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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"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

On October 2, 2017 KSQ Therapeutics reported that they emerged with $76 million in financing and a world-class executive team to advance the development of drugs empowered by the unique biological insights of its proprietary CRISPRomics drug discovery engine (Press release, KSQ Therapeutics, OCT 2, 2017, View Source [SID1234520709]). With CRISPRomics, KSQ is pioneering high-confidence drug development utilizing a suite of CRISPR-based technologies that industrialize, for the first time, a high-throughput, systematic way to elucidate the precise function that each human gene plays across a multitude of diseases. Based on this deep and comprehensive approach, KSQ is advancing a pipeline of oncology and immunology drug development programs against novel therapeutic nodes to create a new set of disease-tailored medicines. KSQ was founded in 2015 by David Sabatini, MD, PhD, of the Whitehead Institute and MIT, William Hahn, MD, PhD, of the Broad Institute and Dana-Farber Cancer Institute, Jonathan Weissman, PhD, of UCSF, and Tim Wang, PhD, of MIT, along with founding investors Flagship Pioneering and Polaris Partners.

KSQ also announced today the appointment of David Meeker, MD, as Chief Executive Officer. Dr. Meeker most recently served as Head of the Specialty Care Business Unit of Sanofi-Genzyme and previously was Chief Executive Officer and President of Genzyme, a Sanofi Company. He brings more than 20 years of industry leadership experience, from leading-edge R&D programs to global operational roles.

"We have a clear goal with CRISPRomics: empower the drug development process to strategically focus on high-confidence, patient-tailored, novel drug candidates," said Dr. Meeker. "There is a compelling need to improve the quality of drug targets and to identify patients most likely to respond because our industry and our health care systems are challenged by the sheer volume of potential new medicines. With our proprietary CRISPRomics engine, KSQ is positioned to play a leading role in shortening drug development timelines, increasing the rate at which meaningful medicines can reach patients, and ultimately, improving the sustainability of our health care systems."

KSQ also announced Frank Stegmeier, PhD, as Chief Scientific Officer and George Golumbeski, PhD, as Executive Advisor and Board Member. Dr. Stegmeier is a leading expert in industrialized functional genomics who led Oncology Target Discovery at Novartis prior to joining KSQ. He has led KSQ’s platform development and R&D efforts since the company’s formation in 2015, demonstrating the early productivity of CRISPRomics. Dr. Golumbeski is a business development executive with an outstanding track record of success in the pharmaceutical industry. During his more than 25-year career, he has identified and evaluated innovative technologies and drug candidates from early-stage biotech companies and accelerated their drug innovation potential through creative partnerships.

"The human genome harbors more than 20,000 genes, however for most diseases we have yet to discern which genes represent the best therapeutic targets. For the first time, CRISPRomics allows us to systematically pinpoint the optimal nodal targets of disease with extraordinary precision and speed," said Dr. Stegmeier. "The genome-scale insights that are possible with CRISPRomics are enabling KSQ to most efficiently focus our drug discovery efforts on the development of medicines with the greatest potential to intervene in disease and, therefore, impact the lives of patients."

KSQ’s financing is led by Flagship Pioneering; Polaris Partners, ARCH Venture Partners, and Alexandria Equities also participated. Since the company’s formation in 2015, KSQ has deployed its CRISPRomics engine to complete the functional assessment of each gene in more than 600 tumor and immune models. The company has compiled new insights in disease biology to identify novel drug targets and new drug combinations designed to elicit maximal impact on disease. This approach has produced KSQ’s initial pipeline of drug development programs, and will serve as a product engine across a wide range of disease areas for the company and future collaborators. KSQ has grown to a team of more than 40 employees.

"KSQ is a pioneering company, unleashing high-confidence drug development for the first time — a step change in the way drugs are discovered and developed," said David Berry, General Partner, Flagship Pioneering. "Led by proven industry leaders, KSQ is uniquely positioned to translate its breakthrough biological insights into therapeutics that can impact the core of many important diseases."

High-Confidence Drug Development
Powered by CRISPRomics, KSQ has elucidated the function that each human gene plays in a multitude of diseases providing a unique and more comprehensive understanding of disease biology. The quality of these insights enables KSQ to identify a multitude of high-confidence, patient-tailored, novel programs for drug development and rapidly rule-out thousands of less relevant targets from the outset; thereby, focusing R&D investment on the development of medicines with the greatest potential to meaningfully impact the treatment of human disease.

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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.

Megamerger deal speculation has swirled around Novartis as the Swiss drugmaker eyes its operations—particularly Alcon—for cash-generating sales or spinoffs (Press release, FiercePharma, SEP 28, 2017, View Source;utm_medium=rss [SID1234520701]). But all along, CEO Joe Jimenez has been pledging bolt-on deals instead, and the latest buzz says he has one on tap.

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That would be Advanced Accelerator Applications, a maker of radioactive tracers used in diagnostic scans, Bloomberg reports. But the target’s real attraction might be its pipeline. Its lead candidate is an actual cancer therapeutic in a field Novartis already knows: neuroendocrine tumors (NETs).

The in-development med, Lutathera, is at the regulatory filing stage, and it would come with two marketed NET diagnostic agents, NetSpot and Somakit. It’s a radiotherapy based on the rare earth metal leutetium, which is now used primarily as a catalyst for cracking hydrocarbons in oil refineries, according to the Royal Society of Chemistry.

"We believe a Novartis acquisition of AAAP for Lutathera in neuroendocrine tumors would be highly synergistic with [its] existing franchise, including Sandostatin and Afinitor, making a potential deal very logical," Canaccord Genuity analyst John Newman said in a Thursday morning note to investors.

With its $16 billion deal for GlaxoSmithKline’s oncology assets in 2015, Novartis beefed up its cancer portfolio, and the recent approval of its CAR-T drug Kymriah gave it another boost. It moved into the CDK 4/6 cancer therapy market with Kisqali earlier this year, and it’s also been racking up new indications for Afinitor, including nods in gastrointestinal and lung NETs last February.

RELATED: New Novartis CEO Narasimhan will face plenty of obstacles despite CAR-T triumph

Right now, AAA’s products are marketed mostly in Europe, with NetSpot its only U.S.-approved agent. Presumably, Novartis would use its expertise at advancing products through the FDA to bring AAA’s meds to the U.S., all while reaping sales in AAA’s established markets. The Big Pharma is adept at winning initial approvals in small patient populations and then expanding into follow-up indications that add significantly to sales prospects.

AAA, which went public in 2015, saw its American depositary receipts surge on the M&A reports, hitting a valuation of $2.6 billion on Thursday morning, Bloomberg says.

Whether Novartis moves forward with a deal remains to be seen; the company has been actively scouting for deals for some time, and various potential buys have been buzzed about over the past couple of years. One of those was Amneal, a generics maker said to be a Novartis target late last year; it’s now reportedly in the sights of Impax Laboratories, the generics maker that recently brought in Actavis/Allergan vet Paul Bisaro as CEO.

But AAA does look like the sort of deal that Big Pharmas have been shopping lately: companies with current revenue streams and late-stage pipeline meds. And if Newman is correct, AAA’s top med could be a boost for Novartis sales for years. "We see very long-duration revenues for Lutathera due to the extremely high barrier for generics, limited supply of leutetium and very high efficacy benefit over current therapies," he wrote.

Just what Novartis plans to do going forward is up in the air, however; Jimenez recently announced his departure, planning to hand the reins to current R&D chief Vas Narasimhan in February.

On September 28, 2017 Tanvex BioPharma, Inc. reported its plans for an international Phase 3 trial of its biosimilar drug candidate, TX05, its investigational trastuzumab biosimilar (a proposed biosimilar to Herceptin) in patients with early stage breast cancer (Press release, Tanvex BioPharma, SEP 28, 2017, View Source [SID1234524596]). In accordance with advice from the US Food and Drug Administration, the global Phase 3 trial, "A randomized, double-blind, parallel group, Phase III trial to compare the efficacy, safety and immunogenicity of TX05 with Herceptin in subjects with HER2 positive early breast cancer", has been designed to compare the therapeutic equivalence of biosimilar candidate TX05 to Herceptin in HER2-positive, early-stage breast cancer patients based on the pathological complete response rate following neoadjuvant therapy. Approximately 800 patients are anticipated to be enrolled from about 209 study centers in 19 countries. The primary efficacy endpoint, pCR, will be assessed through specimens obtained during surgery and analyzed by a central review of local histopathology reports. Equivalence will be considered to be demonstrated if the 95% confidence interval of the risk ratio of the pCR rates (TX05/Herceptin) is within a predefined interval agreed between Tanvex and FDA.

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Worldwide, nearly 2 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. Approximately 20% to 30% of primary breast cancers are HER2-positive.

"This represents another major milestone for our company. TX05 will be our second biosimilar product to enter Phase 3 trials and reinforces our commitment to expand access to affordable, high quality products to patients with serious illness," said Allen Chao, PhD, CEO of Tanvex.

US sales of Herceptin were US$2.7 billion in 2016.