On September 14, 2021 PharmaMar (MSE:PHM) reported that its licensing partner, Specialised Therapeutics Asia, Pte. Ltd. (STA) has received provisional marketing approval for Zepzelca (lurbinectedin) by the Australian Therapeutic Goods Administration (TGA), for the treatment of patients with metastatic Small Cell Lung Cancer (SCLC), that have progressed on or after prior platinum-containing therapy (Press release, PharmaMar, SEP 14, 2021, View Source [SID1234596668]).

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This means patients who have progressed after other existing treatment options will now be able to access another line of therapy. Lurbinectedin is the first new therapy approved by the TGA to treat second-line SCLC in more than two decades.

Australian lung cancer oncologist Professor Paul Mitchell from the Olivia NewtonJohn Cancer and Wellness and Research Centre at the Austin Hospital in Melbourne, Australia, said SCLC was particularly aggressive and more than two-thirds of patients were diagnosed with extensive stage disease. He said fewer than 5% of these
patients currently survived more than five years post diagnosis.

"The new availability of lurbinectedin will be welcomed by patients, families and the medical community, as we strive to improve patient outcomes for this disease," Professor Mitchell said. "With this approval, we now have another option for patients who have progressed after prior platinum-based treatments. This provides an opportunity for them to continue treatment and potentially, improve outcomes."

The TGA approval of lurbinectedin has been granted under a provisional regulatory pathway. The US Food and Drug Administration (FDA) and Australia’s TGA collaborated via ‘Project Orbis’ to accelerate availability to Australian patients.

Lurbinectedin’s approval is based on clinical data from an open-label, multi-center, single-arm phase II study in 105 adult patients with SCLC who had disease progression after treatment with platinum-based chemotherapy.

The data, which appeared in The Lancet Oncology May 2020 issue, demonstrated that in patients with Relapsed SCLC, Lurbinectedin provided an Overall Response Rate (ORR) of 35% and a median duration of response of 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee (IRC).

The provisional approval is the subject of a further confirmatory study in more than 700 patients with 2nd line SCLC including some Australian sites. This study is expected to be completed in 2025.

Lurbinectedin is being made available in Australia by the independent pharmaceutical Company, STA, under an exclusive license from international partner, PharmaMar.

José María Fernández, Ph.D., President of PharmaMar said the Company was delighted Australian patients would now be provided access to lurbinectedin. "We are pleased to bring a new treatment choice to relapsed SCLC patients. The accelerated approval of lurbinectedin underscores its potential to fill an unmet need in this oftenoverlooked SCLC community." And added: "We are very thankful that the TGA has been the first regulatory agency to authorize three compounds from PharmaMar."

STA Chief Executive Officer, Carlo Montagner said the approval of lurbinectedin would potentially make a difference for around 400 Australian patients annually who had run out of treatment options. "We are delighted to be able to provide a new therapy option for patients with this difficult to treat cancer," he said. "While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment. Our mission has always been to provide therapies in area where there is an unmet need and SCLC is certainly one of these areas. We look forward to making a difference for these
patients and their families."

Lurbinectedin is currently available in Australia via a Special Access Program. Commercial supplies of lurbinectedin in Australia will commence early 2022.

On September 14, 2021 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, reported an upcoming presentation of data for eprenetapopt in combination with pembrolizumab for the treatment of advanced solid tumors at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 from September 16 – 21, 2021 (Press release, Aprea, SEP 14, 2021, View Source [SID1234594085]).

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Details for the ESMO (Free ESMO Whitepaper) 2021 mini oral presentation are as follows:

Title: Phase I/II study of eprenetapopt (APR-246) in combination with pembrolizumab in patients with solid tumor malignancies
Speaker: Haeseong Park, Washington University in St. Louis
Presentation #: 516MO
Session: Mini oral session – Developmental therapeutics
Date and Time: Monday, September 20, 2021; 17:35 – 17:40 CEST (11:35 – 11:40am EDT)

On September 14, 2021 Immunophotonics, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary immune-activating carbohydrate polymers for the treatment of metastatic cancers, reported that the U.S. Patent and Trademark Office has issued U.S. Patent No. 11111316 (Press release, Immunophotonics, SEP 14, 2021, View Source [SID1234590685]). The patent covers the composition of matter of Immunophotonics’ lead drug candidate, IP-001, a proprietary synthetic biopolymer anticipated to have applications in the treatment of cancer and infectious diseases.

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The U.S. patent contains 19 claims encompassing the platform potential of IP-001 and structurally similar carbohydrate polymers and will provide Immunophotonics with patent protection in the U.S. until at least 2033, subject to potential regulatory extension if IP-001 is approved for clinical use by the U.S. Food and Drug Administration. With this issuance, the U.S. has joined over 40 countries in granting Immunophotonics patent protection to the composition of matter underlying IP-001.

Tomas Hode, Chief Innovation Officer at Immunophotonics, stated his excitement about the issuance, remarking, "We are thrilled to expand our patent coverage into the United States alongside other key markets where our composition-of-matter claims have been allowed. This patent not only covers our lead drug candidate, IP-001, but will also serve as the core of a biotechnology platform with the potential for myriad applications for activating the immune system against cancer and other diseases. With this issuance, Immunophotonics has completed a crucial step in its development of a robust patent portfolio in the field of oncology and beyond."

Immunophotonics was represented by Foley Hoag LLP of New York in its prosecution of this patent. "We were pleased with the final claims granted in Patent No. 11111316, which protect a family of molecules with a range of pharmacologically relevant structural features. This patent is an ideal foundation for a wide-ranging pharmaceutical platform," observed Lucas Watkins, Ph.D., Deputy Chair of the Patent Prosecution Practice at Foley Hoag.

On September 14, 2021 Pyxis Oncology ("Pyxis" or the "Company") reported the appointment of Jay M. Feingold, M.D., Ph.D., as Chief Medical Officer (Press release, Pyxis Oncology, SEP 14, 2021, View Source [SID1234590283]).

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"Jay’s track record of success taking oncology ADC programs from discovery to commercial launch coupled with his deep understanding of clinical development perfectly align with our mission to improve the lives of patients with difficult-to-treat cancer," said Lara Sullivan, M.D., Chief Executive Officer of Pyxis. "We look forward to working closely with Jay to build and execute our development strategies to advance our portfolio of next generation ADC and immunotherapy programs to the clinic."

Dr. Feingold added, "I am excited to lead the clinical development activities for Pyxis’ robust portfolio which presents a significant opportunity to meaningfully impact the lives of patients with cancer. I am eager to work alongside the team to build on the Company’s impressive preclinical data, further strengthen the clinical strategy and shepherd its candidates towards the next stage of development to significantly improve the treatment landscape for patients with cancer."

Dr. Feingold holds 20 years of experience in clinical development and medical affairs with a history of successfully bringing new hematology and oncology drugs to market. Most recently, Dr. Feingold served as Chief Medical Officer and Senior Vice President of ADC Therapeutics, where he led the clinical development of six ADCs for hematologic malignancies and solid tumors. Previously, Dr. Feingold worked as Vice President of U.S. Medical Affairs and Chairman of the Global Medical Affairs Oversight Committee at Daiichi Sankyo. Earlier in his career, Dr. Feingold held various executive roles of increasing responsibility at Wyeth Pharmaceuticals and was a member of the Departments of Medicine and Pediatrics and an Associate Director of the Bone Marrow Transplant Program at the University of Connecticut. Dr. Feingold earned his M.D. and Ph.D. from the Albert Einstein College of Medicine and trained in Pediatrics and Pediatric Hematology and Oncology at the UCLA Center for the Health Sciences.

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.