On February 15, 2019 Decipher Biosciences (formerly GenomeDx), a leader in the field of urologic cancer genomics, reported a research collaboration with Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, to apply genomic tumor profiling using the Decipher assay and GRID software to identify prostate cancer patients on active surveillance who may benefit most from treatment with sipuleucel-T. PROVENGE (sipuleucel-T) was the first U.S. Food and Drug Administration (FDA)-approved immunotherapy made from a patient’s own immune cells (Press release, GenomeDX BiosciencesInc, FEB 15, 2019, View Source [SID1234533357]).

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"We are pleased to work with Dendreon on this important research collaboration, which we believe will help accelerate the discovery and development of genomic solutions to aid in the treatment and management of prostate cancer," said Elai Davicioni, PhD, chief scientific officer of Decipher Biosciences. "Leveraging Decipher, GRID and machine learning to uncover novel predictors of treatment response will help realize our mutual goal of personalizing therapy for patients with prostate cancer."

As part of the agreement, Dendreon will provide Decipher Biosciences with tumor samples from its Phase 3 ProVent trial (NCT03686683), which will evaluate the effectiveness of sipuleucel-T in reducing disease progression in men with prostate cancer on active surveillance. Decipher Biosciences will use its whole transcriptome Decipher assay to assess the biological behavior of a patient’s tumor and its GRID software and database to evaluate gene expression signatures that may be associated with sipuleucel-T response.

"More than 50,000 men choose active surveillance every year1, which includes regular monitoring to ensure the cancer is not growing or spreading, over more serious treatment options that can negatively impact quality of life," said Bruce A. Brown, M.D., chief medical officer at Dendreon. "It is our hypothesis that treating patients on AS with sipuleucel-T immunotherapy will enable more of them to stay in the AS cohort longer, perhaps indefinitely."

About Decipher Cancer Classifier Tests and GRID

Decipher prostate and bladder cancer classifiers are clinical, commercially available oncology tests that provide a genomic assessment of tumor aggressiveness for individual patients. Decipher Biopsy is indicated for men with localized prostate cancer at diagnosis, Decipher RP is indicated for men after prostate removal surgery, and Decipher Bladder is indicated for patients being considered for neoadjuvant chemotherapy prior to bladder removal surgery. The Decipher tests are used by physicians to stratify patients into more accurate risk groups than determined by traditional diagnostic tools and to help determine which patients may be more likely to benefit from additional treatment.

The Decipher tests are derived from the Decipher Genomics Resource Information Database (GRID). GRID contains the genomic profiles of tens of thousands of tumors from patients with urological cancers, and is believed by Decipher Biosciences to be the largest shared genomic expression database in urologic cancer as well as one of the world’s largest global RNA expression databases using cloud-based analytics. Each tumor analyzed with a Decipher test adds new data to the GRID database, which is compiled into a Decipher GRID Profile that may reveal additional biological characteristics of the tumor for ongoing research purposes. Going beyond risk stratification, Decipher and GRID make genomic information accessible for researchers to predict responses to therapy better and to guide treatment more precisely. In addition, GRID is a platform for interactive research collaboration, and may enable more rapid discovery, development, commercialization and adoption of new genomic solutions for key clinical questions in cancer treatment.

On February 15, 2019 Nektar Therapeutics presented the corporate presentation (Presentation, Nektar Therapeutics, FEB 15, 2019, View Source [SID1234533358]).

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On February 15, 2019 Eli Lilly and Company (NYSE:LLY) reported the successful completion of its acquisition of Loxo Oncology, Inc. (NASDAQ:LOXO) (Press release, Eli Lilly, FEB 15, 2019, View Source [SID1234533343]). The acquisition broadens the scope of Lilly’s oncology portfolio into precision medicines through the addition of a pipeline of highly selective potential medicines for patients with genomically defined cancers.

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Lilly’s tender offer for all outstanding shares of common stock of Loxo Oncology, at a price of $235.00 per share in cash, expired as scheduled at one minute past 11:59 p.m., Eastern time, on Thursday, February 14, 2019. As of the expiration of the tender offer, 26,043,820 shares of Loxo Oncology common stock were validly tendered and not properly withdrawn, representing approximately 84.6 percent of the shares of Loxo Oncology common stock outstanding, and have been accepted for payment under the terms of the tender offer. Following completion of the tender offer, Lilly completed the acquisition of Loxo Oncology through the previously-planned second-step merger.

"We are pleased to announce the completion of our acquisition of Loxo Oncology, which will expand the breadth of our portfolio into precision medicines and target cancers that are caused by specific gene abnormalities," said Anne White, president of Lilly Oncology. "We look forward to working with the Loxo Oncology team and continuing to rapidly advance this pioneering scientific innovation and improve the lives of people with cancer."

"The Loxo Oncology team has always been relentless and unified around the common goal of bringing highly selective medicines to patients with genomically defined cancers," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "With the acquisition now complete, we look forward to realizing the full value of our pipeline with the ongoing support of our teams in Connecticut, Colorado and California."

The acquisition of Loxo Oncology provides Lilly with a promising pipeline of investigational medicines, including:

LOXO-292, a first-in-class oral RET inhibitor that has been granted Breakthrough Therapy designation by the FDA for three indications, with an initial potential launch in 2020. LOXO-292 targets cancers with alterations to the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types, including certain lung and thyroid cancers as well as a subset of other cancers.
LOXO-305, an oral BTK inhibitor currently in Phase 1/2. LOXO-305 targets cancers with alterations to the Bruton’s tyrosine kinase (BTK), and is designed to address acquired resistance to currently available BTK inhibitors. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas.
In November 2017, Loxo Oncology and Bayer Consumer Care AG entered into a global collaboration for the development and commercialization of the TRK inhibitors Vitrakvi (larotrectinib) and LOXO-195. The Bayer/Loxo agreement provides that Bayer may elect to convert the co-exclusive license to an exclusive license in the U.S. and Puerto Rico in the event of a change of control of Loxo Oncology. Bayer exercised its election under the Bayer/Loxo agreement to convert its co-exclusive license to an exclusive license in the U.S. and Puerto Rico, pending clearance under the Hart-Scott-Rodino Antitrust Improvements Act. When the new exclusive licensing arrangement takes effect, Lilly will receive royalties from Bayer on future sales of Vitrakvi and LOXO-195 both in the U.S. and in international markets.

Lilly has reaffirmed its current 2019 financial guidance. The expected financial impact of Lilly’s acquisition of Loxo Oncology has been previously communicated and is reflected in Lilly’s current 2019 financial guidance, as announced on February 6, 2019.

The Offer and the Merger
The tender offer for all of the outstanding shares of common stock of Loxo Oncology at a price of $235.00 per share, net to the seller in cash, without interest and less any required tax withholding (the "Offer"), expired as scheduled at one minute past 11:59 p.m., Eastern time, on Thursday, February 14, 2019. Computershare Trust Company, N.A., the depositary and paying agent for the Offer, has advised Lilly that 26,043,820 shares of Loxo Oncology common stock were validly tendered and not properly withdrawn in the Offer, representing approximately 84.6 percent of the shares of Loxo Oncology common stock outstanding. All of the conditions to the Offer have been satisfied and on February 15, 2019, Lilly and its wholly-owned subsidiary, Bowfin Acquisition Corporation, accepted for payment, and will promptly pay for, all shares validly tendered and not properly withdrawn in the Offer.

Following completion of the Offer, Lilly completed the acquisition of Loxo Oncology through the merger of Bowfin Acquisition Corporation with and into Loxo Oncology, without a vote of Loxo Oncology’s stockholders pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Loxo Oncology surviving the merger as a wholly-owned subsidiary of Lilly. In connection with the merger, each share of common stock of Loxo Oncology not validly tendered into the Offer (other than (1) shares owned by Loxo Oncology immediately prior to the effective time of the merger, (2) shares owned by Lilly or Bowfin Acquisition Corporation at the commencement of the Offer and owned by Lilly or Purchaser immediately prior to the effective time of the merger or (3) shares held by any stockholder that was entitled to and has properly demanded statutory appraisal of its shares) has been converted into the right to receive the same $235.00 per share in cash, without interest and less applicable tax withholding, as will be paid for all shares that were validly tendered and not properly withdrawn in the Offer. Loxo Oncology’s common stock will be delisted from the NASDAQ Stock Market.

On February 14, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported the pricing of its offering of $65.0 million aggregate principal amount of 6.50% convertible senior notes due 2024 (the "notes") (Press release, Inovio, FEB 14, 2019, View Source [SID1234533304]). The notes will be sold in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The sale of the notes is expected to close on February 19, 2019, subject to customary closing conditions. Inovio also granted the initial purchasers of the notes a 13-day option to purchase up to an additional $20.0 million aggregate principal amount of notes.

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The notes will be senior unsecured obligations of Inovio and will accrue interest payable in cash semi-annually in arrears at a rate of 6.50% per annum. The notes will mature on March 1, 2024, unless earlier converted, redeemed or repurchased. Prior to the close of business on the business day immediately preceding November 1, 2023, the notes will be convertible at the option of the holders only upon the satisfaction of certain circumstances. Thereafter, the notes will be convertible at the option of the holders at any time until the close of business on the scheduled trading day immediately before the maturity date. Upon conversion, Inovio will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The initial conversion rate will be 185.8045 shares per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $5.38 per share), subject to adjustment upon the occurrence of specified events.

Inovio may not redeem the notes prior to March 1, 2022. On or after March 1, 2022, Inovio may redeem all, or any portion, of the notes for cash if the last reported sale price per share of Inovio’s common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days (whether or not consecutive) during the 30 consecutive trading days ending on, and including, the trading day immediately before Inovio sends the related redemption notice; and (ii) the trading day immediately before the date Inovio sends such redemption notice. The redemption price will be equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

Inovio estimates that the net proceeds from the offering will be approximately $62.7 million (or approximately $82.1 million if the initial purchasers exercise in full their option to purchase additional notes), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Inovio. Inovio intends to use the net proceeds from the offering for general corporate purposes, including clinical trial expenses, research and development expenses, general and administrative expenses and manufacturing expenses, and for other business development activities.

The offer and sale of the notes and the shares, if any, issuable upon conversion of the notes have not been and will not be registered under the Securities Act or applicable state securities laws, and the notes and such shares may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the notes or any shares issuable upon conversion of the notes, nor shall there be any sale of the notes or such shares, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful.

On February 14, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported it has initiated its Phase 1/2 clinical trial to evaluate ADXS-503, part of the Company’s ADXS-HOT program, in the treatment of non-small cell lung cancer (NSCLC) and has enrolled the first patient in the trial (Press release, Advaxis, FEB 14, 2019, View Source [SID1234533325]). ADXS-HOT is a cancer-type specific immunotherapy program which leverages Advaxis’ proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens. To date, more than 10 drug candidates have been designed for different tumor types under the ADXS-HOT program.

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"Coming on the heels of the presentation of data from our immunotherapy platform at the I/O 360 conference last week, we are excited to announce the enrollment of the first ADXS-HOT patient in our Phase 1/2 trial evaluating ADXS-503 for the treatment of NSCLC. The data presented at I/O 360 suggest that our neoantigen-directed constructs from both our ADXS-NEO and ADXS-HOT programs have the potential to demonstrate best-in-class CD+8 T cell response for neoantigen therapies," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. He continued, "We believe our ADXS-HOT drug constructs have significant advantages compared to certain other neoantigen-focused therapies in development as our ADXS-HOT drug constructs are off-the-shelf and immediately available to administer to the patient and have a favorable cost to manufacture." He concluded, "The ADXS-HOT program supports our goal of leveraging the significant experience we have gained from our proprietary platform in order to advance programs in the fight against cancer for patients in need of new therapeutic options and we look forward to studying these constructs in the clinic."

The Phase 1/2 clinical trial for ADXS-503 will seek to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone (initially) and in combination with a checkpoint inhibitor in approximately 50 patients with NSCLC in different lines of therapy, at up to 20 centers across the U.S. Advaxis anticipates initial data from the first cohort of ADXS-503 in the first half of 2019.

About ADXS-HOT

ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.