On July 20, 2020 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported updates to its clinical programs, the neoantigen vaccine GEN-009 and the neoantigen cell therapy, GEN-011 (Press release, Genocea Biosciences, JUL 20, 2020, View Source [SID1234562111]).

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GEN-009
On July 30, 2020, the Company will share initial clinical data on the first 5 patients from Part B of the ongoing Phase 1/2a clinical trial exploring the combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors. The lead investigator, Dr. Maura L. Gillison, MD, PhD, Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, will present.

GEN-011
In June 2020, the Company submitted the IND to support the initiation of a Phase 1/2 clinical trial and the 30-day FDA review period has just ended. The Company has received verbal notification from the U.S. Food and Drug Administration (FDA) that the agency has completed its review of the Company’s Investigational New Drug Application (IND) for GEN-011. In this verbal feedback, the FDA informed Genocea that it is placing the IND on clinical hold until it receives additional information pertaining to certain third-party reagents used in the GEN-011 manufacturing process. These reagents are not a component of the final cell therapy product. The Company expects to receive official written communication from the FDA regarding the hold and the FDA’s position in the near future and will work with the FDA to resolve their questions as quickly as possible.

On July 20, 2020 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that the first patient has been dosed and continues on therapy in a trial assessing bemcentinib in recurrent glioblastoma (GBM) (Press release, BerGenBio, JUL 20, 2020, View Source [SID1234562076]). The trial is sponsored by Prof. Ichiro Nakano, MD, Professor in the Department of Neurosurgery and co-leader of the Neuro-Oncology Program at University of Alabama at Birmingham and funded by the National Cancer Institute (NCI).

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This is an open label, multi-centre, intra-tumoral tissue pharmacokinetic (PK) study of bemcentinib in patients with recurrent glioblastoma for whom a surgical resection is medically indicated. The study will enrol up to 20 recurrent GBM patients, at up to 15 sites in the USA. 10 patients will be treated prior to surgery and 10 patients will have no pre-surgical treatment. However, all patients will receive treatment with bemcentinib following surgery. The endpoints of the study include an evaluation of bemcentinib’s ability to cross the blood brain barrier, AXL expression, pharmacokinetics, safety and tolerability, as well as efficacy assessments including Progression Free Survival and Overall Survival. More information about the trial can be found at View Source

Increased expression of the receptor tyrosine kinase AXL is significantly correlated with poor prognosis in GBM patients and preclinical data has suggested that bemcentinib may be a promising therapeutic agent for GBM, particularly in post-irradiation mesenchymal-transformed GBM tumors[1]. A comprehensive translational research programme will run in parallel with the clinical trial, this will be conducted by Prof. Jeff Supko, Harvard Medical School and Director of the Clinical Pharmacology Laboratory, Massachusetts General Hospital (Boston, USA).

Prof. Burt Nabors MD, the Chairman of the trial and Director of Neuro-Oncology at University of Alabama at Birmingham (UAB) and Director of UAB’s Centre for Clinical Translational Science’s Clinical Research Unit, commented: "GBM is among the most lethal of adult cancers. The median survival of patients remains less than two years despite the current available therapies, including surgery, radiation, and chemotherapy; development of more effective therapies is urgently needed. We welcome the opportunity to offer patients access to the investigational AXL inhibitor bemcentinib in this pilot study and look forward to initiating additional trial sites across the Adult Brain Tumour Consortium in the USA later this year."

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We congratulate Prof. Nakano and Prof. Nabors on the start of this exciting clinical study, which we believe will provide us with important data regarding the ability of bemcentinib to cross the blood-brain barrier and potentially treat GBM patients. This clinical trial is based on pioneering preclinical research carried out by our collaborators, conducted at high profile research hospitals in the USA and is funded by National Cancer Institute (NCI). We look forward to reporting the potential of bemcentinib to improve patient outcomes in this very aggressive cancer."

On July 19, 2020 Antengene Corporation, a leading innovative hematology and oncology-focused biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and best-in-class therapies, reported that it has successfully closed US$97 million in Series C financing (Press release, Antengene, JUL 19, 2020, View Source [SID1234562180]).

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Antengene Corporation
The financing was led by Fidelity Management & Research Company LLC with additional support from new investors including GL Ventures (an affiliate of Hillhouse Capital), GIC, and a large, reputable long-term investor. Existing investors including Qiming Venture Partners and Boyu Capital also participated.

"We appreciate the recognition and trust from these prestigious investment institutions. This round of financing has drawn support from among the world’s largest asset managers, top-tier healthcare investors widely recognized in the capital markets, and strong continuous support from our existing investors. This is an important milestone to reinforce Antengene’s capabilities to bring cutting-edge therapies to help patients with life-threatening diseases in the Asia Pacific regions and around the world." said Dr. Jay Mei, Founder, Chairman and CEO of Antengene.

Proceeds from the Series C financing will be primarily used to fund the continuing clinical development of Antengene’s robust pipeline of hematology and oncology therapies, expanding in-house research and development capabilities and strengthening the commercial infrastructures in APAC markets. To date, Antengene has made significant progress with its broad pipeline of six clinical-stage programs and six pre-clinical stage oncology assets:

ATG-010 (selinexor) is the first and only oral selective inhibitor of nuclear export (SINE) compound in the world. In July 2019, the U.S. FDA approved selinexor in combination with low-dose dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM). In June 2020, selinexor was approved by the U.S. FDA as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Currently, the registration clinical trials of ATG-010 in RRMM and R/R DLBCL are ongoing in China. The compound is also in late clinical development for various other hematologic malignancies and solid tumors (including KRAS mutant tumors). Pre-clinical studies demonstrated that inhibition of nuclear protein export through XPO1 can effectively treat tumors with such mutation.
ATG-008 (onatasertib) is a second-generation dual mTORC1/2 inhibitor presently studied in multi-regional clinical trials for the treatment of advanced hepatocellular carcinoma (HCC), as well as non-small-cell lung cancer (NSCLC), gynecological malignancies and other cancers as a single agent or in combination with an anti-PD-1 antibody.
ATG-016 (eltanexor) is a second-generation oral selective inhibitor of nuclear export protein XPO1 presently studied in myelodysplastic syndrome (MDS) as well as various types of solid tumors, such as colorectal cancer (CRC) and prostate cancer (PrC).
ATG-019 is a first-in-class PAK4/NAMPT dual-target inhibitor presently studied in a number of clinical trials including non-Hodgkin’s lymphoma (NHL), colorectal cancer, NSCLC, and melanoma. In addition, pre-clinical studies have demonstrated that ATG-019 in combination with anti-PD-1 antibodies can effectively improve the anti-tumor activity and is effective in treating patients that become resistant to anti-PD-1 therapy.
ATG-527 (verdinexor) is an innovative compound in clinical studies as a potential treatment for anti-viral infection and autoimmune diseases – such as Epstein-Barr virus (EBV), respiratory syncytial virus (RSV) infection, cytomegalovirus (CMV) infection, systemic lupus erythematosus (SLE). Phase I healthy volunteer study of the compound has been completed.
ATG-017 is a potent and selective small molecule extracellular signal–regulated kinases 1 and 2 (ERK1/2) inhibitor in clinical development for the treatment of various solid tumors, non-Hodgkin’s lymphoma, acute myeloid leukemia (AML) and multiple myeloma.
In addition, the Antengene drug discovery team is focused on the research and pre-clinical development of innovative small molecules, monoclonal and bi-specific antibodies to treat cancer.

On July 17, 2020 Respected financial management company Oak Stone Limited has said that SoftBank-backed oncology drug manufacturer, Relay Therapeutics Inc., soared 75% in its trading debut after the company expanded its initial public offering to raise $400 million (Press release, Oak Stone, JUL 17, 2020, View Source [SID1234562075]).

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On Thursday in New York trading, Relay’s shares closed at $35.05, giving the Cambridge, Massachusetts-based company a market valuation of around $3 billion.

"Relay sold 20 million shares at $20 each, pricing them above the $18 to $19 marketed range," said James Burnley, Head of Wealth Management at Oak Stone Limited. "The company had earlier expanded the size of the offering from 14.7 million shares and increased the target range from $16 to $18," he added.

In a 2018 Series C funding round, Masayoshi Son’s SoftBank Vision Fund invested $300 million in Relay and owns a 41% stake in the company. An affiliate of D.E. Shaw & Co. also took part in the round, which raised a total of $400 million. Since its founding, Relay has raised a total of $520 million in private rounds.

The clinical-stage business has one drug candidate in Phase 1 trials and a second scheduled for Phase 1 trials towards the end of this year. Its more sophisticated treatment binds and stabilises the SHP2 protein to prevent the growth of cancer cells.

"Relay reported a net loss of $75 million for 2019, compared with a net loss of $49 million the year prior, this was due to its research and development expenses increasing," said Michael Pearson, Head of Corporate Equities at Oak Stone Limited.

Relay Therapeutics offering was managed by JPMorgan Chase & Co., Goldman Sachs Group Inc., Cowen Inc. and Guggenheim Securities. The company’s shares are trading on the NASDAQ under the ticker RLAY.

According to Oak Stone Limited analysts, the market for IPOs has roared back, with tech and biotechnology offerings leading the way. Moreover, that coincides with the stock market’s recovery and hope for a V-shaped economic recovery.

Historically the IPO industry has been dominated by technology firms. That’s mainly due to the huge investments and rapid-growth nature of those companies. However, in the last year biotech and other health care companies took the lead. That comes as the amount invested in this sector continues to expand.

On July 17, 2020 NANOBIOTIX (Paris:NANO) (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenue for the second quarter of 2020 as well as for the first half of 2020 (Press release, Nanobiotix, JUL 17, 2020, View Source [SID1234562074]).

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Revenue for the second quarter of 2020 (unaudited)

Nanobiotix’s revenue for the second quarter 2020 and for the first half of 2020 amounted to €13.4k and €36.9k respectively.

Most of the revenue generated by the Company during these periods result from the cross-charge to its partner, PharmaEngine, of shared external contract research organization costs pursuant to the license and collaboration agreement.

The amount of cash and cash equivalent as of June 30, 2020 is €26.6m. This amount reflects in particular the payment by HSBC of a €5m State-Guaranteed Loan (prêt garanti par l’Etat or PGE) granted pursuant to an agreement approved on June 22, 2020. The second PGE of €5m granted by Bpifrance has been received on July 17, 2020.

In April 2020, the Company provided updates on clinical development continuity in the context of the COVID-19 crisis. In light of the pandemic and to protect the interests of employees, patients, partners, and shareholders, Nanobiotix made organizational adjustments to control costs while priorities regarding clinical development remained unchanged.

Nanobiotix also announced that the protocol for the phase I clinical trial for NBTXR3 in pancreatic cancer under its clinical collaboration with The University of Texas MD Anderson Cancer Center has been allowed to proceed by the US Food and Drug Administration (FDA).

At ASCO (Free ASCO Whitepaper) 2020, Nanobiotix announced positive new data from the expansion part of its phase I trial, evaluating the potential of first-in-class NBTXR3 activated by radiation therapy to improve treatment outcomes for elderly patients with locally advanced head and neck cancer ineligible for chemotherapy or intolerant to cetuximab. In particular, the analysis of 30 evaluable patients for efficacy showed a primary tumor objective response rate of 83%, including a complete response rate of 60% in the target lesion.

At AACR (Free AACR Whitepaper) 2020, Curadigm, a wholly owned subsidiary of the Company, presented results demonstrating that its novel "Nanoprimer" technology could potentially improve the efficacy of therapeutics delivered intravenously (IV). In the study, the Nanoprimer was paired with RNA-based therapeutics and showed to improve treatment outcomes up to 50%.

On June 17, 2020, the US Food and Drug Administration (FDA) provided feedback necessary to proceed with the design of NANORAY-312, a pivotal phase III trial investigating NBTXR3 for elderly head and neck cancer patients ineligible for platinum-based chemotherapy. The FDA also accepted the NBTXR3 chemistry, manufacturing and controls (CMC) development plan to support the future New Drug Application (NDA) for the product and its use in the NANORAY-312 phase III clinical trial.