On December 7, 2020 Sutro Biopharma, Inc. (Nasdaq: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported a proposed underwritten public offering in which it intends to offer and sell 5,000,000 shares of its common stock (Press release, Sutro Biopharma, DEC 7, 2020, View Source [SID1234572382]). In addition, Sutro intends to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock offered in the public offering. All of the shares of common stock are being offered by Sutro. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Cowen, Piper Sandler and Wells Fargo Securities are acting as joint book-running managers in the offering. Wedbush PacGrow and JMP Securities are acting as co-managers for the offering.

Sutro intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and marketable securities, to fund the continued clinical development of STRO-001 and STRO-002 and the remainder to fund the further development of its technology platform, including manufacturing, to broaden its pipeline of product candidates, and for working capital and general corporate purposes.

The shares are being offered by Sutro pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001, by telephone at (800) 326-5897, or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Sutro, 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 December 7, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported positive interim Phase 1 data on HB-201, its replicating monotherapy for the treatment of HPV16+ cancers (Press release, Hookipa Pharma, DEC 7, 2020, View Source [SID1234572314]). The results are from the initial dose escalation cohorts of an ongoing Phase 1/2 clinical trial (NCT04180215) evaluating HB- 201 as therapy for patients with advanced HPV16+ metastatic cancers. HOOKIPA will host a conference call and live audio webcast today at 8:30am EST.

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These interim data support proof of concept for HB-201 monotherapy as a new immunotherapy for a difficult-to-treat patient population with multiple prior treatment failures. As of December 4, 2020, 22 patients have been enrolled in the first two cohorts, of which 15 were eligible for evaluation. Among the 15 evaluable patients, 11 patients had relapsed/refractory metastatic squamous cell head and neck cancer (HNSCC), all of whom had progressed on prior therapy with a PD1 inhibitor. As per RECIST1.1, in patients with third-line or later HNSCC, HB-201 demonstrated an unconfirmed response rate of 18% (one unconfirmed complete responder and one unconfirmed partial responder) and a 73% disease control rate (six stable disease patients, in addition to the two unconfirmed responses referenced above).

Median progression-free survival (mPFS) is currently measured at 72 days and is ongoing. Although not demonstrated in a head-to-head trial, these HB-201 results, in more heavily treated patients who progressed on a PD1 inhibitor, compare favorably to the benchmark data of a 13% overall response rate and a 60-day mPFS1 for nivolumab in second-line PD1 inhibitor naïve HNSCC patients, based on data published from the third-party registrational study.

Encouraging efficacy signals were also seen in the more heterogeneous group of all 15 evaluable patients with HPV16+ cancers treated in this trial, comprised of the 11 HNSCC patients summarized above and four other patients with HPV16+ cervical, anal, or vaginal tumors. In these 15 patients, HB-201 demonstrated an unconfirmed response rate of 13%, a disease control rate of 67%, and a median PFS that is also ongoing and currently measured at 72 days.

"We are thrilled by these preliminary HB-201 data, as they show the potential of our arenavirus platform in oncology and represent future possible therapeutic options for patients with HPV16+ cancers," said Joern Aldag, Chief Executive Officer of HOOKIPA. "The early response with our single-vector HB-201 therapy highlights the potential of our replicating technology, especially as we explore alternating two-vector therapy with HB-201/HB-202, and a future combination with a PD-1 inhibitor, both of which we hope will deliver even greater responses."

Of the 22 patients enrolled on the trial as of December 4th, preliminary safety data show that HB-201 has been well tolerated. Treatment-related adverse events were reported by 41% of participants. Almost all reported events were Grade 1 and 2 and included fatigue, fever, decreased appetite, constipation, nausea, and itching. Only one serious adverse event deemed related to HB-201, Grade 3 fatigue leading to hospitalization, has been reported to date. The rate of adverse events was consistent regardless of administration route.

"There remains a considerable unmet need in the treatment of HPV16+ cancers, particularly those in head and neck, and these preliminary data on HB-201 as a monotherapy are encouraging," said Alan L. Ho, MD, PhD, a medical oncologist at Memorial Sloan Kettering Cancer Center and an investigator on the trial.

About the trial
This Phase 1/2 clinical trial is an open-label dose-escalation and dose-expansion trial in individuals with treatment-refractory HPV16+ cancers. The primary endpoint of the Phase 1 trial is a recommended Phase 2 dose based on safety and tolerability. Secondary endpoints include anti-tumor activity as defined by RECIST 1.1, immunogenicity, safety, and tolerability.

The trial is designed to evaluate different dose levels of HB-201 as a single-vector therapy, as an alternating two-vector therapy together with HB-202, and in combination with a PD-1 inhibitor. Dosing frequencies of every three weeks and every two weeks are being explored during dose escalation.

Since the trial opened in December 2019, 22 patients with metastatic HPV16+ tumors have been enrolled in the HB-201 monotherapy segment: 17 with squamous cell head and neck tumors, two with cervical, one with nasopharyngeal, one with anal, and one with vaginal. Patients had received at least two prior therapies, and most patients progressed on a PD-1 inhibitor, a platinum-containing regimen or both. Enrollment is ongoing and HOOKIPA expects to share additional interim clinical data from the HB-201/HB-202 alternating two-vector therapy segment in mid-2021.

About HB-201/HB-202
HB-201 and HB-202 are engineered using HOOKIPA’s replicating arenaviral vector platform. They are designed to use different arenavirus backbones (LCMV for HB- 201 and PICV for HB-202), while expressing the same antigen, an E7/E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-202 and HB-201 resulted in a ten-fold increase in immune response and better disease control than either compound alone.

Conference call
HOOKIPA will host a conference call and live audio webcast today at 8:30am EST to discuss the HB-201 monotherapy data from the interim analysis of the Phase 1 trial. To access the conference call, please dial +1 877 870 9135 (from the US) or +44 2071 928338 (international) and refer to conference ID 9747865. The webcast and the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

About Human Papillomavirus
Human Papillomavirus, or HPV, is estimated to cause about 5 percent of the worldwide burden of cancers. This includes approximately 99 percent of cases in cervical, up to 60 percent of head and neck, 70 percent of vaginal and 88 percent of anal cancers.

The majority of these cancers are caused by the HPV serotype 16. Most infections with HPV are cleared from the body with no lasting consequences. However, in some cases, HPV DNA becomes integrated into chromosomal DNA. When host cells take up this DNA, they express the HPV E6 and E7 proteins. This uptake can potentially lead to cancer since expression of these proteins leads to alterations in cell cycle control, which in turn predisposes these cells to become cancerous.

On December 7, 2020 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, reported it has entered into a research collaboration and license agreement with Janssen Biotech, Inc. (Janssen) (Press release, Xencor, DEC 7, 2020, View Source [SID1234572333]). The research and license agreement is focused on the discovery of XmAb bispecific antibodies against CD28, an immune co-stimulatory receptor on T cells, and an undisclosed prostate tumor target, for the potential treatment of patients with prostate cancer. Additionally, Xencor has a right to access select, predefined agents from Janssen’s portfolio of clinical-stage drug candidates and commercialized medicines to evaluate potential combination therapies in prostate cancer with agents in its own pipeline in non-registrational clinical studies. Janssen has the same right with Xencor’s portfolio of clinical-stage drug candidates to evaluate potential combination therapies in prostate cancer, as well.

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"Our XmAb bispecific Fc domains enable the creation of a wide range of multi-specific antibody and protein structures, such as bispecific antibodies in our new CD28 platform. These antibodies can co-stimulate T cells in a tumor-target dependent manner and can synergize with both checkpoint inhibitor therapies and other tumor-targeted agents, like CD3 bispecific antibodies, in order to enhance anti-tumor activity," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "In addition, the ability to study combinations of therapies from both companies’ prostate cancer portfolios leverages Xencor’s broad clinical pipeline and the leading prostate cancer therapeutics portfolio at Janssen. This collaboration with Janssen expands the use of our CD28 platform and complements our first wholly owned internal candidate, a B7-H3 x CD28 bispecific antibody designed to treat a range of solid tumors, which is currently advancing through preclinical development."

Under the terms of the agreement, Xencor will apply its XmAb bispecific Fc technology to create and characterize XmAb CD28 bispecific antibody candidates against the tumor target specified by Janssen. Preclinical activities and all clinical development, regulatory and commercial activities will be conducted by Janssen, which has exclusive worldwide rights to develop and commercialize the novel drug candidates. Xencor will receive an upfront payment of $50 million and will be eligible to receive development, regulatory and sales milestone payments and high-single digit to low-double digit percent royalties on net sales.

Upon clinical proof of concept for a bispecific antibody candidate, Xencor has the right to opt-in to fund 20 percent of development costs and to perform up to 30 percent of the detailing efforts in the United States; Xencor would be eligible for milestone payments and low-double digit to mid-teen percent royalties on net sales.

The agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and closing is expected to occur by year end.

On December 7, 2020 NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN : FR0011341205 – the "Company"), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported the start of its roadshow in connection with its intention to issue and sell, subject to market and other conditions, 6,500,000 ordinary shares of the Company in an initial public offering of American Depositary Shares ("ADSs"), each representing one ordinary share, in the United States (the "U.S. Offering") and a concurrent offering of ordinary shares in certain jurisdictions outside of the United States (the "European Offering" and, together with the U.S. Offering, the "Global Offering") (Press release, Nanobiotix, DEC 7, 2020, View Source [SID1234572365]). The Company intends to grant the underwriters for the Global Offering (the "Underwriters") a 30-day option to purchase additional ADSs and/or ordinary shares in an aggregate amount of up to 15% of the total number of ADSs and ordinary shares proposed to be sold in the Global Offering.

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All securities to be sold in the Global Offering will be offered by the Company. The Company has applied to list its ADSs on the Nasdaq Global Market under the ticker symbol "NBTX." The Company’s ordinary shares are listed on the regulated market of Euronext in Paris under the symbol "NANO."

Jefferies LLC is acting as global coordinator and joint book-running manager for the Global Offering, and Evercore Group, L.L.C. and UBS Securities LLC are acting as joint book-running managers for the U.S. Offering. Jefferies International Limited and Gilbert Dupont are acting as managers for the European Offering.

The offering price per ADS in U.S. dollars and the corresponding offering price per ordinary share in euros, as well as the final number of ADSs and ordinary shares sold in the Global Offering, will be determined following a bookbuilding process.

The ADSs and/or ordinary shares will be issued through a capital increase without shareholders’ preferential subscription rights by way of a public offering excluding offerings referred to in Article L. 411-2 1° of the French Monetary and Financial Code (Code monétaire et financier) and under the provisions of Article L.225-136 of the French Commercial Code (Code de commerce) and pursuant to the 2nd and 7th resolutions of the Company’s extraordinary general shareholders’ meeting held on November 30, 2020.

The European Offering will be open only to qualified investors as such term is defined in article 2(e) of the regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017.

The securities referred to in this press release will be offered only by means of a prospectus. When available, copies of the preliminary prospectus relating to and describing the terms of the Global Offering may be obtained from Jefferies LLC, 520 Madison Avenue New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at 888-474-0200, or by email at [email protected]; or from UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, New York 10019, or by telephone at 888-827-7275, or by email at [email protected].

A registration statement on Form F-1 relating to the securities referred to herein has been filed with the U.S. Securities and Exchange Commission ("SEC") but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. The registration statement can be accessed by the public on the website of the SEC.

Application will be made to list the new ordinary shares to be issued pursuant to the Global Offering on the regulated market of Euronext in Paris pursuant to a listing prospectus subject to an approval from the French Autorité des marchés financiers ("AMF") and comprising the 2019 Universal Registration Document (Document d’Enregistrement Universel) of the Company approved by the AMF on May 12, 2020 under number R. 20-010, as amended by its amendment filed with the AMF on November 20, 2020 under number D.20-0339-A01 and a Securities Note (Note d’opération), including a summary of the prospectus. Copies of the 2019 Universal Registration Document and its amendment are available free of charge at the Company’s head office located at 60, rue de Wattignies, 75012 Paris, France, on the Company’s website (www.nanobiotix.com) and on the website of the AMF (www.amf-france.org).

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On December 7, 2020 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule modulators to address unmet medical needs in oncology and autoimmune diseases, reported efficacy data from a study of JBI-802, its novel dual inhibitor of LSD1-HDAC6, in multiple acute myeloid leukemia (AML) models, and the identification of novel, undisclosed biomarkers that will aid in patient stratification (Press release, Jubilant Therapeutics, DEC 7, 2020, View Source [SID1234572383]). The data, presented today in a poster session at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Virtual Annual Meeting, demonstrate superior efficacy in select AML models as compared to single agent inhibitors, with a unique mechanism of action.

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"We are highly encouraged to verify that both LSD1 and HDAC6 mechanisms are operational with JBI-802 and the dual inhibition shows a stronger and more potent effect than the standalone inhibitors. We are also excited about the potential biomarkers we have identified specifically for the dual inhibitor which will be highly valuable in identifying sensitive patient populations," said Syed Kazmi, President and Chief Executive Officer of Jubilant Therapeutics. "We believe JBI-802 could one day serve as a powerful therapeutic agent for the treatment of specific cancers, including myelodysplastic syndrome (MDS), select acute myeloid leukemia (AML) and solid tumor subsets."

A link to the abstract, Novel Dual Inhibitor of LSD1-HDAC6/8 for Treatment of Cancer, is available through the ASH (Free ASH Whitepaper) conference website.

Key highlights from the study of JBI-802 as compared to single agent LSD1 or HDAC6 selective inhibitors in AML models show:

Both LSD1 and HDAC6 mechanisms are operational with JBI-802 resulting in stronger anti-proliferation and efficacy in a subset of cell lines;
Selective biomarkers are modulated with the dual inhibition of JBI-802 not seen by the single agent inhibitors, leading to the potential for patient stratification and the evaluation of treatment response; and
JBI-802 has a superior efficacy, safety and tolerability profile.