On June 26, 2019 BridgeBio Pharma, Inc. ("BridgeBio") reported the pricing of its initial public offering of 20,500,000 shares of its common stock at a price to the public of $17.00 per share, above the range of $14.00 to $16.00 (Press release, BridgeBio, JUN 26, 2019, View Source [SID1234576265]). In addition, BridgeBio has granted the underwriters a 30-day option to purchase up to 3,075,000 additional shares of its common stock. The shares are expected to begin trading on the Nasdaq Global Select Market on June 27, 2019, under the ticker symbol "BBIO" and the offering is expected to close on July 1, 2019, subject to customary closing conditions.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, SVB Leerink LLC, KKR Capital Markets LLC, Piper Jaffray & Co., Mizuho Securities USA LLC, BMO Capital Markets Corp. and Raymond James & Associates, Inc. are acting as book-running managers for the offering.

A registration statement relating to the securities being sold in this offering has been filed with and was declared effective by the U.S. Securities and Exchange Commission on June 26, 2019. This offering is being made only by means of a written prospectus. Copies of the final prospectus may be obtained, when available, from the office of J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-866-803-9204 or by emailing [email protected]; Goldman, Sachs & Co., Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526 or by emailing [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: 1-877-547-6340, or by emailing [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 01220, telephone: 1-800-808-7525, ext. 6132, or by emailing [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or jurisdiction.

On June 26, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported the online publication in The Lancet Oncology of the results from the completed Phase I dose-escalation and expansion clinical trial of IPH4102 in advanced CTCL patients (Press release, Innate Pharma, JUN 26, 2019, View Source [SID1234537267]). The Lancet Oncology publication can be accessed here.

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"We are very pleased with the publication of our IPH4102 Phase I results in a top tier, peer-reviewed medical journal," said Pierre Dodion, Chief Medical Officer of Innate Pharma. "The specific mode of action of IPH4102 and its therapeutic potential in advanced T-cell lymphoma, now available to the broader Lymphoma community, demonstrate that targeting of KIR3DL2 by IPH4102 result in a combination of high and durable responses, a favorable safety profile and a substantial improvement in quality of life in Sézary syndrome. The IPH4102 Phase I study design included several innovative features including a smaller cohort of patients at the lowest dosages and intra-patient dose escalation which allowed for the optimization of the overall study execution. Based on these Phase I clinical trial data, we launched the TELLOMAK Phase II clinical trial in June 2019, which simultaneously could enable the registration of IPH4102 in Sézary syndrome and allow us to explore its potential in broader patient populations of T-cell lymphoma such as Mycosis fungoides (MF) and peripheral T-cell lymphoma (PTCL)."

On June 26, 2019 Vaccibody AS reported strong immunogenicity data from the neoantigen cancer vaccine clinical trial VB N-01 (Press release, Vaccibody, JUN 26, 2019, View Source [SID1234537300]). Immunogenicity was assessed in two patients with renal cell carcinoma (RCC) and two patients with squamous cell carcinoma of the head and neck (SCCHN) after treatment with a VB10.NEO in combination with checkpoint inhibitor therapy as per protocol. Before VB10.NEO vaccination, these patients had been treated with the checkpoint inhibitor nivolumab for 12-32 months with stable disease as best response. One patient was progressing at start of vaccination. All patients had low tumour mutational burden ranging from 1.7-3.2 mutations/Mb. The top 20 neoepitopes predicted by Vaccibody’s proprietary NeoSELECTTM algorithm was selected for each of the fully personalized VB10.NEO neoantigen vaccines. Immunogenicity to each individual neoepitope has so far been assessed after 3 to 6 vaccinations of VB10.NEO by an in vitro stimulated IFN-γ ELISpot. Strong T cell responses were observed in all these first four patients tested. T cell responses were significantly increased in post-vaccination samples towards 63% of the neoepitopes. The response to the vaccine was very solid with an average increase of more than 1200 SFU per million PBMC which is on average a 250-fold increase from baseline. The breadth and the strength increased with number of vaccinations. An amplification of existing neoepitope-specific T cells as well as de novo responses were observed in all patients.

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Agnete Fredriksen President and CSO of Vaccibody, commented: We are very pleased to see the strong T cell responses observed in all of the first four patients at the initial assessments. We are excited to see that the vaccine was able to induce so strong T cell responses even in the patients with a history of many lines of previous treatment and no objective response to long-term treatment with anti-PD-1. All these first patients had low tumour mutational burden (TMB) leaving the number of mutations limited for selection of immunogenic neoepitopes, hence we believe the high percentage of the neoantigen-specific immune responses observed substantiates Vaccibody’s unique neoepitope prediction method and delivery mechanism. We are very intrigued by the de novo responses induced by the vaccine. The baseline responses and hence the number of de novo responses were surprisingly different between the patients assessed so far and we are looking forward to characterizing the T cells in more detail and follow the clinical responses in these patients

On June 25, 2019 LabCorp (NYSE: LH) reported that it will release its second quarter of 2019 financial results before the market opens on Thursday, July 25, 2019, followed by a conference call and webcast beginning at 9:00 a.m. EDT to discuss the results (Press release, LabCorp, JUN 25, 2019, View Source;p=RssLanding&cat=news&id=2402266 [SID1234537268]). Interested parties can access the conference call by dialing 844-634-1444 within the U.S. and Canada, or 1-615-247-0253 internationally, using the passcode 9679477.

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An audio replay of the conference call will be available from 1:00 p.m. EDT on July 25, 2019, until 11:30 a.m. EDT on August 8, 2019, by dialing 855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the passcode 9679477.

The earnings release, accompanying financial information, and a real-time webcast of the conference call will be available on the LabCorp Investor Relations website. The webcast will be archived and accessible through July 24, 2020.

On June 25, 2019 TILT Biotherapeutics Ltd, the leading company globally working in the area of enabling tumor T-cell therapies and checkpoint inhibiting antibodies with oncolytic viruses, reported that it has entered into an agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate its armed oncolytic virus, TILT-123, with avelumab in patients with solid tumors refractory to routine modalities (Press release, TILT Biotherapeutics, JUN 25, 2019, View Source [SID1234537255]).

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"We are pleased to initiate a collaboration with Merck KGaA, Darmstadt, Germany and Pfizer to translate our findings into patients. Preclinical results with TILT-technology and anti-PD(L)1 agents suggest immune activation and efficacy in certain animal models", explains Akseli Hemminki (MD, PhD, eMBA), CEO and Founder of TILT Biotherapeutics.

*Avelumab is under clinical investigation in combination with TILT-123 for treatment of solid tumors and has not been demonstrated to be safe and effective for this use. There is no guarantee that avelumab in combination with TILT-123 will be approved by any health authority worldwide.

About Avelumab

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in more than 45 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, major adverse cardiovascular events (MACE), and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Additional common adverse reactions reported in patients receiving BAVENCIO in combination with axitinib include hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. Clinical chemistry and hematology laboratory value abnormalities have been reported including but not limited to grade 3-4 lymphopenia, anemia, elevated cholesterol and liver enzymes.

For full Prescribing Information and Medication Guide for BAVENCIO, please see www.BAVENCIO.com.