On June 16, 2023 Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS) and Surface Oncology, Inc. (Surface, Nasdaq: SURF) reported that the companies have entered into a definitive merger agreement providing that, at the closing, Coherus will acquire Surface Oncology, a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment (Press release, Coherus Biosciences, JUN 16, 2023, View Sourcenews-releases/news-release-details/coherus-acquire-surface-oncology" target="_blank" title="View Sourcenews-releases/news-release-details/coherus-acquire-surface-oncology" rel="nofollow">View Source [SID1234632739]). The Surface acquisition adds two differentiated clinical stage assets to Coherus’ novel I-O pipeline: SRF388, a novel IL-27-targeted antibody currently being evaluated in Phase 2 clinical trials in lung cancer and liver cancer, and SFR114, a CCR8-targeted antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The transaction was unanimously approved by the boards of directors of both companies and is expected to close in the third quarter of 2023.

"This transaction is well-timed, as it coincides with the accelerating growth of our biosimilar revenues driven by the launch of CIMERLI and near-term launch of YUSIMRY. With the agreement to acquire Surface and the expected near-term approval of toripalimab, Coherus is positioned to become one of the very few I-O companies with demonstrated commercial expertise, significant product revenues, and unique, competitively positioned R&D programs addressing critical unmet medical needs," said Denny Lanfear, Chairman and Chief Executive Officer of Coherus. "Toripalimab has recently demonstrated potentially practice-changing overall survival data in nasopharyngeal carcinoma, and its differentiated mechanism of action defines it as a next-generation PD-1. Existing marketed PD-1’s transformed the treatment of cancer over the past decade but are effective in only a minority of patients. Additional overall survival gains must come from novel combinations that more broadly target the cancer immunity cycle. The addition of Surface’s IL-27 and CCR8 antibodies expands our next-generation I-O pipeline beyond checkpoint inhibition to agents targeting immune-suppressive mechanisms of the tumor microenvironment."

Commenting on the merger, Rob Ross, MD, President and Chief Executive Officer, Surface said, "This combination presents a rare opportunity for two complementary organizations to join together and forge something that is greater than the sum of its parts. By augmenting Coherus’ existing capabilities and infrastructure with Surface’s innovative pipeline and deep I-O expertise, Coherus is well positioned to develop important I-O medicines for patients which deliver real value for the shareholders of both companies."

Regarding the SRF388 data, Dr. Ross added, "While still early, the new hepatocellular carcinoma (HCC) data are encouraging and suggest that when administered in triplet combination with checkpoint and VEGF inhibitors, SRF388 holds exciting potential to improve the treatment paradigm for liver cancer. Based on the growing body of data in HCC, non-small-cell lung cancer (NSCLC) and renal cell carcinoma (RCC), SRF388 would be a compelling agent to study in combination with toripalimab in many highly prevalent tumor types."

Benefits of the Transaction

Strengthens Coherus’ pipeline with global rights to innovative, competitively positioned, clinical-stage I-O assets

SRF388, the only IL-27 targeted antibody in clinical development worldwide, has demonstrated monotherapy activity in multiple tumor types and is currently being evaluated in Phase 2 clinical trials in lung cancer and liver cancer as monotherapy and in combination with checkpoint inhibitors.
SRF114, a high affinity, fully human IgG1 antibody demonstrated to bind exclusively to CCR8, has established proof of mechanism with pharmacodynamic activity observed in the ongoing Phase 1 trial.
SRF388 and SRF114 have potential as monotherapy and as combination treatments with other
I-O agents, including Coherus’ toripalimab.
Expands Coherus’ I-O franchise to the treatment of tumor types with significant unmet needs

Coherus plans to launch toripalimab directly upon approval by the United States Food and Drug Administration (FDA) for nasopharyngeal carcinoma.
Coherus plans to evaluate SRF388 and SRF114 as monotherapies and in combination with toripalimab for lung cancer, head and neck cancer, and certain other tumor types.
Novel I-O clinical development will extend Coherus’ reach in oncology and expand physician experience with toripalimab. Combinations of toripalimab with SRF388 or SRF114 could yield net sales from multiple Coherus proprietary I-O agents.
Positive financial impact

$20 – $25 million in Surface net cash projected at closing will strengthen Coherus’ balance sheet and fund ongoing SRF388 and SRF114 clinical trials through year-end 2024, beyond significant value inflection points in 2023 and 2024.
Pipeline prioritization enabled by the acquisition will focus clinical development activities on competitively positioned I-O programs and reduce budgeted R&D spending by at least $50 million through 2025.
Potential out-licensing of ex-US rights to SRF388 and SRF114 could raise significant non-dilutive capital in 2024 and 2025.
Transaction Details

Under the terms of the agreement, Coherus will issue shares of its common stock at a price of $5.2831 per share to acquire all outstanding shares of Surface stock for a total value equal to the sum of $40 million plus Surface’s net cash at closing of the transaction (currently expected to be between $20 and $25 million). Surface shareholders will also receive CVRs for 70% of milestone and royalty-based value of existing programs with Novartis AG (NZV930) and GSK plc (GSK4381562), as well as CVRs for 25% of upfront payments made pursuant to potential ex-US licensing agreements for SRF114 and 50% of upfront payments made pursuant to potential ex-US licensing agreements for SRF388, subject to certain deductions as set forth in the contingent value rights agreement. Amounts under these CVRs are payable for a period of ten years following the closing of this transaction.

The transaction was unanimously approved by the boards of directors of both companies and is expected to close in the third quarter of 2023. The closing of the transaction is subject to certain conditions, including Surface shareholder approval; the availability at closing of at least $19.6 million of Surface cash net of short-term and long-term liabilities, transaction expenses, and other obligations; and other customary conditions. In conjunction with the transaction announcement, Surface is implementing a workforce reduction of approximately 50% of its employees.

Truist Securities is acting as financial advisor and Arnold & Porter Kaye Scholer LLP and Latham & Watkins LLP are acting as legal advisors to Coherus. Wedbush Securities Inc. is acting as exclusive strategic financial advisor and Goodwin Procter LLP is acting as legal advisor to Surface.

Coherus financial guidance

For Q2 2023, Coherus expects to report at least $48 – 53 million of net product revenue from sales of UDENYCA and CIMERLI. For the fiscal year 2023, Coherus continues to project net revenues in excess of $275 million, including at least $100 million from net sales of CIMERLI, with the balance comprising net sales of UDENYCA, YUSIMRY and toripalimab. Additionally, Coherus affirms prior guidance for full year 2023 combined R&D and SG&A expenses in the range of $315 to $335 million, including approximately $50 million of stock-based compensation expense and excluding the Surface Oncology acquisition cost as well as any potential collaboration upfront payments to Klinge Pharma for the in-license of its Eylea biosimilar program or milestone payments to Junshi Biosciences due upon U.S. approval of toripalimab.

Surface program updates

SRF388, a novel antibody targeting IL-27

In the Phase 2 study evaluating SRF388 as a monotherapy in NSCLC, two confirmed partial responses were observed as of the data cut-off (April 14, 2023) in PD-L1 negative or low patients with squamous NSCLC, as well as one confirmed report of durable disease stabilization in a patient with adenocarcinoma. All 3 of these patients were previously treated with PD-(L)1 antibodies. The overall response rate (ORR) in the subset of patients with squamous NSCLC (n=2/6) was 33% in this data cut.
Surface has fully enrolled the lead-in stage of the Phase 2 trial investigating SRF388 in combination with atezolizumab and bevacizumab for patients with first-line advanced hepatocellular carcinoma (n=30). In an early data cut (April 2023) with an average of 15 weeks of follow-up and only approximately half of patients with more than one post-treatment imaging assessment, SRF388 in combination with atezolizumab and bevacizumab demonstrated a 27% ORR (n=7/26) with a 65% disease control rate in response-evaluable patients. Additional follow-up data are expected by the end of the year.
SRF388 has demonstrated an acceptable safety profile in both studies to date, and there were no concerning safety signals observed in either trial as monotherapy or in combination with other agents including checkpoint inhibitors.
SRF114, a highly selective, competitively positioned antibody targeting CCR8

The Phase 1 trial of SRF114 in patients with advanced solid tumors is currently enrolling in monotherapy dose escalation (n=6). Early evidence of biological effect has been seen with regulatory T cell depletion in peripheral blood CCR8+ Treg cells following treatment with SRF114, with no effect observed on non-CCR8+ Treg cells. No concerning safety signals were observed to date and dose escalation continues.
Near-term projected I-O catalysts

Q3 2023: FDA approval decision on toripalimab
Q4 2023: toripalimab mechanism of action/differentiation as a next generation PD-1 presentation; SRF388 NSCLC data presentation; ILT4 investigational new drug filing
Q1 2024: SRF388 HCC combination data presentation
Q2 2024: ILT4 preclinical data presentation; SRF114 Phase 1 data
Conference Call and Webcast Information

Coherus and Surface Oncology management will host a conference call to review details of the transaction beginning at 8:30 a.m. Eastern Daylight Time/5:30 a.m. Pacific Daylight Time, June 16, 2023.

The press release and live webcast of the conference call can be accessed through a link that is posted on Investors section of the Coherus website: View Source and Investors section of the Surface Oncology website: View Source

Webcast Link: View Source

To access the live conference call, please pre-register through the following link:

https://register.vevent.com/register/BId34739a2380b43eb83e35ac0ed20eb29

All registrants will receive dial-in information and a PIN allowing them to access the live call.

The webcast replay will be available on the Coherus and Surface websites upon completion of the event.

On June 16, 2023 AskGene Pharma Inc. reported an oral presentation at the 15th International Gastric Cancer Congress (IGCC 2023) in Yokohama, Japan of the latest clinical results from NCT04632108 for ASKB589, an anti-CLDN18.2 antibody, for the treatment of solid tumors (Press release, AskGene Pharmaceuticals, JUN 16, 2023, View Source [SID1234632737]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation Details

Title: A Phase I/II Study of ASKB589 (Anti-CLDN18.2 Monoclonal Antibody) in Patients with Solid Tumors
Session: Oral 26 – Clinical Study
Date and Time: Friday, June 16, 2023 16:50-17:22 Local Time
Abstract Number: 01074
Leading PI: Dr. Lin Shen, Professor from Peking University Cancer Hospital
NCT04632108 is a first-in-human study evaluating the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of ASKB589 as a monotherapy and in combination with chemotherapy in patients with advanced solid tumors. The study includes ASKB589 monotherapy dose escalation and expansion (Part A) and dose escalation and expansion of ASKB589 combined with CAPOX (capecitabine and oxaliplatin) (Part B). Patients in dose escalation were enrolled regardless of the expression of CLDN18.2, while patients in the dose expansion were only enrolled if their tumors tested positive for CLDN18.2 by a diagnostic assay at a central laboratory.

As of April 25, 2023, for the 24 patients with measurable lesions, at least one post-treatment tumor assessment, medium to high CLDN18.2 expression, and treatment with 6 and 10 mg/kg ASKB589 in combination with CAPOX (capecitabine and oxaliplatin ), the investigator-confirmed objective response rate (cORR) was 79.2%, and the disease control rate (DCR) was 95.8%.

Efficacy of 1st Line Treatment with ≥ 6mg/kg ASKB589 and CAPOX for CLDN18.2 Positive G&GEJ Cancer Patients (n=24)

Dataset with ≥ 1 Efficacy Evaluation 6mg/kg
(N=13) 10mg/kg
(N=11) Total
(N=24)
Objective Response Rate (Confirmed, PR+CR) 84.6% 72.7% 79.2%
Disease Control Rate (PR+CR+SD) 92.3% 100.0% 95.8%
Median Progression-Free Survival (days) Not Reached Not Reached Not Reached
Median Overall Survival (days) Not Reached Not Reached Not Reached

In addition to demonstrating deep and durable anti-tumor activity, ASKB589 also demonstrated good safety and tolerability. As of April 25, 2023, with a total of 106 patients enrolled in the study, escalation of monotherapy treatment has reached a dose of 20mg/kg, and escalation of ASKB589 in combination with chemotherapy has reached a dose of 15mg/kg with no dose-limiting toxicity (DLT) having been observed. Thus, a maximum tolerated dose (MTD) for ASKB589, either as monotherapy or in combination with chemotherapy, has not yet been reached. In addition, for treatment with ASKB589 at 6 and 10 mg/kg combined with CAPOX, the majority of adverse events (AEs) were grade 1-2, and the most common AEs were GI toxicities, including nausea, vomiting, loss of appetite, and hypoalbuminemia.

Dr. Lin Shen, the PI of this clinical study, commented: "This latest clinical phase II data reflects the success of ASKB589’s design as an antibody with stronger target binding activity and ADCC function than its competitors. Both the 6 mg/kg and 10 mg/kg dose groups have shown encouraging safety and efficacy. We look forward to seeing the differentiating advantages of this innovative drug against this high potential target. We hope to advance this drug to pivotal clinical trials as soon as possible, bringing hope to gastric cancer patients."

AskGene has also developed a CLDN18.2 immunohistochemistry-based companion diagnostic kit with high sensitivity and specificity, which will be used to select patients for treatment in future clinical trials.

Conclusions

ASKB589 at a dose of ≥ 6 mg/kg combined with CAPOX has demonstrated encouraging anti-tumor activity, in addition to good safety and tolerability, for the first-line treatment of patients with advanced/metastatic G and GEJ cancer that is CLDN 18.2 positive. ASKB589 is therefore positioned to become a next-generation anti-CLDN18.2 antibody.

Gastric cancer is one of the most common cancers in the world with more than 1 million new cases and 769,000 deaths each year worldwide. It ranks fifth in incidence rate among malignant tumors and fourth in mortality. According to data from the World Health Organization, there were approximately 480,000 new gastric cancer cases and 370,000 deaths in China in 2020, accounting for 44% and 48.6% of the global gastric cancer new cases and deaths, respectively.

About ASKB589

ASKB589 is an innovative biological drug discovered and developed by AskGene. It is a recombinant humanized monoclonal antibody targeting CLDN18.2. ASKB589 is among the top 3 most advanced therapies against this target with no marketed drugs yet. ASKB589 mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through high-affinity binding to cancer cells. Enrollment in dose escalation for ASKB589 as monotherapy and in combination with CAPOX chemotherapy was completed in 2022. Enrollment continues in expansion cohorts of first-line advanced or metastatic patients with CLDN18.2-positive G&GEJ cancers that are being treated with ASKB589 in combination with chemotherapy. In addition to G&GEJ cancers, ASKB589 is being tested in clinical trials for other CLDN18.2-positive solid tumors such as pancreatic cancer. A pivotal study of ASKB589 in the treatment of gastric cancer is being planned.

On June 16, 2023 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported promising safety and efficacy data from a study of its off-the-shelf CD30.CAR EBVST therapy (TT11X) in patients with relapsed or refractory (R/R) Hodgkin lymphoma (Press release, Tessa Therapeutics, JUN 16, 2023, View Source [SID1234632731]). The results were presented by Tessa collaborators at the Baylor College of Medicine in an oral podium presentation at the 17th International Conference on Malignant Lymphoma (ICML) taking place at Lugano, Switzerland. TT11X, Tessa’s allogeneic "off-the-shelf" cell therapy, is based on Tessa’s proprietary CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) platform.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The podium presentation (#47), titled, "Off-the-shelf CD30.CAR EBV-specific T cells provide a safe and effective therapy for HL," reported data from 18 heavily pre-treated patients with R/R Hodgkin lymphoma who were administered TT11X across four dosing levels (40 × 106 CD30.CAR EBVSTs, 100 × 106 CD30.CAR EBVSTs, 400 × 106 CD30.CAR EBVSTs, and 800 × 106 CD30.CAR EBVSTs). An overall response rate of 78% (14/18 patients) was observed across all four dose levels, including seven complete responses and seven partial responses, with higher doses producing improved clinical responses. Additionally, TT11X was demonstrated to be well tolerated with no dose-limiting toxicities observed, including no evidence of graft-versus-host disease (GVHD) or immune effector cell-associated neurotoxicity syndrome (ICANS). Six episodes of possible cytokine release syndrome were all grade one (mildest of four grades).

"The data reported at ICML suggest that allogeneic CD30.CAR EBVSTs provide a potentially safe and efficacious treatment for CD30-positive lymphomas and affirm previously reported data indicating the technology may avert GVHD and immediate rejection even after multiple infusions," stated Carlos Ramos, M.D., Professor at Center for Cell and Gene Therapy, Baylor College of Medicine, USA. "Importantly, CD30.CAR EBVSTs elicited a clinical response in 14 of 18 patients with R/R Hodgkin lymphoma including seven complete responses. Based on these results, CD30.CAR EBVSTs appear to be a promising platform for off-the-shelf cancer immunotherapy."

Tessa is currently advancing a pipeline of products that utilize CD30.CAR-modified EBVSTs, including its lead allogeneic cell therapy, TT11X, which is being co-developed with the Baylor College of Medicine for the treatment of relapsed or refractory CD30-positive lymphomas. Tessa’s proprietary "off-the-shelf" CD30.CAR EBVST allogeneic cell therapy platform is based on decades-long research and development by researchers at Baylor College of Medicine into the unique properties of virus-specific T-cells (VSTs). These highly specialized T cells have the ability to recognize and kill infected cells while activating other parts of the immune system for a coordinated response. CD30-CAR Allogeneic VSTs without further genetic modification have demonstrated a strong safety profile and efficacy in early trials with minimal risk of GVHD.

"The data presented at ICML are very promising and further validate our "off-the-shelf" CD30.CAR EBVST allogeneic cell therapy platform in R/R Hodgkin lymphoma," stated Ivan Horak, M.D., Chief Medical Officer and Chief Scientific Officer of Tessa Therapeutics. "Tessa is steadfastly focused on advancing the development of TT11X as a potential treatment for CD30-positive lymphomas, while targeting opportunities to extend the EBVST platform to other cancer indications and enhance the cell performance and durability of the technology."

On June 15, 2023 LianBio reported that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted a breakthrough therapy designation to infigratinib (Febseltiq) for the treatment of patients with gastric cancer (Press release, LianBio, JUN 15, 2023, View Source [SID1234633492]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The designation was supported by topline data from a phase 2a trial (NCT05019794), which showed that pretreated patients with locally advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma harboring FGFR2 gene amplification experienced an overall response rate (ORR) of 25.0% (n = 20). The median duration of response (DOR) was 3.8 months.

"Gastric cancer impacts a disproportionately high number of patients in China," Yizhe Wang, PhD, chief executive officer of LianBio, stated in a news release. "Patients whose disease has progressed on existing treatment options face a poor prognosis today. The topline data from this proof-of-concept trial suggest infigratinib has the potential to provide meaningful clinical benefit in third-line or later gastric cancer. We look forward to further investigating the efficacy and safety of infigratinib in this patient population in a phase 2 study designed to support registration in China that we plan to initiate next year."

Infigratinib is an oral, adenosine triphosphate–competitive, FGFR TKI designed to target the FGFR protein and inhibit downstream activity. In May 2021, the FDA granted accelerated approval to infigratinib for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.2

However, in October 2022, LianBio reported that its partner, BridgeBio Pharma, informed the company that Helsinn Healthcare SA was permanently discontinuing distribution of the drug and anticipated requesting withdrawal of the new drug application in the United States due to business reasons.3

In December 2022, the European marketing authorization application for infigratinib was withdrawn by Helsinn Birex Pharmaceuticals for the treatment of patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements.4

The multicenter, open-label, single-arm, phase 2a proof-of-concept study enrolled patients with FGFR2-amplified locally advanced or metastatic gastric cancer or GEJ adenocarcinoma, and those with other advanced solid tumors harboring FGFR alterations, who received at least 2 prior lines of treatment. Patients were also required to have measurable disease per RECIST v1.1 criteria and an ECOG performance status of 0 or 1.5

Key exclusion criteria included a history of other primary malignancies with 3 years except for adequately treated in situ carcinoma of the cervix, non-melanoma carcinoma, or any other curatively treated malignancy that was not expected to require treatment for recurrence during the study; prior treatment with a mitogen-activated protein kinase or selective FGFR inhibitor; or symptomatic central nervous system metastases.

All patients were treated with 125 mg of oral infigratinib per day on a 3-weeks-on/1-week-off schedule.

ORR served as the trial’s primary end point. Secondary end points included DOR, disease control rate, best overall response, progression-free survival, overall survival, and safety.

In the phase 2a portion of the trial, 57.1% of patients received 2 prior lines of therapy, 33.3% were given 3 prior lines of therapy, and 9.5% had more than 3 prior lines of therapy.1

Regarding safety, the most common any-grade treatment-emergent adverse effects reported in at least 20% of patients included hyperphosphatemia, anemia, increased alanine aminotransferase, increased aspartate aminotransferase, decreased white blood cell count, decreased neutrophil count, diarrhea, constipation, palmar-plantar erythrodysesthesia, increased lipase, increased blood alkaline phosphatase, and increased blood bilirubin.

References
LianBio announces topline results from phase 2a proof of concept trial evaluating infigratinib in patients with gastric cancer & receipt of breakthrough therapy designation in China. News release. LianBio. June 6, 2023. Accessed June 15, 2023. View Source
FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma. News release. FDA. May 28, 2021. Accessed June 15, 2023. View Source
United States Securities And Exchange Commission: form 8-K. Securities And Exchange Commission. October 12, 2022. Accessed June 15, 2022. View Source
Withdrawal of application for the EMA marketing authorization of infigratinib. News release. ESMO (Free ESMO Whitepaper). December 1, 2022. Accessed June 15, 2023. View Source
Infigratinib in subjects with GC or GEJ with FGFR2 amplification or other solid tumors with other FGFR alterations (FGFR). ClinicalTrials.gov. Updated June 27, 2022. Accessed June 15, 2023. View Source

On June 15, 2023 Metagen Therapeutics (President & CEO: Taku Nakahara), a company focusing on drug discovery and development based on intestinal microbiome-based therapeutics for various diseases, reported that it has completed its Series A funding in 2 rounds, raising a total of 1.7 billion yen (Press release, Metagen Therapeutics, JUN 15, 2023, View Source [SID1234632772]). Sparx Asset Management, Nippon Venture Capital, Mizuho Capital and SMBC Venture Capital have joined the 1st round investors of JIC Venture Growth Investments, a type of sovereign wealth fund in Japan, JAFCO, Japan’s largest venture capital company, Fast Track Initiative and Keio Innovation Initiative.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With the closing of the 2nd round, Metagen Therapeutics has raised a total amount of 1.93 billion yen since its inception.

Purpose of Financing
There has been a growing movement to utilize intestinal bacteria in the medical field in recent years. In countries such as Australia and USA, "Fecal Microbiota Transplantation (FMT)" has been implemented as a medical procedure, and in April 2023, U.S. FDA approved the world’s first stool-derived oral formulation for a microbiome drug.

With the latest financing, Metagen Therapeutics aims to achieve 3 goals.

The construction and operation of an intestinal microbiota bank, research and development of Microbiota Drug Discovery Programs, and the social implementation of FMT.

By establishing an intestinal microbiota bank in Japan we will be able to connect patients and donors, which in turn will support and promote the social implementation of FMT, and from there help develop internationally competitive microbiome drugs that originates from Japan.

Use of Funds
1. Development and operation of the intestinal microbiota bank

Development of registration system for intestinal microbiota donor candidates
Operation of intestinal microbiota bank (in accordance with institutional guidelines) – Donor recruitment/online interview, donor eligibility evaluation, intake of stool donations, manufacturing/assessment/storage of intestinal microbiota solution
Establishing process regarding preparation and quality control for intestinal microbiota solution
2. Promotion of basic and clinical research for clinical application of FMT (such as joint research related to immune checkpoint inhibitors)

3. Research and development of intestinal microbiota drug discovery program (including probiotics)

Message from investors
Sparks Asset Management Co., Ltd.
Mr. Mitsuhiro Ito, Next Generation Growth Investment Division
FMT therapy has recently been studied mainly overseas, and its social implementation is awaited in Japan as a new treatment method for various diseases including ulcerative colitis. We hope that Metagen Therapeutics, with its abundant intestinal microbiota data accumulated through years of clinical research and advanced bioinformatics technology, will lead the promotion of microbiome medicine and drug discovery and serve as gospel for many patients.

Nippon Venture Capital Co.
Ms. Yuko Kitaoka and Ms. Sayuri Okamoto, Investment Division
It is with great pleasure to be here with Metagen Therapeutics, which is engaged in the research and development of innovative medical and pharmaceutical products such as the social implementation of FMT and microbiome drug discovery, as well as with its many investors. We are very much looking forward to seeing the excellent team led by Mr. Nakahara make a significant contribution to further develop microbiome science and the practical application of new medical and pharmaceutical products.

Mizuho Capital Co.,Ltd.
Mr. Keisuke Omori, Investment Manager
Metagen Therapeutics is a bio-venture company with Japan’s leading research and development capabilities in intestinal microbiota transplantation and microbiome drug discovery. With the increasing number of regulatory approvals for microbiome drugs overseas, we expect to see the creation of innovative medicine and pharmaceutical products based on microbiome science originating from Japan. We, together with our excellent management team led by President Nakahara, CMO Ishikawa, and CSO Terauchi, will continue to support this company with all our resources.

SMBC Venture Capital.
Mr. Masakazu Komahashi, Investment Sales Dept.
Microbiomes are believed to be involved in various diseases other than inflammatory bowel disease, and the development of therapies is attracting worldwide attention. It is a new modality, and we expect to face many challenges in its implementation in society, but with the science and enthusiasm of the Metagen Therapeutics team, I believe we will be able to overcome these challenges. As a leading company in microbiome therapy development, we look forward to bringing therapies to patients as soon as possible.

Message from Taku Nakahara, President and CEO, Metagen Therapeutics
June 15th marks the final close of our Series A funding round, raising a total of 1.7 billion yen. We are very grateful for the deep trust and support of our top-tier investors, including FTI, JAFCO, and KII, who have supported us since the Seed and Pre-A rounds, JIC-VGI, who participated in the Series A First Close in April, and SPARX, NVCC, Mizuho Capital, and SMBC Venture Capital, who joined us at this final close.

This funding will provide a powerful boost to expand the impact of microbiome medicine and drug discovery from Japan to the rest of the world, working to fulfill our mission of "Living up to the hopes of patients through microbiome science". Intestinal microbiome therapy is entering a new phase globally, with the approval of stool-derived oral formulations in the United States. We are determined not to miss this trend and renew our strong determination to bring advanced treatments to patients in Japan as soon as possible.

What is a microbiome?
A microbiome refers to the community of bacteria present throughout the human body including the intestines, skin and mouth. There are known to be approximately 40 trillion* bacterial cells in the human intestine, and in recent years, it has become evident to have significant impact on human health.

* Sender, R., Fuchs, S. & Milo, R. Revised Estimates for the Number of Human and Bacteria Cells in the Body. PLoS Biol. 14, e1002533 (2016)

What is FMT?

FMT refers to the transplantation of intestinal microbiota from the stool of healthy individuals into the intestines of patients using a colonoscope. This is a medical technology and procedure that improves the imbalance of the microbiota, or dysbiosis. Clinical research began in 2014, and Juntendo University has accumulated a track record of FMT in more than 200 patients** with ulcerative colitis, publishing research papers and case studies internationally in a number of top journals.

**View Source

What is the Intestinal Microbiota Bank?

The intestinal microbiota bank is a system that recruits and screens potential intestinal microbiota donors, prepares intestinal microflora solution to be transplanted into patients when performing FMT, and delivers solutions to medical institutions. The intestinal microbiota bank also serves as a foundation for research and development of pharmaceuticals using intestinal bacteria.