Kyowa Kirin Launches New Efforts to Educate and Engage Physicians and Patients with Rare Forms of Cutaneous T-Cell Lymphoma About Treatment with POTELIGEO® (mogamulizumab-kpkc)

On September 23, 2021 Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company, reported the launch of two efforts focused on increasing understanding of mycosis fungoides (MF) and Sézary syndrome (SS), two subtypes of cutaneous T-cell lymphoma (CTCL),2 and the role of POTELIGEO (mogamulizumab-kpkc) in treating them.3 Aimed at physicians, the new Treat the Blood (Press release, Kyowa Hakko Kirin, SEP 23, 2021, View Source [SID1234590295]). Treat the Skin. omni-channel campaign seeks to educate about the importance of measuring and monitoring blood involvement to inform treatment and potentially impact patient outcomes in MF and SS. To reach patients, POTELIGEO patient ambassadors will share their CTCL journeys and experiences on treatment through video testimonials and other educational programming. The launch of both initiatives coincides with Blood Cancer Awareness Month.

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"To have a profound impact in a rare disease like CTCL, it’s important to invest in education and programming that helps to advance disease awareness, recognition and management," said Sue Smith, Vice President, North American Oncology Franchise Head, Kyowa Kirin, Inc. "With increasing blood burden linked to poorer prognosis in both mycosis fungoides and Sézary syndrome, it’s critical that the blood is monitored for disease progression and response to treatment. Our physician effort is focused on increasing understanding of the value of routine blood testing, and the proven efficacy of POTELIGEO in treating MF and SS symptoms."3,4-6

CTCL is a rare type of blood cancer that affects the body’s T cells. Because it first appears on the skin, it is often mistaken for common skin conditions like eczema or psoriasis, which can delay diagnosis by years or even decades.7 Most patients have mycosis fungoides, a chronic and typically slow growing cancer that initially manifests in the skin but can spread within the skin or to other areas, including the blood, in 30% of cases.2,5,8,10 Sézary syndrome is a rare (<5%), serious form of CTCL that affects the skin and blood from the start.11 Increasing blood burden in CTCL has been associated with worsening overall survival, disease-specific survival, and an increased risk of disease progression.5,8,12

Encouraging Physicians to Test More
The new Treat the Blood. Treat the Skin. campaign explains the value of understanding patients’ blood burden when determining appropriate treatment selection in MF and SS. Given that skin inflammation is often focused on as the source of discomfort and visible sign of disease, the campaign aims to call attention to the potential risk associated with blood involvement in MF and SS patients.7,13 A recent post-hoc analysis of data from the phase 3 MAVORIC trial published in the Journal of the European Academy of Dermatology and Venereology, evaluated the efficacy and safety of POTELIGEO in MF and SS across all levels of blood classifications compared to vorinostat.4

The campaign will reach healthcare professionals through a targeted mix of personal, print and digital communications supported by a new healthcare professional website (www.poteligeohcp.com) that reviews POTELIGEO’s efficacy and safety in MF and SS patients with varying levels of blood involvement.1,4 Peer-to-peer education featuring experts in the field is planned to further extend the reach of the initiative is planned for early 2022.

Bringing Real Patient Experiences to Life
Additional efforts are being made to educate patients about POTELIGEO as a treatment option.1 Given CTCL is a rare disease, patients are eager to connect with and learn from others who share the same diagnosis. Research indicates they rely heavily on advocacy groups and online forums for information when assessing and evaluating treatment options.2 To address the need for more information about patient experiences on treatment, educational content and programming has been created featuring the stories of real POTELIGEO patients – including their journey to diagnosis, experiences on treatment and what motivates them to never give up.

"I wanted to share my story to encourage others to never give up, to keep pushing for answers," said Jeff, POTELIGEO ambassador living with mycosis fungoides. "It’s easy to feel overwhelmed, to say it’s just not going to work and to give up. By learning how to advocate for myself, I was able to finally find the right specialists, the right diagnosis and ultimately, the right treatment for me."

Jeff’s and other patient stories will be viewable on www.poteligeo.com, and other online channels. Additional events with patient speakers are planned for 2022.

Please see POTELIGEO Indication and Important Safety Information below.

U.S. Indication

POTELIGEO (mogamulizumab-kpkc) injection for intravenous infusion is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.

Important Safety Information

Warnings and Precautions:

Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).
Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction, and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.
Infections: Monitor patients for signs and symptoms of infection and treat promptly.
Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.
Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.
Adverse Reactions:

The most common adverse reactions (reported in ≥ 10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).
You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch/.
Please click here for full U.S. prescribing information.

About POTELIGEO (mogamulizumab-kpkc)
POTELIGEO is a humanized monoclonal antibody that recruits the body’s own immune cells to kill CCR4+ (CC chemokine receptor 4) malignant T-cells.1,14 CCR4 is overexpressed in Sézary syndrome and in mycosis fungoides at all stages.15,16 POTELIGEO was produced using Kyowa Kirin’s proprietary POTELLIGENT technology platform, which is associated with enhanced antibody-dependent cellular cytotoxicity.16

CyPep-1 Shows Preliminary Safety, Tolerability and Early Signs of Efficacy in Part 1 of its Ph I/IIa CICILIA Trial Which Now Moves to Expansion Phase

On September 23, 2021 Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class tumorolytic agent CyPep-1, reported that it has successfully completed Part 1 of its Ph I/IIa CICILIA study having reached the planned target dose of CyPep-1 while maintaining a favorable safety profile (Press release, Cytovation, SEP 23, 2021, View Source [SID1234590270]).

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To date the trial has recruited 12 patients with a range of solid tumors, each patient having received a minimum of three intra-tumoral injections of CyPep-1. Safety and tolerability in this first part of the study have been encouraging with no serious adverse events or dose-limiting toxicities, while early efficacy signals are positive and remain consistent with the preclinical proof-of-concept data previously generated.

Based on these results, Cytovation plans to advance and expand the study to include a combination arm with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy manufactured by MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, as previously communicated, as well as two extended monotherapy arms, with one of these including the treatment of visceral tumors.

The study, which is being performed at four renowned cancer centers in The Netherlands (Netherlands Cancer Institute, Erasmus MC Cancer Institute, Leiden University Medical Centre, and University Medical Center Utrecht), will now be expanded to add leading sites in Germany, France, Spain, and UK.

The combination arm with KEYTRUDA is part of a clinical trial collaboration with MSD which is intended to progress to a Phase II program in patients with melanoma, advanced head and neck squamous cell carcinoma (HNSCC) and triple negative breast cancer (TNBC). Initial results from Part 1 of the combination arm safety study are expected early next year with the Phase II combination trial scheduled to start shortly thereafter.

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "We are pleased to report the successful conclusion of the first dose escalation phase of our CICILIA clinical trial. Encouragingly, the early clinical profile of CyPep-1, our proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition, continues to mirror the findings from our pre-clinical studies, demonstrating a promising safety profile and encouraging early signs of efficacy. We look forward to reporting on further progress in this trial, including the planned combination arm with KEYTRUDA, MSD’s anti-PD-1 therapy, which may hold great promise for the treatment of a range of solid tumors."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CyPep-1

CyPep-1 is a proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal cells. CyPep-1 eliminates cancer cells by forming pores in the plasma membrane, releasing cancer specific antigens to the immune system, promoting an inflammatory microenvironment, and inducing a tumor-specific immune response by in situ vaccination.

Preclinical data suggest this mode of action is highly synergistic with checkpoint inhibitors.

Onconova Therapeutics, Inc. Announces Proposed Public Offering Of Common Stock

On September 23, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Onconova, SEP 23, 2021, View Source [SID1234590257]). All of the shares to be sold in the offering will be offered by Onconova. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. In addition, Onconova intends to grant the underwriters a thirty-day option to purchase up to an additional 15 percent of shares of its common stock offered in the public offering.

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Guggenheim Securities is acting as sole book-running manager.

Onconova anticipates using the net proceeds from the offering for working capital and general corporate purposes. Pending the use of the net proceeds, Onconova intends to invest the net proceeds in short-term, interest-bearing, investment-grade securities.

The securities described above are being offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission (the "SEC") on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

The securities will be offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

PAVmed Subsidiary, Lucid Diagnostics, Files Registration Statement for Proposed Initial Public Offering

On September 23, 2021 PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), a highly differentiated, multi-product, commercial-stage medical technology company, and its majority-owned subsidiary, Lucid Diagnostics Inc. ("Lucid"), reported that Lucid has publicly filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") relating to the proposed initial public offering of its common stock (Press release, PAVmed, SEP 23, 2021, View Source [SID1234590254]). The number of shares to be offered and the price range for the offering have not yet been determined. Lucid Diagnostics intends to list its common stock on The Nasdaq Stock Market under the ticker symbol "LUCD."

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Cantor Fitzgerald & Co. and Canaccord Genuity LLC will act as joint book-running managers for the proposed offering. BTIG, LLC and Needham & Co., LLC will act as co-lead managers for the proposed offering.

The offering will be made only by means of a prospectus. Copies of the preliminary prospectus related to the offering may be obtained, when available, from any of the following:

A registration statement on Form S-1 relating to the proposed sale of these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

Ovarian CanceRx: New Innovative Clinical Research Effort Seeks to Accelerate the Development of New Treatments for Deadliest Gynecological Cancer

On September 23, 2021 Global Coalition for Adaptive Research (GCAR) reported a new clinical trial initiative, Ovarian CanceRx (Press release, Global Coalition for Adaptive Research, SEP 23, 2021, View Source [SID1234590253]). This innovative trial, referred to as an adaptive platform trial, is designed to test multiple drugs simultaneously against the standard of care treatments to rapidly test and deliver new therapies to patients with advanced ovarian cancer or recurrent platinum-resistant disease.

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The Ovarian CanceRx platform trial is designed to be more efficient and reduce the development time of testing new investigational drugs, while providing a more patient-centric approach that increases access to new potentially life-changing therapeutic options for women with ovarian cancer.

"As a clinician and researcher driven to bring better treatment options to my patients, efforts like Ovarian CanceRx are essential to rapidly advance new treatments that can improve patient survival," said Beth Karlan, Chair of the Ovarian CanceRx Steering Committee. "Working in collaboration with key members of the research, clinical and patient advocacy communities, Ovarian CanceRx capitalizes on novel drug development to give ovarian cancer patients access to potentially beneficial treatments at a time when they need them most – now!"

Ovarian cancer is less common than breast cancer, although it is more deadly. There are nearly 300,000 new cases diagnosed each year worldwide making ovarian cancer the fifth leading cause of cancer-related deaths in women. While there are numerous randomized control trials in ovarian cancer, there are still significant unmet clinical needs in this field. Patients with ovarian cancer have not benefited from new therapeutics the same way other cancer patients have for a number of reasons including a lack of innovative clinical research approaches that can rapidly adapt and evaluate new therapies as they become available. Additionally, there are challenges to recruiting enough patients to participate in trials given that ovarian cancer is a relatively uncommon disease. While the traditional randomized control trial remains the gold standard, it can often be inefficient and very expensive and may not be equipped to accommodate the complexities of the diverse ovarian cancer subtypes.

To address these hurdles, Professor Andrew W. Lo from the Laboratory for Financial Engineering at Massachusetts Institute of Technology (MIT) organized a series of meetings to bring together a committed group of scientists, clinicians, patient advocates, investors, philanthropists, and industry representatives to discuss opportunities in therapeutics and diagnostics and improved financial models for ovarian cancer focusing on innovations in clinical research. With a generous $1 million donation, GCAR, a non-profit organization with extensive experience in developing and executing master protocol and platform trials, has taken the reins to develop Ovarian CanceRx as an efficient, cost-effective and advanced model for drug development and improved patient outcomes.

"Given the challenges of the traditional trials, platform trials, provide a unique opportunity to accelerate advancements in ovarian cancer research," shared Meredith Buxton, CEO, GCAR. "Ovarian CanceRx will help to identify science-driven treatment options for women with advanced ovarian cancer or recurrent platinum-resistant disease. GCAR is excited to provide seed funding, support the work of foremost experts in ovarian cancer clinical care and research, and sponsor this important effort. Ovarian CanceRx represents innovation, efficiency and a patient-centric approach to clinical research."

A key stakeholder in the effort is Ovarian Cancer Research Alliance (OCRA), the world’s largest ovarian cancer charity. OCRA provides funding for research, advocates on Capitol Hill, and supports patients and their families. OCRA has served as an essential partner, providing the voice of the patient, since Ovarian CanceRx efforts initiated.

"We are delighted to partner with GCAR, the gynecologic oncology clinical and research community, and patients on this important effort to identify better treatment options for those with ovarian cancer," stated Audra Moran, President and CEO, Ovarian Cancer Research Alliance. "Collaborating on Ovarian CanceRx fits squarely into one of the cornerstones of our mission to support the most promising scientific research, seek out better treatments, and hasten desperately needed breakthroughs."

The Clearity Foundation, a non-profit science-based advocacy organization for women and families impacted by ovarian cancer, recently joined Ovarian CanceRx to provide clinical trial resources and patient education as well as treatment decision and psychosocial support.

"We believe that all women deserve the best possible therapies for their unique disease as well as personalized emotional support for their particular life challenges," said Hillary Theakston, Executive Director Clearity. "Through GCAR’s Ovarian CanceRx partnership we are gratified to support an innovative clinical trial design that will improve treatment for women with ovarian cancer."