On February 15, 2023 Xspray Pharma reported Interim Report Fourth Quarter 2022 (Press release, Xspray, FEB 15, 2023, View Source [SID1234649578]).

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On February 15, 2023 Biotechnology company Maxion Therapeutics (‘Maxion’) reported the completion of its USD $16 million (GBP £13 million) pre-Series A financing (Press release, Maxion Therapeutics, FEB 15, 2023, View Source [SID1234646397]). The funds will be used to support the development of novel biologics targeting ion channels and G-protein-coupled receptors (GPCRs) via Maxion’s proprietary, patent-protected KnotBody platform. Ion channels and GPCRs are critical cell surface proteins involved in a wide range of previously untreatable or poorly-treated diseases, including autoimmune conditions and chronic pain. The round was led by LifeArc Ventures, including Monograph Capital and BGF as equal participants.

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Maxion was established by its Chief Executive Officer (CEO), Dr John McCafferty, who co-founded CAT (acquired by AstraZeneca for £700m) and IONTAS (acquired by FairJourney Biologics). At CAT, Dr McCafferty invented antibody phage display, the technology used to discover the world’s best-selling drug, Humira. The importance of this invention was recognised by the awarding of the 2018 Nobel Prize in Chemistry to his co-inventor, Sir Greg Winter. Maxion’s Chief Scientific Officer (CSO) and co-founder is Dr Aneesh Karatt Vellatt (also co-founder of IONTAS), who along with Dr McCafferty invented the KnotBody platform.

While multiple small molecule drugs have been developed against ion channels, there are no approved antibody drugs addressing this target class, despite the many advantages of antibodies. Antibodies have the benefit of greater specificity, a superior safety profile, and the ability to engineer their properties using Dr McCafferty’s phage display technology.

The KnotBody platform unlocks the discovery of biologics against ion channels and GPCRs by using naturally occurring cysteine-rich miniproteins called "knottins", which modulate ion channels and GPCRs but have poor drug-like properties. These are fused onto the surface of antibodies, and the resulting "KnotBodies" combine the functional activity of knottins with the excellent drug properties of antibodies. Maxion’s early R&D efforts have yielded KnotBodies to several therapeutically relevant targets, which will be developed as selective and long-acting first-in-class and best-in-class therapeutics.

Dr John McCafferty, CEO and co-founder of Maxion Therapeutics, said:
Until now, ion channels have been a blind spot for antibody therapeutics. Our KnotBody technology gives Maxion the opportunity to address this neglected target class and enable improved treatment of diseases driven by ion channels and GPCRs. We look forward to working with our investors to expand our exciting pipeline.

Dr John McCafferty
Dr Aneesh Karatt Vellatt, CSO and co-founder of Maxion Therapeutics, said:
Maxion’s KnotBody technology combines the power of millions of years of knottin evolution with state-of-the-art antibody engineering technologies to overcome long-standing challenges in ion channel and GPCR drug discovery. We are grateful for our investors’ support as we work towards developing life-changing therapeutics for diseases with high unmet need.
Dr Aneesh Karatt Vellatt

As part of the financing Dr Sohaib Mir (Senior Investment Principal at LifeArc Ventures), Dr Tim Funnell (Partner at Monograph Capital), and Lucy Edwardes Jones (Investor at BGF) will join Maxion’s Board of Directors alongside Dr McCafferty, Dr Karatt Vellatt as well as Dr Tom Weaver who is a Non-executive Director.
Dr Sohaib Mir, Senior Investment Principal, LifeArc Ventures, commented: "Maxion’s founders are seeking to build a category-defining business, and LifeArc Ventures is delighted to collaborate with them as they start to build a promising pre-clinical pipeline. Led by a highly experienced and scientifically world-renowned team, Maxion has the potential to create novel therapies for the significant proportion of patients who fail to respond to current treatments in a wide range of diseases."

Dr Tom Weaver, Non-executive Director, Maxion Therapeutics, said: "The current investment is a strong indicator of the potential of Maxion’s cutting-edge KnotBody technology to successfully target ion channels and GPCRs, especially when paired with stellar team of pioneering experts in antibody development. I look forward to supporting the company as it moves from strength to strength with its high-calibre pipeline of therapeutic candidates, which could one day deliver a significant, positive impact to patients and their families."

On February 15, 2023 Hillstream BioPharma, Inc. (Nasdaq: HILS) ("Hillstream" or the "Company"), a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancers using ferroptosis, an emerging new anti-cancer mechanism resulting in iron-mediated cell death, and immuno-oncology targeted novel biologics, reported that it has regained compliance with the Nasdaq listing minimum bid price requirement for continued listing on the Nasdaq Capital Market exchange (Press release, Hillstream Biosciences, FEB 15, 2023, View Source [SID1234627399]).

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"Ever since our IPO, our Nasdaq listing is an important underlying component of our capital markets strategy," said Randy Milby, CEO of Hillstream. "Although we don’t control our share price, we remain ever steadfast and working as diligently as possible to advance our therapeutic candidates and execute on our business plan."

Hillstream was previously notified by Nasdaq on October 22, 2022 that it was not in compliance with the minimum bid-price listing rule (under Rule 5550(a)(2)) because its common stock failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. To regain compliance , the Company was required to maintain a minimum closing bid price of $1.00 or more for at least ten consecutive trading days which was met on February 13, 2023.

The Company hosted its virtual R&D Day on February 14, 2023 where it covered its product and pipeline goals across its 4 pipeline candidates. Hillstream recently signed an exclusive option agreement with Applied Biomedical Science Institute to license technology for HER2 and HER3 to be developed for potential treatments against drug resistant cancers including HER2-positive metastatic breast cancer, gastric cancer, lung cancer and ovarian cancer.

On February 10 th , Hillstream announced a recent preclinical study of its lead drug candidate HSB-1216 in combination with pembrolizumab, demonstrating positive results against KRAS-G12C-mutated non-small cell lung cancer cells.

On February 15, 2023 Akari Therapeutics presented its corporate Presentation (Press release, Akari Therapeutics, FEB 15, 2023, https://www.akaritx.com/2023/02/15/current-company-presentation/ [SID1234627330]).

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On February 15, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to reported its Phase II diagnostic 64Cu SARTATE trial (DISCO NCT044383041) for patients with known or suspected neuroendocrine tumours (NETs) has reached the fifty percent recruitment milestone, with 32 out of 63 participants enrolled and imaged (Press release, Clarity Pharmaceuticals, FEB 15, 2023, View Source [SID1234627297]).

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DISCO, which derives from "Diagnostic Imaging Study of 64Copper-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumours", is assessing the performance of Clarity’s SARTATE imaging product as a potential new way to help diagnose and manage NETs. It is a Phase II study in up to 63 patients with Gastroenteropancreatic NETs (GEP-NETs) across four sites in Australia, comparing the diagnostic performance of 64Cu SARTATE at 4 and 20 hours post-administration to the current standard of care, 68Ga DOTATATE, at one hour. The trial aims to build on earlier studies with SARTATE (Hicks, R. et al)2 which demonstrated that imaging at later time points, enabled by a longer half-life of 64Cu isotope in comparison to 68Ga, may lead to better identification of disease.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are pleased with the progress of our SARTATE product. There is a clear unmet need in the NET indication with misdiagnosis and delay in diagnosis remaining very common. The vast majority of patients have the cancer spread to distant parts of the body by the time of diagnosis, which significantly affects treatment outcomes for people with NETs. Clarity continues to build on the promising first-in-human data, indicating the safety and potential effectiveness of the product as a new way to detect NETs. Combined with the logistical and supply benefits of central manufacturing enabled by the use of Targeted Copper Theranostics, SARTATE holds promise of delivering timely and crucial diagnostic scans to patients and their treating staff, bringing us closer to our ultimate goal of improving treatment outcomes for children and adults with cancer."

About SARTATE
SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2), including neuroblastoma and neuroendocrine tumours (NETs). Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu SARTATE) or copper-67 (67Cu) for therapy (67Cu SARTATE).

About NETs
NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, represent a heterogeneous group of malignant transformations of cells of the diffuse neuroendocrine system3. They most commonly occur in the gastrointestinal tract (48%), lung (25%), and pancreas (9%), but may also originate in other areas, including the breast, prostate, thymus and skin4. NETs can either be benign or malignant, as well as non-functional and functional5. NETs traditionally have been considered uncommon; however, the incidence has been increasing as a worldwide phenomenon6. This increase is thought to be mostly related to improvements in the way NETs are diagnosed, including better imaging tests and endoscopy, and increased awareness of these tumours7.

Overall, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year, and approximately 175,000 people are living with this diagnosis7. Patients with GEP-NETs present with subtle clinical symptoms, which can lead to a delay in diagnosis of up to 5–7 years, or result in inappropriate management8. As such, about 30-75% of NET patients have distant metastases at the time of diagnosis9. A 10-year relative survival rate for patients with metastatic GEP-NETs is 3–36%10.