About the CRISPR/Cas9 Gene Editing Patent Shareholders of biotechnology firms specialized in CRISPR gene editing technology are in a state of confusion regarding the technology's patents. The confusion is caused by the U.S. Patent and Trademark Office (USPTO) decision to sustain the intellectual property awarded to the Broad Institute of MIT and Harvard. This ruling has caused the stock of the firm Editas (EDIT), which …

Immunomedics (IMMU) and Seattle Genetics (SGEN) announced an exclusive global licensing agreement enabling Seattle Genetics to develop, fund, manufacture, and commercialize Immunomedics’ solid tumor drug candidate IMMU-132. Seattle Genetics accepted to take the responsibility for initiating Phase 3 clinical trial of IMMU-132 for patients with metastatic triple-negative breast cancer (TNBC) and submitting the initial Biologics License Application (BLA) to the FDA for accelerated approval. Also …

Incyte (INCY) and Agenus (AGEN) announced an amendment of the License, Development and Commercialization Agreement that was originally agreed upon by the two firms on January 9, 2015. The amended converts the ongoing antibodies targeting GITR and OX40 programs from co-funded development and profit-sharing arrangements to royalty-bearing programs. In the 2015 agreement, both firms decided to work together on the INCAGN1876 (anti-GITR agonist) and INCAGN1949 …

The FDA’s Center for Drug Evaluation and Research (CDER) informed Portola (PTLA) that it does not plan to hold an Advisory Committee meeting for its Product betrixaban. What is betrixapan? Betrixapan is a small molecule oral, once-daily, Factor Xa inhibitor anticoagulant. The drug directly inhibits the activity of Factor Xa, which is a validated target in the blood coagulation pathway. Why it is used? Betrixapan …

Gilead Sciences (GILD) was subjected to what we believe is an exaggerated stock selloff following the announcement of its 2016 financial reports, which comprised its projections made for 2017. Investors seemed to have focused only on the HCV sales’ revenues while ignoring the sales’ revenues of Gilead’s HIV franchise and other products, which outperformed? Investors ignored assessing the firm’s pipeline investigational products’ values especially those …

Prohost Letter #404 Part 2 Synthetic Biology (2) A Brief History DNA is the software of life. This is how Synthetic Genomics firm, which we believe is now is the leading biotech firm for applied synthetic biology. Synthetic Genomics is still a private firm in spite of that thousands of investors are impatiently waiting for it to turn public and it will. So stay tuned. …

XOMA Establishes Proof-of-Concept for 358 in Congenital Hyperinsulinism and Hypoglycemia Post-Bariatric Surgery Congenital Hyperinsulinism Phase 2 study completed and multi-dose study protocol approved in the United Kingdom. Xoma initiates multi-dose study in hypoglycemic Post-Bariatric Surgery patients The NEWS A few days ago, Xoma announced news about trial results that the firm believes were promising and successful in establishing proof-of-concept for its . . . This …

It seems that the global Takeda (TKPYY) has guessed well what it should pick in order to bring the most effective targeted treatments to cancer patients allover the globe. Cancer management has unreservedly changed. What seems now to have become the best treatment choices are those that would accommodate the new wave of extremely promising immunotherapy approaches. To reach its ultimate success, immunotherapy drugs require …

Incyte and Calithera Biosciences Announce Global Collaboration to Develop and Commercialize CB-1158, a Small Molecule Arginase Inhibitor                         Incyte (INCY) and Calithera Biosciences (CALA) announced a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology. CB-1158 is currently being studied in …

Prohost Letter #404 Part 1 HAPPY SPIRITUAL HOLIDAYS HAPPY NEW YEA

Today, Jounce Therapeutics has begun trading on the NASDAQ under the ticker symbol (JNCE).  The Company, which focuses on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced the pricing of its initial public offering of 6,365,000 shares of common stock at a public offering price of $16.00 per share for aggregate gross proceeds of $101,840,000. In addition, Jounce granted the underwriters …

A few months ago, we heard news that a Belgium firm called Celyad (CYAD) has concluded a deal worth over $300 million with Ono Pharmaceutical. The deal gives Ono the rights to Celyad’s allogeneic NKR-2 T-cell immunotherapy in Japan, Korea and Taiwan. This news did not mean a lot to investors as Celyad had yet to recover from a heartbreaking  setback in a late phase trial …

Vertex (VRTX) entered into a licensing agreement with Merck KGaA, Darmstadt, Germany for the worldwide development and commercialization of four research and development programs that the firm believes represent novel approaches to cancer treatment Merck KGaA will license two clinical-stage programs targeting DNA damage and repair, along with two additional novel pre-clinical programs. Upon the agreement Vertex will receive an upfront payment of $230 million, …

Amgen (AMGN) The Journal of the American Medical Association (JAMA) published findings from three Phase 3 studies of Parsabiv (etelcalcetide), an investigational intravenous calcimimetic agent in the U.S. The studies evaluated Amgen’s drug Parsabiv in more than 1,700 adults with secondary hyperparathyroidism on hemodialysis and showed that the drug produced statistically significant and clinically meaningful reductions in serum parathyroid hormone (PTH) levels, a key marker …

ARIAD Pharmaceuticals’ (ARIA) stock jumped 75% today. The oncology firm entered into a definitive agreement to be acquired by Takeda Pharmaceutical Company Limited under which Takeda will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, or a total enterprise value of approximately $5.2 billion, representing a premium of approximately 75 percent over ARIAD’s closing price on January 6, 2017. Under …

Extremely important, not just exciting, were the results of Halozyme Therapeutics’s (HALO) Phase 2 randomized, multi-center clinical trial of its PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer. The results demonstrated a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving …

GILEAD (GILD) One analyst who aimed at bringing only the negatives about biotech has finally succeeded in convincing other critics and media bloggers that Gilead would not be good for investment until the firm acquires a company that can expand its meager oncology franchise. His story became the melody hummed by every blogger, ignoring the fact that the firm’s revenues and income have doubled overnight …

Hi and Happy New Year 2017 In a couple of days, you will receive the NEW Year 2017 issue #404 of the Prohost Letter where we will set out our prediction regarding breakthrough achievements that we believe will change the way diseases will be treated. Our long article tackles great technological capabilities that we expect will advance products to the market and improve state-of-the-art approaches …

MANUFACTURING ISSUES?!  Why PORTOLA Stock Rallied? On Aug. 17, 2016, we learned that the FDA sent a Complete Response Letter (CRL) to Portola Pharmaceuticals (PTLA) regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa), which is an antidote important for the safety use of several new Factor Xa inhibitors anticoagulants aimed at replacing Coumadin (warfarin). The Factor Xa inhibitors anticoagulants have many advantages over …

Observing the biotech sector’s stock prices post losses yesterday, Wednesday, Dec. 21 convinced us that investors and traders in the biotech sector might have wrongly interpreted a bipartisan Senate report regarding the high price of drugs. The report is the outcome of a study that forms the basis of a recommendation that would enable the Congress take the right action against unjustified increases in the …