On July 14, 2022 EVERSANA and Compai Pharma, a full-service commercialization company with offices in Singapore and Malaysia, reported a strategic partnership to expand services across the Asia Pacific region (Press release, EVERSANA, JUL 14, 2022, View Source [SID1234617514]).

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The partnership will provide medical and commercial resources to healthcare partners to support full market implementation and development for life science and pharmaceutical companies ready to expand into these markets.

EVERSANA CEO Jim Lang commented: "The Asia Pacific region is one of the fastest-growing pharmaceutical markets in the world and requires regional expertise to increase patient access. Together with Compai Pharma, we’re now able to drive greater value and services for our clients to support their evolving commercialization needs."

Capabilities available through the partnership include consulting, market access, medical awareness, education and communication, pharmacovigilance, marketing & sales excellence, as well as distribution and additional services.

The partnership with Compai builds on EVERSANA’s continued global growth, including recent expansion across the European Union and the UK. Additionally in June 2021, EVERSANA announced the growth of its medical communications and integrated compliance services across 18 European countries and in 10 local languages.

On July 14, 2022 Inbiomotion SL, a company developing a unique single-gene-based biomarker for the personalized adjuvant treatment of early-stage (stage I-III) breast cancer patients, reported the results of comparing the clinical efficacy of implementing the proprietary MAFTEST for selection of patients for adjuvant bisphosphonates therapy with current clinical guidance (Press release, Inbiomotion, JUL 14, 2022, View Source [SID1234616694]). The results were presented at the ESMO (Free ESMO Whitepaper) 2022 Breast Cancer Symposium.

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The data show that stratification of early breast cancer patients according to MAF status reduced the risk of death and relapse in MAF negative patients by 26% and 23% respectively, compared to a 12% and 15% reduction in the risk of death or relapse seen with stratification by menopausal status recommended by current ESMO (Free ESMO Whitepaper) and ASCO (Free ASCO Whitepaper) Clinical Guidelines. The data also indicate that adjuvant treatment with bisphosphonates should be avoided in MAF positive patients as the risk of death and relapse is increased 16% and 15% respectively in these patients.

In addition, the study shows that the use of MAF status for selection of early breast cancer patients for treatment with bisphosphonates allows the treatment of young premenopausal patients currently excluded by existing clinical guidance.

"The MAF biomarker allows a new paradigm for selection of patients for adjuvant bisphosphonate treatment of early breast cancer that not only identifies those patients that will benefit from treatment (MAF negatives) but also excludes patients that could be harmed (MAF positives). This new selection criteria not only reduces the risk of death and relapse for selected patients but also provides a new treatment option for young patients currently excluded from this treatment in current clinical practice," said Robert Coleman, Professor Emeritus, Department of Oncology and Metabolism, University of Sheffield, UK.

Currently, clodronate and other bisphosphonates are not approved by the regulatory agencies for use in adjuvant treatment of the broad population of early-stage breast cancer patients. However, they are recommended in the ASCO (Free ASCO Whitepaper)/CCO and ESMO (Free ESMO Whitepaper) clinical guidelines for adjuvant treatment of breast cancer in postmenopausal patients. The study shows that identifying MAF-negative patients for selection for adjuvant treatment with bisphosphonates outperforms current selection by menopausal status and could give more patients, particularly younger patients, the opportunity to benefit from adjuvant bisphosphonates, while avoiding potential harm (or no benefit), than solely using menopausal status as a selection criterion.

"Our results indicate that adjuvant clodronate treatment has a large clinical benefit if restricted to MAF-negative patients," said Prof. Alexander Paterson, principal investigator of the NSABP-B34 clinical trial and Emeritus Clinical Professor at the Department of Oncology, University of Calgary. "Our data provide an objective criterion for patient selection for bisphosphonate adjuvant treatment that outperforms current selection based on menopausal status."

"This study confirms our previous findings and the clinical utility of MAFTEST as a unique tool for precision medicine in early breast cancer. Every year approximately 355,000 women are diagnosed with early breast cancer in Europe with a 10% risk of death at 5 years. Using MAF Test these deaths could be reduced by 26%, which would translate to 9,230 lives saved," said Joël Jean-Mairet, Executive Chairman of the Board of Inbiomotion.

"We have discovered and developed a new biomarker, MAF gene amplification, that if used as selection criteria for adjuvant treatment with bisphosphonates improves the clinical outcome of breast cancer patients compared with current clinical practice," said Prof. Roger Gomis, ICREA Research Professor at IRB Barcelona. "MAF Test is a biomarker that is easy to implement in any clinical pathology lab and should be considered for routine characterization of breast cancer tumors."

Recently the MAFTEST obtained the CE-mark as an in vitro diagnostic medical device for prognostic purposes. Since clodronate and other bisphosphonates are not approved by the regulatory agencies for use in adjuvant treatment of early-stage breast cancer patients, Inbiomotion’s MAFTEST is not authorized to be used as a companion diagnostic as described in the above-mentioned study.

Reference articles:

Impact of MAF selection of patients for adjuvant bisphosphonate therapy and comparison with current clinical guidance Robert Coleman, Roger R Gomis, Alexander H G Paterson.

Full text article: View Source(22)00461-6/fulltext

MAF amplification and adjuvant clodronate outcomes in early-stage breast cancer in NSABP B-34 and potential impact on clinical practice Alexander H G Paterson et al.

Full text article: View Source

Effect of MAF amplification on treatment outcomes with adjuvant zoledronic acid in early breast cancer: a secondary analysis of international, open-label, randomized, controlled, phase 3 AZURE (BIG 01/04) trial Robert Coleman et al.

Full text article: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30603-4/fulltext

Benefits and risks of adjuvant treatment with zoledronic acid in stage II/III breast cancer. 10 years follow-up of the AZURE randomized clinical trial (BIG 01/04) Robert Coleman et al.

On July 14 , 2022 , Shenzhen Aixindawei Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Aixindawei" or "the Company") reported that the first subject of the Phase II clinical trial of its independently developed and world-first product AST – 3424 for the treatment of hepatocellular carcinoma has been successfully enrolled at Guangdong Qifu Hospital and successfully completed the first dose (Press release, Ascentawits Pharmaceuticals, JUL 14, 2022, View Source [SID1234650306]). This trial ( CTR20191399 ) is a development label, single-arm, non-randomized Phase II clinical study designed to evaluate the efficacy and safety of AST-3424 in the treatment of patients with hepatocellular carcinoma. The trial will be conducted in 7 research centers across the country. Dr. Duan Jianxin, founder and chairman of Aixindawei, said: "Liver cancer is a common cancer in China. According to the 2020 Global Cancer Report, in 2020 , the proportion of new liver cancer patients in China accounted for nearly 50% of the new liver cancer patients in the world . In recent years, with the addition of treatment options such as immunotherapy, the overall survival of patients with advanced liver cancer has been significantly improved. However, how to further improve the efficacy and reduce toxic and side effects, accurately select suitable patients, and reduce the payment pressure of patients are still the direction of future efforts. The company’s independently developed small molecule targeted conjugate drug AST-3424 is expected to bring different treatment options for liver cancer patients. "

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About AST-3424

AST-3424 is an innovative small molecule conjugate drug. After entering tumor cells overexpressing AKR1C3 enzyme, it can be highly selectively activated by AKR1C3 enzyme to release effective drugs and achieve precise killing of tumor cells. In the Phase I clinical study of solid tumors, AST-3424 showed good safety and tolerability. With the further development of subsequent clinical research, the company will combine the companion diagnostic kit developed independently to achieve accurate screening and treatment of the target population.

On July 13, 2022 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported it has agreed to sell approximately 16.6 million shares of its common stock to a select group of institutional and accredited investors in a private placement, at a price per share of $7.21 (Press release, Gossamer Bio, JUL 13, 2022, View Source [SID1234616645]). Gross proceeds are expected to be approximately $120 million, before deducting offering expenses. The financing is expected to close on July 15, 2022, subject to customary closing conditions.

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The financing includes participation from new and existing institutional investors, including EcoR1 Capital, New Enterprise Associates (NEA), Weiss Asset Management, Madison Avenue Partners, Rock Springs Capital, Boxer Capital, Invus, and Monashee Investment Management, and certain directors and executive officers of Gossamer. Participating investors entered into lock-up agreements with Gossamer to restrict their ability to sell Gossamer shares.

"We are very pleased this high-quality group of investors came together to support the seralutinib program at this important juncture," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer. "These additional funds will allow us to accelerate and expand our investment in seralutinib ahead of the Phase 2 TORREY Study topline results in the fourth quarter of this year."

In addition to supporting the seralutinib program, Gossamer intends to use the net proceeds from the proposed financing to fund research and development of its other product candidates and development programs and for working capital and general corporate purposes. The proceeds from this financing, combined with current cash, cash equivalents and marketable securities, and access to its debt facility is expected to be sufficient to fund operating and capital expenditures into mid-2024.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Gossamer has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in this private placement.
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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On July 13, 2022 Alpheus Medical, Inc, a privately held company developing a novel sonodynamic therapy (SDT) platform targeting solid body cancers, reported the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug and Fast Track Designations to Alpheus Medical’s CV-01 delivery of sonodynamic therapy (SDT) as a potential treatment for patients with recurrent glioblastoma, the most common primary brain cancer, and other malignant gliomas (Press release, Alpheus Medical, JUL 13, 2022, View Source [SID1234616662]). Northwell Health’s North Shore University Hospital in Long Island, New York, is currently enrolling patients in the multi-center Phase 1 clinical trial. The First-in-Human trial will evaluate the safety, optimal dosage, and efficacy of Alpheus’ SDT platform in patients with recurrent high-grade glioma.

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"The diffuse nature of glioblastomas, often across the hemisphere, makes it an extremely challenging disease to treat. There are very few effective options, leading to poor patient outcomes, and a universally fatal disease," commented Michael Schulder, MD, Director of the Brain Tumor Center and Primary Investigator (PI) for the clinical trial at Northwell Health’s Institute for Neurology and Neurosurgery. "Alpheus’ sonodynamic therapy enables non-invasive, diffuse treatment across the hemisphere. It has the potential to change the landscape of high-grade glioma therapy and we are excited to be part of this important study."

Alpheus Medical’s proprietary, investigational SDT treatment is an innovative, non-invasive drug-device combination that targets cancer cells throughout the entire hemisphere using low-intensity, diffuse ultrasound. The SDT is administered in an outpatient setting and does not require imaging. The multi-center trial (NCT05362409) is designed to study the safety and optimal application of Alpheus’ SDT treatment, as well as efficacy, and is planned to enroll up to 33 patients.

"The FDA Fast Track and Orphan Drug Designations are significant milestones and highlight the importance of innovation within the field of brain cancer," stated Dr. Vijay Agarwal, CEO and founder of Alpheus Medical and a practicing brain tumor surgeon. "Built on a very successful pre-clinical program, we believe our proprietary SDT platform is a game changer and has the potential to significantly advance the treatment of gliomas."

The FDA Orphan Drug and Fast Track programs are designed to facilitate the development of important new therapies and to provide patients with serious and rare conditions access to treatment more quickly. Orphan Drug status is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S. It provides development incentives and post-approval marketing exclusivity for seven years. The Fast Track designation enables early and frequent communication between FDA and product sponsor throughout the development and review process.