IntegraGen reports €12.6m in revenues for 2022 representing 16% growth compared to 2021 and a cash position of €4.5m

On january 13, 2023 IntegraGen (FR0010908723 – ALINT), an OncoDNA Group company specializing in the decryption of the human genome which performs interpretable genomic analyzes for academic and private laboratories and develops diagnostic tools for oncology, reported its unaudited revenue figures for the year 2022 (Press release, Integragen, JAN 13, 2023, View Source [SID1234626205]).

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The 2022 unaudited revenue amount to €12,592k in 2022, representing an increase of 16% compared to 2021. This growth in all activities reflects the firmness of the company’s positioning, both in terms of its main sequencing activities for R&D customers and its expertise in operating platforms on behalf of third parties. This amount does not include the recharge of personnel costs to the parent company.

R&D sequencing activities continued to grow due to the strong order backlog built up since 2021, with orders’ growth resumed in H2 2022. In parallel, sequencing activities performed for external platforms operated by IntegraGen increased in volume for new clinical research projects in oncology also fueling revenue growth.

As of December 31st 2022, the company’s cash position was €4,514k compared to €4,781k end of 2021, a slight decrease due to bank loans reimbursement. The position includes a state guaranteed loan (Prêt Garanti par l’État, PGE) for an outstanding amount of €1,561k that the Company started to reimburse for €339k during 2022.

With a revitalized booking orders as of the end of December, the company confirms its growth perspectives based on the current sales dynamics and existing long-term contracts along with the synergies now in place within the OncoDNA Group.

Bernard Courtieu, IntegraGen CEO, said "2022 has been another year of very strong growth at IntegraGen, and it both confirms the trust of our customers and strength of our business model, combining sequencing services for the R&D community and long-term partnerships with leading health institutions. We will continue to deliver superior value to our customers and are targeting new areas of growth, in conjunction with the OncoDNA Group".

Akiram raises SEK 68 million for clinical development of a drug candidate for rare thyroid cancers

On January 12, 2023 The Swedish radioimmunotherapy company Akiram Therapeutics, developing targeted cancer therapy, reported that it has raised SEK 68 million in a share issue led by Sciety and the network Sciety Venture Partners. The investment company Linc AB participated in the share issue with SEK 20 million (Press release, Akiram Therapeutics, JAN 12, 2023, View Source [SID1234628976]). The proceeds from the financing will be used for GMP production of the drug candidate and for initiating a phase I clinical study.

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Akiram Therapeutics has developed a new type of targeted radioimmunotherapy for anaplastic thyroid cancer. There is no effective treatment for this disease today, and patients survive only a few months after the diagnosis for which there is no effective treatment today. The drug candidate consists of Akiram’s proprietary antibody, the result of many years of research, in combination with the radioactive compound, Lutetium 177.

Akiram has thus far run the project within academia with support from, among others, SciLifeLab, VINNOVA, and the Swedish Cancer Society. Robust preclinical data shows, among other things, that the drug candidate has a significant effect on human thyroid tumours in animals without signs of side effects or damage to the surrounding tissue.

"We would like to thank Sciety and all those who have participated in this successful issue for the great confidence in Akiram and our drug candidate. We now have the means to continue our work at full speed and take the next important steps on our exciting journey. We are very eager to continue the development of our drug candidate and to initiate phase I clinical studies," says Marika Nestor, CEO of Akiram.

We are delighted to see the great interest and trust in our work and to have a group of investors helping us to deliver hope to patients suffering from incurable cancer."

Sciety, Sciety Venture Partners, and Linc invested SEK 68 million in the share issue.

"Targeted radiation therapy is a rapidly growing field expected to become the next breakthrough in cancer treatment. The reasons for our decision to invest are, among others, the founding team’s long experience in the field, both from academia and industry, as well as their solid preclinical data. We now look forward to participating in the company’s continued journey," says Andreas Lindblom, CEO of Sciety.

"We are very impressed with the company’s preclinical work, including the outstanding study results. In addition, we have high confidence in the management’s ability to successfully run both the production development work and the clinical phase 1 trial. We look forward to being part of the company’s future development," says Karl Tobieson, CEO of Linc.

LinusBio Raises $16 Million to Scale Growth and Deliver Tangible Outcomes

On January 12, 2023 LinusBio, a leader in precision exposome sequencing, reported that it raised over $16 million in Series A funding to deliver a novel platform that bridges genomics, the environment, and biological response (Press release, Linus Biotechnology, JAN 12, 2023, View Source [SID1234626233]).

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Historically, many health conditions, such as autism spectrum disorder, have lacked biological tests to aid in diagnosis, monitor progression, or serve as objective endpoints in clinical trials. LinusBio’s proprietary platform introduces precision exposome biomarkers that can facilitate discovery across these domains.

The technology has the potential to fundamentally transform how complex disorders are diagnosed and treated – from autism to gastrointestinal disorders to amyotrophic lateral sclerosis (ALS) to renal disease and cancers.

Furthermore, the LinusBio platform can substantially improve clinical trials by providing data equal to over 500 liquid biopsies or blood samples, but all from a single strand of hair. It is the first technology platform that maps the molecular dynamics of human physiology in a time-dependent manner. The platform can help identify novel compounds for health conditions where genomic biomarkers have previously had limited success. The company is already using this platform in two pharma-sponsored trials and is in the process of partnering with several organizations within the healthcare and pharma ecosystem.

The company’s initial focus is on neurological disorders. One of the company’s early technologies, StrandDx-ASD, can assess the likelihood of autism at birth with 80% to 90% accuracy, and assist with personalized treatment decisions.

As a result, LinusBio’s early autism diagnostic aid has been granted an FDA Breakthrough Designation, reserved for innovations that "provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions." The solution has received CE Mark designation in the European Union as a diagnostic aid.

Early detection is critical for those on the autism spectrum. In fact, the National Institutes of Health found that some children that are diagnosed and treated early make substantial progress.

"Our mission is simple: to deliver better outcomes for people and families affected by complex health conditions," said Manish Arora, PhD., Co-Founder and CEO of LinusBio. "We chose to focus on autism first for many considerations, an important one of them is the dramatically different trajectory in cases of an early detection and effective intervention. The impact on the patient and the patient’s family can be substantial. We’re proud to launch the LinusBio platform to meet the tremendous need for better, faster, and comprehensive diagnostics and treatments for a range of conditions and diseases."

The company’s program pipeline also comprises advanced biomarkers for ALS, oncology (including pediatric cancer), gastroenterology (inflammatory bowel disease) and mental disorders (psychosis & schizophrenia).

The round was led by GreatPoint Ventures and Bow Capital. Other investors included Divergent Investments, Nicole Shanahan (President, Bia-Echo Foundation), the David Bellet Family Office, Gillian Sandler, and Sanford Robertson (Co-Founder of Francisco Partners and former board member of Salesforce), among others.

"Every day, every week, every month that certain diseases fester undetected and untreated impacts a patient’s long-term outlook," said Ashok Krishnamurthi, Managing Partner, GreatPoint Ventures. "We’re looking forward to working with LinusBio to scale their solutions and bring them to market to meet vital needs."

"Our mission is to help shorten the path of innovation from science to society," said Rafi Syed, General Partner, Bow Capital. "We’re proud to collaborate with LinusBio, which has great potential to transform the implications of complex diseases."

LinusBio’s technology examines human physiology at the molecular level through a strand of hair. Leveraging proprietary laser and robotics technology, LinusBio analyzes these strands and collects thousands of data points to measure individuals’ biological response to their lifespan environmental exposures. LinusBio is the first technology platform that maps the molecular dynamics of human physiology in a time-dependent manner.

"This technology is very exciting for those impacted by autism and many other conditions, as well as their families," said Amol Deshpande, Founder of Divergent Investments, and the CEO and Co-Founder of Farmers Business Network. "LinusBio has the opportunity to fundamentally transform the healthcare industry."

Arora, the CEO of LinusBio, is an environmental epidemiologist and exposure biologist. He is a recipient of a Presidential PECASE award from the White House, the highest civilian award given to early career scientists. Drs. Christine Austin, PhD., and Paul Curtin, PhD., also co-founded the company and serve on the leadership team.

The funding will be used to grow the LinusBio team, deliver more positive outcomes across more health conditions, and develop a world-class platform that will serve as a central hub for diagnostics and treatment.

Puma Biotechnology to Present at B. Riley Securities’ 3rd Annual Oncology Conference

On January 12, 2023 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 11:00 a.m. PST/2:00 p.m. EST on January 19 at the virtual B. Riley Securities’ 3rd Annual Oncology Conference (Press release, Puma Biotechnology, JAN 12, 2023, View Source [SID1234626232]). A live webcast of Mr. Auerbach’s presentation will be accessible via registration on the event website at View Source A replay of the presentation will be available at the same address.

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Harbour BioMed Announces IND Clearance for First-in-Class Anti-B7H7 Antibody by the U.S. FDA

On January 12, 2023 Harbour BioMed (the"Company", HKEX: 02142) reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its globally first-in-class fully human monoclonal antibody HBM1020 targeting B7H7 (also known as HHLA2) in the U.S (Press release, Harbour BioMed, JAN 12, 2023, View Source [SID1234626229]). This is an open-label and multicenter study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM1020 in patients with advanced solid tumors. HBM1020 is also the globally first-ever monoclonal antibody targeting B7H7 cleared by the regulatory agency for clinical trials.

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HBM1020 is a first-in-class fully human monoclonal antibody generated from Harbour Mice H2L2 transgenic mice platform targeting B7H7. The antibody can enhance anti-tumor immunity by blocking the novel immune checkpoint target. Preclinical data demonstrated its immune activation and anti-tumor functional activities.

B7H7 is a novel immune modulatory molecule belongs to B7 family members. The B7 family is of central importance in regulating the T-cell response, making these pathways very attractive in cancer immunotherapy. Most of the validated targets in immune-oncology so far are related to B7 family, including PD-(L)1 and CTLA-4. The therapies against B7 family targets have already shifted the paradigm for cancer therapy with outstanding clinical benefits. As a newly discovered member of the B7 family, B7H7 expression is found non-overlapping with PD-L1 expression in multiple tumor types, which indicates an alternative immune evasion pathway besides PD-(L)1. In PD-L1 negative/refractory patients, B7H7 potentially plays a more important role in tumor cells to escape immune surveillance, which is expected to be developed as next-generation immune-oncology therapeutics.

With its innovative biology mechanisms, HBM1020 may present a novel anti-tumor therapeutic complementary to PD-(L)1 therapeutics to patients, especially for PD-L1 negative/refractory patients.