On August 4, 2020 Astellas Pharma US, Inc. ("Astellas") reported the call for entries for the Astellas Oncology C3 Prize (Changing Cancer Care), a global challenge that funds the best non-treatment ideas to improve cancer care for patients, caregivers and their loved ones (Press release, Astellas, AUG 4, 2020, View Source [SID1234562765]). Now in its fifth year, the C3 Prize will award grants and resources totaling $200,000 to concepts that address everyday challenges facing people impacted by cancer. In particular this year, solutions that also ease the increased burden of COVID-19 on cancer care, as well as address health disparities affecting cancer patients, are encouraged.

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The C3 Prize is open to all applicants through September 28. Astellas will select the finalists in December 2020. Each finalist will participate in a pitch event in March 2021 to determine the prize winners. Additional applicant information is available at www.C3Prize.com.

"Over the past five years we have sourced hundreds of ideas from people who embody the Astellas Oncology mission to make every day better for those living with cancer," said Mark Reisenauer, senior vice president, oncology business unit, Astellas US. "The COVID-19 pandemic, as well as existing health disparities, adds to the complexity of cancer care, creating additional emotional, financial and physical strain for people impacted by cancer, their loved ones and the medical professionals who care for them. The C3 Prize is uniquely designed to elicit the best ideas to address these challenges."

Cultivating Ideas that Unify Care Around People Living with Cancer
The C3 Prize is not just for complex solutions – ideas can be in the form of support tools, educational efforts, technology solutions and beyond. Past winners include people who have lived with cancer, caregivers, healthcare providers, patient advocates, entrepreneurs and more. Their winning ideas have included a video game designed to keep pediatric patients active and informed, a specialized childcare network that provides stability and normalcy for families, and a first-of-its kind and easy-to-understand digital audio series about cancer.

Celebrity entrepreneur and cancer activist Bill Rancic is lending his support to the 5th Annual C3 Prize for the third consecutive year to generate awareness about the importance of fostering advances in cancer beyond medicine and as host of the pitch event.

"As the husband of a cancer survivor, it’s been an honor to be a part of an effort that puts a spotlight on life-changing cancer care solutions that ease the burden of the cancer journey for patients and their families," Rancic said. "I’ve been inspired and impressed by the creativity of the submissions we have received over the years, and I encourage anyone with an idea or concept to apply."

Tackling Everyday Challenges Facing the Cancer Community
The 5th Annual C3 Prize finalists will participate in a pitch event with an expert panel of volunteer judges: Mark Reisenauer, senior vice president, oncology business unit, Astellas; Margaret Laws, president and CEO, Hopelab; Ebele Mbanugo, executive director, Run for a Cure Africa; Steve Alperin, CEO, SurvivorNet and Steven Collens, CEO, MATTER.

"I’ve dedicated my life to cancer education and awareness, and through my experience with the C3 Prize I have learned that one good idea can make an immeasurable difference," said Ebele Mbanugo, 2018 C3 Grand Prize winner, 2020 C3 Prize judge and founder/executive director of the nonprofit organization Run For a Cure Africa (RFCA). "Through the grants we’ve received from the C3 Prize to help fund my idea, we’ve been able to provide more comprehensive care for breast cancer patients living in Nigeria."

Astellas Oncology will award the Grand Prize winner $100,000 USD in grants, and the two Innovation Prize winners $50,000 USD in grants each. All winners will be provided with access to tools and resources to help them develop and advance their idea, including a yearlong complimentary membership to MATTER, a global healthcare startup incubator, community nexus and corporate innovation accelerator.

All eligible entries will be evaluated on the following criteria: potential impact on people affected by cancer, originality/differentiation from existing solutions, scalability of idea, and the impact of the C3 Prize on the ability to further the idea.

For more information, visit www.C3Prize.com.

About the Astellas Oncology C3 Prize
The Astellas Oncology C3 Prize, launched in 2016, is a global challenge that aims to address the complexities of the cancer journey by funding the best ideas in cancer care beyond medicine. The C3 Prize sparks innovative developments in cancer care, tackling cancer challenges by awarding the winners with prize money and connecting them with resources and support. The C3 Prize directly reflects the mission of Astellas Oncology: striving to make every day better for those impacted by cancer. Astellas maintains no ownership in the ventures funded by the C3 Prize. For more information, visit the website at View Source and follow on social media with the hashtag, #C3Prize.

On August 4, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on our Probody therapeutic technology platform, reported that Sean McCarthy, D.Phil., president, chief executive officer and chairman, will participate in the 2020 Wedbush PacGrow Virtual Healthcare Conference (Press release, CytomX Therapeutics, AUG 4, 2020, View Source [SID1234562764]).

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Dr. McCarthy will present a Corporate Update on:
Date: Wednesday, August 12, 2020
Time: 1:10 p.m. ET
A live audio webcast of the presentation will be available through the Events and Presentations page of CytomX’s website at www.CytomX.com. An archived replay will be available for 90 days following the event.

On August 4, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference 2020 on Tuesday, August 11, 2020 at 2:00 PM ET (Press release, Jounce Therapeutics, AUG 4, 2020, View Source [SID1234562763]).

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A live webcast of the presentation will be available by visiting "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. A replay of the webcast will be archived for 30 days following the presentation.

On August 4, 2020 GT Biopharma, Inc. (OTCQB:GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company’s proprietary NK cell engager (TriKE) technology reported it had completed treatment of patients enrolled at Dose Levels 1 and 2, and begun enrolling patients for treatment at Dose Level 3, in its GTB-3550 TriKE Phase I/II clinical trial (Press release, GT Biopharma, AUG 4, 2020, View Source [SID1234562762]).

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Following initial treatment, the first patient treated with GTB-3550 achieved stable disease with respect to the number of acute myeloid leukemia (AML) blasts observed in their bone marrow before and after treatment. Additionally, we observed an increase in the patient’s total NK cell population attributable to the IL-15 component of the TriKE molecule with no appreciable increase of any hyper-active T-cell population. All patients treated to date with GTB-3550 have experienced no adverse reactions including no constitutional symptoms such as fever, tachycardia, or chills. Patients now being enrolled will be treated at a dose of 25µg/kg/day.

The clinical trial is being conducted at the Masonic Cancer Center, University of Minnesota under the direction of Dr. Erica Warlick. Additional clinical trial sites are being engaged in States that have modified their COVID-19 restrictions to allow for the restarting of clinical trials.

The open-label, dose-escalation Phase I portion of the trial will evaluate GTB-3550 in patients with CD33-expressing, high risk myelodysplastic syndromes, refractory/relapsed AML or advanced systemic mastocytosis, and will determine safety and tolerability as well as the pharmacologically active dose and maximum tolerated dose of GTB-3550. The Phase II portion of the trial is planned to further evaluate the efficacy of GTB-3550 in this patient population.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented "we are pleased to have advanced treatment to the next higher dose of GTB-3550." Mr. Cataldo further stated "we hope to continue to see additional signals of efficacy at the new higher dose of GTB-3550."

About GTB-3550 Trispecific NK cell Engager (TriKE)
GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment of AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as AML, myelodysplastic syndrome, and other CD33+ hematopoietic malignancies.

On August 4, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported financial results for the second quarter 2020 and provided a corporate update (Press release, Kaleido Biosciences, AUG 4, 2020, View Source [SID1234562761]).

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"We have made several important advancements across critical areas of the business, including initiating two clinical studies in our COVID-19 program and strengthening our financial foundation by extending our cash runway into the second half of 2021," said Michael Bonney, Executive Chair of Kaleido. "We anticipate top-line data from the 350-patient, multi-center COVID-19 study in the fourth quarter. We also continue to make progress on our preclinical programs and look forward to reporting data in the fourth quarter from our immuno-oncology, cardiometabolic and liver disease programs."

Company Highlights

Initiated two non-IND clinical studies that are part of the ongoing COVID-19 clinical development program evaluating KB109 when added to Supportive Self-Care in outpatients with mild-to-moderate COVID-19 disease: clinical study K031 is a multi-center study of approximately 350 patients and clinical study K032, in collaboration with Massachusetts General Hospital, aims to include approximately 50 patients.

Completed a $35.6 million offering of common stock.
Anticipated Milestones

Clinical and ex vivo data from KB174, being developed for the treatment of hepatic encephalopathy (HE), to be featured in poster presentations during The Digital International Liver Congress (EASL 2020) August 27-29, 2020.

Topline data from the multi-center (K031) clinical study of KB109 in patients with mild-to-moderate COVID-19 disease expected in Q4 2020 and top-line data from the study with Massachusetts General Hospital (K032) are expected in the first quarter of 2021. A patient may be enrolled in the study if an initial positive COVID-19 test result is received and the patient remains symptomatic.

Initiating a clinical study in Q3 2020 evaluating KB295 in approximately 30 patients with mild-to-moderate ulcerative colitis (UC). Topline results are expected in mid-2021.

Preclinical data from the immuno-oncology, cardiometabolic and liver diseases programs expected in Q4 2020.

Topline data from Phase 2 clinical trial (UNLOCKED) of KB195 in patients with UCD inadequately controlled on standard of care in second half 2021.
Second Quarter 2020 Financial Results

For the second quarter 2020, Kaleido reported a net loss of $18.9 million, or $0.59 per common share, compared to $24.6 million, or $0.83 per common share, for the second quarter 2019. The 2020 second quarter net loss includes non-cash stock-based compensation expenses of $2.8 million, as compared to $2.4 million in the second quarter of 2019.

Research and development (R&D) expenses were $12.8 million for the second quarter 2020, compared to $18.8 million for the second quarter 2019. The second quarter decrease in R&D, as compared to the second quarter of 2019, was primarily driven by decreased external development, manufacturing, and research costs.

General and administrative (G&A) expenses were $5.6 million for the second quarter 2020, compared to $6.2 million for the second quarter of 2019. The second quarter 2020 decrease in G&A, as compared to the second quarter of 2019, was primarily due to decreased personnel-related costs, partially offset by increased facility-related expenses.

As of June 30, 2020, the Company reported cash and cash equivalents of $71.0 million and has cash runway into the second half of 2021.

About Microbiome Metabolic Therapies (MMT)

Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.