May 2022 – Page 71 – 1stOncology™: Cancer Intelligence Service

NetVation DL Medicine Announces Research Collaboration with Pfizer Inc.

On May 20, 2022 NetVation DL Medicine ("DL Medicine"), a privately held biotechnology company based in Chengdu, China, and focused on the discovery and development of novel drug candidates, reported that it has entered into a two-year research collaboration with Pfizer Inc (NYSE: PFE) (Press release, Pfizer, MAY 20, 2022, View Source [SID1234615153]). Under the terms of the agreement, DL Medicine will screen and collaborate with Pfizer in producing new chemical entities against preselected targets from multiple therapeutic areas. As part of the collaboration, Pfizer has taken a financial stake in DL Medicine.

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DL Medicine utilizes resources, funding and emerging technologies from the expanding biotechnology capabilities of the growing life sciences industry in China and employs novel approaches to identify and develop new drug candidates.

Research conducted under this collaboration will utilize HitGen’s DNA-encoded libraries to validate early targets, identify novel chemical matter, and conduct lead optimization. . Compounds that meet specific requirements will be advanced further in the discovery process. Additional screening technology platforms will also be utilized.

Dr Wei Chen, CEO of DL Medicine, said: "We are delighted to announce this collaboration with Pfizer, and we look forward to working together to potentially discover new chemical entities for the treatment of diseases that negatively impact the health of patients worldwide."

"New target ideas and novel chemical matter are critical to our success in bringing new therapies to patients around the world," said Yuan-Hua Ding, Executive Director, External Science & Innovation, Pfizer. "This collaboration represents our worldwide commitment to partnering with companies that are doing innovative scientific work to help enhance our portfolio across multiple disease areas."

Grant From Research to Prevent Blindness and Castle Biosciences Supports Medical Student Research in Ocular Cancer

On May 20, 2022 Research to Prevent Blindness (RPB) and Castle Biosciences reported that they are partnering to increase opportunities for medical students to gain research experiences, specifically in the field of ocular cancer (Press release, Castle Biosciences, MAY 20, 2022, View Source [SID1234614924]). Ocular cancers, such as uveal melanoma (UM), are rare, affecting approximately 2,000 people per year in the U.S., but can be particularly devastating in terms of their effect on sight and on overall health. For these reasons, it is important to incentivize new research in this area and to bring new talent into the ocular cancer field.

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RPB and Castle Biosciences are providing funding for the RPB/Castle Biosciences Medical Student Eye Research Fellowship in Ocular Cancer, which allows medical students to take a year off from medical school to devote time to the pursuit of a research project within an RPB-supported department of ophthalmology (see list at end of document). The award application is now open; nomination forms are due June 15, 2022, and applications are due July 1, 2022.

"Effective treatment options are critical because, while not common, ocular cancer has such profoundly negative effects. We are so pleased to partner with Castle Biosciences to bring new talent into this area of research," said Brian F. Hofland, Ph.D., president of Research to Prevent Blindness. "Not only will medical student researchers be conducting high quality, meaningful ocular cancer research under the guidance of a senior scientist—therefore leading to opportunities for new knowledge in this area—they will gain invaluable experience and skills that they will take with them into their future careers."

In 2022, the RPB/Castle Biosciences Medical Student Eye Research Fellowship in Ocular Cancer will award one fellowship to a medical student focusing on a research project related to ocular cancer. The fellowship, which must take place prior to the student’s third or fourth year of medical school, will be funded for one year with a $30,000 grant that will provide financial support in furtherance of the recipient’s ocular cancer research activities.

"As a company founded on the desire to improve care for patients impacted by cancers with unmet clinical need, like uveal melanoma, this research fellowship is particularly meaningful to us at Castle," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "While the types of cancers that our diagnostic tests address have expanded over the years, our commitment to patients, research and innovation has remained the same, which is why we are proud to partner with RPB to offer this grant to a deserving student interested in making a difference in the field of ocular cancer."

The ophthalmology departments (by state) that are eligible to nominate students for this award are located at the following medical schools:

California

David Geffen School of Medicine at the University of California, Los Angeles
Stanford University School of Medicine
University of California, Irvine, School of Medicine
University of California, San Diego, School of Medicine
Colorado

University of Colorado School of Medicine
Florida

University of Miami Miller School of Medicine
Illinois

Northwestern University Feinberg School of Medicine
University of Illinois at Chicago College of Medicine
Indiana

Indiana University
Iowa

University of Iowa Carver College of Medicine
Maryland

Johns Hopkins University School of Medicine
Massachusetts

Harvard Medical School
Michigan

The Regents of the University of Michigan School of Medicine
Wayne State University School of Medicine
Missouri

Washington University in Saint Louis School of Medicine
New York

Columbia University College of Physicians & Surgeons
Icahn School of Medicine at Mount Sinai
University of Rochester School of Medicine & Dentistry
SUNY Upstate Medical University
Weill Cornell Medical College
New York University Langone Eye Center
North Carolina

Duke University School of Medicine
Ohio

Cleveland Clinic Lerner College of Medicine of CWRU
Oklahoma

University of Oklahoma Health Sciences Center
Oregon

Oregon Health & Science University School of Medicine
Pennsylvania

University of Pennsylvania School of Medicine
University of Pittsburgh School of Medicine
Tennessee

Vanderbilt University School of Medicine
Texas

Baylor College of Medicine
Utah

University of Utah Health Sciences Center
Washington

University of Washington School of Medicine
Wisconsin

University of Wisconsin-Madison School of Medicine & Public Health

Zymeworks’ Board of Directors Unanimously Rejects Unsolicited, Non-Binding Proposal

On May 20, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that its Board of Directors, after thorough consultation with its financial and legal advisors, unanimously determined that the unsolicited, opportunistic, non-binding proposal from an activist shareholder, All Blue Falcons FZE ("All Blue"), and its affiliates to purchase Zymeworks for $10.50 per share substantially undervalues Zymeworks and is not in the best interest of the Company and its shareholders (Press release, Zymeworks, MAY 20, 2022, View Source [SID1234614923]).

Following a comprehensive review of the unsolicited, opportunistic, non-binding proposal, including independent analyses completed by external financial advisors engaged by Zymeworks, the Board of Directors has determined that the proposal significantly undervalues its prospects related to the Company’s long-term business strategy and potential commercial opportunities. In addition, the non-binding proposal lacks credibility by offering no information regarding potential sources of funding or any details on their ability to consummate such a transaction. As a result, the Board of Directors of Zymeworks has determined that it would not be appropriate to enter into discussions in response to the current proposal at a price of $10.50 per share.

"This non-binding, unsolicited activist proposal was timed opportunistically during a period of substantial market dislocation, and prior to several important near-term events for the Company expected in 2022. We are confident that the execution of our key strategic priorities has the potential to deliver greater value to our shareholders than the current inadequate and non-binding proposal," said Kenneth Galbraith, Chair & CEO of Zymeworks.

While the Company is under no obligation to respond to All Blue’s proposal given its non-binding and informal nature, the Board feels that it is appropriate to provide this information to the market.

Lota Zoth, Zymeworks’ Lead Independent Director, commented, "We welcome constructive engagement with, and input from, all of our shareholders. The Board remains fully committed to doing whatever is in the best interests of the Company and all shareholders."

Reflecting on Zymeworks’ current strategic priorities, Mr. Galbraith said, "Since being appointed as Chair and CEO in January, we have moved quickly to reset and focus on key priorities, including improving our financial position, the formation of new partnerships and collaborations, accelerating enrollment of our two ongoing pivotal trials for zanidatamab, reporting data catalysts for both zanidatamab and ZW49, and showcasing new product candidates developed from our novel platforms. As discussed in our recent Q1 earnings call, we continue to make excellent progress towards our key strategic priorities for 2022 and 2023 and are confident our plan will create significant long-term value for all shareholders."

Zymeworks is on the Right Track to Create Meaningful Value for All Shareholders

The Company’s previously-announced key strategic priorities for 2022 and 2023 remain as follows:

Fully recruit the HERIZON-BTC-01 pivotal clinical study for zanidatamab by mid-2022, which was completed in April 2022. Top-line data from the trial is expected by early 2023;
Fully recruit the HERIZON-GEA-01 pivotal clinical study for zanidatamab by the end of 2023. Upcoming clinical data for zanidatamab in first-line HER2-positive gastroesophageal adenocarcinomas and first-line HER2-positive breast cancer will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, being held from June 3-6, 2022;
Complete or close out other ongoing early-stage clinical studies for zanidatamab as data become available, and use these data to identify and support strategic decisions regarding future clinical development opportunities beyond the ongoing pivotal clinical studies;
Finalize a clear clinical development path for ZW49 based on additional clinical data expected in 2022 from the ongoing Phase 1 clinical trial, and present updated clinical data for ZW49 at a major medical meeting in the second half of 2022;
Select and advance at least two new antibody-drug conjugate or multispecific product candidates leveraging Zymeworks’ novel, therapeutic platforms (Azymetric, ZymeLink, EFECT and ProTECT) to provide the ability to submit two Investigational New Drug (IND) applications before the end of 2024;
Execute on new partnerships and collaborations to support the development and commercialization of zanidatamab, ZW49 and Zymeworks’ early-stage R&D pipeline and technology platforms;
Continue to support and advance Zymeworks’ core technology platforms and collaborations; and
Improve Zymeworks’ financial position over 2022 and 2023 through a combination of alternatives, including forming additional partnerships and collaborations, monetizing existing assets and products, and securing additional financing.
Activist Background to the All Blue Proposal

In late January 2022, All Blue sent a number of letters to the Board voicing its displeasures on various matters. Specifically, on January 24, All Blue expressed its displeasure regarding a rejected financing proposal presented by All Blue. This was followed by another letter on January 27, where All Blue expressed concern regarding the Company’s public offering launched on January 26, which successfully closed on January 31, 2022, resulting in net proceeds to the Company of $107.5 million. In a subsequent email following a meeting with members of the Board, All Blue called for Zymeworks directors to "immediately resign without delay" and threatened to initiate "a very public fight." On April 28, 2022, the Company received an unsolicited, non-binding proposal from All Blue, which revealed its 5.9% stake in Zymeworks. The Board and management are disappointed that All Blue chose to publicly attack the Company while efforts to reinvigorate the Company are well underway, including completing recruitment of the HERIZON-BTC-01 study ahead of guidance, optimizing its operating expense structure to extend financial runway, and completing a comprehensive realignment of its workforce ahead of previous guidance.

Zymeworks looks forward to its continued engagement with its shareholders as it focuses on leading the emerging wave of novel multifunctional biologics development in oncology.

Advisors

Goldman Sachs & Co. LLC and MTS Health Partners, LP are serving as financial advisors, Blake, Cassels & Graydon LLP and Wilson Sonsini Goodrich & Rosati are acting as legal counsel, and Kingsdale Advisors is acting as strategic shareholder and communications advisor to Zymeworks.

Entry into a Material Definitive Agreement

On May 20, 2022, VolitionRx Limited (the "Company") reported that entered into an Equity Distribution Agreement (the "2022 EDA") with Jefferies LLC (the "Designated Agent"), pursuant to which the Company may, through the Designated Agent, offer and sell up to $25 million in shares (the "Shares") of its common stock, $0.001 par value per share (the "Common Stock") (Filing, 8-K, VolitionRX, MAY 20, 2022, View Source [SID1234614921]). The Designated Agent may sell the Shares by any method 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"), or in privately negotiated transactions.

The issuance and sale of the Shares by the Company under the 2022 EDA, if any, will be made pursuant to the Company’s registration statement on Form S-3 (File No. 333-259783), which was declared effective on November 8, 2021 (the "Registration Statement"), and offerings of the Shares will be made only by means of the Company’s prospectus supplement relating to the offering that forms part of the Registration Statement.

The Company is not obligated to sell any Shares under the 2022 EDA. Subject to the terms and conditions of the 2022 EDA, the Designated Agent will use its commercially reasonable efforts, consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of the NYSE American, for the period specified in the placement notices delivered to the Designated Agent by the Company (each, a "Placement Notice"), to sell such Shares up to the amount specified by the Company in, and otherwise in accordance with the terms of, such Placement Notice.

The Company has agreed to pay the Designated Agent a commission of 3.0% of the aggregate gross proceeds from each sale of Shares that occur pursuant to the 2022 EDA, and has agreed to provide the Designated Agent with customary indemnification and contribution rights, including with respect to certain liabilities under the Securities Act.

The 2022 EDA replaces the Company’s prior Equity Distribution Agreement dated September 24, 2021 (the "2021 EDA") that was terminated effective May 7, 2022, as disclosed in Item 5 of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022. No further sales of Common Stock will be made under the 2021 EDA.

The foregoing description of the material terms of the 2022 EDA does not purport to be complete and is qualified in its entirety by reference to the complete text of the 2022 EDA, a copy of which is filed herewith as Exhibit 1.1 and incorporated herein by reference.

The legal opinion of Stradling Yocca Carlson & Rauth, P.C., counsel to the Company, related to the Shares, is filed herewith as Exhibit 5.1.

This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy the Shares, nor shall there by any 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 law of such state or jurisdiction.

TG Therapeutics to Participate in the H.C. Wainwright Global Investment Conference

On May 20, 2022 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will present virtually at the H.C. Wainwright Global Investment Conference taking place next week (Press release, TG Therapeutics, MAY 20, 2022, View Source [SID1234614920]). A webcast of the presentation will be available for on demand download beginning on Tuesday, May 24, 2022, at 7:00 AM ET through Thursday May 26, 2022, on the conference website.

The webcast will also be available on TG’s website at View Source

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Month: May 2022

NetVation DL Medicine Announces Research Collaboration with Pfizer Inc.

Grant From Research to Prevent Blindness and Castle Biosciences Supports Medical Student Research in Ocular Cancer

Zymeworks’ Board of Directors Unanimously Rejects Unsolicited, Non-Binding Proposal

Entry into a Material Definitive Agreement

TG Therapeutics to Participate in the H.C. Wainwright Global Investment Conference