Phoenix Molecular Designs Announces $12 Million in Seed Financing

On November 27, 2019 Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, reported that it has completed its most recent round of seed financing, resulting in a total raised to date of $12M (Press release, PhoenixMD, NOV 27, 2019, View Source [SID1234551550]). The primary use of funds continues to be on the preclinical and clinical advancement of its lead product candidate, PMD-026, a proprietary first-in-class orally-available RSK (kinase) inhibitor. PMD-026 is being developed as a platform technology to treat resistant forms of cancer, such as metastatic breast cancer and, more specifically, triple-negative breast cancer (TNBC).

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Investors in the financing round included Pallasite Ventures and World Changing Ventures.

"We are proud to help fund the PhoenixMD team in their mission to develop better therapeutic options for women with breast cancer," said Dr. Christopher Bissonnette, Managing Partner of Pallasite Ventures. "We believe PMD-026 is a promising new approach to treat advanced breast cancer, both as a monotherapy or in combination with chemotherapy. We are looking forward to working with the team and fellow investors to advance this important product into the clinic."

The company’s Phase 1/1b clinical trial is being conducted at leading medical centers across United States and it will evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of PMD-026 in patients with metastatic breast cancer as well as a sub-group of women with TNBC. Importantly, this trial will include a College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA) certified companion diagnostic (CDx) designed to detect RSK2 activation in breast tumors and to then correlate it with response to PMD-026. Activated RSK2 is highly prevalent in breast cancer as it is expressed in approximately 89 percent of primary tumors. It is also detected in metastatic breast cancers, indicating that this drug target is retained in cancer cells that have moved to other parts of the body. The targeting of RSK2 by PMD-026, together with a validated CDx detecting activated RSK2 in tumors, create a distinct precision medicine approach to treating breast cancer.

"As a company in a challenging disease space, we appreciate the vote of confidence from our investors who join us in the pursuit of new medicines for patients with metastatic breast cancer," said Sandra Dunn, Ph.D., chief executive officer of Phoenix Molecular Designs. "Our seed funding has supported the early development of our lead product candidate, PMD-026, and we are delighted to have opened our Phase 1/1b clinical trial."

The advancement of PMD-026 in the company’s clinical trial is underscored by their teams’ impressive track record of market success in developing targeted therapies for breast cancer. Previously, this team has brought forward FDA-approved CDK4/6, PARP, ER and PIK3CA oral selective small molecule inhibitors. PhoenixMD looks forward to building upon this momentum in the pursuit of additional treatment options for individuals living with TNBC.

About PMD-026
PhoenixMD’s lead candidate, PMD-026, is the first RSK inhibitor being developed for the treatment of TNBC. PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase, out of 519 kinases, that drives the growth of this breast cancer subtype. Preclinical data shows the potential for PMD-026 to be effective alone or in combination with conventional chemotherapies. It has the potential to be a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitization for a wide range of refractory cancers in the future. PMD-026 has begun Phase 1/1b clinical trials in the United States with the first site initiated at the end of October 2019.

Hansoh Pharma’s Class 1 Innovative Drug Flumatinib Approved for Marketing – China’s First Independent Innovative Drug for CML

On November 25, 2019 Hansoh Pharma reported it’s new Class 1 drug, Flumatinib mesylate (trade name: Hansoh Xinfu), was approved by the National Medical Products Administration for the treatment of adult patients with Philadelphia chromosome positive chronic myelogenous leukemia (Ph+CML) in the chronic phase (Press release, Jiangsu Hansoh Pharmaceutical, NOV 25, 2019, View Source [SID1234591475]). Hansoh Xinfu is China’s first innovative drug with independent intellectual property rights in this field and has been approved for marketing through the priority review and approval procedure. It is expected to become a better choice for first-line treatment of CML patients in China.

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▲ Information on the official website of the National Medical Products Administration

CML has changed from malignant tumor to "chronic disease" since the launch of Imatinib mesylate (first-generation TKI for CML treatment), and many treated patients have a survival period of more than 10 years. In 2013, Hansoh Pharma launched the first generic Imatinib mesylate (Xinwei), which has improved drug accessibility and benefited more Chinese patients. Honsoh Xinfu is "two-way optimized" in terms of curative effect and safety, and is a "second-generation+" tyrosine kinase inhibitor (TKI).

Clinical studies have confirmed that compared with Imatinib, Flumatinib has significantly improved safety while achieving the efficacy of second-generation TKI:

▪ Flumatinib has higher cytogenetic and molecular reaction rates in the first-line treatment of chronic myeloid leukemia in chronic phase (CML-CP), and can achieve faster and deeper molecular reaction;

▪ The adverse event types of Flumatinib are similar to those of Imatinib, and some of them have been improved, while no other specific adverse events of second-generation TKI have been observed.

To "create excellence in pharmaceuticals, enhance innovation in China" is Hansoh Pharma’s corporate mission. Since its establishment more than twenty years ago, the company has been striving to solve the unsatisfied clinical needs in China’s major disease fields through continuous innovation while adhering to the national strategy of "Healthy China 2030". Hansoh Xinfu is the third independent innovative drug of Hansoh Pharma after Mailingda (morpholinazole and sodium chloride injection, a new generation of anti-anaerobe drugs) and Fulaimei (polyethylene glycol loxenatide injection, the first independently developed hypoglycemic drug injected once a week in China).

Hematologic oncology is a top priority field of Hansoh Pharma. In addition to Hansoh Xinfu, a series of high-end first generic drugs have been put on the market in recent years, covering a number of diseases in the field of hematological oncology, which have largely solved the problem of drug accessibility in this field, including Xinwei (Imatinib mesylate tablets for the treatment of chronic myelogenous leukemia), Xintai (Bortezomib for injection for the treatment of multiple myeloma) and Xinmei (Decitabine for injection for the treatment of myelodysplastic syndrome). In the future, Hansoh Pharma will further introduce more innovative drugs in the pipeline to benefit the vast number of patients.

Kineta Invited to Participate at the 2nd Annual Evercore ISI HealthCONx Conference

On November 26, 2019 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, neuroscience and biodefense reported that Kineta’s management team has been invited to participate at 2nd Annual Evercore ISI HealthCONx Conference in Boston, MA (Press release, Kineta, NOV 26, 2019, https://kinetabio.com/2019/11/26/kineta-invited-to-participate-at-evercore-isihealthconx/ [SID1234553653]). Shawn Iadonato, Kineta Chief Executive Officer, will provide a corporate overview on Wednesday, December 4th at 3:50-4:10 PM, Eastern Time.

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Savara’s COO and CMO to Present at the Evercore ISI 2nd Annual HealthCONx Conference

On November 26, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported that it will be presenting at the Evercore ISI HealthCONx conference on Wednesday, December 4, 2019 at 2:20 PM ET / 11:20 AM PT at the Four Seasons Hotel in Boston (Press release, Savara, NOV 26, 2019, https://savara.gcs-web.com/news-releases/news-release-details/savaras-coo-and-cmo-present-evercore-isi-2nd-annual-healthconx [SID1234551757]). Taneli Jouhikainen, Savara’s President and Chief Operating Officer, and Badrul Chowdhury, Savara’s Chief Medical Officer, will participate in a fireside chat at the conference.

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Interested parties can access a live audio webcast of the fireside chat on the Investors page of the Savara website at www.savarapharma.com/investors/events-presentations/. An archived presentation will be available on Savara’s website for 90 days following the event.

Audentes Therapeutics to Participate in Upcoming Investor Conferences

On November 26, 2019 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, reported that Natalie Holles, President and Chief Operating Officer, will participate in the following investor conferences in December (Press release, Audentes Therapeutics, NOV 26, 2019, View Source [SID1234551756]):

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31st Annual Piper Jaffray Healthcare Conference
Fireside Chat: Tuesday, December 3, 2019, at 10:00am ET
New York, New York

2nd Annual Evercore ISI HealthCONx
Panel: "Gene Therapy Manufacturing Powerhouses," Wednesday, December 4, 2019, at 8:45am ET
Boston, Massachusetts

To access the live webcast of the Piper Jaffray fireside chat, please visit the Events & Presentations page within the Investors + Media section of the Audentes website. Following the conference, a replay of the live webcast will be available on the Audentes website for approximately 30 days. There is no webcast available for the Gene Therapy Manufacutring Powerhouses panel at the Evercore ISI HealthCONx conference.