On September 14, 2021 Nucleai, a leader in AI-powered spatial biology, and Jefferson Health, a leading cancer center, reported that they have entered into a strategic collaboration to discover spatial immunotherapy biomarkers, leveraging Nucleai’s ATOM platform and Jefferson’s repository of pathology and clinical data (Press release, Nucleai, SEP 14, 2021, View Source [SID1234587793]). The mutual collaboration will help advance AI-based solutions in discovering histological biomarkers and patient selection in clinical trials and clinical settings. The Israeli Innovation Authority supports the collaboration as part of the International Health-Tech Pilot Program.

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Nucleai’s ATOM platform analyzes pathology images using computer vision and machine learning methods to model the tumor and the immune system’s spatial characteristics, creating unique and specific histological biomarkers that may predict patient response to therapy. These biomarkers hold the potential to provide a better understanding of cancer biology, enable further stratification of responder/non-responder patient populations, and improve the success rate of clinical trials and patient care. Nucleai leverages proprietary multimodal datasets of pathology images and clinical data from leading hospitals and Health Maintenance Organizations (HMOs) in the U.S and Israel to develop its platform.

As part of the collaboration between Nucleai and Jefferson, the two parties will test the utility of AI-based predictive biomarkers in a real-world clinical setting and assess the clinical benefit that the novel platform could provide for cancer patients treated with immunotherapy.

"It is now clear that analysis of digital pathology through computational approaches opens access to "hidden" information that is beyond the resolution of a pathologist’s examination through a microscope. We look forward to working with Nucleai to "unlock" such information to learn new disease mechanisms and using it to help our patients," said Stephen Peiper, Peter A. Herbut Professor and Chair Department of Pathology, Anatomy and Cell Biology at Thomas Jefferson University and Senior Vice President for the Enterprise Pathology and Laboratory Medicine Service Line of Jefferson Health System.

"Jefferson is dedicated to providing the highest-quality, compassionate clinical care for patients, preparing tomorrow’s professional leaders for 21st century careers, and discovering new treatments to define the future of care. The collaboration with Nucleai epitomizes this vision," said Zvi Grunwald, the Director of the Jefferson Israel Center.

"We are thrilled to launch this collaboration with Jefferson Health and are honored to be included in the Israeli Innovation Authority pilot program. Nucleai brings a unique spatial biology perspective into precision medicine, and we are eager to apply our platform to support novel biomarker discovery, diagnostics development, and clinical decision support," Nucleai CEO Avi Veidman said in a statement.

On September 14, 2021 AbbVie reported that faced no shortage of criticism and questioning over its decision to abandon its proposed $55 billion Shire buyout back in 2014 (Press release, FiercePharma, SEP 14, 2021, View Source [SID1234587941]). But after years of legal back-and-forth, the company has escaped one high-profile case from hedge funds that alleged the company misled them about its true intentions .

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When AbbVie unveiled its proposed Shire deal in July 2014, the company cited a "strong strategic rationale" for the move—not just the tax benefits of acquiring an Irish drugmaker. But shortly after the U.S. Treasury Department rolled out new rules in September 2014 to crack down on controversial so-called tax inversions, the company gave up on the merger.

That sequence of events led to some big losses at hedge funds, which later sued AbbVie alleging fraud. In their lawsuits, the hedge funds said they bought Shire shares hoping the deal would close but that they suffered losses when AbbVie walked away from the deal in October 2014. They said AbbVie’s public statements didn’t match with its private intentions for pursuing Shire.

In a decision Monday, Cook County Circuit Judge Margaret A. Brennan ruled in AbbVie’s favor, granting summary judgement and tossing the hedge funds’ claims. The plaintiffs were "kind of rolling the dice, hoping to make some money" by buying Shire shares after the buyout announcement, the judge said. They "had to do their own analysis" and "had to be aware that there were possibilities that this may not come through," she added.

Representing AbbVie, Gabor Balassa of law firm Kirkland Ellis said the company’s statements about the merger talks—both before and after the July 14, 2014, announcement—contained cautionary language and opinions about the proposed deal, not statements of fact.

RELATED: Hedge fund sues AbbVie for scuttling $55B Shire buyout

The hedge funds saw things differently. Representing the plaintiffs, Robert B. Tannenbaum of Bartlit Beck said AbbVie "repeatedly" told its clients the deal was "not driven by the tax benefits" but that it was "strategically and financially compelling well beyond the tax benefits." That didn’t match with the company’s behind-the-scenes beliefs, Tannenbaum told the court, as evidenced by the company’s decision to walk away from the deal after the U.S. Treasury Department rolled out its anti-inversion rules.

Even after the U.S. Treasury Department issued those rules, AbbVie’s CEO Richard Gonzalez said in a memo to Shire employees that he was "more confident than ever about the potential of our combined organizations," Tannenbaum pointed out.

Behind the scenes, AbbVie’s execs sought the deal primarily for tax purposes, Tannenbaum said. At the time, tax inversions were "extremely controversial and nearly universally unpopular." In that environment, AbbVie developed a "messaging strategy," he said, to talk up more favorable aspects of the deal.

"AbbVie pursued this false messaging strategy to minimize government scrutiny of the deal, avoid long-term reputational harm as a tax avoider and to avoid losing essential Shire shareholder support for the deal," Tannenbaum said.

SPECIAL REPORT: Biopharma’s top broken, unfulfilled or abandoned promises | AbbVie, Rick Gonzalez

In 2016, hedge fund Elliott Management sued AbbVie over the failed merger, and other funds followed with their own lawsuits over subsequent years. Discovery in the litigation has spanned years, with lawyers taking nearly 100 depositions.

In a separate case, AbbVie settled with Shire shareholders in 2019 for an undisclosed amount.

After AbbVie and Shire parted ways on their talks, Takeda ended up buying the Irish drugmaker in 2018 for $62 billion. AbbVie, for its part, scored another megamerger with its massive Allergan buyout. AbbVie and Allergan merged last May in a deal worth $63 billion.

On September 14, 2021 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that clinical data will be presented at the upcoming 2021 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress, taking place on September 16-21, 2021 (Press release, Epizyme, SEP 14, 2021, View Source [SID1234587681]).

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At the conference there will be two posters on two of the trials examining tazemetostat use in solid tumors. One details updated data from the ongoing safety run-in portion of the EZH-1101 prostate cancer study evaluating tazemetostat in combination with either abiraterone/prednisone or enzalutamide. The second poster describes the ongoing study investigating tazemetostat’s use in combination with other agents to treat solid tumors.

"Consistent with the preliminary data we shared during our Next Episode vision call earlier this year, the data presented at ESMO (Free ESMO Whitepaper) from our EZH-1101 study suggest tazemetostat combinations in prostate cancer led to a subset of patients having durable ≥50% decline in prostate-specific antigen levels (PSA50) with one patient having a radiographic tumor response," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. "We are encouraged to see the progression free survival data with a follow-up of almost two years in the safety run-in, and this data, while still maturing, will be shown in the poster session. Additionally, the adverse events data with the combination treatment were consistent with the known safety profile of the individual agents with no new safety signals. The randomized portion of the EZH-1101 study is ongoing with more than one-third of patients enrolled to date. This study is one part of our overall program exploring tazemetostat as both monotherapy and in combinations across multiple hematologic and solid tumor cancers."

Details of the presentations are listed below:

ESMO Poster Presentations

Title: Safety of Tazemetostat in Combination With Abiraterone/Prednisone or Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
Presenters: Wassim Abida, MD, PhD; Daniel Saltzstein, MD
Abstract Code: 586P
Title: Trial in Progress: Tazemetostat in Combination With a PARP Inhibitor or Durvalumab in Patients With Solid Tumors
Presenter: Charles M. Rudin, MD, PhD; Robert L. Coleman, MD
Abstract Code: 1870TiP
The ESMO (Free ESMO Whitepaper) abstracts are available at View Source All oral and poster presentations will be available on the ESMO (Free ESMO Whitepaper) website on Thursday, September 16, 2021 8:30 a.m. CEST / 2:30 a.m. ET.

About TAZVERIK (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

View the U.S. Full Prescribing Information here: Epizyme.com

On September 14, 2021 Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, reported the pricing of its upsized initial public offering of 10,800,000 shares of common stock at an initial public offering price of $16.00 per share (Press release, Tyra Biosciences, SEP 14, 2021, View Source [SID1234587698]). All of the shares are being offered by Tyra. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Tyra, are expected to be $172.8 million. The shares are expected to begin trading on the Nasdaq Global Select Market on September 15, 2021 under the ticker symbol "TYRA." The offering is expected to close on September 17, 2021, subject to the satisfaction of customary closing conditions. In addition, Tyra has granted the underwriters a 30-day option to purchase up to an additional 1,620,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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BofA Securities, Jefferies and Cowen are acting as joint book-running managers for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission and became effective on September 14, 2021. The offering will be made only by means of a prospectus. When available, copies of the final prospectus may be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at [email protected]; from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected] or by telephone at 877-821-7388; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, 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 offer or sale of these securities in any state or 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 jurisdiction.

On September 14, 2021 Checkmate Pharmaceuticals Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that Barry Labinger, CEO, will present at the Cantor Virtual Global Healthcare Conference on Thursday, September 30 from 10:40-11:10am ET (Press release, Checkmate Pharmaceuticals, SEP 14, 2021, View Source [SID1234587746]). Checkmate will also host 1×1 investor meetings during the conference.

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The webcast can be accessed under "Events & Presentations" in the Investors section of the Checkmate website. An archived copy of the webcast will be available on the Checkmate website for approximately 90 days after the event.