greenberg Traurig is serving as ONO’s legal counsel, KPMG FAS Co., Ltd and KPMG Tax Corporation are serving as ONO’s accounting and tax advisor and WTW and Mercer Japan Ltd. are serving as ONO’s human resource advisor. J.P. Morgan Securities LLC is serving as Deciphera’s financial advisor and Goodwin Procter LLP is serving as Deciphera’s legal counsel.

3. Overview of Deciphera

(１)

Company

Deciphera Pharmaceuticals, Inc.

(２)

Address

200 Smith Street Waltham, MA 02541, USA

(３)

Representative’s
Title and Name

President & CEO, Steven L. Hoerter

(４)

Business Description

R&D and Commercialization of pharmaceuticals

(５)

Stated Capital

US $ 805 thousand (as of December 31, 2023)

(６)

Year of Establishment

2017

(initial company Deciphera Pharmaceuticals, LLC was formed in 2003)

(７)

Major shareholders and
ownership ratio

(as of March 31, 2024)

Brightstar Associates LLC: 28.1%

Redmile Group, LLC: 10.2%

Blackrock Inc.: 7.3%

Deerfield Mgmt, L.P.: 7.0%

(８)

Relationship between ONO and Deciphera

Capital Relationship

N.A.

Personal Relationship

N.A.

Business Relationship

N.A.

Status of A Related Party

N.A.

(９)

Deciphera’s consolidated operating results and consolidated financial position for the past three
years(*1)

Accounting Period

(Unit: thousands of US $)

Fiscal year ended
December 2021

Fiscal year ended
December 2022

Fiscal year ended
December 2023

Total Equity

304,720

341,691

350,916

Total Assets

429,484

454,039

473,566

Equity per share (US $)(*2)

5.25

4.53

4.13

Revenue

96,148

134,036

163,356

Operating Loss

(300,077)

(182,722)

(210,958)

Net Loss

(299,964)

(178,931)

(194,942)

Net loss per share (US $)

(5.16)

(2.37)

(2.29)

Dividend per share (US $)

–

–

–

(*1) Information from Deciphera’s Annual Report on Form 10-K, for the fiscal year ended December
31, 2022 and December 31, 2023, filed by Deciphera with the SEC on February 7, 2023 and
February 7, 2024.

(*2) Calculated by total equity divided by weighted average common shares outstanding.

Table.1 Deciphera’s Development Pipeline

Products

Mode of Action

Indication

Stage

QINLOCK

KIT inhibitor

4L GIST, 2L GIST (KIT Exon 11+17/18)

Approved, P3

Vimseltinib

CSF-1R inhibitor

TGCT,

cGVHD

Regulatory Submission,
P1/2 preparation

DCC-3116

ULK inhibitor

KRAS mutated cancer, GIST

P1b

DCC-3084

Pan-RAF inhibitor

Solid Tumors and Hematologic Malignancies

P1 preparation

DCC-3009

Pan-KIT inhibitor

GIST

IND-enabling

4. Number of shares to be acquired, acquisition price, and status of shareholdings before and
after the Acquisition

(１)

Number of shares already acquired

0 shares (Percentage of voting rights: 0%)

(２)

Number of shares to be acquired(*3)

94,721,482 shares

(３)

Transaction consideration

US $ 25.60 per share (approximately US $ 2.4 Bil in the
aggregate)

(４)

Number of shares held after the
transfer(*3)

94,721,482 shares (Percentage of voting rights: 100%)

(*3) Based on fully diluted shares of common stock outstanding as of April 24, 2024.

5. Schedule

(１)

Signing date

April 29, 2024

(２)

Estimated Completion of acquisition

Second quarter of ONO’s fiscal year 2024

6. Financial Impact of the Acquisition

ONO is still reviewing the impact and will promptly announce any events that are to be publicly reported.

7. About QINLOCK

QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib in the United States, Europe, and various countries including China. QINLOCK global sales reached US $163 million in 2023. The phase III INSIGHT trial is currently underway with the aim of expanding the indication to include second-line (2L) GIST patients with KIT exon 11 + 17/18 mutations. Breakthrough Therapy Designation was granted by the U.S. Food and Drug Administration (FDA) for 4th-line treatment of GIST patients in 2019 and for 2L treatment of GIST patients with any of the above mutations in 2023. In 2019, Deciphera entered into a licensing agreement with Zai Lab Ltd ("Zai Lab"), through which Zai Lab has developed and marketed QINLOCK in Greater China and Taiwan.

8. About Vimseltinib

Tenosynovial giant cell tumor (TGCT) is a locally aggressive tumor that occurs inside or near joints. Surgical excision of the tumor is often used as the first line of therapy., but recurrence is common and systemic treatment options are limited. There is significant unmet medical need for new treatment options with improved efficacy and safety. TGCT is driven by a genetic translocation of the colony-stimulating factor 1 (CSF-1) gene and resultant overexpression of CSF-1. Vimseltinib is a highly potent and selective CSF-1 receptor inhibitor that has received Fast Track designation from the FDA, and demonstrated statistically significant and clinically meaningful efficacy across all primary and secondary endpoints in the Phase III MOTION trial in patients with tenosynovial giant cell tumor (TGCT).

On April 30, 2024 Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs") reported that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by Leads Biolabs with global intellectual property rights has received approval to conduct the single-arm pivotal study for registration and market authorization from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (Press release, Nanjing Leads Biolabs, APR 30, 2024, View Source [SID1234642480]). Currently, there are no similar products approved for marketing domestically or internationally.

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LBL-024 is a bispecific antibody composed of anti-programmed death ligand-1 (PD-L1) and anti-4-1BB (CD137) antibodies. It binds to PD-L1 with high affinity, blocking the PD-L1/PD-1 immunosuppressive pathway while conditionally activating the 4-1BB costimulatory pathway in the tumor microenvironment. This activation of T cells exerts a powerful immune response, resulting in a stronger antitumor effect than anti-PD-1/PD-L1 monoclonal antibodies alone.

LBL-024 received IND approvals from both FDA and NMPA on July 30, 2021 and September 9, 2021 respectively to conduct phase Ⅰ/Ⅱ clinical research, and has achieved outstanding results. The clinical study results of LBL-024 monotherapy in patients with advanced malignant tumors demonstrated good safety profile and encouraging efficacy signals in the advanced solid tumors.

The approved Phase IIb pivotal clinical study is led by Professor Shen Lin from Peking University Cancer Hospital, and detailed clinical data will be disclosed during the ASCO (Free ASCO Whitepaper) Annual Meeting on May 31st to June 4th, 2024. LBL-024 has First-in-Class potential and is expected to offer an effective treatment option to patients with advanced solid tumors.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said " The approval of this pivotal clinical study is an encouraging news. Based on the current treatment status and the available safety and efficacy data, LBL-024 meets the requirements of the drug registration management measures for ‘innovative drugs used to prevent and treat diseases that seriously endanger life or severely affect the quality of life, and for which there are no effective prevention or treatment methods, or there is sufficient evidence to demonstrate significant clinical advantages compared to existing treatment methods.’ The approval of the single-arm pivotal clinical study by CDE will help accelerate the marketing process of LBL-024 and bring more effective treatment options to patients as early as possible."

Dr. Xiaoqiang Kang, founder, chairman and CEO of Leads Biolabs, said " We are delighted to see the positive progress of LBL-024, which has the potential to become an effective immunotherapy and prove 4-1-BB to be druggable immune checkpoint target approved for marketing following PD-1/PD-L1, CTLA-4, and LAG-3. This milestone achievement also reflects our corporate philosophy of focus on innovation and our determination to discover and advance First-in-Class products. We have always been guided by clinical needs in our differentiated approach to innovation, deploying novel targets while combining some targets based on a deep understanding of their biological mechanisms and disease mechanisms to achieve a 1+1>2 effect. The vision of Leads Biolabs is to become a company that can truly develop innovative drugs, delivering safe, effective, and accessible new therapies to patients worldwide. To this end, we will continue to make full efforts to support the subsequent clinical research of LBL-024, and look forward to delivering the benefit earlier to patients around the world.

On April 30, 2024 Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) reported that the company’s lead innovative product Chidamide (Epidaza) , an oral subtype-selective histone deacetylase (HDAC) inhibitor, combined with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), has been officially approved by the National Medical Products Administration (NMPA) for treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) with positive MYC and BCL2 expression (Press release, Shenzhen Chipscreen Biosciences, APR 30, 2024, View Source [SID1234642479]). Up to now, Chidamide has been approved for multiple indications globally. (For more information, please review the global commercialization situation).

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Diffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma, with approximately 30000 new cases occurring annually in China. Clinical diagnosis and treatment guidelines and consensus both domestically and internationally recommend the R-CHOP regimen as the standard first-line treatment for DLBCL. However, about one-third or more of patients in the overall population still experience ineffective or early recurrence of first-line R-CHOP treatment. Meanwhile, approximately 30% of patients with DLBCL exhibit simultaneous overexpression of MYC/BCL2 protein (referred to as "double expression" lymphoma, DEL), and their efficacy and prognosis after R-CHOP treatment are significantly lower than those of non double expression patients. Therefore, how to combine new drugs based on R-CHOP regimen to provide a more effective and safer treatment to our patients is a significant unmet medical need.

The approval of this new indication is based on a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial DEB trial (NCT04231448). The DEB trial is the first Phase III registered clinical study in the world as first line treatment of MYC/BCL2 dual expression diffuse large B-cell lymphoma. This trial is to evaluate the efficacy and safety of Chidamide combined with R-CHOP compared to R-CHOP in primary treatment and MYC/BCL2 dual expression DLBCL subjects. Based on the interim analysis conducted by the Independent Data Monitoring Committee (iDMC), the efficacy and safety indicators set by the protocol were achieved. Compared with the R-CHOP regimen, the Chidamide combination regimen significantly improved the complete response rate (CRR) of the study’s key secondary endpoint, and the study’s primary endpoint, event free survival (EFS), also showed a clear trend of benefit. The experimental safety profile is consistent with known risks, and no new significant safety signals were found. The results of the interim analysis of the DEB Phase III study were selected as the Late breaking Abstract (LBA) for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on April 24, 2024.

Dr. Xianping Lu, Chairman and General Manager of Chipscreen Biosciences, stated, "The classic R-CHOP regimen has been used as a first-line treatment for diffuse large B-cell lymphoma (DLBCL) for nearly 20 years, but its therapeutic effect is not satisfactory in populations with dual expression of BCL2 and MYC proteins. The combination of Chidamide and R-CHOP is the world’s first phase 3 registered clinical study that focuses on first line therapy of dual expressed DLBCL, and also the world’s first R-CHOP improvement study with significant benefits in complete remission rate. We believe that the approval of the new indication will bring new hope and better survival benefits to patients."

About Chidamide (Epidaza)

Chidamide (Tucidinostat, Trade name: Epidaza), a Class 1.1 innovative drug, is a novel molecular entity with global patent protection and the first marketed product developed independently by Chipscreen Biosciences. The first original chemical new drug approved in China, Chidamide is also the first oral subtype-selective histone deacetylase (HDAC) inhibitor in the world, Since its approval in China in December 2014 for the treatment of peripheral T-cell lymphoma, Chidamide has achieved significant commercialization worldwide and continuously explored new indications.

Global commercialization situation:

In December 2014, Chidamide was approved for use in patients with recurrent or refractory peripheral T-cell lymphoma (PTCL) in China;
In November 2019, Chidamide was approved to combine aromatase inhibitors to treat locally advanced or metastatic breast cancer patients with estrogen receptor positive, human epidermal growth factor receptor-2 negative, postmenopausal, and endocrine therapy relapse or progress in China;
In June 2021, Chidamide was approved for monotherapy in the treatment of recurrent or refractory (R/R) adult T-cell leukemia (ATL) in Japan;
In December 2021, Chidamide was approved for monotherapy for recurrent or refractory (R/R) peripheral T-cell lymphoma (PTCL) in Japan;
In March 2023, Chidamide was approved to be used for postmenopausal women with locally advanced or metastatic breast cancer who are hormone receptor positive, type II human epidermal growth factor receptor (HER2) negative, and relapse or worsen after endocrine therapy (in combination with exemestane) in Taiwan, China;
In April 30, 2024, Chidamide was approved to use in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) for previously untreated diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2 expression in China.
Global exploration of other indications:

In addition to ongoing global multicenter phase III clinical trial for the first-line treatment of melanoma in comniation with Opdivo, Chidamide is also conducting multiple clinical trials in China and internationally in combination with different anti-tumor immunotherapies.
In November 2023, the Phase II clinical trial of the first-line treatment of non-small cell lung cancer with Chidamide combined with Tislelizumab was completed and enrolled.
On March 4, 2024, Professor Ruihua Xu and Professor Feng Wang from the Cancer Prevention and Treatment Center of Sun Yat sen University led the research on CAPAbility-01, which was published on the world’s top academic journal Nature Medicine (IF=82.9). As one of the most valuable sub journals under Nature, the publication of Nature Medicine reflects the academic authority’s recognition of CAPAbility-01 research. This study indicates that for patients with microsatellite stable/mismatched repair function intact (MSS/pMMR) type metastatic colorectal cancer (mCRC), a three drug regimen led by Chidamide (Chidamide+sintilimab antibody+bevacizumab) for third line and above treatment, with an 18 week PFS rate of 64.0%, an ORR of 44.0%, and a median PFS of 7.3 months, is considered a promising treatment option for MSS/pMMR advanced CRC patients.
On April 24, 2024, an abstract entitled "Tucidinostat plus R-CHOP in previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2: An interim analysis from the phase III DEB study" was selected the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) LBA list for the 2024 ASCO (Free ASCO Whitepaper), which submitted by Professor Weili Zhao’s team from Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine

On April 30, 2024 Denovo Biopharma LLC (Denovo), a pioneer in applying precision medicine to the development of innovative therapies, reported that the California Institute for Regenerative Medicine (CIRM) has awarded a $11.8M grant for further development of DB107, Denovo’s DGM7 biomarker–guided late–stage gene therapy, for high–grade glioma (HGG) including glioblastoma (GBM), a malignant brain cancer (Press release, Denovo Biopharma, APR 30, 2024, View Source;a-novel-dgm7-genetic-biomarker-guided-gene-therapy-302131547.html [SID1234642478]). CIRM has awarded the grant to Dr. Noriyuki Kasahara, MD, PhD, at the University of California San Francisco (UCSF) and a group of investigators at California universities to conduct a Phase 1/2 clinical trial studying DB107 in patients with newly–diagnosed HGG.

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The trial, titled "A Phase I/IIa Study to Evaluate the Efficacy of DB107–RRV, Administered to Subjects at Time of Resection and Intravenously Thereafter, in Combination with DB107–FC and Radiation Therapy or DB107–FC, Temozolomide (TMZ) and Radiation Therapy in Patients with Newly–Diagnosed High–Grade Glioma," plans to enroll up to 70 patients. The trial aims to demonstrate improvements in progression–free survival.

DB107 consists of two components: DB107–RRV (vocimagene amiretrorepvec) as a prodrug activator gene therapy and DB107–FC (extended-release 5–fluorocytosine [5–FC]) as an oral prodrug. DB107–RRV, a retroviral replicating vector (RRV) administered intratumorally and intravenously, converts the orally administered 5–FC into the potent chemotherapy agent 5–fluorouracil (5–FU) locally at the tumor sites. This enables intratumoral concentrations 30–50 times of those achievable by 5–FU systemic administration, killing tumor cells while minimizing the systemic exposure and off–target toxicities of 5–FU. Using its proprietary biomarker discovery platform including whole genome sequencing (WGS) and artificial intelligence (AI), Denovo discovered the novel germline genetic biomarker, Denovo Genomic Marker 7 (DGM7), which is located in the SHROOM3 gene intron. Retrospective analysis of an earlier randomized clinical trial in patients with recurrent HGG suggested improved overall survival in DGM7–positive patients treated with DB107.

"We are excited to conduct this novel trial which will be investigating several new approaches for the first time in patients with newly–diagnosed high–grade glioma. In addition to DB107–RRV being administered both intratumorally and intravenously to provide more exposure, this study will also use the RRV in conjunction with radiation therapy and chemotherapy with temozolomide. In addition to the direct therapeutic effect of gene therapy, glioma cells will be sensitized to these standard therapies by 5–FU generated directly within the patient’s tumor from DB107–FC. We are also excited to test the DGM7 biomarker to see if we can identify patients who may benefit the most from this unique gene therapy approach," said Dr. Kasahara.

DGM7 status will be determined at the time of enrollment to prospectively assess the effect of the biomarker on clinical outcomes. The study will be conducted at UCSF (Dr. Noriyuki Kasahara, MD, PhD, and Dr. Nicholas Butowski, MD), University of Southern California (USC) (Dr. Thomas Chen, MD, PhD), and University of California San Diego (UCSD) (Dr. David Piccioni, MD, PhD), and will be managed by Anova Enterprises, Inc.

"We are thrilled to continue the clinical development of our biomarker–guided DB107 gene therapy in patients with HGG including GBM, a major unmet medical need with less than 5% of GBM patients surviving 5 years," said Dr. Matthew A. Spear, MD, Denovo’s Chief Medical Officer and Chief Development Officer. "Alongside our recent announcement of positive results in a Phase 2b clinical trial of our DGM4 biomarker–guided DB104 drug (liafensine) in treatment–resistant depression, the CIRM grant provides continued validation of Denovo’s approach to discovering new genetic biomarkers and developing biomarker–guided therapies."

About HGG and GBM
The most common type of high–grade glioma (HGG) is glioblastoma (GBM), which is also the most common type of adult primary brain cancer, with 18,000 newly–diagnosed patients in the US and 13,000 deaths annually. Standard treatments for patients with newly–diagnosed GBM can include surgery followed by radiation and chemotherapy, but treatment options are limited. The 5–year survival rate of patients with GBM is less than 5%.

About DB107 and the DGM7 Biomarker
DB107 is an investigational combination product consisting of the DB107–RRV (vocimagene amiretrorepvec) gene therapy and DB107–FC (extended–release 5–fluorocytosine) oral prodrug. DB107–RRV, an innovative proprietary retroviral replicating vector (RRV), is combined with DB107–FC to selectively infect and kill cancer cells while stimulating a robust and durable anti–cancer immune response against a tumor with minimal toxicity. DB107 has been tested clinically in solid tumors including recurrent high–grade glioma (rHGG) and colorectal cancer, most recently in a randomized 403–patient Phase 2/3 trial in rHGG including glioblastoma (GBM). Using its proprietary biomarker discovery platform, Denovo discovered the novel genetic biomarker, DGM7, which has been shown to be associated with treatment response to DB107 in patients with rHGG including GBM. DB107 has received Fast Track Designation and Breakthrough Therapy Designation from the FDA, as well as Orphan Drug Designations from the FDA and EMA.

On April 30, 2024 Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius" or the "Company"), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported that it has closed its previously announced registered direct offering for the purchase of an aggregate of 21,428,574 shares of its common stock and accompanying warrants to purchase up to an aggregate of 21,428,574 shares of its common stock, at a purchase price of $0.70 per share and accompanying warrant (Press release, Citius Pharmaceuticals, APR 30, 2024, View Source [SID1234642477]). The warrants have an exercise price of $0.75 per share, will be exercisable six months from the date of issuance, and will expire five years from the initial exercise date.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering were approximately $15 million, before deducting the placement agent fees and other offering expenses payable by the Company. Citius currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures.

The securities described above were offered pursuant to a "shelf" registration statement (File No. 333-277319) filed with the Securities and Exchange Commission ("SEC") on February 23, 2024 and declared effective on March 1, 2024. The offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities offered was filed with the SEC and is available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.