On June 22, 2021 ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, and Halozyme Therapeutics, Inc. (Nasdaq: HALO) reported a global collaboration and license agreement that gives exclusive access to Halozyme’s ENHANZE drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV (Press release, Halozyme, JUN 22, 2021, View Source [SID1234584205]).

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Under the terms of the agreement, ViiV Healthcare will make an upfront payment of $40 million to Halozyme for the exclusive license to four HIV small and large molecule targets and is obligated to make potential future payments of up to $175 million in development and commercial milestones per target, subject to achievement of specified development and commercial milestones, including certain specified sales milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialised medicines using the technology.

The PH20 enzyme breaks down a substance called hyaluronan (HA) that is found in the body’s subcutaneous space (under the skin) that acts as a barrier to the flow of fluid. By breaking down HA locally at the injection site and temporarily removing that barrier, large amounts of fluid can be injected into the subcutaneous space and dispersed. This facilitates the rapid delivery of large volume fluids by subcutaneous injection, potentially reducing the treatment burden of injectable drugs and providing optimised treatment options to patients. The HA is restored under the skin via normal processes within 24-48 hours.

Halozyme’s technology provides ViiV Healthcare with more opportunities to develop ultra-long acting medicines (dosing intervals of three months or longer) with its long-acting portfolio and pipeline products. Plans are underway to initiate the first experiments with the technology by the end of 2021 for investigational, long-acting cabotegravir for prevention of HIV, which is currently administered every two months.

"Many people living with HIV and those vulnerable to HIV tell us that for a variety of reasons, taking medicine every day is a challenge, and we have listened to them," said Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare. "We believe long-acting medicines are the future of HIV therapies and will help address these unmet needs. Our collaboration with Halozyme will keep us at the forefront of developing additional, innovative new options for HIV treatment and prevention as we work towards reducing the burden of HIV treatment."

"We are excited to partner with ViiV Healthcare to create new delivery options for innovative medicines for HIV," said Helen Torley, M.B. Ch. B., M.R.C.P., president and chief executive officer, Halozyme. "This collaboration demonstrates the potential value of our technology to facilitate rapid, large volume subcutaneous injections of not only more traditional medicines but also long-acting injectables, including small molecules, which in turn may further extend dosing intervals for people taking medicines for the treatment and prevention of HIV."

The license gives ViiV exclusive use of Halozyme’s proprietary rHuPH20 technology for four, specific HIV medicine targets that will expand opportunities for development of nearly all of ViiV’s pipeline assets. These assets are integrase inhibitors, reverse transcriptase inhibitors limited to nucleoside reverse transcriptase inhibitors (NRTI) and nucleoside reverse transcriptase translocation inhibitors (NRTTIs), capsid inhibitors and broadly neutralising monoclonal antibodies (bNAbs), that bind to the gp120 CD4 binding site.

Halozyme has licensed its technology to 11 pharmaceutical and biotechnology companies, for potential use in oncology, autoimmune disease, rare disease and infectious disease with products currently approved in oncology and immune deficiency indications. In addition, Halozyme currently has a Cooperative Research and Development Agreement with the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center in the US, which includes a bNAb, N6LS, that ViiV Healthcare licensed from the National Institutes of Health in 2019.

On June 22, 2021 Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of its New Drug Application (NDA) for PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors (Press release, Fennec Pharmaceuticals, JUN 22, 2021, View Source [SID1234584222]). The Prescription Drug User Fee Act (PDUFA) target action date has been set for November 27, 2021.

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"We are pleased that the FDA has accepted our PEDMARKTM resubmission," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, Inc. "We look forward to working closely with the FDA through the review process. We are committed to bringing this treatment to children receiving cisplatin chemotherapy, an area of high unmet medical need. If approved, PEDMARKTM stands to be the first FDA approved therapy to reduce the risk of cisplatin induced ototoxicity in pediatric patients."

PEDMARK has been granted both Fast Track Designation and Breakthrough Therapy Designation by the FDA. The Complete Response Letter (CRL) received on August 10, 2020, referred to deficiencies with the facility of the drug product manufacturer; no clinical safety or efficacy issues were identified and there was no requirement for further clinical data.

About PEDMARK

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult, and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA). PEDMARK received Breakthrough Therapy and Fast Track Designation from the FDA in March 2018.

On June 22, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that adds two new products to its portfolio to help improve the management of patients with late-stage and metastatic cancers (Press release, Guardant Health, JUN 22, 2021, View Source [SID1234584240]). The Guardant360 Response test represents a breakthrough as the first commercially available, blood-only, liquid biopsy test that detects changes in circulating tumor DNA (ctDNA) levels to provide oncologists an early indication of a patient’s response to treatment . The Guardant360 TissueNext test, the company’s first tissue-based test, is now available, if needed, to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment.

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Both products expand on the trusted Guardant360 portfolio to offer oncologists end-to-end testing solutions, covering treatment selection, with the option of ordering tissue biopsy results if needed, and treatment response monitoring, to help improve clinical outcomes for patients with advanced cancer.

The Guardant360 Response liquid biopsy test detects changes in ctDNA levels from a simple blood draw, to assess treatment response up to eight weeks earlier than RECIST (Response Evaluation Criteria in Solid Tumors),1-11 giving oncologists a new tool to use when considering whether to continue, stop, or explore other treatment options for their patients with late-stage or metastatic cancer. Molecular responders (those with decreasing ctDNA levels) show significantly longer progression-free and overall survival rates, compared to molecular non-responders.1-12 In over 50 studies, Guardant Health has demonstrated that molecular response, as measured by changes in ctDNA levels, can help provide an early indication of treatment response across therapies (targeted, immunotherapy, and chemotherapy) and cancer types including non-small cell lung, colorectal, breast, and bladder.1-12

"Using circulating tumor DNA levels to monitor treatment response is a promising new approach in the management of patients with advanced cancer," said Craig Eagle, MD, Guardant Health Chief Medical Officer. "We are delighted to offer oncologists a simple blood test that can provide an early assessment of whether their patient is responding to treatment, or not. Multiple studies using the Guardant360 Response test have shown that molecular response, as measured by circulating tumor DNA levels, can help predict clinical benefit, and longer progression-free survival."

The Guardant360 TissueNext test can now be ordered, alongside the Guardant360 CDx blood test, to prepare for cases when the Guardant360 CDx test does not find actionable biomarkers. While starting with the Guardant360 CDx blood test to perform complete genomic testing finds nearly 80 percent of patients with actionable biomarkers in only seven days,13-15 compared to finding only 50 percent of patients when starting with a tissue biopsy, and which can take two to four times longer,13-15 there are cases when results are needed from a tissue biopsy. The new Guardant360 TissueNext test offers oncologists the most efficient "blood-first, tissue-next" workflow to complete genomic testing, ensuring that as many patients as possible are identified who may benefit from biomarker-informed treatment.

"With the new Guardant360 Response blood test, we are excited to offer a cutting-edge test able to predict patient response to treatment sooner than standard radiographic assessment, to help inform clinical decisions and improve outcomes," said Helmy Eltoukhy, Guardant Health CEO. "By broadening our Guardant360 portfolio to cover not only treatment selection but treatment response, we provide oncologists a more complete view of their patient’s tumor evolution and resistance to interventional therapies, including immunotherapies. Furthermore, while starting with the Guardant360 CDx liquid biopsy for biomarker testing is shown to be more efficient than starting with an invasive tissue biopsy13-15 which has a longer turn-around time to return results, the addition of our new Guardant360 TissueNext test strengthens our treatment selection offering, by providing oncologists the benefits of ‘blood-first, tissue-next’ testing options to find as many patients as possible, who may benefit from biomarker-informed treatment."

The Guardant360 CDx test, the new Guardant360 TissueNext test, and the new Guardant360 Response test are all part of the Guardant360 portfolio, which provides oncologists a more complete genomic picture across the treatment journey. This comprehensive set of cancer tests empowers oncologists to optimize treatment, and know confidently what to do next. From fast treatment selection, starting first with the FDA-approved Guardant360 CDx test, to reflex testing with the Guardant360 TissueNext test, if needed, to early treatment response monitoring with the Guardant360 Response test, the Guardant360 portfolio helps oncologists unlock the full potential of precision oncology for their patients with late-stage and metastatic cancers.

On June 22, 2021 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) along with one of its wholly owned subsidiaries reported that they have reached an agreement with Celgene Corporation (Celgene), a wholly-owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in the US (Press release, Sun Pharma, JUN 22, 2021, View Source [SID1234584223]).

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Pursuant to the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell (subject to USFDA approval) certain limited quantity of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022. In addition, the license will also allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.

As a result of the settlement, all Hatch-Waxman litigation between Sun Pharma and Celgene, regarding the Revlimid patents, will be dismissed. Additional details regarding the settlement are confidential. The agreement is subject to customary regulatory approvals. -All brand names and trademarks are the property of respective owners

On June 22, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported a collaboration with Quest Diagnostics (NYSE: DGX) to provide laboratory testing services to Quest patients for its Target Selector NGS-based liquid biopsy targeted lung cancer panel (Press release, Biocept, JUN 22, 2021, View Source [SID1234584241]). Quest Diagnostics is the leading provider of diagnostic information services, including in advanced diagnostics.

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The Biocept Target Selector NGS-based liquid biopsy assay is a less invasive, lab developed test that can be used for genomic profiling in patients with advanced non-small cell lung cancer (NSCLC) to help qualify them for advanced targeted therapies and monitor the effectiveness of treatment. With a physician order, patients will be able to provide a blood specimen for testing at one of Quest’s 2,200 conveniently located patient service centers across the United States. The two parties expect the service to be available to Quest Diagnostics’ providers and patients in the fourth quarter of 2021.

"We are pleased to expand Biocept’s relationship with Quest Diagnostics, as we believe its expertise and reach will allow us to serve more patients and potentially grow our customer base," said Michael Nall, President and CEO of Biocept. "Quest shares our focus on improving care for patients with lung cancer, and this agreement provides a strong collaborator to help us provide oncologists with the answers they need to create more personalized, responsive treatment plans for their patients."

"Lung cancer is one of the most prevalent and deadliest cancers," said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics. "Better tools to aid in therapy selection and monitoring are urgently needed to improve patient outcomes, which is why we are so excited to work with Biocept on this focused test. Quest has the national scale, oncology expertise and network provider relationships to broaden access to this important innovation in order to potentially improve care for patients in treatment for lung cancer."

Biocept Target Selector NGS-based targeted lung cancer panel includes the most prevalent clinically actionable genes for NSCLC. It combines Biocept’s liquid biopsy biomarker testing expertise with next-generation sequencing and decision support resources. The NGS solution is targeted and actionable—approximately 70% of the biomarkers investigated are based on National Comprehensive Cancer Center guidelines and/or FDA-approved therapies.