On July 3, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported updated interim results from the biliary cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the efficacy of neratinib in HER2-mutated cancers, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer 2019, currently taking place in Barcelona, Spain (Press release, Puma Biotechnology, JUL 3, 2019, https://investor.pumabiotechnology.com/press-release/puma-biotechnology-presents-interim-results-biliary-tract-cohort-its-phase-ii-summit-b [SID1234537375]). "Treating HER2-mutant Biliary Tract Cancer with Neratinib: Benefits of HER2-directed Targeted Therapy in the Phase 2 SUMMIT ‘Basket’ Trial" was an oral presentation by James J. Harding, MD, Assistant Attending, Gastrointestinal Oncology and Early Drug Development Service, Memorial Sloan Kettering Cancer Center on July 3rd at 6:10 p.m. CEST. In addition, a poster presentation summarizing the trial results will be presented on July 4 beginning at 11:05 a.m. CEST. The slides and poster presentation will be available on the Puma website.

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The Phase II SUMMIT ‘basket’ trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating, somatic HER2 mutations. The biliary cancer cohort comprised 20 patients with advanced and/or metastatic disease treated with neratinib monotherapy. More specifically, 9 patients had cholangiocarcinoma, 9 had gallbladder cancer and 2 had cancer of the Ampulla of Vater. Patients received a median of 2 (range 0-7) prior systemic regimens before entering this trial. Most patients had received a gemcitabine-based regimen (n=18, 90%), 11 patients (55%) had undergone prior surgery, and 4 patients (20%) received prior radiation therapy. The confirmed objective response rate was 10% (95% CI: 1.2–31.7). The clinical benefit rate was 30% (95% CI: 11.9–54.3) and included 2 patients with confirmed partial responses and 4 patients with stable disease that lasted ≥ 16 weeks. The median progression-free survival was 1.8 months (95% CI: 0.9–3.7).

The safety profile observed in the neratinib-treated biliary tract cancer cohort is consistent with that previously reported for all HER2-mutated cancer patients in the SUMMIT trial. The most frequently observed adverse event was diarrhea, any grade (n=10, 50%) including 4 (20%) patients with grade 3 diarrhea. None of the diarrhea events resulted in dose discontinuation within the biliary tract cancer cohort; 2 patients reduced study drug due to diarrhea events.

"Somatic HER2 mutations represent a distinct class of oncogenic driver mutations that appear to be clinically actionable for a subset of metastatic biliary tract cancers. A subset of cholangiocarcinoma and gallbladder cancer patients had tumor shrinkage or extended disease control suggesting anti-tumor activity in this rare population. These early findings in targeting HER2 in advanced bile duct cancers warrant further clinical and translational investigation." said Dr. Harding.

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are very pleased with the initial activity seen with neratinib in this cohort of patients with biliary tract cancer. We look forward to the further enrollment of patients in the SUMMIT trial and further development of neratinib in this HER2-mutated patient population."

On July 3, 2019 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its second quarter 2019 financial results on Tuesday, July 16, 2019 after the close of financial markets (Press release, Seattle Genetics, JUL 3, 2019, View Source [SID1234537368]). Following the announcement, management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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LIVE access on Tuesday, July 16, 2019

1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 800-458-4121 (domestic) or +1 323-794-2093 (international); conference ID 3271918
Webcast with slides available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Tuesday, July 16, 2019 through 5:00 p.m. PT on Friday, July 19, 2019 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 3271918
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

On July 2, 2019 Asieris MediTech Co, Ltd (Asieris), a China-based biotech company specializing in the development and commercialization of new drugs for the treatment of genitourinary tumors and related diseases, and Photocure ASA (Photocure, PHO: OSE), The Bladder Cancer Company, reported that they have entered into a License Agreement for world-wide development and commercialization of Cevira for the treatment of HPV induced cervical precancerous lesions (Press release, Asieris Pharmaceuticals, JUL 2, 2019, View Source [SID1234561778]).

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"We are proud to announce this agreement with Asieris, providing a global roadmap for the development and commercialization of Cevira," said Daniel Schneider, President and CEO of Photocure. "Cevira has the potential to be developed into the standard of care for the treatment of HPV infections and precancerous lesions, as a large population of women could benefit from a non-invasive treatment option for this condition. This agreement is in line with our vision of becoming a global bladder cancer company by divesting products that do not fit our therapeutic focus.We look forward to further cooperation with Asieris into bringing Cevira to the market."

"Cevira is a strategic fit for Asieris’ therapeutic focus on genitourinary (GU) diseases, particularly the oncological ones," said Kevin Pan, CEO of Asieris. "Photocure is a global leader in developing photodynamically activated therapeutic and diagnostic products. Asieris has built strong development capabilities in the GU area in China and is rapidly expanding its global capability. Through the partnership with Photocure, we will endeavour to bring this innovative, non-surgical product to global market to fulfil a substantial unmet medical need in Women’s Health."

Cevira is in development as a treatment for high grade cervical dysplasia. It consists of a convenient, fully integrated drug delivery and light device to be applied intravaginally by the gynecologist. The patient can leave the physician office immediately and go back to daily activities, easily removing the device when the treatment is completed.

Asieris plans to launch a global clinical development program with an initial focus on the China market based on Photocure’s Phase 2b data and the Phase 3 study design elements agreed with the US FDA. The development for U.S. and the EU markets will follow when clinical data from the China focusedPhase 3 study confirm the safety and efficacy, estimated to be finished in 2022.Asieris will assume responsibility for the manufacture of the Cevira product while Photocure retains responsibility for the manufacture of the active pharmaceutical ingredient.

Under the License Agreement, Asieris will pay Photocure a total signing fee of USD 5 million within 6 months after signing. In addition, Photocure may receive a total of USD 18 million based upon achievement of certain clinical and regulatory milestones in China and up to USD 36 million for certain clinical and regulatory milestones in USA and EU. Approval of a second indication in China, USA and EU would result in payments of up to USD 14 million. Additionally, sales royalties will apply in all markets.

About Cevira
Cevira is a photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade cervical dysplasia. Cevira is easily placed on the cervix by the gynecologist and removed by the patient, with no disruption of normal daily activities. Only one or two treatments are needed.

On July 2, 2019 ORPHELIA Pharma, a biopharmaceutical company whose mission is to develop and market pediatric medicines in the fields of neurology and oncology, reported that it has signed a collaboration and licensing agreement with Gustave Roussy, a leading cancer center in Europe, to develop Kimozo, the first pediatric formulation of temozolomide (Press release, ORPHELIA Pharma, JUL 2, 2019, View Source [SID1234538116]).

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Temozolomide is an essential anti-cancer drug for the treatment of malignant gliomas in children. Unfortunately, there is no suitable pediatric formulation, which forces caregivers to open the adult capsules and disperse their contents into a food to administer the treatment to the children. The medical need has been underlined by the European Medicines Agency (EMA), in its document "Draft Inventory of paediatric therapeutic needs – EMA / 381728/2014".

"Temozolomide is one of the cancer drugs for which the need for a formulation for children is the strongest," says Professor Gilles Vassal, Director of Clinical Research Gustave Roussy. "This need has been recognized by the international pediatric oncology community and has led us to develop innovative, child-friendly hospital care."

Kimozo was developed on the basis of the hospital preparation developed by Gustave Roussy. The first pediatric formulation of temozolomide, Kimozo comes in the form of an oral suspension with taste masking, in a sealed bottle. Five oral syringes (for a 5-day course) will allow the drug to be administered effectively and safely. Kimozo is being industrialized by ORPHELIA Pharma.

"When the adult capsule is used, children may regurgitate the product, the dose administered is not precisely known, and finally, the family and caregivers may be exposed to this cytotoxic agent during pregnancy. preparation. Gustave Roussy has developed a hospital preparation that is extremely useful for children and on which we rely for Kimozo ", commented Jérémy Bastid, ORPHELIA Pharma’s Development Director.

"There is a significant medical need in pediatrics," says Hugues Bienayme, Founder and CEO of ORPHELIA Pharma. "In addition to malignant gliomas, temozolomide is prescribed in several rare solid cancers of the child. The uses of Kimozo will therefore be multiple. "

On July 2, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that Professor Dr. Eric Van Cutsem from Universitair Ziekenhuis Leuven (UZ Leuven) will present data from the NKG2D-based autologous and allogeneic CAR-T candidates, CYAD-01 and CYAD-101, respectively, at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer (WCGIC) to be held on July 3-6, 2019, in Barcelona, Spain (Press release, Celyad, JUL 2, 2019, https://www.celyad.com/en/news/celyad-to-host-conference-call-to-review-clinical-update-from-esmo-21st-world-gi-congress-1 [SID1234537378]). Following the oral and poster presentations at WCGIC, Celyad’s management team will host a conference call to discuss the initial clinical results from the SHRINK and alloSHRINK trials.

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Filippo Petti, CEO of Celyad noted "We are honored to have Professor Dr. Van Cutsem present preliminary data from our SHRINK and alloSHRINK trials, including an initial glimpse of data from the industry’s first off-the-shelf investigational non-gene edited CAR-T candidate, CYAD-101. The comparable trial designs investigating similar NKG2D-based CAR-T therapies should provide for a unique comparison of an autologous and allogeneic engineered cell therapy approach for the treatment of metastatic colorectal cancer."

Poster Oral Presentation

Title: Phase 1 studies assessing the safety and clinical activity of autologous and allogeneic NKG2D-based CAR-T therapy in metastatic colorectal cancer

Abstract: SO-009

Presenter: Eric Van Cutsem, M.D., Universitair Ziekenhuis Leuven (UZ Leuven)

Date: Friday, July 5, 9:00 a.m. CEST

Location: Auditorium B, Level 0

The poster (same title, same number) will be presented in the Exhibit Hall, Level 0 on Friday, July 5, 2019 from 10:35am – 11:05am CEST and 04:35pm – 05:05pm CEST.

Conference Call / Webcast Details

A conference call including a Q&A session will be held by the Company on Friday July 5, 2019 at 2:00 pm CEST / 8:00 am EDT.

The conference call can be accessed using the details below:

United States: +1 877 407 9208

International: +1 201 493 6784

Conference ID: 13692101

Alternatively, participants may also access an audio webcast of the event using the link below: View Source

Background on CYAD-01 and CYAD-101

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the NKG2D CAR of CYAD-01 and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). The expression of TIM reduces signalling of the TCR complex, which is responsible for Graft versus Host Disease (GvHD).

Background on SHRINK and alloSHRINK Trials

SHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and activity of CYAD-01 administered concurrently with FOLFOX chemotherapy in patients with metastatic colorectal cancer (mCRC). Patients will receive six cycles of FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) chemotherapy every two weeks and three administrations of CYAD-01 every two weeks.

alloSHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with unresectable mCRC. Similar to the SHRINK trial for CYAD-01, patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks.