On September 25, 2017 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported the closing of its public offering of 8,846,154 shares of its common stock at a public offering price of $6.50 per share, before underwriting discounts (Filing, 8-K, Iovance Biotherapeutics, SEP 26, 2017, View Source [SID1234520655]). The shares of common stock issued and sold in the offering at the closing include 1,153,846 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price less the underwriting discount.

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The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are approximately $57.5 million.

Jefferies LLC and Wells Fargo Securities, LLC were joint book-running managers, Oppenheimer & Co. Inc. was the lead manager, and H.C. Wainwright, LLC and Chardan were co-managers for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock offered in the public offering was previously filed and declared effective by the Securities and Exchange Commission (the SEC). A preliminary prospectus supplement relating to the shares of common stock sold in this offering was filed with the SEC on September 19, 2017. A final prospectus supplement relating to the offering was filed with the SEC on September 21, 2017. Copies of the final prospectus supplement and the accompanying prospectus may be obtained from Jefferies LLC, 520 Madison Avenue, New York, New York, 10022, or by email to [email protected], or by phone at (877) 821-7388; or from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, or by email to [email protected], or by phone at (800) 326-5897.

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

On September 26, 2017 Glythera Limited (Glythera), the next generation antibody drug conjugate (ADC) development company, and Cancer Research UK* reported an agreement giving Glythera exclusive, worldwide rights to the charity’s novel CDK11 inhibitor payload series for the development of multiple ADCs conjugated using Glythera’s proprietary PermaLink conjugation platform (Press release, Cancer Research Technology, SEP 26, 2017, View Source [SID1234523160]).

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According to the agreement, Glythera and Cancer Research UK will select and optimise toxins from the inhibitor payload series for development in ADCs. Glythera will then progress multiple ADCs, optimised according to cancer cell-kill profiles, for difficult-to-treat tumours. Glythera is currently evaluating a range of clinically important antibody targets and intends to identify its first clinical ADC candidate by 2019.

This agreement follows a successful period of collaboration between the parties during which the viability of selected low molecular weight CDK11 molecules was demonstrated in relevant ADC models.

The CDK11 inhibitor programme has identified a series of low molecular weight, synthetically tractable compounds which potently inhibit and are selective against other kinase targets. The series demonstrates highly potent anti-proliferative activity in dividing and non-dividing tumour cells and represents an exciting approach for ADCs.

Under the Terms of the agreement, Cancer Research UK will receive an undisclosed up-front fee, milestone payments on programme success for each resulting ADC, and royalties on worldwide product sales. Glythera is responsible for the development, manufacturing and commercialisation of any ADC products resulting from the agreement.

Dr Hamish Ryder, Director of Cancer Research UK’s Therapeutic Discovery Laboratories, said: "This collaboration highlights the success of our drug discovery approach in translating the most promising early stage research into new cancer treatments."

"We’re excited to work with Glythera to identify and advance the very best novel agents and develop targeted treatments for cancer patients. By continuing to bring together industry and world leading academics in this field, we hope to transform the outlook for people with cancers that are the hardest to treat."

Dr Dave Simpson, Chief Executive Officer, Glythera, said: "I am delighted that Glythera is working with Cancer Research UK as we look to identify and develop CDK11 inhibitor payloads and antibody conjugates to combat difficult-to-treat solid tumours and improve the lives of patients living with cancer."

On September 25, 2017 SignalRx Pharmaceuticals Inc. reported the presentation of scientific data on the company’s in silico platform technology for the rational design of dual small-molecule PI3K/BRD4 inhibitor for immune-oncology relative to activating anti-tumor immunity (Press release, SignalRx, SEPT 25, 2017, http://www.ireachcontent.com/news-releases/signalrx-presents-in-silico-design-of-dual-pi3kbrd4-inhibitors-for-combinatorial-activation-of-anti-tumor-immunity-in-treating-cancer-647615323.html [SID1234527320]). The presentation by Dr. Donald L. Durden, MD, PhD, senior scientific advisor for SignalRx, was made at the Immunomodulatory Small Molecules section of the 15th Annual Discovery on Target meeting in Boston, MA on September 25, 2017 at 8:40 a.m.

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The presentation was entitled "A Novel Dual PI3K/BRD4 Inhibitor, SF2523 for Combinatorial Activation of Anti-Tumor Immunity in Cancer via the Orthogonal Inhibition of MYCN and MYC" and highlighted advancements in the development of single small-molecules that simultaneously inhibit both PI3 kinase (PI3K) and the new epigenetic cancer target BRD4 in vivo.

Key highlights presented are:

Dual inhibitory chemotype disclosed which blocks MYC via two orthogonal independent pathways.
Synergistic anticancer effects of dual inhibition: PI3K inhibition induces MYCN degradation and BRD4 inhibition blocks MYCN transcription.
Dual PI3K/BRD4 inhibitor SF2523 blocks MYCN transcription and induces MYCN degradation
SF2523 shown to block tumor growth, metastasis, and PI3K/BRD4 signaling in vivo.
Demonstrated that SF2523 abrogates the macrophage immunosuppressive effects on tumor immunity via the blockade of the M1- M2 transition in vivo, and activates the adaptive T cell immune response against the tumor.
Data also was also presented related to the recent discovery of SRX3207, a novel dual inhibitor which inhibits PI3K and a recently discovered new immune checkpoint kinase. This inhibitor has potent immunostimulatory properties and blocks the immunosuppressive macrophage compartment.
SignalRx, focused on developing more effective oncology drugs through molecular design imparting multiple target-selected inhibition, is also announcing that it is seeking partnerships to accelerate the development of their novel small molecules into first-in-man clinical trials. These molecules include single-targeted novel BRD4 inhibitors and CDK inhibitors with picomolar potencies.

(Filing, 10-K, Palatin Technologies, 2017, SEP 25, 2017, View Source [SID1234520832])

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On September 25, 2017 SpringWorks Therapeutics, a mission-driven medicines company dedicated to developing innovative potential new treatments for underserved patient communities, reported its launch with a completed $103 million Series A financing funded by Bain Capital Life Sciences, Bain Capital Double Impact, OrbiMed, Pfizer (NYSE:PFE) and LifeArc (formerly known as MRC Technology) (Press release, SpringWorks Therapeutics, SEP 25, 2017, View Source [SID1234529339]). SpringWorks Therapeutics also has rights to four clinical-stage experimental therapies from Pfizer.

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"SpringWorks Therapeutics will pursue the development of medicines across therapeutic areas, focused on diseases where there is an urgent need and the potential for the greatest impact for patients," said Lara S. Sullivan, M.D., MBA, Founder and President of SpringWorks Therapeutics and a former Vice President at Pfizer. "We initially have rights to four very promising experimental therapies and, over time, plan to expand our pipeline by partnering with other life science companies and academic institutions who share in our mission."

New Approach to Drug Development

SpringWorks Therapeutics was originally conceived by Pfizer as an innovative way to advance investigational therapies that may hold significant promise for underserved patients. SpringWorks Therapeutics’ collaborative business model is designed to deliver both social and financial returns via partnerships with a variety of stakeholders, including scientists, biopharmaceutical partners, patient groups, funders and philanthropists. Pfizer’s contribution consists of both equity capital and royalty- and milestone-bearing licenses to experimental therapies.

"Pfizer sees SpringWorks Therapeutics as a groundbreaking new model for collaboration to deliver on the promise of medical research and development, so that more people have the potential to overcome disease. We hope that our investment in SpringWorks Therapeutics will, over time, enable us to realize even more value for patients and society," said Freda Lewis-Hall, M.D., DFAPA, Executive Vice President and Chief Medical Officer, Pfizer. "SpringWorks Therapeutics started as an idea about a new way to get things done with—and for—patients, it’s been a tremendous team effort, and we and our partners are excited to see it become a reality."

Promising Pipeline with Four Clinical-Stage Experimental Therapies

SpringWorks Therapeutics is focused on underserved patient populations where there is great medical need. The company plans to move forward potential programs for four diseases, all of which currently have no cure. SpringWorks Therapeutics plans to expand its pipeline by partnering with other life science companies and academic institutions who share in the company’s mission.

DESMOID TUMOR

A desmoid tumor is a rare, non-metastatic tumor of connective tissue cells, which can cause severe morbidity, pain and loss of function in children and adults. Desmoid tumors can show up in almost any part of the body, and desmoids that are faster growing or located near vital organs can cause life-threatening problems. Approximately 900-1,200 people are diagnosed with desmoid tumors each year in the U.S.1 Currently available treatments include unapproved medical therapy, radiation therapy, thermal ablation and surgery, which can be dangerous, costly and offer limited effectiveness. SpringWorks Therapeutics is planning to initiate a Phase 3 program to establish safety and efficacy of nirogacestat (PF-03084014), its gamma-secretase inhibitor, and will work collaboratively with the Desmoid Tumor Research Foundation to enable the needs of the patient community to be addressed.

NEUROFIBROMATOSIS

Neurofibromatosis (NF) refers to three genetic disorders—NF1, NF2 and schwannomatosis—which cause tumors to grow on nerves throughout the body and can lead to blindness, deafness, disfigurement, cancer, bone abnormalities, learning disabilities and severe pain. NF1 affects one in 3,000 individuals and usually is diagnosed in childhood when symptoms begin to appear.2 MEK inhibitors have shown encouraging activity in reducing tumor size in clinical Phase 1-2 studies in patients with plexiform neurofibromatosis, one of the many manifestations of NF1. SpringWorks Therapeutics is planning to initiate a Phase 3 program to establish safety and efficacy of its MEK 1/2 inhibitor (PD-0325901) in the NF1 population and will work collaboratively with the Children’s Tumor Foundation to enable the needs of the patient community to be addressed.

HEREDITARY XEROCYTOSIS

Hereditary xerocytosis (HX) is a genetic disorder in which red blood cells become dehydrated due to loss of potassium and cell water. The fragility of the dehydrated red cells can lead to a ranging severity of anemia and can cause complications including jaundice, fatigue, splenomegaly and gallstones. In some cases, it will lead to severe anemia that requires frequent blood transfusions. HX affects an estimated one in 10,000 people, and symptoms begin shortly after birth.3 There is no approved therapy for this disease. Senicapoc (PF-05416266) has demonstrated a good safety/tolerability profile in previous Phase 1-3 studies in other indications. SpringWorks Therapeutics plans to assess the potential activity of senicapoc in hereditary xerocytosis.

POST-TRAUMATIC STRESS DISORDER

Post-traumatic stress disorder (PTSD) is a chronic condition that some people develop after experiencing traumatic or life-threatening events, serious injury or sexual violence. PTSD involves the persistent re-experiencing of the traumatic event, which results in avoidance of trauma-related stimuli, as well as negative feelings and heightened anxiety-like symptoms. PTSD is often seen in military veterans, first responders, rape and battery victims, and abused children. Around 8.6 million people in the U.S. between the ages of 18-64 have been diagnosed with the disease.4 Over 200,000 veterans in the U.S. live with PTSD, which is currently treated with antidepressants such as SSRIs and trauma-focused psychotherapy; however, the disease can result in suicide even with treatment. SpringWorks Therapeutics’ FAAH inhibitor (PF-0445784) has demonstrated a good safety/tolerability profile in previous Phase 1 studies. The effectiveness of PF-0445784 in PTSD is to be determined. Cohen Veterans Bioscience (CVB) and SpringWorks Therapeutics plan to assess patient populations that could benefit from this mechanism.

Experienced Leadership Team

SpringWorks Therapeutics is led by a preeminent team of industry veterans, including:

Daniel S. Lynch, Executive Chairman, who has over 25 years of industry experience serving in management and board positions for a number of top-tier biotechnology and pharmaceutical companies.
Lara S. Sullivan, M.D., Founder and President, who brings more than two decades of senior leadership experience in biopharmaceuticals, healthcare and life sciences, most recently at Pfizer, where she had previously led the portfolio strategy for the company’s early stage pipeline and its Medical collaboration funding platform.
Stephen Squinto, Ph.D., Acting Head of Research & Development, Member of the Board of Directors, who brings over 25 years of biotechnology industry experience as both a scientist and senior executive.
Saqib Islam, JD, Chief Financial Officer and Chief Business Officer, who brings over 25 years in international business management with a focus on business development, global strategic planning and capital markets in the healthcare sector. Most recently, within the biotechnology industry, Saqib was an Executive Vice President and Chief Strategy Officer at Alexion Pharmaceuticals and Chief Business Officer at Moderna Therapeutics.
L. Mary Smith, Ph.D., Vice President, Clinical Research and Development, who brings more than 20 years of research and clinical development experience from both pharmaceutical and biotech companies. Most recently, Smith was the Vice President of Product Development at United Therapeutics and led the development and approval of Unituxin for high-risk neuroblastoma, a rare pediatric cancer.
In addition to Lynch, Sullivan and Squinto, SpringWorks Therapeutics has appointed the following seasoned directors to the board:

Carl L. Gordon, Ph.D., CFA – Partner, OrbiMed
Peter Keen – Trustee, LifeArc
Freda Lewis-Hall, M.D., DFAPA – Executive Vice President and Chief Medical Officer, Pfizer
Deval Patrick – Managing Director, Bain Capital Double Impact
Jeffrey Schwartz – Managing Director, Bain Capital Life Sciences