On December 1, 2021 GlaxoSmithKline (GSK) plc reported Target the Future, an international, multi-year initiative dedicated to advancing innovation and addressing key needs in the multiple myeloma community (Press release, GlaxoSmithKline, DEC 1, 2021, View Source [SID1234596337]). The programme will provide education on progress in the field of multiple myeloma, identify key challenges the community faces, and facilitate solutions to help create a better future for patients, their caregivers and loved ones.

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Target the Future was inspired by the recent advances in the field of multiple myeloma combined with the remaining challenges that patients face. Multiple myeloma is the third most common blood cancer worldwide[i] and second most common blood cancer in the US;[ii] it is generally considered treatable, but not curable.[iii] Despite recent treatment advances and the availability of newer and combination therapies, outcomes remain poor for patients with relapsed/refractory multiple myeloma.[iv]

"We’ve seen significant innovation in the development of new therapies for multiple myeloma during the past two decades, yet patients still face significant challenges, including access to care, emotional distress and disparities in outcomes among certain populations," said Tania Small, Vice President, Global Medical Oncology Franchise Head, GSK. "As part of our ongoing commitment to the myeloma community, we connected with patients and caregivers to identify some of the community’s key challenges, and now, we’re calling on innovative minds around the world to contribute potential solutions to help address these issues. Together, we can accelerate ideas that will make a positive and meaningful impact for patients with multiple myeloma."

Target the Future Think Tank Challenge

Target the Future aims to foster understanding of unmet needs in the multiple myeloma community and assist in developing solutions for these challenges. Beginning today, the programme’s Target the Future Think Tank Challenge will accept submissions of ideas to create a better future for the multiple myeloma community. A grant of £70,000 (equivalent to approximately $100,000) will be awarded to the strongest proposal that will bring the idea to life. Between now and 11 February 2022, patients, caregivers, healthcare professionals, researchers, data scientists, advocates or non-profit organisations can submit their proposals at www.targetthefuturemm.com. GSK will share the winning idea with the community and continue the programme in the years ahead to provide additional education and solutions for the myeloma community.

Persistent Challenges in the Multiple Myeloma Community

GSK consulted with patients and caregivers to identify key issues impacting the myeloma community that entrants could address with their proposals, including:

Understanding treatment options: While more treatments are available, understanding the appropriate options at each step of the journey can be difficult.
Getting the right care: Finding or traveling to the right healthcare provider can be hard for patients with limited transportation or location options.
Relieving the emotional burden: Managing stress associated with diagnosis, treatment, relapse, or the overall disruption to one’s life can be taxing for both patients and their caregivers.
Addressing disparities and inequities: New ideas can help ensure equal access to care and resources.
Entries for the Think Tank Challenge will be judged based on criteria such as potential to impact the issue(s), novelty of the idea, feasibility to execute and alignment with unmet needs. The submissions will be evaluated by a multidisciplinary advisory group comprised of people personally and professionally connected to the multiple myeloma community.

To learn more about Target the Future or apply to the Think Tank Challenge, please visit View Source

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, tumour cell targeting therapies and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination.

On December 1, 2021 RefleXion Medical, Inc., a therapeutic oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its biology-guided radiotherapy* (BgRT) for use in treating lung tumors (Press release, RefleXion Medical, DEC 1, 2021, View Source [SID1234596356]). The breakthrough potential of BgRT lies in its ability to detect and then immediately treat moving tumors. It is the first and only technology to use injected radiotracers to produce active signals, called emissions, from each tumor to guide treatment delivery.

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"Lung tumors are often fast moving, and a patient may have multiple tumors at the time of diagnosis, which limits the use of standard radiation techniques in the lungs," said Terence Williams, M.D., Ph.D., chair of radiation oncology at City of Hope Comprehensive Cancer Center. "The potential of biology-guided radiotherapy overcomes these limitations to offer us a promising, cost-efficient, comprehensive, and more targeted treatment for these common malignancies."

The FDA Breakthrough Devices Program recognizes medical devices that meet certain criteria and hold the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. Lung cancer is the most common cause of cancer- related death, accounting for 25% of all cancer deaths in the United States.1 The lungs are also among the most common location for metastatic tumors arising from cancers located in other parts of the body.

"The unmet need in lung cancer is staggering," said Todd Powell, president and CEO of RefleXion. "By harnessing the continuous biological interaction between the radiotracer and the cancer cells, BgRT has the potential to manage tumor motion with unprecedented precision. Our designation as a Breakthrough Device reflects the significance of our potential future contribution in the leading cause of cancer mortality in the U.S."

The vision for BgRT is to expand treatment options for patients with all stages of cancer. Several recent lung cancer clinical trials combining radiotherapy with drug therapy demonstrate significant improvements in overall and progression-free survival, despite the inability of current technology to reach more than one to three tumors. BgRT aims to overcome this limitation and eventually deliver radiotherapy to more sites of disease in hopes of improving outcomes for more patients with advanced disease.

On December 1, 2021 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported it has launched its EsoGuard Telemedicine Program in partnership with UpScriptHealth, a leading, nationwide, direct-to-consumer telemedicine company (Press release, Lucid Diagnostics, DEC 1, 2021, View Source [SID1234596379]).

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"Many, if not most, chronic heartburn sufferers treat their symptoms without physician supervision using widely available, heavily advertised, over-the-counter heartburn medications—entirely unaware they may be at risk for esophageal precancer and cancer"

Chronic heartburn patients in four metropolitan areas—Phoenix, Denver, Salt Lake City, and Las Vegas—can now access a Lucid-branded web-based telemedicine platform to request video evaluation of their condition by an independent UpScriptHealth-managed telemedicine physician. If clinically indicated, the patient will be referred to a local Lucid Test Center or other clinical facility offering rapid, office-based testing to detect esophageal precancer using Lucid’s EsoGuard DNA Esophageal Test ("EsoGuard"). A direct-to-consumer marketing campaign utilizing radio, television, billboards and digital media, will be launched, tested and refined in the Phoenix market before proceeding to other Lucid Test Center cities.

"Many, if not most, chronic heartburn sufferers treat their symptoms without physician supervision using widely available, heavily advertised, over-the-counter heartburn medications—entirely unaware they may be at risk for esophageal precancer and cancer," said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive Officer. "An important pillar of our growth strategy is to educate consumers on the link between chronic heartburn and esophageal cancer, and the availability of a rapid, office-based test to detect esophageal precancer before it progresses to cancer."

"The launch of Lucid’s EsoGuard Telemedicine Program is a very important milestone which completes the foundation for our multi-channel EsoGuard commercialization strategy directly targeting primary care physicians (PCPs), gastroenterologists and now consumers. We believe, based on the experience of other successful early cancer detection companies, that telemedicine programs with direct-to-consumer engagement can have broad reach, accelerate commercialization, and drive long-term growth. We are fortunate to have an ideal partner in UpScriptHealth, a pioneer in online healthcare prescribing with a nationwide network of telemedicine physicians, as we look to expand the EsoGuard Telemedicine Program and Lucid Test Center network regionally and nationally."

Lucid Test Centers currently operate in leased medical office suites located in three locations in Phoenix and one each in Denver, Salt Lake City and Las Vegas. Lucid plans to add upcoming test centers in the Pacific Northwest and then steadily expand nationwide. Each test center is staffed with Lucid-employed clinical personnel who use Lucid’s EsoCheck Cell Collection Device ("EsoCheck") to collect esophageal cells which are sent for EsoGuard testing. Lucid estimates that a single nurse practitioner can perform up to twenty EsoCheck procedures per day and expects each center to cover its personnel and medical office leases costs with only a few tests per week.

Since their launch, the test centers have been seeing patients referred for EsoGuard testing by their PCPs. Now, patients who respond to direct-to-consumer engagements can request video telemedicine evaluation through the EsoGuard Telemedicine Program by contacting 1-888-FOODTUBE or registering at www.EsoGuardConsultation.com. If clinically indicated, the telemedicine physician will refer the patient to a Lucid Test Center or other clinical facility for EsoGuard testing. The EsoGuard test result will be reported to this physician who will refer the patient for gastroenterology evaluation if indicated.

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer (EAC). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment. The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard and EsoCheck are the missing element and constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths, through the early detection of esophageal precancer in at-risk GERD patients.

EsoGuard is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer. EsoGuard is commercially available in the U.S. as a Laboratory Developed Test (LDT) performed at a CLIA/CAP-certified laboratory.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s third-party CLIA-certified laboratory partner for EsoGuard testing.

On December 1, 2021 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported it has received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its ZetaMet (Zeta-BC-003) technology (Press release, Zetagen Therapeutics, DEC 1, 2021, View Source [SID1234643705]). Previously known as ZetaFuse, ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

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"We are pleased to receive this important designation from the Agency and look forward to partnering with them," said Joe C. Loy, CEO of Zetagen Therapeutics. "Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions."

ZetaMet (Zeta-BC-003) works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts". The combination technology has, thus far, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration.

Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called "lytic lesions." Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.[1]

ZetaMet (Zeta-BC-003) has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022.

On December 1, 2021 Imago BioSciences, Inc. ("Imago" or the "Company") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported that a virtual investor event will be hosted by the company’s management team following the company’s presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition (Press release, Imago BioSciences, DEC 1, 2021, View Source [SID1234596321]).

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Individuals interested in listening to the event at 11:00 a.m. ET on Sunday, December 12 may do so by dialing (844) 348-6880 for domestic callers, or (914) 800-3944 for international callers and reference conference ID: 4488627; or from the webcast link in the investor relations section of the company’s website at: www.imagobio.com. The webcast will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

Imago will participate in two oral presentations on during the ASH (Free ASH Whitepaper) exposition and the abstracts are available on the ASH (Free ASH Whitepaper) meeting website at www.hematology.org and can also be accessed through "Events and Presentations" on Imago’s investor relations website.

The titles of the oral presentations are:

Oral Presentation Title: "A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Advanced Myelofibrosis"
Presentation Date/Time: December 11, 2021, at 12:00 PM ET
Oral Presentation Title: "A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Essential Thrombocythemia (ET)"
Presentation Date/Time: Sunday, December 12, 2021, at 9:45 AM ET