On November 19, 2021, Kezar Life Sciences, Inc. (the "Company") reported that entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen"), with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.001 per share (the "Common Stock"), having aggregate gross proceeds of up to $100.0 million (the "Shares") through Cowen as its sales agent (Filing, 8-K, Kezar Life Sciences, NOV 19, 2021, View Source [SID1234595848]).

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Under the Sales Agreement, the Company will set the parameters for the sale of Shares, including the number of Shares to be issued, the time period during which sales are requested to be made, limitations on the number or dollar value of Shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms of the Sales Agreement, Cowen may sell the Shares by any method that is deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on The Nasdaq Global Select Market or any other trading market for the Common Stock. The Company will pay Cowen a commission equal to three percent (3.0%) of the gross sales proceeds of any Shares sold through Cowen under the Sales Agreement, and has provided Cowen with customary indemnification and contribution rights. The Sales Agreement will terminate upon the earlier of (i) the sale of all Shares subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with its terms.

Any Shares to be offered and sold under the Sales Agreement will be issued and sold pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-248752), which was filed with the Securities and Exchange Commission ("SEC") on September 11, 2020 and which became effective on September 23, 2020 (the "Form S-3"). The Company filed a prospectus supplement with the SEC on November 19, 2021 in connection with the offer and sale of the Shares pursuant to the Sales Agreement.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is furnished as Exhibit 1.1 to this Current Report on Form 8-K (this "Current Report") and is incorporated herein by reference.

Cooley LLP, counsel to the Company, has issued an opinion to the Company, dated November 19, 2021, relating to the validity of the Shares to be issued and sold pursuant to the Sales Agreement, a copy of which is filed as Exhibit 5.1 to this Current Report.

This Current Report shall not constitute an offer to sell or the solicitation of an offer to buy any Shares, nor shall there be any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

On November 19, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported the successful completion of the cash tender offer, through a subsidiary, Astros Merger Sub, Inc., for all of the outstanding shares of common stock of Acceleron Pharma Inc. (Nasdaq: XLRN), at a purchase price of $180 per share in cash, without interest and less applicable tax withholding. As of the tender offer expiration at 5:00 p.m., Eastern Time, on Nov. 19, 2021, 38,752,614 shares of common stock of Acceleron were validly tendered and not withdrawn from the tender offer, representing approximately 63.3% of the total number of Acceleron’s outstanding shares (Press release, Merck & Co, NOV 19, 2021, View Source [SID1234595847]). All such shares have been accepted for payment in accordance with the terms of the tender offer, and Astros Merger Sub, Inc. expects to promptly pay for such shares.

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Merck intends to complete the acquisition of Acceleron through a merger of Astros Merger Sub, Inc. with and into Acceleron, with Acceleron being the surviving corporation, in which all shares not tendered into the offer will be cancelled and converted into the right to receive cash equal to the $180 offer price per share, without interest and less any applicable tax withholding. After the completion of the merger, Acceleron will become a wholly owned subsidiary of Merck and the common stock of Acceleron will no longer be listed or traded on the Nasdaq Global Market.

On November 16, 2021 Bright Peak Therapeutics, Inc., a biotechnology company developing next-generation cytokine immunotherapies, reported that it has entered into a license agreement with Livzon Mabpharm, Inc. ("Livzon"), a subsidiary company of Livzon Pharmaceutical Group, to use LZM009, Livzon’s proprietary anti-PD-1 monoclonal antibody currently in late-stage clinical trials, to develop novel PD-1 targeted immunocytokines ("PD-1 ICs") (Press release, Livzon Pharmaceutical Group, NOV 19, 2021, View Source [SID1234595846]). The PD-1 ICs will be comprised of optimized cytokine payloads developed by Bright Peak conjugated to LZM009 for the treatment of a variety of cancers. PD-1 ICs are designed to selectively target and activate cytotoxic CD8+ T cells ("CTLs") that express the inhibitory immune checkpoint PD-1 while avoiding the broad activation of other immune cells. Dual targeting of two receptors on the same CTL with a PD-1 inhibitor and a cytokine payload (cis-signaling) offers the added potential for synergistic efficacy.

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Bright Peak is dedicated to creating next-generation immunotherapies that exploit the potent biological activity of cytokines while showing a significantly improved safety profile. Using Bright Peak’s unique chemical protein synthesis and engineering platform, cytokines can be precisely designed to fine-tune receptor binding, optimize efficacy, and simultaneously insert conjugation handles at any desired site in a protein. This allows for rapid conjugation of enhanced cytokines as payloads to commonly used antibodies, creating novel and proprietary "Bright Peak Immunocytokines." One of the many advantages of Bright Peak’s technology is the ‘off-the-shelf’ ability to convert existing therapeutic antibodies into dual-targeting immunocytokines by a simple and rapid chemical process. The platform also readily enables the screening of various cytokine payloads with differential properties to elicit the desired biological effects. Moreover, Bright Peak’s approach allows the use of antibodies ‘as-is,’ avoiding the complex process of generating recombinant antibody-cytokine fusion proteins which involves lengthy protein expression, optimization and cell-line development.

"We are delighted to license Livzon’s anti-PD-1 monoclonal antibody LZM009 to broadly develop PD-1 directed immunocytokines by leveraging our proprietary platform technology," said Fredrik Wiklund, President and Chief Executive Officer of Bright Peak. "PD-1 inhibitors have changed the landscape of cancer therapy in recent years. However, despite the remarkable efficacy observed in a subset of patients treated with PD-1 inhibitors, most patients do not respond. Bright Peak’s PD-1 ICs have the potential to enhance the activity of PD-1 inhibition to bring the promise of immunotherapy to a greater number of patients."

"We are excited to apply the power and versatility of our synthetic protein engineering platform to generate PD-1 ICs by conjugating optimized cytokine payloads to a clinical stage antibody. PD-1 ICs are designed to utilize the concept of cis-signaling cytokines acting on the same cell that is targeted by the anti-PD-1 antibody. As a result, they are more potent and selective and have an increased capacity to induce superior CD8+ T cell responses," said Bertolt Kreft, Ph.D., Chief Scientific Officer of Bright Peak.

"Livzon’s PD-1 molecule has proprietary patents with broad application potential, and we are very happy to enter into an agreement with Bright Peak who possesses an innovative conjugation and protein engineering technology platform to explore and achieve dual-targeting effects of novel molecules to benefit patients with unmet medical needs," said Jianing Liu, Ph.D., Chief Investment Officer and Head of BD of Livzon Pharmaceutical Group. "Livzon Mabpharm is more than happy to support innovative global R&D with inspiring partners leveraging on our existing pipelines and experience in biologics, and we believe this is one step further to demonstrate Livzon MabPharm’s capabilities and readiness for global outreach," said Jiaming Yang, Ph.D., Executive Vice President of Livzon Mabpharm, Inc.

Under the terms of the license agreement, Bright Peak will receive the right to develop, manufacture and commercialize PD-1 ICs on a worldwide basis while Livzon retains certain rights of first negotiation to obtain exclusivity in the greater China territory. Livzon will receive a one-time upfront cash payment from Bright Peak and is eligible to receive additional cash payments upon the achievement of future development and regulatory milestones, as well as royalties in the low-to-mid single digit percentage range on worldwide net sales. Bright Peak will solely control and fund all activities related to development and commercialization on a worldwide basis, subject to Livzon’s right of first negotiation in greater China.

About LZM009
LZM009 is a human IgG4 monoclonal antibody which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T cells to kill cancer cells. LZM009 has been approved for clinical trials and completed clinical dose exploration trials in both China and the United States. LZM009 is undergoing extensive clinical trials, including pivotal trials in thymic cancer in China, with promising initial safety and efficacy data.

On November 19, 2021, Xenetic Biosciences, Inc. (the "Company") reported that entered into an At The Market Offering Agreement (the "ATM Agreement") with H.C. Wainwright & Co., LLC, as the exclusive sales agent ("Wainwright"), pursuant to which the Company may offer and sell, from time to time through Wainwright, shares (the "Shares") of its common stock, par value $0.001 per share ("Common Stock") (Filing, 8-K, Xenetic Biosciences, NOV 19, 2021, View Source [SID1234595845]). The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-260201) and the related prospectus, as supplemented by a prospectus supplement dated November 19, 2021 (the "Prospectus Supplement") and filed with the Securities and Exchange Commission (the "SEC") on such date pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act"), and is currently limited to a number of Shares of up to $4,000,000 of Common Stock pursuant to General Instruction I.B.6 of Form S-3.

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Pursuant to the ATM Agreement, Wainwright may sell the Shares in sales deemed to be "at-the-market" equity offerings as defined in Rule 415 promulgated under the Securities Act, including sales made directly on or through the Nasdaq Capital Market. If agreed to in a separate terms agreement, the Company may sell Shares to Wainwright as principal, at a purchase price agreed upon by Wainwright and the Company. Wainwright may also sell Shares in privately negotiated transactions with the Company’s prior approval. Sales of the Shares through Wainwright, if any, will be made in amounts and at times to be determined by the Company from time to time, but the Company has no obligation to sell any of the Shares and either the Company or Wainwright may at any time suspend offers under the Agreement or terminate the Agreement. Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock and determinations by the Company of the appropriate sources of funding for the Company. The offer and sale of the Shares pursuant to the ATM Agreement will terminate upon the earlier of (a) the issuance and sale of all of the Shares subject to the ATM Agreement or (b) the termination of the ATM Agreement by Wainwright or the Company pursuant to the terms thereof.

The Sales Agreement provides that Wainwright will be entitled to compensation of up to 3.0% of the gross sales price of any Shares sold by Wainwright under the Sales Agreement. The Company also will reimburse Wainwright for certain specified expenses in connection with entering into the ATM Agreement. The Company has agreed to provide Wainwright with customary indemnification and contribution rights, including for liabilities under the Securities Act. The ATM Agreement contains customary representations and warranties and conditions to the placements of the Shares pursuant thereto.

A copy of the ATM Agreement is filed as Exhibit 1.1 to this Current Report on Form 8-K, and the description of the terms of the ATM Agreement is qualified in its entirety by reference to such exhibit. A copy of the opinion of Westward Law LLC relating to the legality of the issuance and sale of the Shares is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any offer, solicitation, or sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On November 19, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the publication of an abstract highlighting new clinical data for zanidatamab, a HER2-targeted bispecific antibody (Press release, Zymeworks, NOV 19, 2021, View Source [SID1234595844]). Zanidatamab in combination with chemotherapy was well tolerated, with encouraging and durable antitumor activity in heavily pretreated patients with HER2-positive breast cancer. A poster with an updated and expanded data set will be presented at SABCS taking place in San Antonio, Texas and virtually on December 7-10, 2021. In addition, Zymeworks will present a Trial in Progress poster detailing the ongoing clinical trial evaluating zanidatamab in combination with the CD47-blocker, evorpacept (ALX148).

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SABCS Data Presentation

Abstract highlights from May 3, 2021 data cut:

Twenty heavily pretreated HER2-positive breast cancer patients had been treated with zanidatamab in combination with standard of care chemotherapy (either vinorelbine, capecitabine, or paclitaxel).

The confirmed objective response rate was 37.5% and the disease control rate was 81.3% in 16 response-evaluable patients.

Treatment-related adverse events were generally consistent with previous reports of zanidatamab and/or the chemotherapy regimens, with the majority reported as Grade 1 or 2 in severity.

The abstract is available on the SABCS conference website. The presentation will be available on Wednesday, December 8 at 5:00 pm CT to conference registrants on the SABCS conference website as well as to the general public on the Zymeworks website.

Title: Zanidatamab (ZW25), a HER2-targeted bispecific antibody, in combination with chemotherapy (chemo) for HER2-positive breast cancer (BC): Results from a phase 1 study Lead Author: Philippe L. Bedard, M.D., Princess Margaret Cancer Center, Toronto, ON Canada Abstract: #93

Program Number: P2-13-07

Trials in Progress Presentation

The abstract is available on the SABCS conference website. The presentation will be available on Wednesday, December 8 at 5:00 pm CT to conference registrants on the SABCS conference website as well as to the general public on the Zymeworks website.

Title: Zanidatamab in combination with ALX148 in advanced Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers, including breast cancer: a phase 1b/2, multicenter, open-label, dose-finding and cohort-expansion study (ZWI-ZW25-204)

Lead Author: Sara A. Hurvitz, M.D., University of California, Los Angeles; Jonsson Comprehensive Cancer Center, Los Angeles, CA, US

Abstract: #182

Program Number: OT1-14-01

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. Zanidatamab’s unique binding properties result in multiple mechanisms of action including HER2-receptor clustering, internalization, and downregulation; inhibition of growth factor- dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations from the FDA as well as the European Medicines Agency for the treatment of biliary tract and gastric cancers.