On September 20, 2022 Invenra, a company developing next generation therapeutic antibodies, reported that Chief Scientific Officer Daniel Pereira, Ph.D., will present preclinical data supporting the ongoing development of INV322, an antibody-based cancer therapeutic (Press release, Invenra, SEP 20, 2022, View Source [SID1234619698]). The preclinical research findings will be presented at the 13th Annual World Bispecific Summit, Thursday, September 22nd, 2022 and at the Immuno-Oncology Summit, Wednesday, October 12th, 2022, both in Boston.

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The presentation will highlight preclinical data related to the lead candidate INV322, a SNIPER Bispecific Antibody co-targeting CTLA-4 and CD25. In vitro studies have characterized avidity-mediated binding of INV322 to these tumor Treg antigens as well as an antibody dependent cell cytotoxicity (ADCC) mediated mode of action. In vivo studies using a murine surrogate also show potent anti-tumor responses after a single dose and selective regulatory T cell (Treg) depletion in syngeneic mice. Moreover, synergistic anti-tumor activity was also observed in combinations with anti-PD-1 and anti-PD-L1 agents.

"We are very pleased with the strong preclinical data that our research team has generated with INV322 using our proprietary multispecific B-Body Platform. INV322 also appears well tolerated in ongoing toxicology studies and thus we are also encouraged by its therapeutic potential as we progress our IND-enabling activities," said Pereira. "These efforts are also providing validation for both the SNIPER Bispecific antibody therapeutics approach, and our robust multispecific B-Body Platform."

Jonathan Davis, Ph.D., Invenra VP of Innovation and Strategy, will also be presenting on the Invenra B-Body Platform at the 13th Annual World Bispecific Summit. "Our platform has binding, biophysical, and manufacturing properties equivalent to the best conventional monoclonal antibodies, and far superior to the typical bispecific antibody platform," said Davis. "We are very excited to see the B-Body Platform and SNIPER Bispecific antibodies advancing in multiple indications and believe this will be a pivotal platform for bispecific antibody therapeutics."

About INV322

INV322 is a next generation anti-CTLA-4 x CD25 bispecific mAb developed using Invenra’s high-developability B-Body Platform. Using the SNIPER Bispecific approach, the antibody was designed with optimized affinities for both antigens, permitting avid antibody binding specifically when both antigens are present. The antibody was also optimized for an ADCC-mediated MOA and has exhibited excellent developability properties at scale.

On September 20, 2022 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage, clinical biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders with high unmet need, and Renovacor, Inc. (NYSE: RCOR), a biotechnology company focused on delivering innovative precision therapies to improve the lives of patients and families battling genetically-driven cardiovascular and mechanistically-related diseases, reported a definitive agreement under which Rocket will acquire Renovacor in an all-stock transaction for an implied value of approximately $2.60 per share, based on the volume weighted average trading price of Rocket shares of $15.51 for the 30 trading days through and including Monday, September 19, 2022 (Press release, Rocket Pharmaceuticals, SEP 20, 2022, View Source [SID1234619697]). The boards of directors of both companies have unanimously approved the transaction, which is currently expected to close by the first quarter of 2023.

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"The acquisition of Renovacor aligns with our strategy to expand our leadership position in AAV-based gene therapy for cardiac disease and gives us a perfect opportunity to continue on our mission to transform the lives of heart failure patients through the power of gene therapy," said Gaurav Shah, M.D., Chief Executive Officer of Rocket. "Building on our success in Danon Disease to date, I am particularly excited to expand our cardiology focus and capabilities and address a clear unmet medical need in BAG3-associated dilated cardiomyopathy. By combining Renovacor’s compelling preclinical work with our joint clinical, regulatory and CMC expertise, we believe we will be well-positioned to bring the highest impact gene therapy with the best chance for success to these patients in the most productive and efficient manner possible."

Dr. Shah continued, "Given the positive pediatric safety data previously announced from our Phase 1 RP-A501 Danon Disease program, and the upcoming pediatric efficacy data and longer-term adult cohort data we anticipate presenting at the Heart Failure Society of America (HFSA) Scientific Meeting at the end of this month, this strategic acquisition gives us what we believe is the broadest platform in the field to address these devastating rare cardiac diseases. Furthermore, the acquisition will bring to Rocket key personnel, namely a team of leading cardiology drug development experts, critical capabilities, and valuable IP to support continued development of the BAG3 as well as other potential cardiac programs, including a gene therapy research collaboration for arrhythmogenic cardiomyopathy."

Renovacor’s most advanced program, REN-001, is an AAV-based gene therapy targeting BAG3-associated dilated cardiomyopathy (DCM), a severe form of heart failure. BAG3-DCM represents a significant unmet medical need in a patient population with rapidly progressive cardiac dysfunction in whom no treatments targeting the underlying mechanism of disease exist. Renovacor has deep technical expertise in the development of precision therapies that address genetically driven cardiac diseases. Further, Renovacor is supported by world-class scientific collaborators, a robust intellectual property portfolio and personnel with expertise in BAG3-DCM. These assets and capabilities, all together, represent tremendous value and will enhance Rocket’s leading position in cardiac AAV-based gene therapy.

"Renovacor has made tremendous progress in advancing targeted gene therapies to address the high unmet medical needs of patients living with genetically driven forms of heart disease," said Magdalene Cook, MD, Chief Executive Officer of Renovacor. "Our experienced team is excited to join Rocket in a shared vision of broadening patient access to precision medicines for cardiovascular disease and addressing common barriers jointly. We look forward to combining the considerable resources and expertise of Renovacor and Rocket in creating a category leader in the precision cardiology field. As a result of this combination, we will be suspending current guidance regarding preclinical and clinical timelines for our programs as we evaluate these items with the Rocket team."

Transaction Details

Under the terms of the definitive agreement, Renovacor shareholders will receive approximately 0.1676 shares of Rocket in exchange for each of their shares in Renovacor (subject to adjustment as described below) and are expected to own approximately 4.6% percent of Rocket equity on a fully diluted basis immediately following the closing of the transaction. The exchange ratio implies an equity deal value of approximately $53 million based on fully diluted shares outstanding and the acceleration and vesting of all earnout shares, or $2.60 per share of Renovacor, based on the volume weighted average trading price of Rocket shares of $15.51 for the 30 trading days through and including Monday, September 19, 2022. The exchange ratio is subject to adjustment based on Renovacor net cash at closing.

It is currently anticipated that the transaction will close by the first quarter of 2023, subject to approval by Renovacor and Rocket shareholders, receipt of any required customary regulatory approvals and the satisfaction of other customary closing conditions. RTW Investments, LP, a significant shareholder of both Rocket and Renovacor, has entered into a voting agreement with Renovacor, pursuant to which they have agreed, among other things, and subject to the terms and conditions of the agreement, to vote in favor of the Renovacor acquisition as a Rocket stockholder.

SVB Securities is serving as exclusive financial advisor and Goodwin Procter LLP is serving as legal counsel to Rocket. Wells Fargo Securities is serving as exclusive financial advisor and Troutman Pepper Hamilton Sanders LLP is serving as legal counsel to Renovacor.

Investor Webcast Information

Rocket management will discuss the transaction via webcast today, Sept. 20, 2022, at 8:00 a.m. ET. To access the webcast, please register online at: View Source Participants are requested to register a minimum of 15 minutes before the start of the call. The webcast replay will be available on the Rocket website upon completion of the event.

On September 20, 2022 NorthStar Medical Radioisotopes, LLC (‘NorthStar’), a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and IBA (Ion Beam Applications S.A., EURONEXT), the world leader in particle accelerator technology, reported a new agreement under which NorthStar will purchase two additional Rhodotron TT300 HE electron beam accelerators, and the associated beamlines, from IBA for the production of molybdenum-99 (Mo-99) (Press release, NorthStar Medical Radiostopes, SEP 20, 2022, View Source [SID1234619696]).

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The purchase marks a total of five Rhodotron accelerators that NorthStar has purchased from IBA to date. NorthStar previously purchased two electron beam accelerators from IBA in 2019 for the production of Mo-99, and purchased a third accelerator in 2021 for production of the therapeutic radioisotope actinium-225 (Ac-225). The additional accelerators will be used to further expand NorthStar’s commercial-scale radioisotope production capabilities at its Beloit, Wisconsin headquarters. All NorthStar production processes employ innovative, environmentally preferable technology and are non-uranium based.

NorthStar’s first Accelerator Production facility expansion in Beloit is nearing completion and moving to the final phase of activities required for licensure and FDA approval. Both accelerators are operating at full power and undergoing final testing. Equipment in the adjacent Isotope Processing facility has been installed and is undergoing final testing. Construction of NorthStar’s dedicated Actinium-225 Production facility is also well underway, with shipment of the third IBA Rhodotron accelerator expected by the end of 2022.

"NorthStar continues to invest in the future of nuclear medicine using innovative technology to advance environmentally sustainable radioisotope production, and the purchase of these additional accelerators marks another milestone of our highly productive relationship with IBA," said Stephen Merrick, Chief Executive Officer of NorthStar. "IBA has demonstrated extensive commercial expertise and excellent performance in delivering electron beam accelerators for our Mo-99 production expansion program, and in the design and custom-build of our Ac-225 accelerator. We are proud that IBA is a partner in helping to make these important diagnostic imaging and therapeutic radioisotope products available to advance patient health, and look forward to continuing to work with them."

Olivier Legrain, Chief Executive Officer of IBA commented, "We are delighted to sign this latest agreement with NorthStar Medical Radioisotopes and to continue to deliver innovative solutions for reliable radioisotope supply. IBA’s Rhodotron accelerators provide the most advanced electron accelerator technology in the world, enabling a non-uranium based and highly efficient method for producing medical radioisotopes such as Mo-99, Ac-225 and Cu-67. We look forward to continuing to work with NorthStar to advance research and help patients."

On September 20, 2022 Pionyr Immunotherapeutics, Inc., a company developing first-in-class Myeloid TuningTM antibody therapeutics that enhance the body’s anti-tumor immunity by altering, or "tuning," immune cells within the tumor microenvironment, reported it has begun dosing patients in its Phase 1b expansion study investigating PY159 in patients with prioritized cancer types: ovarian cancer, pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), HR+HER2- breast cancer, head and neck squamous cell carcinomas (HNSCC), and colorectal cancer (CRC) (Press release, Pionyr Immunotherapeutics, SEP 20, 2022, View Source [SID1234619695]).

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"We developed PY159 to target TREM1 and reprogram myeloid cells within the tumor microenvironment to promote anti-tumor responses – a novel approach to TREM1 biology for anti-tumor drug development," said Leonard Reyno, M.D., Pionyr Executive Vice President and Chief Medical Officer. "In the Phase 1a dose escalation study, PY159 was well tolerated in doses up to 10 milligrams per kilogram and showed dose-proportional pharmacokinetics. With these conclusions from Phase 1a, we are excited to begin this Phase 1b expansion study with leading clinical sites and investigators."

PY159 is an afucosylated humanized monoclonal antibody (mAb) that specifically binds human Triggering Receptor Expressed on Myeloid Cells 1 (TREM1). In preclinical studies, PY159 effectively induces signaling through the TREM1–DAP12 complex, leading to downstream phosphorylation, and an increase in production of cytokines and chemokines and the upregulation of costimulatory and activation markers. Taken together, Pionyr’s research indicates that PY159 converts suppressive tumor-associated myeloid cell populations into inflammatory cells that promote anti-tumor immune responses.

This Phase 1b portion of the study follows Pionyr’s Phase 1a dose-escalation trial. The multi-centered, US-based Phase 1a study evaluated the safety and tolerability of PY159 alone and in combination with pembrolizumab in multiple solid tumors and determined a recommended Phase 1b dose for expansion.

The Phase 1b study will evaluate PY159 administered alone and in combination with pembrolizumab in predefined tumor types. The first patient has been dosed in the single-agent ovarian cancer cohort. In addition to characterizing the anti-tumor activity of PY159, this study will continue to evaluate the safety, tolerability, and pharmacokinetics of PY159. Additional exploratory biomarkers will be evaluated, including analysis of TREM1-expression in the immune infiltrate of tumor biopsy samples. For more information, please visit www.clinicaltrials.gov (Identifier: NCT04682431).

PY159 is an investigational compound and is not approved by any regulatory authority.

About Myeloid TuningTM

Pionyr has developed a therapeutic platform called Myeloid Tuning, a process that rebalances the tumor microenvironment (TME) to promote anti-tumor immunity. Myeloid cells are a type of immune cell and are part of a family of cell types that play an important role in both the activation and suppression of the immune response to cancer.

One such critical type of myeloid cell, tumor-associated macrophages (TAM), are a key component of the TME. TAMs are generally categorized into two functionally contrasting subtypes called M1-like and M2-like macrophages: M1-like typically exerts anti-tumor functions, including directly mediating antibody-dependent cell-mediated cytotoxicity (ADCC) to kill tumor cells; M2-like macrophages can promote the occurrence and metastasis of tumor cells, inhibit T cell-mediated anti-tumor immune response, promote tumor angiogenesis and lead to tumor progression.

Myeloid TuningTM effectively describes the mechanism of introducing agents that shift the balance of inhibitory myeloid cells – including M2-like TAMs – towards more inflammatory M1-like TAMs to promote anti-tumor immune responses in the TME and destroy solid tumors.

On September 20, 2022 Alliance Pharma plc (AIM: APH), the international healthcare group, reported its interim results for the six months ended 30 June 2022 ("the Period") (Press release, Alliance Pharma, SEP 20, 2022, View Source;lang=en-GB&companycode=uk-aph&v= [SID1234619694]). The Group navigated the challenges of H1 well and is on track to accelerate revenues in H2 as supply constraints ease and our marketing and product development initiatives stimulate greater demand. We remain on track to meet market expectations for full year financial performance, noting that the timing of certain orders in Q4 is dependent on the rate of recovery in those markets.

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OPERATING AND FINANCIAL HIGHLIGHTS

· H1 revenue growth impacted by lockdown in Shanghai, and associated temporary disruption to supply chain, therefore, as previously indicated, performance more heavily weighted to H2 due to order phasing

· Consumer Healthcare see-through revenue* up 1% to £57.4m (H1 21: £56.8m) with 15% growth in Other Consumer Healthcare revenues offsetting softer performance in key brands

·Robust Prescription Medicine performance with revenues of £24.1m in line with prior year (H1 21: £24.1m)

· Free cash flow of £5.1m (H1 21: £6.5m). Highly strategic acquisition of ScarAway and US rights to Kelo-cote for $19.4m (£14.8m) led to an increase in net debt and Group leverage of 2.05x at Period end.

DEVELOPING OUR BUSINESS

· Integration of ScarAway and US rights to Kelo-cote completed, with revenues in-line with expectations

·Last remaining Nizoral marketing authorisations transferred from J&J to Alliance in China and Vietnam, new top-tier Chinese distributor appointed and manufacturing supply consolidation progressing well which will result in improvements in efficiencies and COGS

· Several new complementary proprietary products launched, or planned to launch this year, including Kelo-cote Kids and Kelo-cote Scar Sheets in China, and Canker-X in the USA, all of which will contribute to ongoing organic growth

· ERP system successfully rolled out to further territories including North America

· Scope 1 and 2 emissions target set to achieve net zero in 2030, with an interim reduction of 65% by 2025

Commenting on the results, Peter Butterfield, Chief Executive Officer of Alliance, said:

"I am pleased with the performance of the Group in the first half of 2022 against the backdrop of difficult global trading conditions. Our portfolio continues to provide a robust platform from which to grow our consumer healthcare brands. I was also delighted to close a highly strategic US acquisition in the Period which consolidates our position in the scar reduction market. The integration of ScarAway has gone very smoothly and we continue to evaluate opportunities to acquire selective complementary new products to enhance our Consumer Healthcare platform.

"The second half of 2022 has got off to an encouraging start as lockdowns and supply constraints have eased. We anticipate strong sales growth in H2 as our marketing campaigns yield benefits, we integrate our new distribution partners and launch new products to grow our market share. Our FY 22 expectation includes several large distributor orders in Q4 to meet increased demand, with the timing of these orders dependent on the rate of recovery in those markets. Our base business remains strong with further new product launches expected in 2023 to secure future growth."

* The performance of the Group is assessed using Alternative Performance Measures ("APMs"), which are measures that are not defined under IFRS but are used by management to monitor ongoing business performance against both shorter term budgets and forecasts and against the Group’s longer term strategic plans. APMs are defined in note 17.

Specifically, see-through revenue includes all sales from Nizoral as if they had been invoiced by Alliance as principal. For statutory accounting purposes the product margin relating to Nizoral sales made on an agency basis is included within Revenue, in line with IFRS 15.

ANALYST MEETING & WEBCAST

A meeting for analysts will be held at 9.30am this morning, 20 September 2022, at Investec Bank plc, 30 Gresham Street, London EC2V 7QP. For further details, analysts should contact Buchanan at [email protected].