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Janssen Receives Positive CHMP Opinion Recommending Expanded Use of Imbruvica®▼(ibrutinib) in Two Indications in Europe

On June 28, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Imbruvica (ibrutinib) in two indications (Press release, Johnson & Johnson, JUN 28, 2019, View Source [SID1234537331]). One recommendation is for the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia (CLL).1 The second is for use of ibrutinib plus rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).1

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Dr Alessandra Tedeschi, Medical Director, Department of Hematology, Niguarda Hospital, Milan, Italy, and investigator in both the iNNOVATE and iLLUMINATE studies, said: "This is an important step forward in further enhancing our ability as haematologists to meet the treatment needs of more patients with these complex blood cancers. Ibrutinib has already offered important progress in both CLL and WM in the indications for which it is currently approved, and these new combination regimens show the potential to further extend the remission period for patients versus standard of care."

The Positive Opinion for CLL was based on results from the Phase 3 iLLUMINATE (PCYC1130) study, published in The Lancet Oncology, which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.2 After a median follow-up of 31.3 months (interquartile range [IQR] 29.4–33.2), median progression-free survival (PFS) was significantly longer in the ibrutinib plus obinutuzumab group (median not reached [95 percent confidence interval [CI] 33.6–non-estimable]) than in the chlorambucil plus obinutuzumab group (19.0 months [15.1–22.1]; hazard ratio 0.23; 95 percent CI 0.15–0.37; p<0.0001).2

In WM, the Positive Opinion was supported by data from the Phase 3 iNNOVATE (PCYC-1127) study, presented at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2018. The study evaluated the safety and efficacy of ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.3 At a median follow up of 30.4 months, a significant improvement in the Independent Review Committee (IRC)-assessed primary endpoint of PFS was seen with ibrutinib plus rituximab when compared with placebo plus rituximab (estimated 30-month PFS rates were 79 percent vs. 41 percent, respectively).3

Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).4,5

"We are incredibly encouraged by these CHMP recommendations, which represent our continued commitment to develop chemotherapy-free combinations for those living with CLL and WM," said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag France. "Ibrutinib has been used to treat more than 140,000 patients worldwide and we are continuing to deliver on our ambition to optimise outcomes for patients with complex B-cell malignancies, that have in the past been very difficult to treat."

Both Positive Opinions will now be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

Dr Alessandra Tedeschi is co-investigator in both the iNNOVATE and iLLUMINATE studies. She was not compensated for any media work.

#ENDS#

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.6 By blocking this BTK protein, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.7

Ibrutinib is currently approved in Europe for:8

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell lymphoma.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy.
Ibrutinib is approved in more than 95 countries, and, to date, has been used to treat more than 140,000 patients worldwide across its approved indications.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.8

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.9 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.10 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.11

The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

About Waldenström’s macroglobulinemia
Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).12 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.13 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.14 The causes of WM are unknown, with it typically affecting older adults and being slightly more common in men than women.12,14.

Biodesix to Acquire Oncimmune in the United States

On June 28, 2019 Biodesix, Inc. reported that it will extend the company’s blood-based lung cancer diagnostic portfolio with acquisition of Oncimmune’s laboratory and incidental pulmonary nodule (IPN) malignancy test in the United States (Press release, Biodesix, JUN 28, 2019, View Source [SID1234537330]). The United Kingdom-based company’s U.S. operations, including a CLIA lab in De Soto, Kansas, will transition to Biodesix on November 1, 2019. The lab is the sole U.S. provider of Oncimmune’s EarlyCDT -Lung test.

"Oncimmune’s extensive experience and patent portfolio in autoantibodies, and their relationship to cancer, attracted us to evaluate the use of Oncimmune’s EarlyCDT Lung test as a strategic addition to our diagnostic test offering in the U.S.," said David Brunel, CEO of Biodesix. "Biodesix is the leader in blood-based diagnostic solutions for lung cancer that provide actionable results and reimbursement with best-in-class turnaround time. Our Nodify XL2 test is used to help rule-out malignancy in low-to-moderate risk incidental lung nodules. EarlyCDT Lung is a rule-in test for lung cancer risk, and a natural and important extension of our commitment to care in the early disease setting."

Each year 1.6 million Americans are diagnosed with incidental lung nodules. Most of these nodules are benign, but the EarlyCDT Lung test helps identify those that could be cancerous. The blood-based lung nodule test enables earlier intervention by helping clinicians detect lung cancer at all stages of disease (I-IV). The extensively validated proteomic test measures seven autoantibodies to tumor-associated antigens created by the body’s response to cancer.

In addition to the lung nodule indication, the Early Cancer Detection Test – Lung Cancer Scotland (ECLS) study, a 12,210 patient study investigating the utility of the EarlyCDT Lung test in lung cancer screening, recently announced meeting primary end-points. ECLS is believed to be the largest randomized controlled study using biomarkers for detection of lung cancer and could lead to a future screening indication for the EarlyCDT Lung test. Full results from the study will be published in a peer-reviewed publication later this year.

"The addition of EarlyCDT Lung to the Biodesix portfolio will allow more patients to benefit from this unique diagnostic tool," said Scott Hutton, COO of Biodesix. "The Nodify XL2 and EarlyCDT Lung tests complement each other to help provide physicians with the ability to stratify patients into distinct nodule management pathways."

"This agreement is a significant milestone for Oncimmune," said Adam M. Hill, MD Ph.D, CEO of Oncimmune. "Like us, Biodesix is committed to developing and delivering lung cancer diagnostic solutions to improve patient outcomes. EarlyCDT Lung is highly complementary to Nodify XL2 to help guide treatment decisions, and Biodesix is an excellent partner for Oncimmune in the U.S. market."

Additional terms of the agreement provide that Biodesix will make milestone payments to Oncimmune upon achieving certain commercial objectives. In addition, Oncimmune will continue to collaborate with Biodesix on new strategic endeavors to improve patient outcomes in lung cancer.

Annual Report for the Year Ended December 31, 2018

On June 28, 2019 Verseon (AIM:VERS), the clinical-stage pharmaceutical company developing disruptive life-science technologies to advance global health, reported its Final Results for the year ended December 31, 2018 (Press release, Verseon, JUN 28, 2019, View Source [SID1234537329]). The report and accounts are available for download from the Company’s website (www.verseon.com).

Adityo Prakash, CEO of Verseon Corporation, commented: "In 2018, we reached a major milestone with our first drug program entering clinical trials. The phase 1 study of VE-1902, our lead precision oral anticoagulant (PROAC), is ongoing with first results expected in Q4 2019. We have also nominated our first development candidate for the oral treatment and prevention of diabetic macular edema, and launched a new discovery program focusing on the treatment of metabolic disorders."

"Heading into 2019, we remain committed to advancing drug development and improving patients’ lives through our active clinical trials program, growing number of novel drug candidates, and our robust and diversified pipeline."

Highlights
Finance

Results for the year ended December 31, 2018:

Total assets on the balance sheet stood at $56.4 million, compared to $54.2 million at the end of 2017.
Cash, cash equivalents, and short-term investments stood at $3.6 million, compared to $11.6 million at the end of 2017.
Property, equipment, buildings, and land totaled $51.3 million, compared to $40.7 million at the end of 2017.
Research and development expenses were $13.8 million, compared to $15.1 million in 2017.
General and administrative expenses were $8.0 million, compared to $6.3 million in 2017.
Non-cash expenses include stock-based compensation of $1.7 million, compared to $0.9 million in 2017 and also a currency exchange loss of $4 thousand, compared to a gain of $0.6 million in 2017.
Net loss was $21.6 million or $0.14 per basic share, compared to a net loss of $20.4 million or $0.13 per basic share in 2017.
Going concern

The Company’s financials have been prepared on a going concern basis, and the rationale for this is discussed in the footnotes to the financial statements under Note D, Summary of Significant Accounting Policies.
Anticoagulation

VE-1902, our first precision oral anticoagulant (PROAC) for long-term anticoagulant-antiplatelet combination therapy, entered phase 1 clinical trials.
A second PROAC, VE-2851, is also advancing toward clinical trials in 2020.
Diabetic macular edema

We nominated the first development candidate for clinical trials in our oral diabetic macular edema program.
The development candidate VE-4839 is expected to enter phase 1 in H1 2020.
Hereditary angioedema

Our oral drugs for this rare, potentially life-threatening disease, continue to show good potency and pharmacokinetics.
Oncology

In preclinical testing, our new anticancer agents for the treatment of multidrug resistant cancers show improved potency and are largely unaffected by common modes of drug resistance.
Pipeline development

We initiated a new discovery program targeting metabolic disorders.
Fintech

We founded a wholly owned fintech subsidiary, BlockRules, that is developing transformative blockchain technology to power our preferred share offering on the blockchain (see post-period events).
Post-period events:

Changed London Stock Exchange ticker to VERS.
Closed common share subscription raising $10.7 million from existing shareholders.
On March 18, 2019, announced intention to undertake a preferred share offering in 2019, backed by a prospectus and with transactions recorded on the blockchain (a security token offering). Once live, this global offering will enable us to accelerate the development of our diverse drug pipeline.

Sorrento Therapeutics Announces Proposed Public Offering of Common Stock and Warrants

JMP Securities and H.C. Wainwright & Co. are acting as joint book-running managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering will be completed, or as to the actual size or terms of the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-221443) previously filed with the Securities and Exchange Commission (the "SEC") on November 9, 2017, amended on December 1, 2017 and declared effective by the SEC on December 6, 2017. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting JMP Securities LLC, 600 Montgomery Street, Suite 1100, San Francisco, California 94111, Attention: Prospectus Department, by calling (415) 835-8985 or by e-mail at [email protected] or H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Sorrento Therapeutics Announces Pricing of Underwritten Public Offering of Common Stock and Warrants

On June 28, 2019 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a clinical stage, antibody-centric biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases, reported the pricing of its public offering of 8,333,334 shares of its common stock, Series A warrants to purchase up to an aggregate of 8,333,334 shares of its common stock, Series B warrants to purchase up to an aggregate of 8,333,334 shares of its common stock and Series C warrants to purchase up to an aggregate of 8,333,334 shares of its common stock, at a price to the public of $3.00 per share and accompanying Series A, Series B and Series C warrant (Press release, Sorrento Therapeutics, JUN 28, 2019, View Source [SID1234537327]). The Series A warrants will be exercisable commencing six months from the date of issuance, will expire on the 10-year anniversary of the date of issuance and will have an exercise price of $3.75 per share, subject to certain adjustments. The Series B warrants will be exercisable commencing on the date of issuance, will expire on the date that is nine months from the date of issuance and will have an exercise price of $3.00 per share, subject to certain adjustments. The Series C warrants will be exercisable six months from the date of issuance and only to the extent and in proportion to a holder of the Series C warrants exercising its corresponding Series B warrants, will expire on the 10-year anniversary of the date of issuance and will have an exercise price of $3.75 per share, subject to certain adjustments. Gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $25.0 million. Sorrento currently intends to use the net proceeds from the offering for the continued clinical development of its RTX, CEA CAR-T and CD38 CAR-T programs and general research and development, working capital and general corporate purposes. In addition, Sorrento has granted the underwriters a 30-day option to purchase up to 1,250,000 additional shares of its common stock and/or 1,250,000 warrant combinations, which consists of 1,250,000 Series A warrants, 1,250,000 Series B warrants and 1,250,000 Series C warrants. The offering is expected to close on or about July 2 2019, subject to satisfaction of customary closing conditions.

JMP Securities and H.C. Wainwright & Co. are acting as joint book-running managers for the offering.

The public offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-221443) previously filed with the Securities and Exchange Commission (the "SEC") on November 9, 2017, amended on December 1, 2017 and declared effective by the SEC on December 6, 2017. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from JMP Securities LLC, 600 Montgomery Street, Suite 1100, San Francisco, California 94111, Attention: Prospectus Department, by calling (415) 835-8985 or by e-mail at [email protected] or H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by e-mail at [email protected].