On July 2, 2021 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported the closing of an underwritten public offering of 4,758,620 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 620,689 shares, at the public offering price of $145.00 per share (Press release, Intellia Therapeutics, JUL 2, 2021, View Source [SID1234584571]). The gross proceeds raised in the offering, before underwriting discounts and commissions and estimated expenses of the offering, were approximately $690 million.

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Goldman Sachs & Co. LLC, Jefferies, SVB Leerink, and Barclays acted as joint book-running managers for the offering. Truist Securities acted as co-manager for the offering.

The shares of common stock were offered by Intellia pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC) and automatically became effective upon filing. A final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on July 1, 2021. The final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; Jefferies LLC, by mail at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at [email protected]; SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Barclays Capital Inc., by mail at c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the 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 July 2, 2021 Philogen S.p.A. (BIT:PHIL), a clinical-stage biotechnology company focused on the development of innovative medicines based on tumor targeting antibodies and small molecule ligands, reported to provide an update on three R&D programs: Fibromun, OncoFAP and ABBV-022 (Press release, Philogen, JUL 2, 2021, View Source [SID1234584934]). A full pipeline update will be made to the market on 28 September, 2021, in the Company’s Half Year results announcement.

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Prof. Dr. Dario Neri, Co-Founder, Chief Executive Officer and Chief Scientific Officer of Philogen S.p.A., said: "We are extremely pleased to see that our technology has been delivering exciting product candidates of diverse nature, both by our partners such as AbbVie and under our ownership, across a variety of clinical trials. The early signs of activity support our ambition to bring innovative treatment options to patients with serious unmet medical need."

Fibromun

Fibromun (L19TNF), wholly-owned by Philogen, is a fully-human immunomodulatory product consisting of the L19 antibody and TNF (a strong pro-inflammatory cytokine). Recombinant TNF has so far been approved only for certain loco-regional clinical applications.

Promising interim survival benefits have been demonstrated in the European Phase I/II trial, investigating Fibromun as a monotherapy for the treatment of IDH wildtype WHO Grade III-IV High-Grade Glioma at first recurrence/relapse. Data on progression free survival at six months are being finalized, while the overall survival data will be consolidated by the end of 2021, with expected publication in a peer-reviewed scientific journal in 2022.
In the European Phase I/II trial, in which Fibromun is combined with lomustine for the treatment of Glioblastoma at first recurrence/relapse, a partial response has been observed already in the first patient treated in the study. The historical overall response rate for this patient population is 4.3% (Wick et al., J Clin Oncol 2010, 28,1168)
A Parallel Scientific Advice (PSA) with the European Medicines Agency and the US Food and Drug Administration has been completed in June 2021. The development plan for the treatment of glioblastoma and the proposed strategy for marketing authorization have been discussed and agreed with competent authorities. Philogen will follow the recommendations that were provided during the PSA.
In the European Phase II trial, in which Fibromun is combined with dacarbazine for the treatment of pretreated advanced/metastatic Soft Tissue Sarcoma (3rd line), the second patient treated in the study enjoyed a partial response. The historical overall response rate for this patient population is 4.0% (Garcia-del-Muro et al., J Clin Oncol 2011, 29,2528). After the run-in part of the trial, the trial progresses to a randomized part.
Fibromun is investigated in six clinical trials, of which five have a pivotal potential. In Soft Tissue Sarcoma, the European Phase III trial in 1st line and the Phase II trial in 3rd line are expected to read out by the end of 2023.

OncoFAP

OncoFAP is a small molecule radiotracer, wholly-owned by Philogen, with ultra-high affinity for Fibroblast Activation Protein (FAP). The product is suitable for the non-invasive detection of a variety of metastatic solid tumors, as FAP is overexpressed in more than 90% of epithelial cancers (e.g., malignant breast, colorectal, ovarian, lung, skin, prostate, and pancreatic cancers, as well as in some soft tissue and bone sarcomas)

Clinicians from the Department of Nuclear Medicine at the University Hospital of Münster have employed a OncoFAP-based radionuclide conjugate (OncoFAP-68Ga) in clinical scanning of patients with various FAP-positive cancer types and have shown excellent tumor uptake in both primary and metastatic lesions with low uptake in healthy organs (including kidneys) after intravenous injection.
These clinical results also support the investigation of OncoFAP-177Lu for Radionuclide Ligand Therapy (RLT).
Philogen is currently planning international, exploratory, clinical trials to investigate OncoFAP in a variety of cancer indications. The results from these studies will provide the basis for a pivotal clinical program in selected cancer types.

ABBV-022

ABBV-022, a product out-licensed by Philogen to AbbVie, consists of an IL-22 payload fused to a targeting antibody. The cytokine, selectively delivered to the epithelial surface of damaged gut mucosa, promotes survival of intestinal stem cells, improves goblet cell function and epithelial barrier, thereby reducing inflammation.

ABBV-022 has started a Phase I clinical trial for the treatment of Ulcerative Colitis. The original collaboration between Philogen and AbbVie began in 2014.

On July 2, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that it will release its financial results for the second quarter of 2021 before the market opens on Thursday, July 29, 2021 (Press release, LabCorp, JUL 2, 2021, View Source [SID1234584572]). The company will host a conference call and webcast beginning at 9 a.m. ET that day to discuss the results. The earnings release and accompanying financial information will be posted on the Labcorp Investor Relations website.

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Interested parties can access the conference call by dialing 1-877-898-8036 within the U.S. and Canada, or 1-720-634-2811 internationally, using the conference ID 1789612. In addition, a real-time webcast of the conference call will be available on the Labcorp Investor Relations website.

An audio replay of the conference call will be available from 1 p.m. ET on July 29, 2021, until 11:30 p.m. ET on August 12, 2021, by dialing 1-855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the conference ID 1789612. The webcast of the conference call will be archived and accessible through July 15, 2022, on the Labcorp Investor Relations website.

On July 2, 2021 Orion reported that it will publish Half-Year Financial Report for January–June 2021 on Monday, 19 July 2021 at approximately 12.00 noon EEST (Press release, Orion , JUL 2, 2021, View Source [SID1234584575]). The release and related presentation material will be available on the company’s website at www.orion.fi/en/investors after publishing.

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Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held on Monday, 19 July 2021 at 13.30 EEST. The event will be held only online and by conference call.

A link to the live webcast will be available on Orion’s website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.

On July 2, 2021 CEL-SCI Corporation (NYSE American: CVM) reported that the discussion at the Annual Shareholder Meeting, on July 1, 2021 at 10:00 am EDT, regarding its Phase 3 head and neck cancer trial results is available at View Source (Press release, Cel-Sci, JUL 2, 2021, View Source [SID1234584576]).

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The discussion on the Phase 3 results was presented by Geert Kersten the Chief Executive Officer, Dr. Eyal Talor the Chief Scientific Officer and John Cipriano the Senior Vice President of Regulatory Affairs. In the landmark Phase 3 study, Multikine produced a significant 14.1% 5-year survival benefit (62.7% vs 48.6%) in the group of advanced primary head and neck cancer patients who received surgery plus radiotherapy. The Company plans to file for FDA approval in this patient population.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational cancer immunotherapy that is known to contain 14 natural human cytokines, the body’s immune system regulators including interleukins, interferons, chemokines, and colony stimulating factors which are elements of the body’s natural mix of defenses against cancer and other diseases. A patented, mass-produced, off the shelf and ready to use non-autologous biological product, Multikine is manufactured using a proprietary process following Good Manufacturing Practice (GMP) requirements from Source Leukocytes, an FDA licensed product, at CEL-SCI’s manufacturing facility near Baltimore, Maryland.