On June 22, 2020 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. ("LMI"), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, reported that it has completed its previously announced merger with Progenics Pharmaceuticals, Inc. ("Progenics") (Nasdaq: PGNX), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer (Press release, Lantheus Medical Imaging, JUN 22, 2020, View Source [SID1234561335]). The merger agreement was first announced on October 2, 2019.

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"Today marks an important day for Lantheus and Progenics. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio," said Mary Anne Heino, Lantheus President and Chief Executive Officer. "The transaction leverages Lantheus’ long-standing expertise in complex manufacturing, supply chain and commercial excellence, with Progenics’ three leading FDA approved products, clinical pipeline and development capabilities. We’re excited to welcome the talented Progenics employees to the Lantheus organization to help build upon our solid foundation."

Upon completion of the merger, Progenics stockholders received, for each share of Progenics common stock, 0.31 of a share of Lantheus common stock and one non-tradeable contingent value right, which is payable in two contingent payments, subject to a cap, upon the achievement of certain milestones related to the financial performance of PyLTM (18F-DCFPyL), Progenics’ prostate-specific membrane antigen targeted imaging agent designed to visualize prostate cancer.

The Company will continue to trade on Nasdaq under the ticker symbol LNTH. Progenics is being delisted.

On June 22, 2020 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its broad viral vector expertise and their potential to transform the fight against cancer at the AACR (Free AACR Whitepaper) 2020 Virtual Annual Meeting II (Press release, Transgene, JUN 22, 2020, View Source [SID1234561334]).

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myvac
Transgene presents data demonstrating that the prediction algorithm used to customize TG4050 for each patient is accurate at identifying immunogenic cancer mutations even among a large set of candidate tumor mutations.
The poster is entitled:
"Performance of neoantigen prediction for the design of TG4050, a patient specific neoantigen cancer vaccine" (#4566)

Because only 1 to 5% of tumor mutations are immunogenic, they can be particularly difficult to identify. To demonstrate the accuracy of the prediction algorithm, Transgene and NEC analyzed 6 tumor samples from patients with non-small cell lung cancer eligible for tumor resection. NSCLC are highly mutated tumors that thus generated a massive amount of data that proved compatible with the machine learning approach.
More than 86% of top ranked peptides identified were immunogenic. The NEC/Transgene prediction system was also able to identify immunogenic peptides that were missed by netMHCpan 4.0, the industry standard predictor.
These results demonstrate that the specificity of our approach outperforms the industry standard and are expected to translate in enhanced activity in patients.
Two PoC Phase 1 clinical trials evaluating TG4050, the first therapeutic vaccine leveraging this algorithm, are ongoing in the USA and in Europe.
The poster can be downloaded on the AACR (Free AACR Whitepaper) website and here.

___________________

Invir.IOTM

Transgene is presenting preclinical data on two oncolytic viruses derived from the Invir.IO platform, the clinical-stage BT-001 and the new candidate TG6010.

BT-001
Transgene and BioInvent are presenting a poster that supports the clinical development of BT-001, an anti-CTLA4 antibody-encoding oncolytic virus, against solid tumors:
"BT-001, an oncolytic Vaccinia virus armed with a Treg-depletion-optimized recombinant human anti-CTLA4 antibody and GM-CSF to target the tumor microenvironment." (#5602)

Cure rates exceeding 70% were seen in multiple mouse models, demonstrating the powerful therapeutic effect of BT-001 when used as a single agent, providing a solid basis for BT-001’s upcoming clinical development, with a Phase 1 clinical trial expected to start before the end of 2020.
The anti-CTLA-4 antibody and GM-CSF accumulate in tumors with low systemic exposure. Concentrations of the anti-CTLA-4 antibody in the tumor after intratumoral injection of BT-001 is more than 10-fold higher than after intraperitoneal injection of 3 mg/kg of the recombinant antibody in a xenograft tumor model.
When tumor cells were re-implanted in mice that had been cured after a first BT-001 treatment, a strong tumor-specific response and long-lasting immune memory were developed by these mice.
BT-001, even at sub-optimal dose, reinforced the therapeutic activity of anti-PD-1 treatment – opening up potential combinations for powerful dual checkpoint blockade treatment regimens
The poster can be downloaded on the AACR (Free AACR Whitepaper) website and here.

More details are available in the press release distributed simultaneously and available on www.transgene.fr.

TG6010
Transgene is also presenting preclinical data obtained with TG6010, an Invir.IO based oncolytic virus encoding human cytidine deaminase (hCD) in a poster entitled:
"Oncolytic Vaccinia Virus expressing Cytidine Deaminase induces DNA damage and shows potent anti-tumor effects" (#4576)

In addition to the intrinsic properties of the Invir.IO viral vector (superior oncolysis, immunogenic cell death, stimulation of innate and adaptive immune responses), TG6010 directly expresses hCD in the tumor micro-environment.
hCD is an enzyme that converts cytidine into uridine. Cytidine being one of the 4 nucleotides that compose DNA, it is absolutely necessary to enable cell replication and tumor progression.
By expressing hCD in the tumor, TG6010 will indirectly deprive cancer cells from the material they need to replicate, leading to DNA instability and ultimately cell death (apoptosis).
The preclinical data presented at AACR (Free AACR Whitepaper) also show that the activity of TG6010 is associated with a significant decrease of available cytidine in the plasma, which resulted in a distant antitumor effect.
Additional experiments are being conducted to further assess the potential of TG6010 as a single agent and in combination with other treatments that target tumor cells DNA, and DNA repair mechanisms.

On June 22, 2020 BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported new proof-of-concept data for two different types of monoclonal antibodies targeting tumor necrosis factor receptor 2 (TNFR2) (Press release, BioInvent, JUN 22, 2020, View Source [SID1234561333]).

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TNFR2 is particularly upregulated on tumor-associated regulatory T cells (Tregs) and has been shown to be important for their expansion and survival. As a part of its Treg program, BioInvent identified and characterized a wide panel of TNFR2-specific antibodies, generated from its proprietary n-CoDeR library and unique F.I.R.S.TTM discovery tool, of which BI-1808 and BI-1910 are the lead development candidates.

In vivo studies show that both ligand-blocking and agonistic antibodies regress large established tumors and synergize with anti-PD-1 therapy. Further mode-of-action dissection demonstrate that while the ligand-blocking antibody depleted intratumoral Tregs, the agonist increased intratumoral CD8+ T effector cells. Both antibodies expanded tumor-specific CD8+ T cells and induced long-lasting T cell memory.

Main points from the presentation included:

The two different types of TNFR2 targeting antibodies are being developed by BioInvent – BI-1808 (a ligand blocker), and BI-1910 (an agonist).
BI-1808 and BI-1910 act through differential targeting of intratumoral Tregs and CD8+ T cells to regress large inflamed tumors and sensitize the host to anti-PD-1 therapy.
Treatment with both antibodies result in an increase in numbers and activation of tumor specific T cells at the tumor site.
Martin Welschof, CEO of BioInvent, says: "The proof-of-concept data presented in this poster show very exciting potential for these two TNFR2 antibodies in improving treatment for solid cancers, and are further reinforcement of the productivity of BioInvent’s technology platform. This provides a foundation for further development and we look forward to investigating these antibodies in clinical trials, with BI-1808 expected to start a Phase l study in 2020."

These promising findings are available in a poster, which can be downloaded from the BioInvent website.

Title of the poster: "Targeting TNFR2 for Cancer Immunotherapy – Ligand blocking depletors versus receptor agonists"
Authors: Linda Mårtensson, Kirstie Cleary, Monika Semmrich, Mathilda Kovacek, Petra Holmkvist, Carolin Svensson, Mimoza Demiri, Therese Blidberg, Ulla-Carin Thornberg, Vincentiu Pitic, Osman Dadas, Sean H Lim, Stephen A Beers, Mark S Cragg, Björn Frendéus, Ingrid Teige
Session Date: June 22-24, 2020
Poster Session Title: Immune Checkpoints 1
Poster Number: 936 // Abstract Number: 5892

On June 22, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that data from two investigational Innate Cell Engagers (ICE) developed from its fit-for-purpose ROCK platform were presented as posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II (Press release, Affimed, JUN 22, 2020, View Source [SID1234561332]). Affimed researchers presented data on AFM24, a bispecific EGFR/CD16A ICE with the potential to overcome resistance to current targeted treatments for EGFR-positive malignancies. Researchers from Genentech, a member of the Roche Group, presented preclinical data on the pharmacology and safety of RO7297089, a novel anti-BCMA/CD16A bispecific antibody for the treatment of multiple myeloma built from the ROCK platform; Affimed researchers contributed as co-authors on the poster.
"The data presented at AACR (Free AACR Whitepaper) on AFM24 and RO7297089 further confirm the importance of activating the innate immune system to deliver transformative medicines to patients," said Dr. Arndt Schottelius, Affimed’s Chief Scientific Officer. "Moreover, it is very exciting to see that both molecules show potent and targeted killing of tumor cells in vitro without high levels of cytokine release. With AFM24, we have already progressed to the 2nd dose cohort in our Phase 1/2A clinical study and very much look forward to seeing continued consistent safety profile and early signs of activity in future cohorts."

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AFM24 activates innate immunity to kill solid tumors, inducing both ADCC and ADCP
The data presented on Affimed’s AFM24 further elucidated its preclinical profile as a novel ICE that harnesses the innate immune system to induce potent tumor cell killing via ADCC and ADCP. Due to its distinctive mechanism of action (MOA), AFM24 is potentially eligible for treatment of EGFR-positive tumors, regardless of EGFR-pathway mutations and EGFR receptor density. Unlike other EGFR targeted therapies, EGFR is used as a docking site only, AFM24’s cytotoxicity is independent of EGFR functionality and the downstream signal cascade. The pre-clinical data suggest that AFM24 is well tolerated with no toxicity in cynomolgus monkeys. Based on its preclinical profile, AFM24 shows promising therapeutic benefit for a broad set of patients with hard-to-treat EGFR-expressing cancers. AFM24 is currently being studied in a Phase1/2A study.

RO7297089 shows potent cell killing of BCMA positive tumor cell lines employing NK cells and macrophages
The data presented on Genentech’s RO7297089 provided preclinical characterization of a novel BCMA/CD16A ICE, also based on the ROCK platform, for the treatment of multiple myeloma. It was shown that RO7297089 is a potent therapeutic agent in vitro and selectively kills BCMA expressing multiple myeloma tumor cells by activating innate immunity (ADCC and ADCP). The in vitro assessment demonstrated that, unlike T cell redirecting therapies, RO7297089 is unlikely to have a risk of acute cytokine release. In a one-month repeat-dose study in cynomolgus monkeys, RO7297089 was well tolerated, and there were no test article-related adverse effects at up to 50 mg/kg, with no significant cytokine release. RO7297089 represents a novel and promising MOA with a favorable safety profile, distinct from the T cell-based BCMA-targeting modalities in the clinic.

More details about the program for the AACR (Free AACR Whitepaper) Virtual Annual Meeting II including the abstracts and poster presentations on AFM24 and RO7297089 are available online at www.aacr.org.

On June 22, 2020 BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported preclinical data demonstrating high cure rates in solid tumors of BT-001, an anti-CTLA4 antibody-encoding oncolytic virus (Press release, BioInvent, JUN 22, 2020, View Source [SID1234561331]).

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Cure rates exceeding 70% were seen in multiple mouse models, demonstrating the powerful therapeutic effect of BT-001 when used as a single agent, providing a solid basis for BT-001’s upcoming clinical development, with a phase I clinical trial expected to start before the end of 2020.

BT-001 is a next-generation oncolytic virus (OV) being co-developed by Transgene and BioInvent. It was generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR oncolytic virus, which has been engineered to encode a Treg-depleting, anti-CTLA4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, as well as the cytokine GM-CSF.

BT-001 has multiple mechanisms of action. It has been designed to combine the killing of cancer cells (oncolysis), and the production of the anti-CTLA4 antibody and GM-CSF directly in the tumor site, while also generating an immune response against tumor cells.

These data indicate that BT-001 has the potential to make a significant difference in the treatment of solid tumors and as such, underpin the effectiveness of both BioInvent’s and Transgene’s technology platforms.

Main points from the presentation included:

The anti-CTLA-4 antibody and GM-CSF accumulate in tumors with low systemic exposure. Concentrations of the anti-CTLA-4 antibody in the tumor after intratumoral injection of BT-001 is more than 10-fold higher than after intraperitoneal injection of 3 mg/kg of the recombinant antibody in a xenograft tumor model.
When new tumor cells were implanted in mice that had been cured after a first BT-001 treatment, a strong tumor-specific response and long-lasting immune memory were developed by these mice.
BT-001, even at sub-optimal dose, reinforced the therapeutic activity of an anti-PD-1 antibody – opening up potential combinations for powerful dual checkpoint blockade treatment regimens.
These promising findings are available in a poster being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, on June 22-24, 2020. It can be downloaded from the AACR (Free AACR Whitepaper) website and from both BioInvent’s and Transgene’s websites.

Title of the poster: "BT-001, an oncolytic Vaccinia virus armed with a Treg-depletion-optimized recombinant human anti-CTLA4 antibody and GM-CSF to target the tumor microenvironment."
Authors: Jean-Baptiste Marchand, Monika Semmrich, Laetitia Fend, Matilda Rehn, Nathalie Silvestre, Ingrid Teige, Johann Foloppe, Linda Mårtensson, Eric Quéméneur, Björn Frendeus
Session Date: June 22-24, 2020
Poster Session Title: Inflammation, Immunity, and Cancer / Modifiers of the Tumor Microenvironment 2
Poster Number: 5602 // Abstract Number: 2902
About BioInvent

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. Two preclinical programs in solid tumors are expected to enter clinical trials by the end of 2020. The Company’s validated, proprietary F.I.R.S.TTM technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.

The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company’s fully integrated manufacturing unit. More information is available at www.bioinvent.com.