On January 26, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, will provide a clinical update during today’s conference call and webcast at 4:30 p.m. EST. Live and archived versions of the event can be accessed via the Company’s website (Press release, Cue Biopharma, JAN 26, 2022, View Source [SID1234608262]).

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Members of the Cue Biopharma executive management team will provide an update from the Company’s ongoing clinical trials with CUE-101, its lead and representative IL-2 based drug product candidate from the CUE-100 series. CUE-101 is currently in a Phase 1b clinical trial for the treatment of third line and beyond HPV+ recurrent/metastatic head and neck squamous cell carcinoma. The discussion will focus on recent data updates from the Phase 1b monotherapy dose expansion trial and the dose escalation combination trial evaluating CUE-101 front line with Merck’s KEYTRUDA (pembrolizumab). Management will also provide an update on the Company’s pipeline development progress from the IL-2 based CUE-100 series including CUE-102, with an Investigational New Drug (IND) filing planned for the first quarter of 2022, as well as updates on its strategic objectives and anticipated milestones.

Webcast Details

Wednesday, January 26, 2022 at 4:30 p.m. EST
Investors: 877-407-9208
International: 201-493-6784
Conference ID: 13726509
Webcast: View Source;tp_key=7a7d92f501

On January 26, 2022 Aclys Bio Corp ("Aclys"), a company discovering and developing precision biologics for the treatment of cancer, earlier this month reported a new exclusive research and commercial license option agreement with Genmab A/S (Nasdaq: GMAB), an international biotech company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer (Press release, Celdara Medical, JAN 26, 2022, View Source [SID1234608166]).

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Under the terms of the agreement, Genmab secures exclusive rights to Aclys antibodies (specific to an undisclosed target) for further research in conjunction with Genmab’s proprietary platforms. Genmab is also granted the option to advance development and commercialization of resulting products.

Aclys has built a broad range of antibodies using its PILA platform to create targeted therapeutics for solid tumors. The agreement with Genmab recognizes the capability of the Aclys PILA platform to identify novel precision targets.

"We have differentiated, high value targets, unique antibody engineering capabilities, and a team that has delivered some of the most valuable monoclonal antibodies currently in development.", said Dr. Tony Cooper, Aclys Cofounder and CEO. "This agreement with Genmab is integral to advancing our goal of delivering life-saving therapies to patients." Aclys is a leader in the emerging field of precision immune medicine. Aclys utilizes a proprietary set of patient molecular data to select differentiated targets and create precision biologics with the safety profile and response rates only achievable with precision biologics.

On January 26, 2022 Nordic Pharma reported that on the 24th of January, the European Commission (EC) approved the new indication for Teysuno (tegafur/gimeracil/oteracil) for the treatment of patients with metastatic colorectal cancer who cannot continue fluoropyrimidine treatment due to specific toxicities: hand-foot syndrome and cardiotoxicity (Press release, Nordic Pharma, JAN 26, 2022, View Source [SID1234607539]).

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Nordic Pharma received a positive scientific opinion recommending approval of the use of Teysuno in metastatic colorectal cancer from EMA’s Committee for Medicinal Products for Human Use (CHMP) in December 2021.

Based on this approval, Teysuno will be indicated in adults:

for the treatment of advanced gastric cancer when given in combination with cisplatin (current indication).
as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting

New fluoropyrimidine for patients with metastatic colorectal cancer

nordic_pharma_thumbnail_green_colon

In metastatic colorectal cancer the typical first-line chemotherapy consists of a fluoropyrimidine used in various combinations.

Teysuno is an oral fluoropyrimidine with similar efficacy, but improved specific safety profile compared with other fluoropyrimidines.

Jean-Michel Quinot, CEO of Nordic Pharma stated: "This is important news for patients with metastatic colorectal cancer. Teysuno offers those patients suffering from toxicities that can cause discontinuation of therapy an alternative fluoropyrimidine therapy which allows them to continue systemic treatment that is known to significantly prolong survival. By being able to meet this medical need, we hope to contribute to improving the lives of these patients. We want to particularly thank medical oncologists and patients in different European countries who contributed to collecting crucial clinical data for this new indication."

Iris van Lakerveld, Global Oncology Lead added: "Fluoropyrimidines are, and will continue to be, the cornerstone of chemotherapy treatment in metastatic colorectal cancer. A significant group of patients can now be offered an alternative, in the event that chemotherapy needs to be delayed, the dose reduced or fully stopped because of hand-foot syndrome or cardiotoxicity. Side effects with chemotherapy are inevitable. With Teysuno, physicians and patients will have an additional therapy when needed, allowing optimal benefit of fluoropyrimidine treatment.

Nordic Pharma licences Teysuno from Taiho Pharmaceutical Co., Ltd. in Japan. In Japan, the product is known as TS-1 and is approved for various solid tumours, including gastric and colorectal cancer. Since 2011 Teysuno has been on the European market in 17 countries. In total, the product is marketed in over 30 countries worldwide. The approval of the European Commission is an important step in providing patients with metastatic colorectal cancer access to Teysuno. Subsequently country-specific reimbursement applications will be done at the level of each Member State to ensure this access.

On January 26, 2022, Epizyme, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with Jefferies LLC, as representative of the several underwriters listed therein (collectively, the "Underwriters"), relating to an underwritten public offering (the "Offering") of 56,666,667 shares (the "Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock") at a public offering price of $1.50 per share. All of the Shares are being sold by the Company (Filing, 8-K, Epizyme, JAN 26, 2022, View Source [SID1234607443]). The Underwriters have agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $1.41 per share. Under the terms of the Underwriting Agreement, the Company has also granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 8,500,000 shares of Common Stock (the "Additional Shares"), at the same price per share as the Shares.

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The Company estimates that the net proceeds from the Offering will be approximately $79.5 million, or approximately $91.4 million if the Underwriters exercise in full their option to purchase Additional Shares, in each case, after deducting underwriting discounts and commissions and estimated offering expenses. Based on the Company’s research and development plans and its timing expectations related to the progress of its programs, the Company expects that the net proceeds from the Offering, together with the Company’s existing cash, cash equivalents and marketable securities as of December 31, 2021, and product revenue the Company expects to generate from product sales, will enable the Company to fund its operating expenses and capital expenditure requirements into the third quarter of 2023.

The Shares, and any Additional Shares, will be issued pursuant to a prospectus supplement dated January 26, 2022 and an accompanying base prospectus dated May 13, 2021 that form a part of the registration statement on Form S-3 that the Company filed with the U.S. Securities and Exchange Commission ("SEC") (File No. 333-255806), which was declared effective by the SEC on May 13, 2021. The closing of the Offering is expected to take place on or about January 31, 2022, subject to the satisfaction of customary closing conditions.

The Underwriting Agreement contains customary representations, warranties, covenants and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. A copy of the Underwriting Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to such exhibit.

On January 26, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that it has commenced an underwritten public offering of its common shares and, in lieu of common shares to certain investors, pre-funded warrants to purchase its common shares (Press release, Zymeworks, JAN 26, 2022, View Source [SID1234607442]). The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. In addition, Zymeworks intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares offered in the offering (including shares underlying the pre-funded warrants), at the public offering price, less the underwriting discounts and commissions.

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Jefferies, Evercore ISI, Stifel and Wells Fargo Securities are acting as joint book-running managers for the proposed offering. Raymond James is acting as lead co-manager for the proposed offering.

An automatically effective shelf registration statement relating to the securities offered in the public offering described above was filed with the Securities and Exchange Commission (the "SEC") on October 1, 2021. The proposed offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected], Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected], or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, by telephone at (833) 690-2713, or by email at [email protected].

No securities are being offered or sold, directly or indirectly, in Canada or to any resident of Canada.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.