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Agenus Milestone Triggers $7.5M Payment from Gilead

On March 13, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, reported that the FDA has accepted the company’s IND filing for AGEN1423 – a milestone in its partnership with Gilead Sciences, Inc (Press release, Agenus, MAR 13, 2019, View Source [SID1234534290]). This milestone triggered a cash payment of $7.5M. Agenus is eligible to receive additional milestone payments in 2019 and beyond.

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"This marks the first milestones in our collaboration with Gilead," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "AGEN1423 is a first-in-class molecule which we designed to block mechanisms that tumors use to escape and grow; we believe that this molecule has great potential for patients with cancer."

The collaboration between the two companies was announced in December 2018. Under the terms of the agreement, Agenus received $150 million in upfront cash payment and equity investment and is also eligible for approximately $1.7 billion in potential future fees and milestones. Gilead received worldwide exclusive rights to AGEN1423, and exclusive option to license two additional programs: AGEN1223 and AGEN2373. Agenus is responsible for developing the option programs up to the option decision points, at which time Gilead may acquire exclusive rights to the programs on option exercise. For one of the option programs, Agenus will have the right to opt-in to shared development and commercialization in the U.S. Gilead also received right of first negotiation for two additional, undisclosed preclinical programs.

AGEN1423, AGEN1223 and AGEN2373 are investigational agents that have not been approved for any uses. Efficacy and safety have not been established.

Trovagene Receives Approximately $3.0 Million From Exercise of Warrants

On March 13, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage oncology therapeutics company, using a precision medicine approach to develop drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, reported that it has received approximately $3.0 million in proceeds from holders exercising common stock purchase warrants at an exercise price of $6.60 per share (Press release, Trovagene, MAR 13, 2019, View Source [SID1234534289]). The warrants were issued as part of the units sold in the Company’s public offering which closed on June 12, 2018.

Trovagene is a clinical-stage oncology therapeutics company, using a precision medicine predictive biomarker approach to develop drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers. Onvansertib, its lead drug candidate, is a first-in-class, 3rd generation, highly-selective oral Polo-like Kinase 1 (PLK1) Inhibitor. The Company currently has two ongoing open-label clinical trials: a Phase 1b/2 trial in acute myeloid leukemia (AML) and a Phase 2 trial in metastatic castration-resistant prostate cancer (mCRPC).

"We are pleased with recent activities as more investors are becoming aware of our multi-faceted clinical development program of Onvansertib, a first-in-class, 3rd generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor," said Thomas Adams, Chief Executive Officer and Chairman of Trovagene. "Our program currently includes three open-label trials – Acute Myeloid Leukemia, metastatic Castration Resistant Prostate Cancer and metastatic Colorectal Cancer – all of which are indications where there is a significant need to bring new treatment options to patients."

BioInvent expands US patent protection for its F.I.R.S.T.™ platform

On March 13, 2019 BioInvent International AB (OMXS: BINV) reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance, informing the company that a patent application relevant to its F.I.R.S.T. platform has been allowed and can proceed to grant (Press release, BioInvent, MAR 13, 2019, http://www.bioinvent.com/media/press-releases/releases?id=A2FA3A84867D4C4E [SID1234534288]). The patent is expected to be issued once BioInvent has responded to the Notice. It covers methods for differential biopanning.

This patent, once issued, strengthens the protection in the US for BioInvent’s unique, function-based F.I.R.S.T. platform, which allows for simultaneous identification of clinically relevant target structures and matching antibodies.

The now allowed application is a so called continuation application based on a US patent that was granted in 2013. A similar patent was granted some years earlier by the European patent office, and it is valid in 20 European countries.

X4 Pharmaceuticals Completes Merger with Arsanis

On March 13, 2019 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR, as of March 14, 2019), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, reported the completion of its merger with Arsanis, Inc. (Nasdaq: ASNS, through March 13, 2019), effective as of March 13, 2019 (Press release, X4 Pharmaceuticals, MAR 13, 2019, View Source [SID1234534287]).

"With the acquisition of synergistic R&D capabilities, X4 intends to establish a globally-recognized Center of Research Excellence to build upon our core science and technology, and to create long-term growth for a sustainable global rare disease business."

The holders of shares of X4 capital stock outstanding immediately prior to the merger received 0.5702 shares of Arsanis common stock in exchange for each share of X4 capital stock in the merger. On March 13, 2019, Arsanis is effecting a six-for-one reverse stock split. As a result of the reverse stock split, every six shares of Arsanis common stock outstanding following the merger, including the shares issued to the holders of shares of X4 capital stock in the merger, will be combined and reclassified into one share of Arsanis common stock. No fractional shares will be issued in connection with the reverse stock split. Instead, cash, based on the average closing price per share of Arsanis common stock on the Nasdaq Global Market on the 10 consecutive trading days prior to March 13, 2019, will be paid in lieu of fractions of shares.

Following the merger and the reverse stock split, the combined organization is expected to have approximately 6.7 million shares outstanding.

In connection with the merger, Arsanis will change its name to X4 Pharmaceuticals, Inc. The combined organization will commence trading on March 14, 2019 on the Nasdaq Capital Market under the symbol "XFOR".

The combined organization will operate under the leadership of X4’s management team prior to the merger, including Paula Ragan, Ph.D., President and Chief Executive Officer, and Adam S. Mostafa, Chief Financial Officer. The board of directors of the combined organization is comprised of six directors: four directors from the former X4 board, Michael S. Wyzga, Isaac Blech, Gary J. Bridger, Ph.D. and Dr. Ragan, and two directors from the former Arsanis board, David McGirr and René Russo, Pharm.D., BCPS. Mr. Wyzga is the new chairman of the board. The corporate headquarters of the combined organization is located in Cambridge, Massachusetts.

About WHIM Syndrome

WHIM syndrome is a primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene resulting in susceptibility to certain types of infections. WHIM is an abbreviation for the characteristic clinical symptoms of the syndrome: Warts, Hypogammaglobulinemia, Infections, and Myelokathexis. There is no approved therapy for the treatment of WHIM syndrome.

Propanc Biopharma Receives Notice of Allowance for Additional Claims from Foundation Patent in the U.S.

On March 13, 2019 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) confirming composition of matter claims involving trypsinogen and chymotryosinogen have been allowed (Press release, Propanc, MAR 13, 2019, View Source [SID1234534283]). The additional composition claims are a continuation from the original foundation patent in the U.S. and as a result, both method of treatment and composition claims will protect the Company’s lead product candidate, PRP, a pharmaceutical composition for treating cancer.

A Notice of Allowance is issued by the USPTO to indicate that it believes an invention qualifies for a patent. The reasons for allowance stipulated by the USPTO examiner stated that the scientific declarations presented establishes that compositions comprising trypsinogen and chymotrypsinogen exhibit a synergistic ability to inhibit the growth of various cancer cell lines, and that this effect would be unexpected to one of ordinary skill in the art, thus concluding the claims were patentable.

"We are delighted to receive allowance of additional claims from the USPTO, and composition of matter claims represent the strongest protection possible for PRP in our most important jurisdiction," said James Nathanielsz, Propanc’s Chief Executive Officer, "Presently, we have 65 patents either in force, or pending, in major global regions around the world, and our rapidly growing IP portfolio is becoming very significant as we advance PRP towards human trials."