On December 10, 2018 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, and LG Chem Life Sciences, the life sciences division of the South Korean LG Group, reported a multi-target collaboration and development agreement (Press release, Avacta, DEC 10, 2018, View Source [SID1234531989]). The agreement provides LG Chem with the exclusive rights to develop and commercialize, on a worldwide basis, multiple Affimer therapeutics intended for treatment of patients in the fields of inflammatory disorders, and oncology. Under the terms of the agreement, Avacta will generate and carry out the discovery, optimization and protein engineering of Affimer drug candidates against a set of undisclosed targets. LG Chem and Avacta will collaborate to progress these candidates through to drug candidate selection and LG Chem will be responsible for preclinical and clinical development and world-wide marketing of any resulting products.

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Additionally, the agreement provides that Avacta and LG Chem will collaborate jointly in the development of two different Affimer PK/ADME modifiers – Affimers that can be fused to other therapeutic proteins to modify certain properties of those biological drug moieties such as serum half-life and tissue localization. Both parties will have the right to develop PK/ADME modified products, and by exercise of an option, to take exclusive responsibility for the development, manufacture and commercialization of those products.

This multi-target therapeutics development agreement provides upfront and near-term milestone payments, plus longer-term clinical development milestones. Avacta will also receive royalties on any future product sales and LG Chem will cover Avacta’s costs of research and development associated with the collaboration. Avacta may receive additional option fees and milestone payments should LG Chem elect to exercise their options for additional targets.

The Affimer technology is Avacta’s proprietary alternative to antibodies with wide applications in the life sciences for drug development, diagnostics and research tools. Avacta’s in-house therapeutic pipeline is focused on immuno-oncology and it expects to advance its lead programme, a PD-L1/LAG3 bispecific, into the clinic in 2020 whilst building out its pipeline of innovative Affimer drug candidates.

Alastair Smith, Chief Executive of Avacta Group, commented:
"I am delighted to be entering into this therapeutic development partnership with LG Chem which is a strong validation of the potential of the Affimer platform.

"This alliance is an exciting opportunity, not only to work with a partner who has first class biologics manufacturing and clinical development capabilities, but who also has a pioneering vision to develop innovative therapies.

"This landmark agreement with LG Chem reflects the substantial progress that we have made in developing the Affimer technology as a therapeutic platform and I look forward to updating the market on future progress and other partnerships."

Dr. Jeewoong Son, President of LG Chem Life Sciences, commented:
"We are very pleased to announce this collaboration with Avacta Group. Utilizing Avacta’s Affimer technology – a novel non-antibody protein format overcoming limitations of classical antibody-based therapy – and LG Chem’s biologics capability in development and manufacturing, it will take us to the next level of treatment paradigm and to open up a new horizon in biologics therapeutic strategies. I believe, this innovative collaboration will deliver value to patients and will transform patients’ lives"

On December 10, 2018 Biogen Inc. (Nasdaq:BIIB) reported it will report fourth quarter and year-end 2018 financial results Tuesday, January 29, 2019, before the financial markets open (Press release, Biogen, DEC 10, 2018, View Source [SID1234532005]).

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Following the release of the financials, the Company will host a live webcast with Biogen management from 8:00-9:00 am ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website

On December 10, 2018 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, reported that the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application, indicating that Sermonix may proceed directly to a Phase 2 clinical study in the personalized medicine arena involving its lead investigational drug, lasofoxifene (Press release, Sermonix Pharmaceuticals, DEC 10, 2018, View Source [SID1234532259]).

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The open-label, randomized, multi-center study is expected to begin enrollment in early 2019 and will evaluate the activity of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation.

"We are delighted the IND application was favorably reviewed by the FDA and brings us ever closer to delivering a novel endocrine treatment option for these women in great need," said Sermonix Chairman Dr. Anthony Wild. "This marks an important milestone in Sermonix’s effort to develop lasofoxifene as a precision medicine for women with advanced breast cancer."

A large amount of clinical data from earlier non-oncology development, along with new, compelling preclinical data have enabled Sermonix to commence directly into the Phase 2 study. The study will include postmenopausal women with ESR1 mutations, identified using a liquid biopsy clinical trial assay, who have progressed after aromatase inhibitor and CDK 4/6 inhibitor therapy. ESR1 mutations occur in up to 40 percent of women with metastatic breast cancer and may confer a worse prognosis and poor response to currently available endocrine treatments1.

"As ESR1 mutations are highly prevalent in ER+ metastatic breast cancer, we look forward to demonstrating lasofoxifene’s potential promise in this area of significant unmet medical need," said Dr. David Portman, Sermonix founder and chief executive officer. "Acceptance of the IND application allows us to maintain momentum in the important effort to bring lasofoxifene to patients who desperately need more options for this incurable disease, so we are thrilled to receive this news from the FDA."

1 Chandarlapaty S et al, JAMA oncology 2016 Oct 1;2(10):1310-1315)

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide.

Lasofoxifene’s binding affinity and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized and bioavailable SERM, lasofoxifene, if approved, could play a critical role in the personalized treatment of advanced ER+ breast cancer.

On December 10, 2018 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the expanded use of Axumin (fluciclovine F 18) in adults for the detection and continuing assessment of glioma (Press release, Blue Earth Diagnostics, DEC 10, 2018, View Source [SID1234531990]).

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Fluciclovine is a synthetic amino acid labeled with the radioisotope F 18, enabling PET imaging to visualize the increased amino acid transport that occurs in malignant tumors such as glioma, which is a serious and life-threatening condition accounting for about 80% of all malignant brain tumors.

18F-Fluciclovine, under the tradename Axumin (fluciclovine F 18) injection, is FDA-approved for use in positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate specific antigen (PSA) following prior treatment. 18F-Fluciclovine PET imaging is being investigated for the detection and continuing assessment of glioma. (For additional product information please see the end of this news release.) 18F-Fluciclovine has previously been granted Orphan Drug status by both the FDA and the European Medicines Agency for the diagnosis of glioma.

"We are very pleased that the FDA has accepted for review our sNDA submission for the use of 18F-fluciclovine PET imaging in glioma," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "Expanding the label for Axumin is part of our mission to develop and commercialize innovative PET imaging products that address unmet medical needs for patients with cancer."

"Glioma is the twelfth leading cause of death from cancer, and certain aggressive forms of the disease, such as glioblastoma multiforme, can progress rapidly," said Peter Gardiner, MB ChB, MRCP, FFPM, CMO of Blue Earth Diagnostics. "Physicians need precise information about the location and extent of the tumor to help guide surgical procedures and radiation therapy, as well as for subsequent continued assessment and monitoring of the disease. We are exploring the potential utility of 18F-fluciclovine PET to assist them in these efforts."

Blue Earth Diagnostics recently announced results from one of the Phase 3 clinical trials supporting the sNDA submission to the FDA at the Society for Neuro-Oncology annual meeting in November 2018. The study, BED006, was a prospective, blinded image evaluation that examined the diagnostic performance of 18F-fluciclovine PET imaging, in conjunction with various types of MRI, for imaging of suspected glioma when interpreted by readers unfamiliar with 18F-fluciclovine PET. Results indicated a Positive Predictive Value (PPV) of more than 90% for each of the three blinded readers and consistent image interpretation across these readers. In addition, 18F-fluciclovine PET with MRI (CE-T1W MRI) identified additional regions suspicious for glioma that MRI alone was unable to identify, which subsequent biopsies confirmed as malignant. To date, the safety profile of 18F-fluciclovine PET imaging in patients with glioma appears to be consistent with that summarized in the current Axumin U.S. prescribing information.

About 18F-fluciclovine PET in Glioma

18F-Fluciclovine PET is a diagnostic imaging radiopharmaceutical for PET imaging that consists of a synthetic amino acid labeled with the radioisotope F 18, enabling the visualization of the increased amino acid transport that occurs in malignant tumors. 18F-Fluciclovine, under the trade name Axumin, is approved by the U.S. Food and Drug Administration (FDA) for PET imaging in men with recurrent prostate cancer. The clinical trial program to support the safety and efficacy, in terms of diagnostic performance, of 18F-fluciclovine PET imaging in adults for the detection and continuing assessment of glioma encompasses four trials conducted in Japan by Nihon Medi-Physics Co., Ltd and two studies in Europe and the United States by Blue Earth Diagnostics. To date, the safety profile of 18F-fluciclovine PET imaging in patients with glioma appears to be consistent with that summarized in the current Axumin prescribing information. 18F-Fluciclovine has been granted Orphan Drug status by both the FDA and the European Medicines Agency for the diagnosis of glioma. The compound was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences.

About Glioma

Glioma, the most commonly occurring type of primary brain tumor, is a serious and life-threatening condition. Cancer of the brain and central nervous system (CNS) is the twelfth most common cause of cancer death worldwide. Glioma accounts for about 25% of all brain tumors, and 80% of all malignant brain tumors. The most aggressive form of glioma, glioblastoma multiforme, is associated with significant morbidity and mortality with relatively low 5-year survival estimates after diagnosis. Current treatment options for patients with glioma include surgery, radiation and chemotherapy. Accurate evaluation of the location and extent of a glioma tumor is essential before or during surgery and radiotherapy and in assessing the continuing status of the disease. The detection and assessment of gliomas typically involves magnetic resonance imaging (MRI), which may be complemented by metabolic imaging using an appropriate amino acid-based PET radiopharmaceutical as recommended in the Response Assessment in Neuro-Oncology (RANO) working group and European Association for Neuro-Oncology (EANO) guidelines.1

U.S. Indication and Important Safety Information About Axumin*

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full U.S. Axumin prescribing information is available at www.axumin.com.

*This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States. Please be aware that the approval status and product label for Axumin varies by country worldwide. Refer to the individual country product label for complete information or contact Blue Earth Diagnostics.

On December 10, 2018 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer reported that the U.S. Food and Drug Administration ("FDA") has cleared the Investigational New Drug ("IND") application for a humanized bispecific GD2 antibody (Press release, Y-mAbs Therapeutics, DEC 10, 2018, View Source [SID1234532006]). It is anticipated that a Phase 1/2 clinical trial will soon be initiated to begin screening patients with relapsed/refractory neuroblastoma, high grade osteosarcoma and other GD2(+) solid tumors, where patients have relapsed or refractory disease that is resistant to standard therapy.

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This bispecific product candidate is a fully humanized IgG-scFv format antibody, licensed by Memorial Sloan Kettering to Y-mAbs, in which the anti-CD3 scFv is linked to naxitamab IgG1 and the Fc region is mutated to help prevent cytokine release as well as complement-mediated pain side effects. Y-mAbs expects that this bispecific GD2 antibody may have potential advantages over other bispecific antibodies, such as improved potency due to bivalency, binding to neonatal Fc receptor and longer serum half-life, which obviates continuous infusion and enables more convenient administration to the patient.

Y-mAbs Founder, President and Head of Business Development and Strategy, Thomas Gad said, "This is a novel bivalent tumor targeting bispecific antibody for the treatment of GD2 positive solid tumors in both pediatric and adult cancers. We believe that these bispecific antibodies have the potential to overcome many of the limitations associated with existing bispecific constructs."

Dr. Claus Møller, Chief Executive Officer further notes, "I am excited to see this bispecific antibody make its way towards the clinic, to establish the safety profile and to determine the maximum tolerated dose."