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Integrated cancer biotech Infinitopes secures £12.8m seed financing to enhance its Precision Immunomics™ antigen discovery technologies to target five more cancers

On April 30, 2024 Infinitopes Precision Immunomics, an integrated cancer biotech combining world leading platforms in precision antigen discovery with vaccine vectors capable of durably stimulating protective immune responses, reported the completion of a £12.8m seed funding round led by Octopus Ventures (Press release, Infinitopes, APR 30, 2024, View Source [SID1234642484]). The round was heavily oversubscribed, also drawing in funds from Cancer Research Horizons, Cancer Research Institute, CRIS Cancer Foundation, Kindred Capital, Manta Ray, Martlet Capital, Meltwind Advisory, Saras Capital, Wilbe Capital, and expert angel investors. The total funds raised combine new equity investment and a prestigious non-dilutive award from Innovate UK’s Future Economy Investor Partnership scheme.

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Right targets, right vectors, right patients, right time

Since incorporation in 2021, Infinitopes has moved swiftly to cement its leadership position in cancer vaccines by overcoming three key challenges in the field. Firstly, using its Precision ImmunomicsTM antigen discovery technologies, the Company can identify and rank tumour signatures, without prior bias, enabling the accurate selection of novel, synergistic tumour targets. Secondly, Infinitopes continues to develop safe and effective, proprietary vector delivery systems, capable of stimulating durable T-cell responses necessary to prevent the recurrence of life-threatening cancer metastases. Finally, the Company leverages its deep knowledge of immunology, partnering with disease KOLs, in order to optimally schedule therapies to drive maximal protection for patients.

Lead phase I/IIa on schedule to begin this autumn

Infinitopes’ lead asset, a novel cancer vaccine called ITOP1, is scheduled to commence a phase I/IIa study in first line cancer patients in the third quarter of 2024. This rapid transition into the clinic has become possible after receiving an Innovative Licensing & Access Pathway (ILAP) innovation passport from the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) in August 2022.

Best-in-class antigen discovery

The new investment accelerates the installation of best in class, next generation LC-MS/MS mass spectrometer equipment, enhancing the company’s proprietary tumour antigen discovery and computational immunobiology/AI/machine learning techniques, to identify and rank the best target combinations, to treat five more cancers.

Supported by Cancer Research UK

Infinitopes is a Cancer Research UK (CRUK)-led spinout from Oxford University, combining underlying technologies, know-how, patents and licenses that were developed with CRUK funding across the laboratories of Professor Paul Klenerman and Associate Professor Nicola Ternette, and clinical programmes led by Professor Mark Middleton.

Jonathan Kwok, CEO and co-founder of Infinitopes said:

"Since founding in September 2021, Infinitopes has established world leading capabilities to design, develop, and clinically evaluate an exciting new class of precision targeted, durable cancer vaccines. Our therapies are emerging at a time when blockbuster checkpoint inhibitors are hitting their peak, capable of preventing tumour recurrence in 30-40 per cent of patients at best. Our preclinical results suggest that our vaccines may significantly outperform them, to transform care for future cancer patients. We’re excited to announce this fundraise, which enables us to pursue our uniquely integrated strategy of selecting the right targets, with the right vectors, for the right patients, at the right time in their treatment journey. We continue to seek academic and Big Pharma collaborators, smart technical investors, and passionate new hires and interns to join our mission to cure cancer."

Phil Masterson, Associate Director, Cancer Research Horizons commented:

"Infinitopes is at the forefront of the cancer vaccine revolution emerging from Covid-era technology advances. Cancer Research Horizons’ investment strategy focuses on maximising patient impact – Infinitopes is empowering the immune system to fight the cancer metastases that cause 70 to 90 percent of cancer deaths through better targeting, better delivery mechanisms and better clinical trials. We are delighted to support the building of a leading company based on innovative CRUK-funded foundational science."

Hugo Villanueva, Octopus Ventures, said:

"At Octopus Ventures, we back the entrepreneurs who are revitalising healthcare. The Infinitopes team is a great example of this ─ their work to design, develop and clinically assess novel cancer vaccines is incredibly important, and we’re delighted to support them in their work to combat cancer."

John W Cassidy, General Partner, Kindred Capital, added:

"At Kindred, we don’t just invest; we partner with trailblazers who reimagine the future. Infinitopes exemplifies this spirit, weaving together scientific acumen with technological foresight to architect the next frontier in cancer care. This significant funding milestone underscores our collective commitment to empower healthcare innovation that promises not only to challenge the current paradigms but to redefine them. Infinitopes is charting a bold course towards a world where cancer is no longer a formidable foe but a conquerable condition. We are delighted to support them in this mission."

Julia Schrameier, Investor at Manta Ray, added:

"Our initial investment in Infinitopes in December 2022 was driven by our strong conviction that they were the right team at the right time to create a leading computational, proteomics-driven antigen discovery platform. Their focus on accessible, non-personalised treatments, combined with the team’s deep scientific expertise and remarkable track record, distinctly set them apart from other companies in the space. After observing their impressive progress and growth over the past year, our conviction has only strengthened. Working with Jonathan and his team has been remarkable, and we are excited to follow our initial investment and continue supporting Infinitopes on its journey to cure cancer, one epitope at a time."

Infinitopes presented at the 8th Immuno Oncology Europe (London, April 23-25) and Immuno’24 (London, April 25-26) last week, and will attend the 7th European Neoantigen Summit (Amsterdam, April 29-May 1), and BioEquity (San Sebastián, May 12-14).

Jacobio Pharma Announced its KRAS G12C inhibitor reached the primary endpoint

On April 30, 2024 Jacobio Pharma (1167.HK) reported that the data from the Phase II registrational study of the KRAS G12C inhibitor glecirasib were offically reported at the April ASCO (Free ASCO Whitepaper) Plenary Series, which was held online (Press release, Jacobio Pharmaceuticals, APR 30, 2024, View Source [SID1234642483]).

Prof. Yuankai Shi, chief physician of Cancer Hospital Chinese Academy of Medical Sciences, the lead principal investigator of this clinical trial, presented the data in the form of an online oral presentation (Abstract 468214).

The efficacy data showed that among second-line non-small cell lung cancer patients receiving monotherapy treatment, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%.

The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months. The median duration of response (mDoR) has not been reached:6-month and 12-month DOR rates were 73.6% and 56.6%, respectively.

Safety data showed that glecirasib has a manageable safety profile. No grade 5 treatment related adverse event (TRAE) was observed, and only 5.0% of patients discontinued the treatment due to TRAEs. Gleciasib has a favorable gastrointestinal (GI) profile compared to other KRAS G12C inhibitors.

"If glecirasib can match or even bypass current efficacy data with an overall improved side effect profile, this agent would be an attractive treatment option." commented Julia Rotow, MD, of the Dana-Farber Cancer Institute, who critiqued the glecirasib findings. She said that the unique toxicity profile of glecirasib may offer the potential for combination with agents that cannot be readily combined with other existing KRAS G12C inhibitors due to overlapping toxicities.

"The trend in the treatment of lung cancer is to reduce the use of chemotherapy. Currently, for lung cancer patients harboring the KRAS G12C mutation who fail first-line treatment, chemotherapy such as docetaxel is the main second-line treatment in China. The ORR is 14%, mPFS is 3.0 months, and OS is 9.1 months. Existing clinical data show that glecirasib is more effective and safer than chemotherapy and is expected to bring more treatment options to patients." Said Prof. Yuankai Shi.

About Glecirasib

Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of Phase I/II clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, and combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China.

Caris Life Sciences and COTA, Inc. Announce Collaboration to Expand Collective Multi-Modal Data Offering

On April 30, 2024 Caris Life Sciences(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, and COTA, Inc. (COTA), an oncology real-world data (RWD) and analytics company used by the world’s leading pharmaceutical companies, reported a collaboration to expand their multi-modal data offerings to support and accelerate biopharmaceutical drug development and patient care (Press release, Caris Life Sciences, APR 30, 2024, View Source [SID1234642482]).

The combination of the breadth and depth of Caris’ genomic, transcriptomic, proteomic and imaging data and COTA’s high-quality curated clinical data that captures the treatment journeys and outcomes of cancer patients will result in a broad real-world, multi-modal data offering, at scale, to power the next wave of cancer therapeutics.

"Caris’ partnership with COTA will enable biopharma to leverage a more complete dataset to power research and AI approaches for therapeutic development. This breadth of data allows the flexibility to build specific cohorts for understanding mechanisms of resistance, determinants of response and relevant biomarkers to improve success of their clinical trials," said Brian Lamon, PhD, Chief Business Officer at Caris.

As the pioneer in precision medicine and molecular profiling, Caris has created a molecular-rich, multi-modal database generated from nearly 10 million tests that contains more than 60 petabytes of oncology-specific genomic, transcriptomic, proteomic and imaging data. Caris was the first in the molecular diagnostic industry to provide Whole Exome Sequencing (WES) DNA coverage and Whole Transcriptome Sequencing (WTS) RNA coverage for every viable sample.

"By combining COTA’s high-quality, curated data sourced from electronic health records with Caris’ molecular data, life sciences researchers will be able to capture previously unseen insights to optimize cancer treatments that can improve a patient’s prognosis and quality of life," said C.K. Wang, MD, Chief Medical Officer at COTA.

COTA’s data includes more than two million cancer patients who have received treatment across 200 sites of care in both academic medical centers and community practices in rural and urban settings, providing a powerful representative picture of cancer care across the U.S. COTA synthesizes those records into data that life sciences companies use to develop better, more personalized cancer treatments.

ONO Enters into a Definitive Agreement to Acquire Deciphera Pharmaceuticals

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.

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).

A Potential First-In-Class Drug: CDE Approved Single-Arm Pivotal Clinical Study of LBL-024, An Anti-PD-L1/4-1BB Bispecific Antibody Developed by Leads Biolabs

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.

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.