On July 11, 2022 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule therapeutics, reported that it has raised $50 million in a Series D financing round, co-led by new investors Sands Capital and Vivo Capital, with additional participation from new investor Dreavent 6 (Press release, Inspirna, JUL 11, 2022, View Source [SID1234616576]). Existing investors also participated in the financing round including Novo Holdings A/S, Sofinnova Partners, Sixty Degree Capital Fund, New York City Investment Fund LLC, Lepu Holdings, and additional investors. In addition, Michael Ginder, of Sands Capital, and Jack Nielsen, of Vivo Capital, will join Inspirna’s Board of Directors.

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Proceeds from the financing will support the clinical development of Inspirna’s lead drug candidate RGX-202-01 ("RGX-202"), a first-in-class oral small molecule inhibitor of SLC6a8 to treat RAS mutant advanced colorectal cancer (CRC), and RGX-104, an oral small molecule activator of LXR/APOE to treat lung cancer and endometrial cancer. The financing will provide the company with the funds necessary to further evaluate efficacy and safety for RGX-202 in second-line RAS mutant CRC in an ongoing Phase 1b clinical trial, for which the company recently disclosed interim data in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"I would like to thank both our new and existing investors for the confidence they continue to demonstrate in the potential of our unique drug candidates to make a profound impact on patients in the clinic," said Masoud Tavazoie, MD, PhD, and Chief Executive Officer and co-founder of Inspirna. "We are currently evaluating RGX-202 and RGX-104 in clinical trials in high unmet medical need settings and, with renewed support from our investors, are now well-positioned to further build on the promising efficacy signals and safety profiles for these drug candidates."

On June 11, 2022 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, JUL 11, 2022, View Source [SID1234616575]).

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The share buy-back program is expected to be completed no later than August 31, 2022 and comprises up to 370,000 shares.

The following transactions were executed under the program from July 4, 2022 to July 8, 2022:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 380,883 shares as treasury shares, corresponding to 0.58% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated June 17, 2022.

On July 11, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that it will be presenting at the Proactive One2One Virtual Investor Forum on Thursday 14 July 2022 (Press release, Redx Pharma, JUL 11, 2022, View Source [SID1234616574]). The webinar event will begin at 18:00 BST and investors can register to attend here: View Source There will also be the opportunity for investors to ask questions during the event.

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Lisa Anson, Chief Executive Officer of Redx, will be presenting an overview of the Company following the recent successful fundraise of £34.3m and strong progress reported at the time of the Company’s Interim Financial Results in June. This included the acceptance of the Investigational New Drug (IND) submission for JZP815, a pan-RAF inhibitor from the Company’s partnership with Jazz Pharmaceuticals. JZP815 is the fifth molecule from the Redx Discovery Engine to enter the clinical stage of development, highlighting the strength of Redx’s worldclass medicinal chemistry expertise and drug discovery capabilities. The presentation will also include updates on the clinical programmes for Redx

On July 10, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that it has dosed the final patient and completed recruitment into the Phase III pivotal study ZIRCON (Zirconium in Renal Cancer Oncology, NCT03849118) of its investigational renal (kidney) cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) (Press release, Telix Pharmaceuticals, JUL 10, 2022, View Source [SID1234616573]). This global study has dosed 300 patients to date, exceeding the target enrolment of 252 patients, announced on 8 March 2022.

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TLX250-CDx, which has received "Breakthrough Designation" from the U.S. Food and Drug Administration (FDA)1, is being developed as an imaging agent for use in the characterization of indeterminate renal masses previously identified on computed tomography (CT) or magnetic resonance imaging (MRI) as clear cell renal cell cancer (ccRCC) or non-ccRCC.

The detection of renal masses is increasing due to widespread use of cross-sectional imaging. Many of these are small renal masses and represent a diagnostic challenge as current imaging cannot reliably distinguish benign or malignant lesions from renal cell carcinoma, leading to invasive biopsy or partial nephrectomy to confirm the diagnosis. These procedures are not always necessary and can lead to complications2. It is estimated that up to 80% of small renal masses are malignant3.

If the study is successful, TLX250-CDx may provide a non-invasive method to aid in diagnosis and staging of ccRCC and the identification of metastatic disease through whole body imaging, ultimately leading to improved patient management by minimizing the need for surgical intervention for diagnosis and guiding treatment decisions.

In addition to its potential use as a diagnostic and staging tool, Telix is considering the potential for TLX250-CDx to also be used as an active surveillance tool for patients not deemed surgical candidates.

Brian M Shuch, MD, Director of the Kidney Cancer program at UCLA said: "We may well be on the cusp of a paradigm shift in how we manage renal masses. The incidence of small renal masses is increasing, yet there is currently no imaging tool that can effectively diagnose or stage clear cell renal cancer. Most patients are scheduled for the operating room without a firm diagnosis and often surgery is found to be unnecessary. Should this study report positive results, it may provide the non-invasive imaging tool to aid in accurate diagnosis that patients and clinicians have been waiting for. Congratulations to Telix for completing this ambitious international trial."

Renal cell carcinoma (RCC) is the deadliest of all urological cancers with a late-stage 5-year survival rate of 14%4. ccRCC is the most common sub-type and accounts for approximately 80% of all renal cell carcinoma cases5. RCC is also an increasingly frequent cancer, having more than doubled in incidence in the developed world over the last 50 years.6 Worldwide, there were more than 400,000 new cases in 2020, and >175,000 people died from their disease.7

TLX250-CDx will be available in selected countries to eligible patients under an Expanded Access Program (EAP) (also known as early access, pre-approval access or emergency use), in accordance with Telix’s Compassionate Use Policy and subject to jurisdictional regulatory requirements.8

Dr Colin Hayward, Telix’s Chief Medical Officer said, "The completion of this trial will bring us a step closer to commercialization for this diagnostic imaging agent which may address a significant unmet need in the diagnosis and management of ccRCC. It also builds on Telix’s commitment to urologic oncology, with the potential of delivering a major new imaging indication. This milestone could have not been achieved without the support of our many collaborators including the 36 clinical sites who participated in the trial, our global manufacturing teams and the associated auxiliary team who have supported this study. Most of all we wish to thank the patients who have volunteered to participate in this study."

ZIRCON is a confirmatory, prospective, open-label, multi-centre phase III study to evaluate sensitivity and specificity of 89Zr-TLX250-CDx PET/CT imaging to non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients with indeterminate renal masses (IDRM), scheduled for partial or total nephrectomy. Telix expects to report the outcome from the ZIRCON study in 2H, 2022.

About TLX250-CDx

TLX250-CDx (89Zr-girentuximab) is an investigational product being developed by Telix for the purpose of non-invasive detection of clear cell renal cancer in patients with "indeterminate renal masses" (IDRMs) are, typically identified based on CT or MRI imaging and are an increasing medical dilemma as more scans are performed and more IDRMs are identified. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx, reflecting the significant unmet clinical need to improve the characterization of indeterminate renal masses previously identified on CT or MRI as ccRCC or non-ccRCC. , ccRCC is the most common and aggressive form of kidney cancer.

About the ZIRCON Study

ZIRCON (Zirconium Imaging in Renal Cancer Oncology, NCT03849118) is an international multicentre Phase III study at 34 sites in Europe, Australia, Turkey, Canada and the United States. ZIRCON is a prospective imaging trial in renal cancer patients undergoing kidney surgery with the objective of determining the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic "standard of truth" determined from surgical resection specimens.

On July 8, 2022 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that effective as of July 7, 2022, the Company closed the Phase 2 study (CP-MGA271-06) evaluating the investigational regimen of enoblituzumab (Fc-optimized B7-H3-directed monoclonal antibody) in combination with either retifanlimab (anti-PD-1 monoclonal antibody) or tebotelimab (PD-1 × LAG-3 bispecific DART molecule) in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) (Press release, MacroGenics, JUL 8, 2022, View Source [SID1234616572]).

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The decision to discontinue the study was based on an internal review of safety data, which included the occurrence of seven fatalities potentially associated with hemorrhagic events in both arms of the study (of 62 total patients treated). Six of the seven fatal events observed in the CP-MGA271-06 study were assessed by investigators as secondary to disease progression and/or unrelated to the study treatment, and one event was assessed as possibly related. Fatal tumor-related hemorrhages and airway obstruction are known risks in patients with SCCHN. The incidence of fatal events observed in the study that were potentially hemorrhagic in origin was higher than what has been reported for this patient population in the medical literature (i.e., 1 – 3.6% as per Argiris, et al., J Clin Oncol. 2019 Dec 1, 37(34):3266) and in the context of a risk : benefit analysis, prompted the Company’s decision to close the study. Accordingly, the Company informed investigators and the U.S. Food and Drug Administration (FDA) of the study closure and instructed investigators that no additional patients in the study were to be enrolled or receive further treatments as of July 7, 2022.

MacroGenics continues to investigate and monitor these events, and an analysis of the data is ongoing. There were no hemorrhagic events or coagulopathies observed in nonclinical toxicology studies of enoblituzumab, and the incidence of any fatal hemorrhage reported in earlier studies of enoblituzumab evaluated in over 340 patients across a broad range of tumor types was less than 1%.

"Our top concern in conducting clinical trials is the safety of study participants," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We were surprised by the emergence of these events in first-line SCCHN patients, as we had not observed any such events in an earlier, smaller study in patients with later-line SCCHN disease who were treated with enoblituzumab in combination with an anti-PD-1 antibody. Similar safety events have not been reported in patients treated with MGC018, our B7-H3-targeted ADC molecule, and the decision to close the CP-MGA271-06 study does not impact our ongoing MGC018 study activities. We’d like to thank all patients, their families and caregivers who participated in the CP-MGA271-06 study."

About Enoblituzumab
Enoblituzumab is an investigational anti-B7-H3 monoclonal antibody that incorporates an immunoglobulin G1 fragment crystallizable (Fc) domain designed to enhance Fcγ receptor-mediated antibody-dependent cellular cytotoxicity. B7-H3, a protein in the B7 family of immune regulator proteins, is widely expressed by a number of different tumor types and may play a key role in regulating the immune response to various types of cancer.

About Retifanlimab
Retifanlimab is an investigational anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. Retifanlimab was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. MacroGenics retains the right to develop the molecule in combination with product candidates from its pipeline.

About Tebotelimab
Tebotelimab is an investigational, bispecific DART molecule designed to block PD-1 and lymphocyte-activation gene 3 (LAG-3) checkpoint molecules to sustain or restore the function of exhausted T cells.