On September 14, 2021 Zai Lab Limited, an innovative commercial-stage biopharmaceutical company, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for investigational bemarituzumab (FPA144), for first-line treatment for patients with FGFR2b overexpressing and human epidermal growth factor receptor (HER2)-negative metastatic and locally advanced gastric and GEJ cancers in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin) (Press release, Zai Laboratory, SEP 14, 2021, View Source [SID1234633498]).

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"In granting Breakthrough Therapy Designation, we are pleased to see that the CDE recognizes the promise of bemarituzumab. In combination with chemotherapy, bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or GEJ cancer as a frontline therapy," said Alan Sandler, M.D., president and head of global development, oncology, at Zai Lab. "We look forward to working with regulatory authorities in China as we advance bemarituzumab into global, registrational studies."

The designation is supported by results from the Phase 2 FIGHT study, which evaluated bemarituzumab plus chemotherapy (modified FOLFOX6) versus chemotherapy alone in patients with FGFR2b overexpression, HER2-negative frontline advanced gastric or GEJ cancer. All three efficacy endpoints in the FIGHT trial – PFS, OS and ORR – achieved pre-specified statistical significance in the bemarituzumab arm compared to the placebo arm. Additional analysis showed a positive correlation between benefit and the prevalence of FGFR2b overexpression tumor cells, affirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target. The Breakthrough Therapy Designation was granted based upon this subset of patients, based on IHC testing, showing at least 10% of tumor cells overexpressing FGFR2b.

More than one million new gastric cancer cases are diagnosed annually, and approximately half of all gastric cancer cases occur in China1. Nearly 88% of patients with advanced gastric and GEJ cancers are HER2-negative, and approximately 30% of these patients present with FGFR2b overexpression.

The Breakthrough Therapy Designation review policy is designed to promote the research and creation of drugs with apparent clinical advantages, which are intended for the prevention or treatment of serious life-threatening diseases or diseases which severely impact the quality of life for which there is no existing treatment or where sufficient evidence indicates advantages of the novel drug over currently available treatment options. Drugs that have been granted the Breakthrough Therapy Designation are prioritized by the CDE in communications, and in receiving guidance to promote the drug development progress.

Source: (1) Globocan 2020.

About Bemarituzumab

Bemarituzumab (anti-FGFR2b), also called FPA144, is a potential first-in-class investigational targeted antibody that is designed to block fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Bemarituzumab is being developed in gastric and GEJ cancers as a targeted therapy for tumors that overexpress FGFR2b.

Zai Lab has an exclusive license to develop and commercialize bemarituzumab in Greater China. Zai Lab collaborated with Five Prime (later acquired by Amgen) on the Phase 2 FIGHT trial in Greater China.

Initiation of the registrational program of bemarituzumab by Amgen is planned for the fourth quarter of 2021. Planning is underway for bemarituzumab clinical studies in other solid tumors, including squamous NSCLC.

On September 14, 2021 Skyhawk Therapeutics, Inc. reported that Fidelity Management & Research Company LLC has led a $133 million oversubscribed investment round in Skyhawk, along with other major investors (Press release, Skyhawk Therapeutics, SEP 14, 2021, View Source [SID1234626568]). This brings total equity funding plus partnership capital in the Company to over $600 million thus far, with potential future milestones of over $20 billion plus ongoing royalties.

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"This investment round strengthens Skyhawk’s capacity to advance our internal pipeline of drug candidates deep into the clinic," said Bill Haney, co-founder and CEO of Skyhawk Therapeutics. "We are delighted that investors support our novel platform, a strong foundation from which to advance a series of our internal drugs for patients, even as we expand our work making drug candidates for our pharma collaborators."

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.