On June 8, 2020 Alphamab Oncology (stock code: 9966 HK) a clinical stage biopharmaceutical company focusing on innovative biologics medicine for oncology, and Sanofi (EURONEXT: SAN andNASDAQ: SNY), a global biopharmaceutical leader, reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of Alphamab Oncology, signed an agreement with Sanofi (China) Investment Co., Ltd (" Sanofi") to establish strategic collaboration to advance clinical studies to investigate KN026 in combination with Taxotere (Docetaxel) in HER2+ breast cancer, and Sanofi is granted an exclusivity period to negotiate the in-licensing of KN026 subject to the achievement of certain clinical milestones (Press release, Alphamab, JUN 8, 2020, View Source [SID1234560908]).

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KN026 is an anti-HER2 bispecific antibody which can simultaneously bind two non-overlapping epitopes of HER2 and lead to a dual HER2 signal blockade, presumedly causing HER2 to aggregate on the cell surface and endocytose. Current clinicals trials shown promising preliminary efficacy and excellent safety profile in late-stage breast cancer patients who have failed multiple treatments in China, laying a solid foundation for future development of combination therapies in multiple front line settings. Given its clinical profile, KN026 has the potential to address the medical needs of around 2 million patients suffering from HER2-positive breast cancer in China, USA and key European markets.

Taxotere (Docetaxel) is a microtubule inhibitor that interferes with the growth and spread of cancer cells in the body. It is used to treat breast cancer, lung cancer, prostate cancer, gastric cancer. In China, Taxotere is indicated for breast cancer (BC) including: 1) single agent for locally advanced or metastatic BC after chemotherapy failure; 2) with trastuzumab for the 1st line treatment of metastatic BC patients with HER2 overexpression; 3) and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC.

Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "KN026 is a core candidate of our innovative bispecific antibody pipeline, and has shown convincing advantages in safety and efficacy from current clinical studies. There are significant unmet need for the treatment of HER2-positive breast cancer. We hope, through the collaboration with Sanofi, a global biopharmaceutical leader, to further drive KN026’s China and global development strategy, to provide a superior therapeutic solution to Her-2 positive patients."

Pius S. Hornstein, PhD, General Manager General Medicines and Country Lead, Sanofi China commented, "Building on Sanofi’s heritage in oncology, we see a significant opportunity to impact the health of breast cancer patients by partnering with Alphamab, a biopharmaceutical leader in China. This strategic partnership also demonstrates Sanofi’s ambition to play a more active role in the Chinese healthcare ecosystem, offering more new treatments for the large Chinese population with joint efforts from other leading companies."

Under terms of the agreement, Jiangsu Alphamab and Sanofi will collaborate to evaluate the combination of KN026 and Taxotere (Docetaxel) for HER2+ breast cancer. Patient enrollment has started for the initial multicenter, open-label study.

About KN026

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab and Pertuzumab alone or in combination, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.

KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has excellent safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.

On June 8, 2020 Microbiotica, a leading player in microbiome-based therapeutics and biomarkers, Cancer Research UK and Cambridge University Hospitals NHS Foundation Trust ("CUH"), reported a collaboration to identify and develop microbiome co-therapeutics and biomarkers for cancer patients receiving immune checkpoint inhibitor therapy (Press release, Microbiotica, JUN 8, 2020, View Source [SID1234560907]).

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The collaboration is based on clinical studies conducted by CUH that evaluate immune checkpoint inhibitor drug response in cancer patients, combined with Microbiotica’s unrivalled microbiome profiling and analysis capability.

Two clinical studies are involved: MELRESIST, a completed class-leading melanoma study, and MITRE, a major landmark study in melanoma, lung and renal cancer, involving 1,800 patients, specifically designed for evaluation of microbiome and other biomarker effects.

The MITRE study will be co-led by Dr Trevor Lawley, Microbiotica’s co-founder and CSO, and Dr Pippa Corrie, Consultant in Medical Oncology at CUH, and will involve comprehensive patient sample collection, data collection and biochemical analysis, with medicines provided by the NHS. Microbiotica will undertake mass culturing of patient gut bacteria, microbiome sequencing and machine learning analysis.

Checkpoint inhibitors have transformed the management of cancer, due to the range of cancers that can be treated and their high levels of efficacy, including complete remission in some cases. However, response rates are low, typically in the range 10-40% of patients. There is therefore a major unmet need for co-therapies to extend the number of responders and for biomarkers to stratify patients for treatment.

Several studies have shown that the gut microbiome plays a critical and causative role in determining which patients respond to these medicines. However thus far they have failed to identify a consistent gut bacterial signature associated with treatment response or resistance. Microbiotica has used its unique microbiome profiling platform with MELRESIST data to identify for the first time a common signature predictive of drug response across multiple melanoma studies, and this is being progressed within the Company. MITRE will take this further by examining the effects in different cancers, a range of immunotherapy regimens, as well as association with side-effects of immunotherapy.

Microbiotica’s platform comprises the world’s leading Reference Genome Database and Culture Collection of gut bacteria, and an unrivalled capability to culture and characterise all gut bacteria from patients at scale. This is complemented by a suite of bioinformatic and machine learning tools that enable the identification of previously undetectable gut bacterial signatures linked to patient phenotype. The Company also has capabilities to develop and take such products to the clinic.

The collaboration will identify specific gut bacterial signatures correlated with drug efficacy and side effects in patients under treatment for melanoma, non-small cell lung cancer and renal cancer. From these signatures, Microbiotica will progress live bacterial products as co-therapies and microbiome biomarkers predictive of immunotherapy response and toxicity into the clinic.

On June 4, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will participate in a virtual fireside chat at the Raymond James Human Health Innovation Conference at 12:20 p.m. ET on Thursday, June 18, 2020 (Press release, AngioDynamics, JUN 8, 2020, View Source [SID1234560906]).

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A live webcast of the fireside chat will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

On June 8, 2020 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported the appointment of Jason O’Neill as chief executive officer, effective June 1, 2020 (Press release, Dendreon, JUN 8, 2020, View Source [SID1234560905]). O’Neill brings extensive pharmaceutical leadership experience to Dendreon, with prominent roles in the areas of general management, commercial development and marketing in the United States and Asia.

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"The opportunity to join Dendreon at this critical stage in the company’s growth is exciting," said O’Neill, chief executive officer of Dendreon. "My experience developing successful growth and market entry strategies is a timely addition to the company as we work to build a robust R&D pipeline and expand access to the life-extending benefits of PROVENGE (sipuleucel-T) in the United States and internationally."

O’Neill was previously responsible for leading Sanofi’s oncology portfolio during six of his nine years with the company. That portfolio included Taxotere (docetaxel), the most widely prescribed chemotherapy in the metastatic prostate cancer setting.

He also recently served as chief executive officer at Iridium Therapeutics, a pre-clinical stage pharmaceutical company focused on maximizing the benefits of proven therapies by improving their delivery and adherence. Iridium’s lead candidates were 3- and 6-month injectable formulations of anastrozole, the leading hormone treatment for postmenopausal women with hormone receptor positive breast cancer.

He has also held a variety of general management and senior new product development roles throughout his career at major pharmaceutical companies including Roche/Genentech, Mallinckrodt, Bristol-Myers Squibb and Pfizer. His experience in the Asia Pacific market will contribute to Dendreon’s long-term strategy of growing into a multi-product, multi-market company.

O’Neill holds a Bachelor of Arts degree from Yale University and a Master of Business Administration from the Kellogg School of Management at Northwestern University.

On June 8, 2020 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported that on June 5, 2020 it has entered into a privately negotiated agreement (the "Exchange Agreement") with a holder of its outstanding 5.75% Convertible Senior Notes due 2021 (the "2021 Notes") (Press release, Rocket Pharmaceuticals, JUN 8, 2020, View Source [SID1234560904]). Pursuant to the Exchange Agreement, Rocket will exchange $7.5 million aggregate principal amount of the 2021 Notes for (a) $7.5 million aggregate principal amount of its newly issued 6.25% Convertible Senior Notes due 2022 (the "2022 Notes") (an exchange ratio equal to 1.00 2022 Notes per exchanged 2021 Note) and (b) an amount of cash equal to the accrued and unpaid interest, if any, on the exchanged 2021 Notes from, and including, February 1, 2020, to, but excluding, the closing date of the exchange transactions adjusted to take into account the unearned accrued interest on the 2022 Notes from, and including, February 20, 2020. The exchange transaction is expected to close on or about June 12, 2020, subject to customary closing conditions.

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The 2022 Notes to be issued in the exchange transaction will be issued as additional notes pursuant to the indenture, dated as of August 5, 2016, between Rocket and Wilmington Trust, National Association, as trustee, as supplemented by the second supplemental indenture, dated as of February 20, 2020, governing the 2022 Notes, and will constitute the same series of securities as the $39.35 million aggregate principal amount of 2022 Notes issued on February 20, 2020. After giving effect to the issuance of the additional 2022 Notes and the exchange of the 2021 Notes pursuant to the exchange transaction, $46.85 million aggregate principal amount of the 2022 Notes is expected to be issued and outstanding and $5.15 million aggregate principal amount of the 2021 Notes is expected to remain issued and outstanding.

The additional 2022 Notes and any of Rocket’s common stock issuable upon conversion of the additional 2022 Notes have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and may not be offered or sold without registration under, or an applicable exemption from, the registration requirements.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.