On December 1, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will host an investor event on December 10 during the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in New Orleans, LA (Press release, Affimed, DEC 1, 2022, View Source [SID1234624722]).

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Investor event information
Date and Time: Saturday, December 10 at 4:00 p.m. CST / 5:00 p.m. EST / 23:00 CET
Location: New Orleans, LA and virtual
Affimed will host an investor event to review AFM13 clinical data and development plans in CD30 expressing malignancies. The investor event will take place in-person and virtually and a webcast of the event will be available in the "Webcasts" section on the "Investors" page of Affimed’s website at View Source
To access the event via phone, please dial +1 (929) 205-6099 for U.S. callers, or +44 (203) 481-5240 for international callers, and reference meeting ID 847 4106 6227 approximately 15 minutes prior to the call.
To reserve your place in the live event, please contact Alex Fudukidis via e-mail at [email protected].
A replay of the webcast/call will be archived on Affimed’s website for 30 days after the call.

About AFM13
AFM13 is a CD30/CD16A bispecific Innate Cell Engager (ICE) that is investigated in Hodgkin Lymphoma (HL) and T cell lymphoma (TCL). AFM13 has shown single agent efficacy in HL and TCL and is currently being evaluated as monotherapy in a single arm registration-directed trial in peripheral TCL (REDIRECT). In addition, AFM13 showed high response rates in combination with the anti-PD-1 antibody Keytruda (ORR: 88%, CR: 46%) and in combination with allogeneic cord blood-derived NK cells (ORR: 100%, CR: 71%). Affimed recently entered into a partnership with Artiva to develop AFM13 in combination with Artiva’s allogeneic, cryopreserved, NK cell product AB-101 in HL and TCL.

On December 1, 2022 Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, reported that it has assumed full commercial activities and is relaunching oral AKYNZEO (netupitant/palonosetron capsules) in Canada (Press release, Knight Therapeutics, DEC 1, 2022, View Source;in-Canada-12-1-2022 [SID1234624720]).

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Knight and Helsinn Healthcare SA ("Helsinn") entered into an exclusive license, distribution and supply agreement for oral/IV AKYNZEO in Canada, Brazil, Argentina, Uruguay and Paraguay, and ALOXI oral/IV (palonosetron) in Canada (the "Products") in May 2022.

AKYNZEO (netupitant/palonosetron capsules) for oral administration is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. According to IQVIA, sales of AKYNZEO in Canada and Brazil were approximately $7 million in 2021.

"We are excited to take over Canadian commercialization of AKYNZEO, an innovative once-per-cycle fixed dose, dual combination antiemetic that offers a leading and guideline-recommended prophylactic treatment for chemotherapy induced nausea and vomiting," said Samira Sakhia, President and CEO of Knight. "AKYNZEO builds upon Knight’s growing Canadian oncology portfolio, increasing our presence in this important therapeutic area."

"Chemotherapy induced nausea and vomiting remain some of the most feared potential side effects of chemotherapy. While remarkable advances have been made in new chemotherapeutics, benefitting the lives of our patients, it is incumbent upon oncologists to try to make their journeys as safe and comfortable as possible. AKYNZEO, a combination of the pharmacologically and clinically distinct 5-HT3 receptor antagonist palonosetron and the selective NK1 receptor antagonist netupitant, has simplified antiemetic prophylaxis, providing an effective therapy with the lowest pill burden, and has been greatly appreciated by our cancer patients," said Dr. Sandeep Sehdev, medical oncologist at the Ottawa Hospital Cancer Centre & Scientific Advisor for the Canadian Breast Cancer Network.

About AKYNZEO
AKYNZEO is the first and only 5-HT3 and NK1 receptor antagonist fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO given with dexamethasone prior to chemotherapy has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. AKYNZEO oral is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. AKYNZEO oral is also approved and marketed in Argentina and Brazil for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

On December 1, 2022 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that, following the recent receipt of official minutes from its pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration (FDA), the Company plans to submit an NDA as soon as the end of 2022 for marketing approval of the investigational drug candidate ADX-2191 for the treatment of primary vitreoretinal lymphoma (Press release, Aldeyra Therapeutics, DEC 1, 2022, View Source [SID1234624719]).

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"Pending FDA review, ADX-2191 could be the first FDA-approved therapy for primary vitreoretinal lymphoma, a rare but potentially fatal cancer with a median survival of less than five years," stated Todd C. Brady, M.D., Ph.D., Aldeyra’s President and Chief Executive Officer.

ADX-2191, which has received FDA Orphan Drug Designation for the treatment of primary vitreoretinal lymphoma, is a novel, vitreous-compatible formulation of methotrexate. The planned NDA submission is expected to include a combination of published literature on the safety and efficacy of methotrexate for the treatment of primary vitreoretinal lymphoma and safety data from the recently completed Phase 3 GUARD Trial of ADX-2191 in proliferative vitreoretinopathy. During the Phase 3 GUARD Trial, no safety signals were observed, and ADX-2191 was well tolerated; there were no observed treatment-emergent serious adverse events. The most common adverse event associated with ADX-2191 treatment was punctate keratitis, a frequently observed side effect of intravitreal methotrexate, that was most commonly mild in severity. In the Phase 3 GUARD Trial, the incidence of punctate keratitis with ADX-2191 administration was observed to be less than that previously reported with intravitreal injection of compounded methotrexate.1

Based on the pre-NDA meeting minutes, Aldeyra intends to request Priority Review designation, which reduces the review period in which the FDA aims to take action on an NDA to within 6 months (compared to 10 months under standard review). The designation is intended to direct overall attention and resources to the evaluation of applications for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

In addition to the planned NDA submission for ADX-2191 in primary vitreoretinal lymphoma, a Type C meeting with the FDA to discuss the completion of clinical development of ADX-2191 for the prevention of proliferative vitreoretinopathy is planned for the first half of 2023, and results from the Phase 2 clinical trial of ADX-2191 in retinitis pigmentosa are expected in the first half of 2023.

About ADX-2191

ADX-2191 (methotrexate injection, USP) is a sterile, non-compounded intravitreal formulation of methotrexate for the potential prevention or treatment of specific rare retinal diseases, including primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and retinitis pigmentosa. The ADX-2191 intravitreal formulation is preservative-free, designed to be vitreous-compatible, and optimized for excipient composition, viscosity, density, tonicity, pH, concentration, and volume of administration. ADX-2191 has received FDA Orphan Drug Designation for the prevention of proliferative vitreoretinopathy, and the treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.

About Primary Vitreoretinal Lymphoma

Primary vitreoretinal lymphoma is a rare, aggressive, and potentially fatal retinal cancer that is diagnosed in approximately 300 to 600 patients in the United States per year. The median survival for newly diagnosed patients is 4.83 years. The most common ocular complaints reported by patients include blurred vision, painless loss of vision, floaters, red eye, and photophobia. No approved treatments are currently available, though methotrexate represents the current standard of care.

On December 1, 2022 Qurient Co. Ltd. (KRX: 115180), a clinical-stage biotech company based in Korea, reported that the first patient has been dosed in the Phase 1/2 dose-escalation and expansion study of Q901 in patients with advanced solid tumors (Press release, Qurient Therapeutics, DEC 1, 2022, View Source [SID1234624718]).

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The Q901 Phase 1/2 study (NCT05394103) is being conducted at six investigative sites in the U.S., and approximately 70 patients with advanced solid tumors are scheduled to be enrolled. The primary objectives of the Phase 1/2 study are to determine the maximum tolerated dose, safety profile, and anticancer efficacy of Q901.

Kiyean Nam, Ph.D., CEO of Qurient, commented, "The initiation of this study represents a significant milestone for Qurient as it marks the second oncology program to enter into clinical development. We look forward to the eventual completion of this Phase 1/2 study, which will guide the further development of Q901 both as monotherapy and in combination with other standard of care therapies that could benefit from genomic instability triggered by Q901."

About Q901

Q901 is a highly selective CDK7 inhibitor that disrupts tumor cells division cycle progression and blocks DNA damage repair, resulting in tumor cell apoptosis. The genomic instability triggered by Q901 not only contributes to cell death but also provokes immune surveillance against tumor cells. Q901 is the company’s second oncology drug candidate being developed to treat patients with advanced solid tumors.

In preclinical studies, Q901 has demonstrated a high level of tumor growth inhibition activity as a monotherapy in a variety of tumor models, including prostate, pancreatic, colorectal, and breast cancers, that do not respond to conventional therapies. Q901 also has substantial activity in other preclinical cancer models where CDK4/6 cell cycle inhibitors have minimal or reduced activity

On December 1, 2022 Tevogen Bio, a late-stage clinical biotechnology company specializing in the development of cellular immunotherapies in oncology, neurology, and virology reported that its intention to study potential therapeutic use of its allogeneic genetically unmodified precision T cell technology in multiple sclerosis (MS) by developing Epstein-Barr virus (EBV) specific CD8+ cytotoxic T lymphocytes (CTL) (Press release, Tevogen Bio, DEC 1, 2022, View Source [SID1234624717]). These CTLs will also be studied for the potential use in EBV-related cancers, such as nasopharyngeal carcinoma and certain lymphomas.

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"Recent studies on MS have suggested a probable link between infection with EBV and later onset of the inflammation that degrades the myelin sheath and causes MS," said Dr. Neal Flomenberg, Tevogen’s Chief Scientific Officer. "We look to apply our significant expertise in off-the-shelf allogeneic SARS-CoV-2 specific CD8+ cytotoxic T lymphocytes to explore EBV specific CTL therapy as a possible means of addressing the unmet needs of MS patients and certain cancer patients," Flomenberg added.

"With nearly 1 million patients living with multiple sclerosis in the United States alone, we hope to bring additional arsenal to help treat this debilitating disease, which impacts patients in their most productive years," said Sadiq Khan, M.B.A, Tevogen’s Chief Commercial Officer.

"We believe that cell therapies are expected to be the norm, not the exception," said Tevogen CEO Ryan Saadi, M.D., M.P.H. "Tevogen aspires and is designed to be the very first biotech to achieve commercial success and patient affordability through advanced science and efficient business models."

About Tevogen’s Next Generation Precision T Cell Platform

Tevogen’s next generation precision T cell platform is designed to provide increased immunologic specificity to eliminate malignant and virally infected cells, while allowing healthy cells to remain intact. Multiple targets are selected in advance with the goal of overcoming the mutational capacity of cancer cells and viruses which can otherwise allow for escape from immunologic targeting.

Tevogen is investigating its technology’s potential to overcome the primary barriers to the broad application of personalized T cell therapies: potency, purity, production-at-scale, and patient-pairing, without the limitations of current approaches. Tevogen’s goal is to open the vast and unprecedented potential of developing personalized immunotherapies for large patient populations impacted by common cancers and viral infections.

Tevogen announced the completion of patient enrollment in the Proof-of-Concept clinical trial of its lead product, TVGN-489, for ambulatory, acute-risk COVID-19 patients, with no dose-limiting toxicities or significant treatment-related adverse events observed for any patient at any dose level.

TVGN-489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with activity against multiple, precise targets across the entire SARS-CoV-2 genome.