On February 27, 2020, Deka Biosciences reported that an upcoming episode of Advancements with Ted Danson, scheduled to broadcast 2Q/2020, will explore innovative treatment solutions for maladies, such as Inflammatory Bowel Disease (IBD), specifically Crohn’s Disease (Crohn’s), and Oncology (Press release, Deka Biosciences, FEB 27, 2020, View Source [SID1234580080]). Check local listings for more info.

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This segment will focus on a novel platform developed by Deka Biosciences, Inc. (Deka Biosciences), that will enable the delivery of next generation cytokine or combination of cytokines to a specific tissue of interest. Viewers will learn how this cutting-edge technology, termed Diakines, has led to the development of two potential therapeutic molecules involving an affinity modified Interleukin 10 cytokine.

The show will also explore how Deka Biosciences is using Diakines to harness the spectrum of therapeutically useful and clinically validated IL10 and other cytokine specific biologies. Spectators will see how these Diakines can maximize patient benefits through improved PK/PD function combined with a MOA directed patient selection strategy.

"The biopharma industry has known for a while that cytokines play an integral role in immunology and disease management, and that delivery of cytokine therapeutics into diseased tissues will dramatically enhance therapeutic benefit," said Dr. John Mumm, co-founder & CEO of Deka Biosciences. He continued to say, "Deka Biosciences has harnessed the wealth of clinical knowledge around cytokines and IL-10 in particular, to develop a novel delivery platform to enrich cytokine variants in effected tissues, coupled with methods to determine how to select the patients with the greatest likelihood of response to ensure that the right patients get the right medicines."

In addition, the show will also inform about Deka Biosciences’ Precision Medicine strategy, which enables Deka to identify the right patients to treat with these new medicines.

"Deka’s platform has the potential to enable discoveries of next generation therapies," said Richard Lubin, senior producer for DMG Productions and the Advancements series. "We are eager to explore how Deka is set to influence future treatment options for IBD, Crohn’s."

On February 27, 2020 In honor of Rare Disease Day on February 29th, Incyte (NASDAQ:INCY) is reported the launch of Rare Reflections: MPNs Unmasked, a disease awareness initiative focused on raising awareness of and educating about myeloproliferative neoplasms (MPNs), a group of rare, chronic blood cancers (Press release, Incyte, FEB 27, 2020, View Source [SID1234555965]).

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As part of ongoing efforts to raise awareness of MPNs, Incyte has partnered with J.G. Jones, a renowned comic book artist who was diagnosed with an MPN over a decade ago, to capture the experiences of those impacted by MPNs. Rare Reflections features a series of portraits by Jones who uses graphic art to tell the powerful and personal stories of real patients with MPNs and those impacted by MPNs.

The illustrations can be viewed at www.VoicesofMPN.com/RareReflections, along with more information about Jones’ disease journey and the stories of others living with MPNs.

"Art has the amazing ability to capture the emotions of its subjects beyond the surface, and I am honored to partner with Incyte on Rare Reflections to raise awareness of MPNs by doing the work I love," said Jones. "I know first-hand how living with an MPN can affect many aspects of a person’s life – physically and emotionally – and I hope, through increased awareness and education, to empower others living with an MPN to take control of their journey."

"Rare Disease Day offers a time for patients, caregivers, advocates and healthcare providers to join together to shine a light on the estimated 200,000 individuals in the United States living with an MPN," said Hervé Hoppenot, Chief Executive Officer, Incyte. "Incyte is pleased to partner with a respected illustrator such as J.G. Jones to bring to life the real stories of those living with an MPN and to highlight the unique experiences of people across the MPN community."

In honor of Rare Disease Day, Incyte is also supporting several efforts intended to raise awareness of MPNs and help patients with MPNs find tools and resources to help address the daily challenges they may face:

Ask an MPN Expert Facebook Live: Tune into Voices of MPN’s "Ask an MPN Expert" Facebook Live, where Incyte Oncology Clinical Nurse Educators (OCNEs) will provide educational information about MPNs and answer your MPN-related questions. The Facebook Live Chat will begin tonight, February 27, at 7:00 p.m. ET. Join the conversation here.
Nominate your MPN Hero: Honor the individual or organization in your life who has contributed to the MPN community by going above and beyond to make a real difference. In honor of Rare Disease Day, the nomination period for the 2020 MPN Heroes program opens tomorrow, February 28, and nominations are being accepted through September 12, 2020. To learn more about the program or to submit a nomination, visit www.MPNHeroes.com.
Stay connected and informed about all of the MPN awareness activities by "Liking" the "Voices of MPN" Facebook page, following "Voices of MPN" on Pinterest and following "Voices of MPN" on Twitter.

About Myeloproliferative Neoplasms

Myeloproliferative neoplasms (MPNs) are a closely related group of blood cancers in which the bone marrow functions abnormally. The bone marrow is where the body’s blood cells are made. MPNs are progressive blood cancers that can strike anyone at any age, but they are more common in older adults. Estimates of the prevalence of MPNs vary, but analysis of claims data suggests there may be as many as 200,000 people in the U.S. living with MF, PV or ET.1

On February 27, 2020 The American Society for Radiation Oncology reported that a new phase II trial finds that a combination of radiation therapy and immunotherapy led to encouraging survival outcomes and acceptable toxicity for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) (Press release, ASTRO, FEB 27, 2020, View Source [SID1234555007]). The combination of radiation and pembrolizumab may offer a new treatment option for patients who are ineligible for cisplatin chemotherapy, part of standard treatment for the disease. Findings will be presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium, taking place February 27-29 in Scottsdale, Arizona.

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The single-arm trial was designed specifically for patients who normally would receive platinum chemotherapy together with radiation but may not be able to tolerate its side effects, most often due to preexisting hearing problems that place patients at risk of permanent hearing loss. Preexisting kidney damage and nerve damage also tend to be aggravated by cisplatin and place patients at risk for permanent side effects.

"That is a common dilemma in the exam room because cisplatin, while effective, tends to be particularly toxic for patients and can lead to permanent side effects for some," explained lead author Jared Weiss, MD, an associate professor of medicine at the University of North Carolina Lineberger Comprehensive Cancer Center. "I will have patients I want to treat with platinum chemotherapy, but I also want to align treatment with their values. Is the patient willing to accept a risk of deafness or exacerbated ringing in their ears? These are not acceptable consequences for most people."

The single-arm trial included 29 patients with locally advanced HNSCC. All patients would have ideally received cisplatin with their radiation but were ineligible for platinum chemotherapy. Patients were treated with three cycles of pembrolizumab and concurrent radiation therapy over six weeks, followed by three additional cycles of the immunotherapy drug.

With a median follow-up of 21 months, the rates of one-year progression-free and overall survival were 76% [95% CI 56-88] and 86% [67-95], respectively. Estimated two-year PFS was 71% [49-84] and estimated two-year OS was 75% [51-88]. For patients with p16+ oropharynx cancer, the one-year PFS and OS rates were 88% and 94%, respectively; for the other patients, the rates were 58% and 75%, respectively.

Most toxicities were mild (grade 1-2) with the exception of grade 3-4 lymphopenia, which affected 59% of patients. "This toxicity profile is better than what patients generally experience with cisplatin and radiation," explained Dr. Weiss. "It was more consistent with what we see from radiation therapy alone, with the exception of a high rate of lymphopenia that warrants additional study."

While engaging PD-1/PD-L1 blockade following chemoradiotherapy has improved survival in lung cancer, this trial is one of the first to show its potential efficacy for head and neck cancers. "There are convincing arguments that radiation sensitizes patients to immunotherapy and can enhance its effects. And the opposite direction also seems to be true – radiation therapy needs a functional immune system to work, and our hope was that pembrolizumab might be a radiation sensitizer for these patients," said Dr. Weiss.

Additionally, unlike chemoradiation therapy, the combination of radiation and pembrolizumab pairs two active modalities that can be curative by themselves. "If you look back to the historic studies, radiation alone often cures patients with this disease.Some of the first patients treated with pembrolizumab for recurrent/metastatic cancer are still alive many years out, with no evidence of disease," said Dr. Weiss. "And so, our concept was that, in addition to whatever synergy the immunotherapy might provide with radiation, we also conceived of it in a more straightforward way as a ‘second shot on goal’ toward cure."

Dr. Weiss cautioned that findings need confirmation in a randomized trial before the combination is recommended to patients.

Dr. Weiss will present "Progression-free survival, overall survival and immunophenotyping outcomes for patients with stage III-IV head and neck cancer and cisplatin contraindication treated with definitive radiotherapy plus pembrolizumab" tomorrow during the symposium’s Oral Abstract Session. The study was funded by Merck. Email [email protected] for a copy of the abstract or presentation slides from the meeting.

Attribution to the 2020 Multidisciplinary Head and Neck Cancers Symposium requested in all coverage. This release includes updated information not available in the abstract.

2020 Head and Neck Cancers Symposium News Planning Team
Robert L. Ferris, MD, PhD; Maie St. John, MD, PhD; Francis P. Worden, MD; Charu Aggarwal, MD, MPH; Sue Yom, MD, PhD; Brian O’Sullivan, MD, FASTRO; disclosures available online.

ABOUT THE SYMPOSIUM
The 2020 Multidisciplinary Head and Neck Cancers Symposium is a two-and-a-half-day meeting that convenes radiation oncologists, medical oncologists, surgeons and all members of the treatment team for a practical and comprehensive examination of treatment advances for patients with head and neck cancers. Scientific, interactive and case-based educational sessions will cover the latest research on multidisciplinary therapies, clinical applications and new treatment strategies, supportive care and toxicity mitigation. The meeting is cosponsored by the American Society for Radiation Oncology (ASTRO), the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the American Head and Neck Society (AHNS) and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

On February 27, 2020 Two scientists from Wake Forest School of Medicine, part of Wake Forest Baptist Health, reported that they have received a total of $1.5 million in research funding from the American Cancer Society (ACS) to study new chemotherapy and immunotherapy treatments for cancer (Press release, Wake Forest Baptist Medical Center, FEB 27, 2020, View Source [SID1234555006]).

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One of the grants, for $792,000 over four years, was awarded to Yong Lu, Ph.D., assistant professor of microbiology and immunology, to study a new approach to immunotherapy for metastatic and treatment-resistant cancers.

Using specialized white blood cells or T cells that he discovered, Lu and his research team will determine if the administration of these blood cells can eradicate advanced tumors and prevent recurrence of resistant tumors in an animal model.

Cancer recurrence may cause cancer treatment failure and death in more than 90% of patients with advanced tumors, especially with metastatic disease, which often develops resistance to the initial treatments, Lu said.

"We hope our work will shed light on the mechanisms underlying how T cells, the major type of white blood cells, prevent resistance and hopefully establish a foundation for translating that into more effective immunotherapies in human cancers," Lu said.

The second grant, for $782,000 over four years, was awarded to David Soto-Pantoja, Ph.D., assistant professor of surgery and cancer biology.

The grant will support his team’s efforts to create preclinical models to study cardiotoxicity – damage to the heart muscle – that results from some chemotherapy and immunotherapy drugs.

"In the next 10 to 15 years, there will be 20 million cancer survivors in the U.S. thanks to newer cancer drugs that are very effective," Soto-Pantoja said. "Unfortunately, many of these drugs have other side effects such as heart disease that can occur many years after treatment."

Soto-Pantoja’s goal is to better understand how chemotherapy drugs can affect the heart and develop strategies to prevent future development of cardiac diseases, as well as to find new treatments for those patients who have already developed heart disease.

For example, when he was a fellow at the National Institutes of Health prior to coming to Wake Forest Baptist, his team identified a molecule present on cells that when blocked prevents some of the damage caused by chemotherapy drugs.

"The molecule enhanced the immune system to attack the tumor but protected normal tissue from the negative effects of chemotherapy," Soto-Pantoja said.

This grant will support his continued efforts to understand how this molecule works and hopefully lead to a new approach to cancer therapy.

On February 27, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported full-year 2019 financial results (Press release, CytomX Therapeutics, FEB 27, 2020, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-full-year-2019-financial-results" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-full-year-2019-financial-results" rel="nofollow">View Source [SID1234554988]).

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As of December 31, 2019, CytomX had cash, cash equivalents and short-term investments of $296.1 million.

"During 2019, CytomX made substantial progress in advancing our clinical stage pipeline of innovative Probody therapeutics from Phase 1 platform proof of concept into Phase 2 clinical studies. We took major steps forward with our proprietary programs and in our partnerships and set the stage for significant updates throughout 2020," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "We also strengthened our product development capabilities with the recruitment of deeply experienced leadership, positioning ourselves to maximize the potential of our lead, wholly-owned assets, CX-072 and CX-2009, and of our entire portfolio. My colleagues and I look forward to continued pipeline momentum throughout the coming year as we maintain our focus on the discovery, development and ultimate commercialization of potentially transformative cancer treatments."

Business Highlights and Recent Developments

Initiation of Combination Phase 2 Study of CX-072, An Anti-PD-L1 Probody Therapeutic

In the fourth quarter of 2019, CytomX initiated the PROCLAIM (Probody Clinical Assessment In Man) CX-072-002 Phase 2 study evaluating the efficacy and tolerability of the anti-PD-L1 Probody CX-072, in combination with the anti-CTLA-4 antibody Yervoy (ipilimumab), in patients with relapsed or refractory melanoma. Stage 1 of this two-stage trial will enroll up to 40 patients with initial data anticipated in 2020. Additional information is available at ClinicalTrials.gov using the identifier NCT03993379.
Initiation of Phase 2 Study of CX-2009, An Anti-CD166 Probody Drug Conjugate

In the fourth quarter of 2019, CytomX initiated the PROCLAIM CX-2009 Phase 2 expansion study of CX-2009 monotherapy (7 mg/kg, administered every three weeks) in up to 40 patients with hormone receptor (ER, PR) positive, HER2-negative breast cancer. Initial data from this trial is anticipated in 2021. Additional information on this trial is available at ClinicalTrials.gov using the identifier NCT03149549.
Initiation of Part 2a of Ongoing Study by Bristol-Myers Squibb of BMS-986249, An Anti-CTLA-4 Probody Therapeutic

Initiation by Bristol-Myers Squibb of a Phase 2 randomized cohort expansion in its ongoing first-in-human Phase 1/2a trial of the anti-CTLA-4 Probody BMS-986249, a Probody version of the anti-CTLA-4 antibody Yervoy (ipilimumab), in combination with Opdivo (nivolumab) in patients with metastatic melanoma. The advancement of BMS-986249 into this study triggered a milestone payment of $10 million from BMS to CytomX. Additional information is available at ClinicalTrials.gov using the Identifier NCT03369223.
Ongoing Dose Escalation Phase 1 Study of CX-2029, An Anti-CD71 Probody Drug Conjugate, within AbbVie Alliance

Continued patient enrollment by CytomX in the dose escalation phase of PROCLAIM-CX-2029 Phase 1/2 study, partnered with AbbVie, evaluating CX-2029 as monotherapy in patients with solid tumors. Initial data from Phase 1 dose escalation arm is anticipated in 2020 with proof-of-concept data from the first cohort expansion studies in specific tumor types anticipated in 2021. Additional information is available at ClinicalTrials.gov using the Identifier NCT003543813.
Phase 1 Study Initiation by Bristol Myers Squibb of BMS-986288, An Anti-CTLA-4 Probody Therapeutic

In September 2019, Bristol-Myers Squibb initiated the dose escalation phase of a Phase 1/2a clinical study of a second anti-CTLA-4 Probody, BMS-986288, based on a modified version of Yervoy, administered as monotherapy and in combination with Opdivo in patients with selected advanced solid tumors. Additional information is available at ClinicalTrials.gov using the Identifier (NCT03994601).
ImmunoGen Collaboration

In December 2019, CytomX obtained exclusive worldwide development and commercial rights to ImmunoGen’s preclinical epithelial cell adhesion molecule (EpCAM)-targeting program that was developed utilizing CytomX’s Probody technology and ImmunoGen’s drug conjugate technology.
Probody T-Cell Bispecific Program

CytomX’s most advanced program in the T-Cell Bispecific (TCB) modality is an Epidermal Growth Factor Receptor-CD3 TCB which is partnered with Amgen. CytomX anticipates advancing a lead candidate for this program during 2020.
Clinical Development Team Appointments

In October 2019, the Company announced the appointment of Amy C. Peterson, M.D., as executive vice president and chief development officer. In this new role, Dr. Peterson has oversight of a multi-disciplinary team focused on advancing all aspects of CytomX’s clinical development and product registration activities.
In February 2020, the Company announced the appointment of Alison Hannah, M.D., as senior vice president and chief medical officer. In this role, Dr. Hannah oversees CytomX’s clinical development activities.
Anticipated 2020 Milestones

PROCLAIM-CX-072 (Anti-PD-L1)

Data is anticipated from the expansion arms of the Phase 1/2 trial of CX-072 as monotherapy in multiple selected tumor types.
Initial data is anticipated from Stage 1 of the Phase 2 study of CX-072 in combination with Yervoy.
PROCLAIM-CX-2009 (Anti-CD166)

Data is anticipated from the CX-2009 Phase 1 dose escalation and dose ranging studies.
PROCLAIM-CX-2029 (Anti-CD71)

Initial data is anticipated by CytomX and its partner, AbbVie, from the Phase 1 dose escalation stage of the PROCLAIM CX-2029 Phase 1/2 study.
Full Year 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $296.1 million as of December 31, 2019, compared to $436.1 million as of December 31, 2018.

Revenue was $57.5 million for the year ended December 31, 2019, compared to $59.5 million for the year ended December 31, 2018. The net decrease in revenue of $2.0 million for 2019 compared to 2018 was primarily due to a decrease in revenue of $13.1 million from AbbVie under the CD71 Co-Development and Licensing Agreement with AbbVie Unlimited Company (AbbVie), as well as decreases in revenue under our agreements with Amgen, Pfizer and ImmunoGen, partially offset by an increase in revenue from Bristol-Myers Squibb due to the accelerated recognition of revenue related to the cessation of research on certain targets under our agreement with Bristol-Myers Squibb in the first quarter of 2019.

Research and development expenses increased by $27.8 million during the year ended December 31, 2019 compared to the corresponding period in 2018. The increase was largely attributed to an increase in personnel-related expenses; expenses relating to the acquisition of technical know-how during the first quarter of 2019; license fees paid to the University of California, Santa Barbara (UCSB) in connection with an amendment to our license agreement with UCSB in the second quarter of 2019; and an upfront license fee paid to ImmunoGen in the fourth quarter of 2019 for the EpCAM program.

General and administrative expenses increased by $3.3 million during the year ended December 31, 2019 compared to the corresponding period in 2018. The increase was primarily due to an increase in personnel-related expenses due to an increase in headcount.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 1686972. An archive of the webcast will be available on the CytomX website from February 27, 2020, until March 6, 2020.