SOTIO Expands its Antibody-Drug Conjugate Pipeline with Exclusive Collaboration and License Agreement with LegoChem Biosciences

On November 16, 2021 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported an exclusive, target-specific license and option agreement with LegoChem Biosciences Inc., a biotechnology company focused on developing its clinical-stage platform technology enabling antibody-drug conjugates (ADCs) with an excellent therapeutic index (Press release, SOTIO, NOV 16, 2021, View Source [SID1234628156]). SOTIO will obtain rights to deploy LCB’s ADC technology for up to five therapeutic programs targeting distinct tumor-associated antigens.

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The deal enables SOTIO to combine its proprietary antibodies with LCB’s ADC technology platform in order to deliver novel therapeutics for the treatment of solid tumors and includes LCB’s proprietary conjugation technology ConjuAll and potent linker-payload platform including multiple different payloads.

Under the terms of the multi-target agreement, LCB is eligible to receive upfront and potential milestone payments worth up to $1027.5 million, payable based on certain developments and regulatory achievements, plus royalties on net sales. The deal includes upfront and near-term milestones worth up to $29.5 million, subject to exercise of the options and achievement of success-based milestones. No further financial details are disclosed.

"At SOTIO we are building an innovative pipeline of ADC programs and plan IND filing for our lead program SOT102 by the end of 2021. The licensing agreement with our new, experienced partner LegoChem allows us to broaden our oncology pipeline with additional programs and solid tumor targets. We are looking forward to using the potential of LegoChem’s ADC technology platform and to develop innovative ADCs for patients in need," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO.

SOTIO will be responsible for research, development, manufacturing and commercialization of the ADC products, while LCB will support and work closely with SOTIO for the research activities and the manufacturing of components that are specifically related to its proprietary ConjuAll and the linker-payload technologies.

Dr. Yong-Zu Kim, CEO and President of LCB added: "This collaboration is yet another example that illustrates how the value proposition of the LCB platform can increase the competitive position of our partners within the ADC space. SOTIO is an ideal partner for LCB due to its expertise and strategic focus on innovative antibody drug conjugates, and we look forward to working closely together on multiple innovative programs."

Apellis Pharmaceuticals Announces Pricing of Public Offering of Common Stock

On November 16, 2021 Apellis Pharmaceuticals, Inc., (Nasdaq:APLS), a global biopharmaceutical company and leader in complement, reported the pricing of its underwritten public offering of 8,750,000 shares of its common stock at a public offering price of $40.00 per share, for total gross proceeds of $350 million, before deducting underwriting discounts and commissions and expenses payable by Apellis (Press release, Apellis Pharmaceuticals, NOV 16, 2021, View Source [SID1234595729]). All of the shares in the offering are being sold by Apellis. In addition, Apellis has granted the underwriters a 30-day option to purchase up to 1,312,500 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on November 18, 2021, subject to customary closing conditions.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering. Robert W. Baird & Co. Incorporated, Oppenheimer & Co. Inc. and Raymond James & Associates, Inc. are acting as lead managers for the offering.

The shares are being offered by Apellis pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on January 7, 2020. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or Evercore Group L.L.C., Attention: ECM General Counsel, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [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.

Vigeo Therapeutics Announces New Phase 1/2 Data from its Expansion Study of VT1021 at the Society of NeuroOncology’s 2021 Annual Meeting

On November 16, 2021 Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, reported new clinical data from its Phase 1/2 expansion study evaluating the single-agent activity of VT1021 in subjects with recurrent glioblastoma (rGBM) (Press release, Vigeo Therapeutics, NOV 16, 2021, View Source [SID1234595721]). The data is being presented in a poster session at the Society for NeuroOncology’s (SNO) 2021 Annual Meeting, taking place from November 18-21, 2021 in Boston.

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VT1021 is a first-in-class compound that, by binding to MDSCs, induces the expression of thrombospondin-1 (Tsp-1) in the tumor microenvironment (TME. Tsp-1 then blocks the CD47 immune checkpoint and reprograms the CD36 receptor to induce tumor cell apoptosis, inhibit angiogenesis, and reprogram macrophages from the M2 to M1 phenotype. In the completed open-label, multicenter Phase 1/2 study (NCT03364400), the safety and preliminary anti-tumor efficacy of single-agent VT1021 was evaluated in subjects enrolled in both dose escalation and dose expansion cohorts.

In the rGBM expansion cohort, VT1021 demonstrated significant single agent activity. Among 22 evaluable GBM subjects, 3 had complete response (CR), 1 had partial response (PR), and 7 had stable disease (SD). The overall disease control rate (DCR) was 50%. In the responder group, the average time on study was over 300 days with 2 subjects still on study for over 480 days as of October 31, 2021. These two subjects will continue receiving VT1021 through an extension study.

"Glioblastoma is the most common and aggressive form of brain cancer in adults, recurring after treatment in more than 90% of all patients," said Vigeo COO Dr. Jing Watnick. "In the expansion study, VT1021 demonstrated noteworthy single-agent clinical activity in rGBM, particularly in subjects with high expression levels of CD36 and CD47. Vigeo is committed to studying the potential of VT1021 in both newly diagnosed and recurrent GBM subjects in future clinical trials."

Vigeo plans to initiate Phase 2/3 studies in GBM as well as pancreatic cancer during the first half of 2022.

Details for the SNO 2021 presentation are as follows:

Title: Clinical efficacy and biomarker assessment of VT1021, a CD36/CD47 dual-targeting agent, in recurrent glioblastoma
Presenter: Manmeet Ahluwalia, MD
Session: Poster Session
Poster #: CTIM-06
Date and time: November 19, 2021, 7:30 pm – 9:30 pm

About VT1021
Vigeo’s lead asset, VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates the apoptotic and macrophage reprogramming activity of CD36. The result of the dual modulating activity is the induction of apoptosis as well as an increase in both CTL:Treg and M1:M2 macrophage ratio. The biological/therapeutic activity of VT1021 is mediated by the stimulation of thrombospondin-1 (Tsp-1). Through these dual-modulating effects VT1021 reprograms the tumor microenvironment (TME) from one that is immune suppressive, or "cold," to immune enhanced (or sensitized), or "hot," that are more susceptible to attack from the immune system. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.

Deka Biosciences Raises USD 20 Million in Series A Financing

On November 16, 2021 Maryland-based biotech company Deka Biosciences ("Deka") reported that it has successfully closed a USD 20 Million Series A financing with a syndicate of life science investors led by Leaps by Bayer, the impact investment arm of Bayer AG, and new investor Lumira Ventures (Press release, Deka Biosciences, NOV 16, 2021, View Source [SID1234595719]). Additional investors include O-Bio (Echo Investment Capital), Viva BioInnovator, and Alexandria Venture Investments.

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Novel cytokine-based therapies have the potential to provide patients with innovative curative treatment options for cancer, autoimmune diseases, and many types of infectious diseases. Understanding the known function of each cytokine, Deka has developed Diakines – intentionally engineered therapeutic proteins that are designed to deliver clinically validated cytokines, coupled in combination in the Diakine structure, to diseased tissue. Deka has also combined this therapeutic platform with companion diagnostic assays that ensure delivery of each Diakine to patients that will benefit the most.

In Deka’s Diakines, the scaffold platform is derived from a human antibody fragment, called a single-chain variable fragment, that uniquely functions both as a stabilizing, half-life extension technology and a targeting vector to deliver the cytokine(s) function to specific cell types or the microenvironment of affected tissues. Through stabilization and improved manufacturing techniques, the Diakine scaffold increases production yields and reduces manufacturing costs, and the unique structure enhances the specific functions of each cytokine, unlike most other half-life extending technologies. The company has demonstrated positive responses in preclinical studies, in both cancer and inflammatory disease models. Through extensive investigation, Deka has found that not all people respond to the same cytokine in the same way. Deka has therefore developed assays that evaluate each patients’ response to each cytokine pair and found genetic signatures that are uniquely associated with response to each Diakine. Deka will evaluate this genetic signature in future clinical trials to ensure that each patient is matched with their best Diakine. The team at Deka is committed to developing Diakines that can treat every patient.

"This investment by our multi-national, top-tier syndicate enables our first step in developing the Diakine platform," said John Mumm, CEO and founder of Deka Biosciences. "We are proud to join forces with our board of directors to bring these life-changing medicines to patients as quickly and effectively as possible. We share the vision to fundamentally change the nature of drug development and change the standard of healthcare through coupling our platform technology with predictive precision medicine. We are honored to have Leaps by Bayer as our lead investor as we share the goals to develop cures for patients through innovative science and precision medicine. We dare to leap as they do."

"Leaps by Bayer aims to achieve life transforming breakthroughs for patients, this is why we invest in technologies of tomorrow already today," said Juergen Eckhardt, MD, Head of Leaps by Bayer. "One of humankind’s biggest challenges and one of the big goals Leaps by Bayer is trying to solve is to prevent and cure cancer. We believe next-generation immunotherapies will play a pivotal role in addressing this challenge and Deka Biosciences’ cytokine therapy approach has the potential to change treatment-paradigms for cancer patients and for those suffering from auto-immune diseases."

"Deka Biosciences has developed a unique and strongly differentiated platform to produce cytokines with therapeutically complementary functions that circumvent several challenges associated with naturally occurring and modified cytokines," said Benjamin (Beni) Rovinski, PhD, Managing Director of Lumira Ventures. "At Lumira, our mission is to invest in companies at the forefront of biomedical innovation whose products have the potential to transform patient outcomes. It is gratifying to support Deka in pursuit of such a goal."

"Deka has made impressive progress since its inception. We are excited to partner with Deka, and its Diakine platform, to provide best-in-class therapies to patients," said Yi-Yen Chen, managing director at Echo Investment Capital’s O-Bio fund, a life science focused fund headquartered in Oklahoma City.

The investment will enable Deka to advance its research and talent acquisition and further expand development of its platform, in particular to file the Investigation New Drug (IND) application for the lead oncology program and advance the lead compound into Phase I clinical trials.

ViewRay Announces Pricing of Public Offering of Common Stock

On November 16, 2021 ViewRay, Inc. (Nasdaq: VRAY), maker of the MRIdian, which combines MRI and external-beam radiation therapy to simultaneously image and treat cancer patients, reported the pricing of an underwritten public offering of 12,500,000 shares of common stock at a price to the public of $5.60 per share, for gross proceeds of $70 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by ViewRay (Press release, ViewRay, NOV 16, 2021, View Source [SID1234595717]). All of the shares to be sold in the offering will be offered by ViewRay. In addition, ViewRay has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,875,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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ViewRay intends to use the net proceeds from the offering for general corporate purposes, including working capital, capital expenditures, continued research and development and commercial expenses.

Piper Sandler and Stifel are acting as the joint book-running managers for the offering. Guggenheim Securities is also acting as a book-running manager for the offering. B. Riley Securities and BTIG are acting as co-managers for the offering.

The offering is expected to close on or about November 19, 2021, subject to satisfaction of customary closing conditions.

A registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") and automatically became effective upon filing. This offering is being made solely by means of a prospectus supplement and accompanying prospectus included in the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Alternatively, copies of the final prospectus supplement, when available, and the accompanying prospectus may be obtained by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected], or 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].

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