On July 22, 2021 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation cancer immunotherapies, reported thar it will host its second quarter 2021 financial results and corporate update conference call and live audio webcast on Thursday, July 29th at 8:30 a.m. E.T (Press release, Genocea Biosciences, JUL 22, 2021, View Source [SID1234585088]).

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Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 6789021. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source

A webcast replay will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On July 22, 2021 TAE Life Sciences (TLS), a biological-targeting radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported that as part of its growing pipeline of investigational therapies, it has identified several proprietary drug candidates, including TC220 and TC221 (Press release, TAE Life Sciences, JUL 22, 2021, View Source [SID1234585105]).

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"TLS is the only company developing comprehensive, in-house target drugs as well as a neutron technology system called Alphabeam to enable the next-generation in biologically targeted radiation therapy. Today’s news brings us closer to our goal of providing new hope to patients with the most difficult to treat cancers," said Bruce Bauer, PhD, CEO of TAE Life Sciences. "Historically, brain, head and neck, and melanoma cancers have been treated with BNCT and studies have shown improvements in survival compared to other cancer therapies. New boron drugs expand the potential to treat other indications including breast, lung and liver cancers."

Most BNCT clinical studies to date have been carried out using boronophenylalanine (BPA) as the boron target drug. When neutron radiation is applied, the boron atoms react to generate alpha particles that destroy cancer cells. Healthy cells without the boron are spared, resulting in less normal tissue damage. This is a key difference compared to conventional radiation therapy. While historical BNCT clinical outcomes have been encouraging, the availability of better boron-10 drugs and access to an in-hospital neutron system will now provide more opportunities for clinical research and potential improved efficacy of this new cancer therapy.

TC220 and TC221 have similar targeting as BPA, but have several more favorable properties, including:

Delivers more boron selectively to tumor cells compared to BPA in pre-clinical studies.
Much greater solubility than BPA, potentially allowing for of easier administration and delivery of far more boron to tumor tissue. This could be key for improving clinical outcomes.
In pre-clinical studies, TC220 is retained longer in the tumor compared to BPA, making it possible to attain a greater tumor to normal tissue ratio for boron than possible with BPA. This should provide greater flexibility in treatment planning.
As demonstrated by early preclinical data, TC220 and TC221 have shown consistent superior delivery of boron in multiple human tumor xenografts compared with BPA, expanding their potential clinical application.
"It is very exciting to add these two new compounds to our rich pipeline of boron containing drugs and to nominate them as product candidates so quickly," said Kendall Morrison, PhD, Chief Scientific Officer of TAE Life Sciences. "Our early pre-clinical data has shown TC220 and TC221 to have excellent boron delivery properties. The next step will be to identify a contract manufacturer and evaluate the two compounds in stability, pharmacokinetic, toxicokinetic and pre-clinical efficacy studies."

About Biologically Targeted Radiation Therapy (BNCT)

BNCT is a non-invasive, biologically targeted particle therapy that combines a non-toxic compound containing boron-10 and a low-energy, epithermal neutron beam. This combination generates a therapeutic dose at the cellular level that destroys tumor cells while sparing healthy tissues surrounding the tumor. This results in less toxicity for the patient and the potential to escalate the therapeutic dose to the cancer cells. BNCT has the potential to treat undetected metastases in the local region of the tumor in the same treatment session, which is difficult to impossible for conventional radiotherapy because of the logistical patient treatment setup barriers and the amount of radiation that would be delivered to healthy cells. In addition, BNCT may be utilized for several cancers which are resistant to many, if not all, current cancer therapies available, such as glioblastoma multiforme.

On July 22, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Friday, August 6, 2021, at 8:00 a.m. ET to discuss a corporate update and financial results for the second quarter 2021 (Press release, Oncolytics Biotech, JUL 22, 2021, View Source [SID1234585073]).

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Conference Call & Webcast

A webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using reference code: 148-191#.

On July 22, 2021 Invivoscribe. Inc., an industry pioneer in developing and commercializing diagnostic products and reagents for hematological malignancies, reported a key submission in the EU, and expanded presence and activity in China (Press release, Invivoscribe Technologies, JUL 22, 2021, View Source [SID1234585089]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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As of May 26, 2022 IVDs in the EU must be certified per the new in vitro diagnostic regulations (IVDR (2017/746)) prior to being put on the market. Further, all on-market IVDs will require submission to IVDR qualified notified bodies in Europe. As a leading diagnostic company, Invivoscribe, Inc. has demonstrated their preparedness via their early submission to BSI (Netherlands) and has planned and set the stage for further IVDR submissions. In these rapidly evolving times, Invivoscribe, Inc. is poised to continue as a leading provider of oncology precision diagnostics, in the EU and globally, as demonstrated with the June submission of the LeukoStrat CDx FLT3 Mutation Assay to BSI.

Tony Lialin, Chief Commercial Officer at Invivoscribe shared, "In being one of the first to submit we are quick to develop a relationship with our notified body and master the IVDR regulatory guidelines, which are expected to expedite submission of all our assays. As an early player, submission requirements were still being finalized by BSI in parallel to Invivoscribe generating the Class C companion diagnostic submission package, demonstrating our strength in pivoting to meet changing regulatory requirements." He adds, "Our early submission and additional packages in preparation help ensure there will be no interruption in test coverage for EU patient populations."

Invivoscribe’s IVDR companion diagnostic submission rapidly follows substantial milestones with this same CDx in China. The LeukoStrat CDx FLT3 Mutation Assay was used to select patients in a Phase III drug trial resulting in the NMPA/CDE February 2021 conditional approval of the Astellas drug gilteritinib fumarate used to treat R/R FLT3+ AML patients. This assay is under evaluation at 3 AAA hospitals and is currently available as a clinical research service at Invivoscribe’s Shanghai-based laboratory. Invivoscribe Diagnostic Technologies (Shanghai) Co., Ltd. has recently expanded their presence as a China based CRO by constructing a lab that is offering both molecular and flow cytometry testing services standardized with those available through the LabPMM network of clinical laboratories which have been serving our partners and customers in the USA, the EU, and Japan for some time.

With internationally standardized kits and services, custom assay development solutions, clinical trial management, regulatory expertise, and most recently expanding as a front runner for IVDR submissions in the EU while expanding capabilities in China, Invivoscribe is strategically positioned to provide comprehensive support to our global partners.

Intended Use

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).

On July 22, 2021 Illumina, Inc. (NASDAQ: ILMN) reported its commitment to re-acquire GRAIL, a healthcare company focused on multi-cancer early detection (Press release, Illumina, JUL 22, 2021, View Source [SID1234585106]).

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"This acquisition is procompetitive, and we have offered far-reaching structural and behavioral remedies to address any potential concerns. Illumina will continue to work with the European Commission (EC) to ensure that it has the information and assurances necessary to approve this transaction. We look forward to presenting our position during the Phase II process," said Charles Dadswell, General Counsel for Illumina.

Illumina is also challenging the EC’s jurisdiction to investigate the transaction under Article 22 of the European Union (EU) Merger Regulation. The Commission reversed decades of merger policy in asserting jurisdiction under Article 22 of the EU Merger Regulation on April 19, 2021, seven months after the deal was announced. Illumina has filed an action in the General Court of the EU seeking annulment of the EC’s jurisdiction to review the acquisition.

"The Commission’s unprecedented decision to assert jurisdiction to review this transaction between two U.S.-based companies leaves businesses around the world uncertain as to how the EU Merger Regulation will be applied in the future," said Dadswell.

Illumina’s re-acquisition of GRAIL means that millions of citizens across the European Economic Area (EEA) will be able to access life-saving early cancer screening years sooner. "When people have access to early cancer detection, lives will be saved," said Francis deSouza, Chief Executive Officer of Illumina. "If this acquisition does not proceed, GRAIL’s European roll-out will be slower and the cost will be measured in the unnecessary loss of life. Re-uniting GRAIL with Illumina will accelerate availability of the GRAIL test by many years in the EEA and globally, saving tens of thousands of lives, and leading to significant health care cost savings."