On January 22, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, ImmunoGen, JAN 22, 2020, View Source [SID1234553409]). ImmunoGen also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the number of shares of common stock offered in the public offering. All of the shares of common stock to be sold in the offering are to be offered by ImmunoGen.

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ImmunoGen intends to use the net proceeds of the offering, together with its existing capital, to fund its operations, including, but not limited to, clinical trial activities, supply of drug substance and drug product, pre-commercialization activities, capital expenditures, and working capital.

Jefferies, Cowen and William Blair are acting as joint book-running managers for the proposed offering.

The securities described above are being offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement, when available, may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (631) 274-2806; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by e-mail at [email protected] or by telephone at (800) 621-0687.

On January 22, 2020 The Cutaneous Oncology Program at the George Washington University (GW) Cancer Center reported that it was selected as the first global site for a clinical trial for patients with high-risk cutaneous squamous cell carcinoma (Press release, The George Washington University, JAN 22, 2020, View Source [SID1234553408]). This designation highlights the GW Cancer Center’s growing regional and global reputation for treating patients with advanced squamous cell carcinoma, the second most common form of skin cancer behind basal cell carcinoma. The study, sponsored by Regeneron, will examine outcomes for patients treated with Libtayo (cemiplimab) — an immunotherapy treatment — prior to surgery and radiation therapy.

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In June 2019, the GW Cancer Center was selected as the first global site for a related clinical trial on the effectiveness of Libtayo given after primary surgery and radiation therapy. This new study will focus on the impact of Libtayo on tumors prior to surgery, with the goal to help shrink the tumor and potentially prevent the cancer from returning or metastasizing. Preliminary results from a similar trial at MD Anderson Cancer Center showed promising responses to pre-surgical checkpoint inhibitors in patients with advanced cutaneous squamous cell carcinoma of the head and neck.

"By being selected as the first global site for not one, but two clinical trials in 2019, we are continuing to grow our reputation as one of the most innovative programs for patients with advanced cutaneous squamous cell carcinoma," said Vishal A. Patel, MD, FAAD, FACMS, director of the Cutaneous Oncology Program at the GW Cancer Center and principal investigator of the study. "Our growth means even more patients in our region will have access to the latest potentially promising treatments and therapies."

The phase II trial is intended to investigate the safety and effectiveness of Libtayo in helping reduce the size of tumors and prevent recurrence in high risk cutaneous squamous cell carcinoma, particularly when given early. The study, currently only available at the GW Cancer Center, is estimated to enroll over 75 participants.

"This clinical trial fits clearly within our mission to drive transformational research and personalized therapy," said Eduardo M. Sotomayor, MD, Dr. Cyrus Katzen Family Director of the GW Cancer Center and professor of medicine at the GW School of Medicine and Health Sciences. "Our role as an academic cancer center means we are uniquely positioned to get the latest therapies from bench to bedside, and expanding our clinical trial offerings highlights our commitment to advancing both cancer research and patient care."

Libtayo was approved by the U.S. Food and Drug Administration in September 2018 as cemiplimab-rwlc to treat patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. The immunotherapy treatment is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and was the first treatment approved and available in advanced cutaneous squamous cell carcinoma in the U.S. Current treatment options for the disease include surgery, such as Mohs micrographic surgery, radiation therapy, and systemic chemotherapy for metastatic disease. Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

"Clinical investigations like this one are critical to expanding the treatment options available to patients," said Mitchell Smith, MD, PhD, associate center director for clinical investigations at the GW Cancer Center. "By examining neoadjuvant applications of immunotherapy drugs like Libtayo, the hope is that patients will be able to be treated with less invasive surgeries or avoid surgery altogether."

The Cutaneous Oncology Program at the GW Cancer Center brings together dermatologists; dermatologic surgeons; medical, surgical, and radiation oncologists; and dermato-pathologists to provide comprehensive and personalized skin cancer care to patients. The program also houses the Supportive Oncodermatology and Cutaneous T-Cell Lymphoma multidisciplinary clinics.
The potential use of Libtayo in neoadjuvant cutaneous squamous cell carcinoma is investigational, and its safety and efficacy have not been evaluated by any regulatory authority for this use.

On January 22, 2020 Genialis and Oncologie reported that they have formed a partnership to evaluate and predict biomarkers for gastric cancer (Press release, Oncologie, JAN 22, 2020, View Source [SID1234553407]).

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They initially will concentrate on modeling gene expression signatures that might predict potential treatments for the condition. Houston-based Genialis already has begun applying its Expressions software to the clinical and translational expertise of Oncologie in an effort to improve methodologies for patient stratification, according to the companies.

"One of the most encouraging trends in drug development is innovation around integrating and interrogating diverse datasets," Genialis CEO Rafael Rosengarten said in a statement. "Our work in data science requires a great deal of artistry in addition to technology and benefits from hand-in-hand collaboration with biology domain experts, which makes this opportunity with Oncologie so special.

Boston-based Oncologie said that it eventually wants to take its methodologies to expand into other tumor microenvironment phenotypes.

"To be able to better understand the patient’s tumor microenvironment phenotype and how it is related to patient benefit represents a key objective for the future success of our company," Oncologie CEO Laura Benjamin said in a statement.

On January 22, 2020 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported the completion of patient recruitment in the triple combination arm of its ongoing Phase 2a COMBAT/KEYNOTE-202 study (Press release, BioLineRx, JAN 22, 2020, View Source [SID1234553404]).

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"We are pleased to see the triple combination arm of our Phase 2a pancreatic study advance according to plan," stated Philip Serlin, Chief Executive Officer of BioLineRx. "This follows very promising initial results that were presented last month at the ESMO (Free ESMO Whitepaper) IO conference, demonstrating robust and durable responses to the triple combination treatment. As previously stated, we remain on track to announce progression-free and overall survival data from the triple combination arm in mid-2020."

A total of 40 patients diagnosed with unresectable stage IV metastatic pancreatic adenocarcinoma (PDAC), who have progressed following first-line gemcitabine-based therapy, were enrolled as planned in the triple combination arm focusing on second-line pancreatic cancer patients. Patients receive Motixafortide (BL-8040) monotherapy priming treatment for five days, followed by combination cycles of chemotherapy (Onivyde/5-fluorouracil/leucovorin), KEYTRUDA and Motixafortide until progression. The primary endpoint of the study is the objective response rate (ORR). Secondary endpoints include overall survival, progression free survival, and disease control rate.

Last month, the Company shared preliminary data at the ESMO (Free ESMO Whitepaper) IO conference showing that the triple combination demonstrated a 32% overall response rate (ORR) and a 77% disease control rate (DCR) out of 22 evaluable patients at the time. This compares favorably to the current chemotherapy standard-of-care treatment in second-line patients with ORR of 17% and DCR of 52%. In addition, the median duration of clinical benefit for all 17 patients with disease control (7 partial response and 10 stable disease patients) was 7.8 months, compared to approximately three months of response duration with other treatments for second-line pancreatic cancer.

The COMBAT/KEYNOTE-202 Study
The Phase 2a COMBAT/KEYNOTE-202 study was originally designed as an open-label, multicenter, single-arm trial to evaluate the safety and efficacy of the dual combination of Motixafortide and KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in over 30 subjects with metastatic pancreatic adenocarcinoma. The study was primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies, and was carried out in the US, Israel and additional territories. The study is being conducted by BioLineRx under a collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary.

In July 2018, the Company announced the expansion of its immuno-oncology collaboration with MSD to include the triple combination arm investigating the safety, tolerability and efficacy of Motixafortide, KEYTRUDA and chemotherapy as part of the Phase 2a COMBAT/KEYNOTE-202 study.

About Motixafortide in Cancer Immunotherapy
Motixafortide is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.

Motixafortide is a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.

In a number of clinical and preclinical studies, Motixafortide has been shown to affect multiple modes of action in "cold" tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor niche, turning "cold" tumors, such as pancreatic cancer, "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).

On January 22, 2020 AstraZeneca reported that it will support UNICEF with a $12.5 million grant to support programming which will reach more than five million young people, train 1,000 youth advocates, and positively shape public policy around the world, over the next six years (Press release, AstraZeneca, JAN 22, 2020, View Source [SID1234553403]).

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The announcement follows AstraZeneca’s decision in October 2019 to continue to fund its Young Health Programme to 2025 with an overall commitment of $35m (£28m).

The AstraZeneca Young Health Programme will work with UNICEF and other partners to raise awareness of the risks and effects of non-communicable diseases (NCDs) such as cardiovascular disease, preventable cancers and mental health conditions among young people and key decision-makers.

The World Health Organisation (WHO) identifies NCDs as the number one cause of death worldwide1 and found that 70% of premature deaths from NCDs can be linked back to behaviours that first appear in adolescence2. Similarly, the World Economic Forum (WEF) has predicted that NCDs will cost the worldwide economy more than $47 trillion in lost productivity and wages by 20303.

Pascal Soriot, Chief Executive Officer, said: "We believe in the power of young people to change the trajectory of the staggering burden of disease we face today, all over the world. Improving the health outcomes of future generations is a critical part of developing strong and stable healthcare systems, which in turn support sustainable markets and the economic prosperity of nations."

Since its launch in 2010, the Young Health Programme has reached more than 3.5 million young people across six continents and trained more than 50,000 peer educators.

Gary Stahl, Director, UNICEF Private Fundraising and Partnerships, said: "The health and futures of young people must not be compromised by unhealthy lifestyles and behaviours. I am happy that UNICEF is joining a coalition of committed partners with the support of AstraZeneca to bring attention to NCDs which are now the world’s biggest killers. The burden of these diseases is closely linked to socio-economic factors and more work needs to be done on delivering the right messages through the right channels in countries to encourage healthy behaviours."

The other allies in the Young Health Programme are founding partner, and community-based programming lead, Plan International, youth engagement and development lead One Young World, and more than 30 other non-profit partners around the world, all working to improve health outcomes for young people through thoughtful programming, research and youth engagement activities.

The Young Health Programme

Since 2010 the Young Health Programme has reached over three million young people, through a mix of programmes, advocacy and research activities designed to increase awareness and understanding of NCD prevention. These have ranged over 24 countries and six continents from Australia to Zambia. Programmes range from one-to-one mentoring in Sweden, to long-running community-based behaviour change programmes involving hundreds of thousands of young people in Brazil and India. The methods may vary, but the drive is always the same – to help young people to lead longer, happier and healthier lives. For more information please visit younghealthprogrammeyhp.com.