Puma Biotechnology to Host Conference Call to Discuss Second Quarter Financial Results

On July 21, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 4, 2022, following the release of its second quarter 2022 financial results (Press release, Puma Biotechnology, JUL 21, 2022, View Source [SID1234616861]).

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The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

InnoCare Announces First Prescription of Tafasitamab in Combination with Lenalidomide for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Under Boao Hope City’s Early Access Program

On July 21, 2022 InnoCare (HKEX: 09969) reported that tafasitamab (Minjuvi) in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT) (Press release, InnoCare Pharma, JUL 21, 2022, View Source [SID1234616860]). Through this program, the first prescription of tafasitamab in combination with lenalidomide was filled in China at the Ruijin Hainan Hospital for an eligible DLBCL patient.

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Boao Lecheng International Medical Tourism Pilot Zone, also known as Boao Hope City, allows individuals with urgent unmet needs to access innovative drugs, medical devices and technologies that have not yet been approved by NMPA in China but that have been approved by regulatory authorities overseas.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "This prescription marks the first application of tafasitamab for patients in China. InnoCare has been committed to bringing innovative drugs to patients and physicians in China. In addition to Hainan practice, as previously announced, we are advancing the registrational trial recently approved by the NMPA with the goal of providing relapsed or refractory diffuse large B-cell lymphoma patients with unmet medical needs access to this combination, if approved."

Tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, is not approved by the NMPA for any indication in China, except for the early access program in Boao Lecheng International Medical Tourism Pilot Zone for the treatment of eligible DLBCL patients.

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for ASCT.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally. In China, DLBCL accounts for 45.8% of all NHLs1.

About tafasitamab

Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy.

In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name MONJUVI in the U.S., and marketed by Incyte under the brand name Minjuvi in Europe, the UK and Canada. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

XmAb is a registered trademark of Xencor, Inc.

Zymeworks to Host Second Quarter Results Conference Call

On July 21, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will report its second quarter 2022 financial results after market close on August 4th, 2022 (Press release, Zymeworks, JUL 21, 2022, View Source [SID1234616859]). Following the announcement, management will host a conference call and webcast to discuss financial results and provide a corporate update on August 4th, 2022 at 4:30 p.m. ET.

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Conference Call and Webcast Information

The event will be webcast live with dial-in details and webcast replays available on Zymeworks’ website at View Source

PharmaCyte Biotech Commences First Phase of Two-Phase Pig Study

On July 21, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has commenced the pilot phase of its two-phase pig study (Press release, PharmaCyte Biotech, JUL 21, 2022, View Source [SID1234616858]). The pig study is the last of several requirements PharmaCyte has complied with related to the requests from the U.S. Food and Drug Administration (FDA) to lift the clinical hold on PharmaCyte’s planned Phase 2b clinical trial for locally advanced, inoperable pancreatic cancer (LAPC).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, explained, "As part of the Investigational New Drug Application process in preparation for our planned clinical trial in LAPC, the FDA requested data in a large animal, such as a pig, which allows for assessment of safety and distribution of CypCaps following infusion using the clinical route of application, devices, and procedures.

"The study will be conducted in two phases. The first phase, which began today, is a short pilot study in two pigs. The objective of this pilot study is to assess microcatheter-based delivery of CypCaps in the pancreatic arterial system. Volume of dose, number of CypCaps, and treatment location will be evaluated using imaging and histology. Also, the CypCaps used in the study will contain radiopaque microspheres, which will be evaluated to track the movement of the CypCaps.

"The data obtained from the pilot study will allow us to finalize the full-scale pig study protocol, which will involve 90 pigs. We will then present the protocol to the FDA in our planned Type A meeting which will provide us an opportunity to interact with the FDA to receive guidance on this and several other outstanding issues relating to the clinical hold. Subject to any FDA-suggested modifications to the protocol, we are fully prepared to carry on with the full-scale study. We feel that this strategy will provide the greatest likelihood for ultimate success."

The pilot study will involve two 90-pound Yorkshire pigs. They will receive a single intra-arterial injection of 100 CypCaps into the pancreatic arterial system through a microcatheter. Fluoroscopy will be used to qualitatively evaluate parameters such as vascular anatomy, treatment site suitability, and acute deployment characteristics. Over the course of a week, the animals will be clinically observed, given health and incision site checks, and body weight and condition will be scored.

At the conclusion of the clinical phase, whole blood and serum will be analyzed, and tissue will be collected including the pancreas and adjacent areas and CT imaged to evaluate potential spillover of the CypCaps containing radiopaque microspheres. After CT imaging is performed, various tissue sections will be histologically evaluated by a board-certified veterinary pathologist. Light microscopy will be used to examine collected tissues to evaluate for any adverse effects associated with implantation of the CypCaps. Evaluation of pancreatic samples will include the presence of microspheres, necrosis, fibroplasia, fibrosis, inflammation, mineralization/ossification, and evidence of vascular injury. Light microscopy of additional tissues will be reviewed to assess for adverse effects associated with treatment, including thrombosis, necrosis, inflammation, and presence of embolic material.

Both phases of the pig study are being conducted by CBSET, Inc., located in Lexington, Massachusetts.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch PharmaCyte’s documentary video complete with medical animations at: View Source

Adaptimmune to Report Q2 2022 Financial Results and Business Updates on Thursday, August 4, 2022

On July 21, 2022 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, reported that it will report financial results and provide business updates for the second quarter ended June 30, 2022, before the US markets open on Thursday, August 4, 2022 (Press release, Adaptimmune, JUL 21, 2022, View Source [SID1234616857]). Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) that same day.

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The press release will be available in the investor section of Adaptimmune’s corporate website. A live webcast of the conference call and replay can be accessed at View Source Call in information is as follows: (800)-952-5114 (US or Canada) or +1 (416)-406-0743 (International and additional options available HERE). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (5869059).