Pipeline Review Check

We can target, starve, penetrate, and destroy tumors. We have demonstrated checkpoint immunomodulation and have been able to show that co-expressing two different moieties on a single cell generates a synergistic response (Company Pipeline, Rubius Therapeutics, OCT 2, 2017, View Source [SID1234520728]). We are building a combinatorial portfolio of binding, stimulation, and killing modalities in a range of hematological and solid tumors.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Southern Research-Bionetix Collaboration Seeks Novel Cancer Drug That Targets A Genetic Switch

On October 2, 2017 Southern Research and Bionetix Inc., a South Korea-based biotech firm, reported that they have signed a research and license agreement to develop a new anti-cancer drug that affects a key genetic switch associated with suppression and regulation of the growth of certain types of cancer (Press release, Bionetix, OCT 2, 2017, View Source [SID1234525825]).

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The goal of the research is to develop a novel drug that would block, or inhibit, certain epigenetic processes linked to changes in tumor cell DNA that allow those cells to survive and begin spreading. A new drug that inhibits these processes could also be useful against chemotherapy-resistant tumors in combination with targeted cancer therapeutics and as an adjunct therapy for cancer immunotherapies.

This collaboration is based on the extensive expertise of Southern Research in the discovery of novel cancer therapeutics including promising research on the regulation of tumor growth by controlling how genes are turned on and off in the cell

"The collaborative effort with Bionetix will allow us to accelerate our exploration of an epigenetic approach that could produce life-saving anti-cancer agents as well as continue our commitment to the identification of novel therapeutics," said Mark J. Suto, Ph.D., vice president of Southern Research’s Drug Discovery Division.

Doo Young Jung, CEO of Bionetix, said the teams seek to develop new epigenetic enzyme inhibitors that are more effective than existing drugs so their use can be expanded to successfully treat a broader range of cancers.

"I believe that this collaborative research program will help to expedite the development of novel inhibitors into the clinic so that we can contribute benefits to cancer patients," he said.

Under the Bionetix agreement, Southern Research will conduct studies to identify and optimize new inhibitors of methyl transferases as potential drug candidates. In collaboration with Bionetix, Southern Research will also define the overall development strategy for the new compounds.

"What we are looking at in this exploratory effort is a wide range of specific genes and biomarkers," Suto added. "That will help us identify the types of tumors that should be targeted and which patients would be most likely to benefit from the treatment based on this epigenetic approach."

Southern Research and Bionetix plan to complete the collaborative research program and begin preclinical and clinical development programs by early 2019.

As part of the arrangement, Bionetix can exercise an option to acquire the global exclusive commercialization rights for the optimized inhibitors and the application technologies, and will develop them further independently.

The deal with Bionetix represents the first licensing agreement signed by Southern Research in a decade. Bionetix, based in Suwon, South Korea, is a start-up company backed by venture capital investments.

Bionetix is providing research support for Southern Research, which will provide its extensive expertise in biology and chemistry to move the drug discovery research program forward.

Cullinan Oncology Secures $150 Million Series A Financing To Build Innovative Development Company

On October 3, 2017 Cullinan Oncology, LLC reported a $150 million Series A financing co-led by the UBS Oncology Impact Fund (OIF) managed by MPM Capital, a worldwide leader in oncology investing, and F2 Ventures (Press release, Cullinan Oncology, OCT 3, 2017, https://www.cullinanoncology.com/2017/10/03/cullinan-oncology-secures-150-million-series-a-financing-to-build-innovative-development-company/ [SID1234520759]). Created by MPM Capital, Cullinan was formed to develop high-value oncology therapeutics with a unique, cost-efficient business model.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"MPM continues to seek innovative ways to finance and develop new therapies in the increasingly dynamic oncology marketplace," said Ansbert Gadicke, Chairman of Cullinan and MPM Co-Founder. "We have assembled a diverse team of seasoned executives, and we have confidence in their ability to generate novel therapies and strong returns."

Cullinan Co-founder and Chief Scientific Officer and MPM Managing Director Patrick Baeuerle stated, "We look forward to capitalizing on recent scientific breakthroughs across a broad range of cancer targets and therapeutic modalities. The pace of discovery in oncology is nearly unmatched, and will continue to drive better outcomes for patients."

Led by an accomplished team of oncology researchers, biopharma executives and experienced entrepreneurs, Cullinan is a company predicated on distributing risk while maximizing optionality through the construction of a diversified portfolio of internally developed as well as externally sourced oncology assets. Cullinan’s scalable model minimizes the fixed costs and inefficiencies of many traditional development approaches through strategic partnerships and a shared services platform.

"This capital infusion, coupled with the talent and structural advantages of Cullinan, positions us well to execute our vision of building a portfolio of assets geared towards dramatically improving the standard of care for those living with cancer," stated Owen Hughes, Cullinan CEO and MPM Managing Director.

World Class Management

CEO Owen Hughes joined Cullinan from Intarcia Therapeutics, where he served as the Chief Business Officer and Head of Corporate Development. While at Intarcia, he was responsible for business development, M&A, and financing, including one of the largest ex-US licensing deals to date. In addition, he helped raise approximately $1.8 billion in private capital through various equity, debt and royalty structures. Prior to Intarcia, Hughes accumulated over 16 years of Wall Street experience, most notably as a director at Bain Capital Public Equity.

Having played key roles in multiple breakthrough oncology therapies, Cullinan’s highly distinguished scientific management team includes:

Patrick Baeuerle, PhD, Cullinan’s Co-founder and Chief Scientific Officer, Biologics, and MPM Managing Director. An immune oncology pioneer, Baeuerle has co-founded MPM oncology start-ups Harpoon, TCR², iOmx, and Maverick, and led the development of BiTE antibody Blincyto, which was approved within three months by the U.S. FDA for relapsed/refractory acute lymphoblastic leukemia (ALL). Prior to Cullinan and MPM, Baeuerle served as Vice President, Research and General Manager of Amgen Research Munich GmbH, and Chief Scientific Officer of Micromet from 1998-2012. To date, he has published 238 PubMed-listed papers that have been cited more than 64,000 times.
Leigh Zawel, PhD, Cullinan’s Chief Scientific Officer, Small Molecules and MPM Managing Director. Zawel is an oncology expert with significant pharmaceutical experience over-seeing large and small molecule projects at Pfizer, Merck, Sanofi-Aventis and Novartis. Most recently, Zawel was Vice President and East Coast Site Head for Pfizer’s Centers for Therapeutic Innovation where he managed a portfolio of large and small molecule projects spanning oncology, immunology and rare disease from which five clinical stage programs emerged in five years.
Briggs Morrison, MD, Clinical Advisor to Cullinan and MPM Managing Director. Dr. Morrison is also the CEO of Syndax Pharmaceuticals (NASDAQ: SNDX), an MPM portfolio company. His distinguished career includes leading roles at AstraZeneca, Pfizer and Merck, with direct involvement in the development of oncology drugs Zolinza, Lynparza, Iressa & Tagrisso.
Complementing the clinical leadership is a team of business development and financial executives that provide deep industry experience to guide Cullinan’s future progress, including:

Corinne Savill, PhD, Cullinan’s Chief Business Officer. An accomplished pharmaceutical executive, Savill was most recently at Novartis, where she was Head of Business Development and Licensing for the Pharma Division, and previously led Pricing and Market Access and the European Transplant Business Unit for Novartis. Savill started her career in research roles at AstraZeneca and Imutran Ltd. in the UK.
Kristen Laguerre, MBA, Cullinan’s CFO and MPM Managing Director, Finance. With 18 years of financial leadership and management experience in the venture industry, Laguerre was most recently Partner and CFO at Flare Capital Partners and, previously, at Atlas Venture and SoftBank Capital. She began her early career at Arthur Andersen LLP.
About Cullinan

Regulation FD Disclosure

Soligenix, Inc. (the "Company") has updated its corporate presentation (the "Presentation") to include updates to the Presentation since it was last included as an exhibit to the Company’s Form 8-K filed with the U.S. Securities and Exchange on June 8, 2017 (Filing, 8-K, Soligenix, SEP 29, 2017, View Source [SID1234520714]).

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The Company updated the Presentation to reflect the receipt of approximately $3.7 million in non-dilutive funding. The National Institutes of Health (the "NIH") awarded the Company approximately $1.5 million over two years to support the conduct of its pivotal Phase 3 clinical trial evaluating SGX301 (synthetic hypericin) as a treatment for cutaneous T-cell lymphoma. Further, the NIH granted the Company an additional award of approximately $1.5 million over two years to support the conduct of its pivotal Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for severe oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. Finally, the Company will be participating in a grant awarded to the University of Hawai’i at Manoa for the development of a thermostabilized Ebola vaccine, with the Company awarded funding of approximately $700,000 over five years.

Additionally, the Company updated the estimated timeframe for the Phase 3 clinical trial of SGX301 development milestone, as its achievement may have the potential to occur later in the year.

TESARO Expands Our Way Forward Program for the Ovarian Cancer Community and Partners With Olympic Gymnast Shannon Miller

On September 28, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the availability of a number of new support resources and services that address unmet educational needs for women living with ovarian cancer (Press release, TESARO, SEP 28, 2017, View Source [SID1234520693]). The new resources are part of the expansion of the Our Way Forward platform — a program launched earlier this year, which features the results of a national survey that uncovered gaps in communication amongst patients and physicians. The expanded website includes numerous resources and tools for ovarian cancer patients and their loved ones, as well as a series of local ovarian cancer educational programs, including a special storytelling event with "The Moth" this fall. World-champion gymnast and gold medalist, Shannon Miller, will join TESARO to complement the Our Way Forward program and educate and empower the ovarian cancer community, sharing her experience as an ovarian cancer survivor.

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"As the Our Way Forward survey indicated, we as a community still have a long way to go to meet the needs of women with ovarian cancer. As a company, we measure our success by the number of patients and their loved ones that we impact in a positive manner," Mary Lynne Hedley, Ph.D., President and Chief Operating Officer. "By offering expanded educational content that emerged from perspectives and experiences of patients, survivors and caregivers like Shannon, we are committed to addressing the physical and emotional challenges that ovarian cancer brings to women."

The Our Way Forward website expansion used the findings uncovered in the Our Way Forward survey to develop informed resources and provide a call-to-action for patients, their loved ones and physicians to rethink how they talk about advanced, recurrent ovarian cancer. The Our Way Forward survey was conducted online in the U.S. by Harris Poll on behalf of TESARO, Inc. between April 2017 and May 2017, among 254 women living with ovarian cancer and 232 physicians who treat ovarian cancer patients. The updated website includes tailored content that addresses the emotional support needs of the caregiver, self-care and empowerment tips for women at any point during their personal ovarian cancer experience, first-person perspectives from women living with ovarian cancer and video content from "The Moth" storytelling event.

"As an ovarian cancer survivor, I am well aware of the anxiety and fear that goes along with an initial diagnosis, as well as the fear of recurrence even after treatment. It’s something that is always there. That’s why I am thrilled to join TESARO to be a part of a program that directly addresses the unique challenges of women after an ovarian cancer diagnosis and those currently living with ovarian cancer," said Mrs. Miller. "With Our Way Forward, TESARO has demonstrated their commitment to women like me — and their families and caregivers — who are faced with the possibility of cancer returning. As new medicines become available to treat women living with recurrent ovarian cancer, programs to support women from an emotional and psycho-social standpoint remain equally critical."

Upcoming resources will include new content created by Mrs. Miller, as she shares her personal ovarian cancer story, including the risks one still faces with an ovarian cancer diagnosis and treatment.

The Our Way Forward survey revealed that around half (53 percent) of patients polled felt that ovarian cancer had a severe or very severe impact on their lives. For patients who are currently in treatment or who have been treated, about half (49 percent) admitted that they find not being sure of the path forward after diagnosis to be very or extremely challenging. According to the survey, more than two in five patients who are either currently in treatment, or who have been treated, find not knowing what to expect during treatment (46 percent) or after treatment (47 percent) to be very or extremely challenging.

Approximately 85 percent of women with advanced ovarian cancer will experience recurrent disease after treatment. Despite high response rates to chemotherapy, its effectiveness diminishes over time. Many women have been told to "watch and wait" — along with the healthcare professionals, monitoring the cancer for recurrence. Until recently, before maintenance treatments were available, after a response to platinum-based chemotherapy, women had limited treatment options that would delay progression of the disease. These treatments have been shown to extend patients’ time in remission and increase progression-free survival rates.

About the Our Way Forward Survey
The Our Way Forward survey was conducted online in the U.S. by Harris Poll on behalf of TESARO, Inc. between April 13 and May 2, 2017, among 254 women 18+ years of age living in the U.S. who have been diagnosed with ovarian cancer. Survey respondents were selected from individuals who had agreed to participate in surveys through the Harris Poll and their partners, or were recruited to participate by patient advocacy organizations, NOCC and OCRFA. Results are representative of only those surveyed. A parallel survey was conducted between April 17 and May 5, 2017, among 232 physicians who treat ovarian cancer patients in the U.S., consisting of 201 medical oncologists and 31 gynecologic oncologists. Survey respondents were selected from physicians who had agreed to participate in surveys through the Harris Poll and their partners. More information about the campaign, full survey methods and survey findings, including important resources to enhance conversations about ovarian cancer, are available on the Our Way Forward website at www.ourwayforward-oc.com and via NOCC at ovarian.org and OCRFA at ocrfa.org.

About Ovarian Cancer

Approximately 22,000 women in the United States are diagnosed with ovarian cancer each year, many of whom will be diagnosed with advanced disease; while more than 65,000 women are diagnosed annually in Europe. In 2017 alone, 14,000 women will die of ovarian cancer, as it is the fifth leading cause of cancer death among women. Despite high-response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85 percent of patients will experience recurrence within two years.