Qurient Announces Collaboration Agreement with MSD to Evaluate Selective CDK7 Inhibitor Q901 in Combination With KEYTRUDA (pembrolizumab)

Qurient Co. Ltd. (KRX: 115180), a clinical-stage biotech company based in Korea, have announced that the company have entered into a clinical collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ., USA), for clinical study of Q901, a selective CDK7 inhibitor in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab).

Under this agreement, Qurient will conduct a phase 1/2 study in the U.S. to evaluate safety and efficacy of Q901 in combination with KEYTRUDA for the treatment of selected advanced solid tumors.

Terms of the collaboration were not disclosed.

Biocytogen Announces Collaboration with FineImmune to Develop TCR-Mimic Antibody-based Cell Therapy

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. have announced a strategic collaboration with Guangzhou FineImmune Biotechnology Co., LTD. to co-develop cell-based therapeutic drugs targeting intracellular tumor-associated antigens. 

Biocytogen will use their proprietary TCR-mimic antibody platform to discover fully human antibody sequences that will be further developed using FineImmune’s unique cell therapy platform.

Biocytogen’s TCR-mimic antibody development platform utilizes its proprietary fully human antibody RenMice™ (RenMab™ and RenLite® mice) that have been further engineered to express a human leukocyte antigen (HLA) gene. Antibodies against intracellular tumor-associated antigens are subjected to advanced high-throughput antibody screening technologies to discover antibodies with high specificity and affinity.

Bristol Myers Squibb Announces CheckMate -76K Trial Results of Opdivo (nivolumab) for Adjuvant Treatment in Stage IIB/C Melanoma

Bristol Myers Squibb ($BMY) have announced that the Phase 3 CheckMate -76K trial evaluating Opdivo (nivolumab) as a single agent in the adjuvant setting in patients with completely resected stage IIB/C melanoma met its primary endpoint and demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo at a pre-specified interim analysis. No new safety signals were observed at the time of the analysis.

CheckMate -76K is part of BMS’ development program studying Opdivo and Opdivo-based combinations in earlier stages of cancer, which currently spans seven tumor types.

CheckMate -76K is a randomized Phase 3, double-blind study evaluating adjuvant Opdivo (nivolumab) 480 mg Q4W for up to 12 months versus placebo in patients with completely resected stage IIB/C melanoma.

The primary endpoint of the trial is recurrence-free survival (RFS). Secondary endpoints of the trial include overall survival (OS), distant metastases-free survival (DMFS), progression-free survival on next-line therapy (PFS2), and safety endpoints.

CARsgen Releases the First Clinical Batch of CAR T Cells from its RTP GMP Manufacturing Facility in North Carolina

 

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR Tcell therapies for the treatment of hematologic malignancies and solid tumors, announces that the company’s Current Good Manufacturing Practice (CGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (“The RTP GMP Manufacturing Facility”) has started GMP production of autologous CAR T-cell products and successfully released the first GMP batch for the clinical trials.

The RTP GMP Manufacturing Facility, with a total gross floor area of approximately 3,300 sq.m, will provide CARsgen additional manufacturing capacity of autologous CAR T-cell products for 700 patients annually to support clinical studies and early commercial launch in North America and Europe.

CARsgen's RTP GMP Manufacturing Facility (Photo: Business Wire)

Boehringer Ingelheim's spesolimab receives US FDA approval for generalized pustular psoriasis flares in adults

Boehringer Ingelheim have announced that the U.S. Food and Drug Administration have approved spesolimab as a treatment option for generalized pustular psoriasis (GPP) flares in adults.

Spesolimab, marketed in the U.S. as SPEVIGO, is a novel, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of GPP.

The FDA’s approval of spesolimab is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial. In the 12-week trial, patients experiencing a GPP flare were treated with spesolimab or placebo. Most patients at the outset of the trial had a high, or very high, density of pustules, and impaired quality of life. After one week, 54% of patients treated with spesolimab showed no visible pustules compared to placebo (6%).1

In addition to the U.S. approval, spesolimab is currently under review by several other regulatory authorities. To date, spesolimab has received Breakthrough Therapy Designation in the U.S., China and Taiwan, Priority Review in the U.S. and China, Orphan Drug Designation in the U.S., Korea, Switzerland and Australia, Rare Disease Designation and fast track in Taiwan, for the treatment of GPP flares. The European Medicines Agency validated the marketing authorization application for spesolimab in GPP in October 2021 and the submission is currently under evaluation.

OMBLASTYS (omburtamab) goes to ODAC on October 28 2022

Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, have announced that a meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has been scheduled for October 28, 2022 to review the Company’s Biological License Application (BLA) for its product candidate, OMBLASTYS (omburtamab), an investigational radiolabeled antibody construct. 

Y-mAbs resubmitted the BLA for OMBLASTYS on March 31, 2022, and the FDA assigned a Prescription Drug User Fee Act goal date of November 30, 2022, for the completion of its priority review of the OMBLASTYS BLA.

European Society for Medical Oncology (ESMO 2022) - Abstract publication schedule

Online Programme available here

Publication schedule of accepted abstracts:

Abstracts	Date and time
Regular abstracts accepted as: Proffered Paper (suffix ‘O’) Mini Oral (suffix ‘MO’) Poster (suffix ‘P’) Poster (suffix ‘TiP’) EONS Poster (prefix ‘CN’)	Monday, 5 September 2022 00:05 Central European Summer Time (CEST)
All late-breaking abstracts (prefix ‘LBA’)	Thursday, 8 September 2022 00:05 Central European Summer Time (CEST)
Dedicated embargo for LBA1 and 903O	Friday, 9 September 2022 00:05 Central European Summer Time (CEST)
Dedicated embargo for LBA10	Monday, 12 September 2022 00:05 Central European Summer Time (CEST)

1. All regular abstracts accepted for presentation at ESMO 2022 as Proffered Paper (suffix O), Mini Oral (suffix MO), Poster (suffix P or TiP) will be published online via the ESMO website at 00:05 CEST on Monday, 5 September 2022.
2. All Late-breaking abstracts accepted for presentation at ESMO 2022 as Proffered Paper or Mini Oral (prefix LBA) will be published online via the ESMO website at 00:05 CEST on Thursday, 8 September 2022.
3. LBA1 and Abstract 903O will be published online via the ESMO website at 00:05 CEST on Friday, 9 September 2022.
4. LBA10 will be published online via the ESMO website at 00:05 CEST on Monday, 12 September 2022.
5. The official hashtag is #ESMO22: using it will allow you to join the conversation around the Congress
6. To follow ESMO on Social Media:

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Guardant Health Expands Strategic Collaboration With Merck KGaA, Darmstadt, Germany, to Help Accelerate Development of Precision Oncology Therapeutics

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced an expanded collaboration with Merck KGaA, Darmstadt, Germany, a leading science and technology company, operating its biopharmaceuticals business in the U.S. and Canada as EMD Serono, to further leverage the GuardantINFORM real-world evidence (RWE) platform to help accelerate development efforts for Merck KGaA, Darmstadt, Germany‘s precision oncology pipeline. The expanded strategic collaboration will focus on therapy development for core cancer indications with significant unmet need.

Under the expanded collaboration, Merck KGaA, Darmstadt, Germany, will work closely with data scientists at Guardant Health on a variety of therapy development initiatives that utilize the genomics and clinical information accessible through the GuardantINFORM platform.

About GuardantINFORM

The GuardantINFORM clinical-genomic platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test. With data from more than 225,000 patients diagnosed with locally advanced and metastatic cancers, this robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers, including non-small cell lung, breast, colon, and prostate.

FDA Approves KRYSTEXXA® (pegloticase) Injection Co-Administered With Methotrexate, Expanding the Labeling to Help More People with Uncontrolled Gout Achieve a Complete Response to Therapy

Horizon Therapeutics (Nasdaq: HZNP) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) expanding the labeling to include KRYSTEXXA (pegloticase) injection co-administered with methotrexate, which will help more people with uncontrolled gout achieve a complete response to therapy.

The expanded labeling for KRYSTEXXA with methotrexate is based on the results from the MIRROR randomized controlled trial in which adults living with uncontrolled gout were randomized to receive methotrexate (15 mg/week) or placebo for four weeks, and then treatment with KRYSTEXXA with methotrexate or KRYSTEXXA with placebo for 52 weeks. The primary endpoint was defined as the proportion of serum uric acid (sUA) responders during Month 6 (defined as sUA less than 6 mg/dL at least 80% of the time).

AIDS Healthcare Foundation (AHF) urges the World Health Organization to declare Monkeypox as a Pandemic

With more than 7,600 cases throughout 58 countries globally, AIDS Healthcare Foundation (AHF) urges the World Health Organization not to repeat the past mistake of delaying declarations for COVID-19 and immediately declare the monkeypox outbreak a public health emergency of international concern (PHEIC).

A PHEIC declaration for monkeypox would also add urgency to produce and widely distribute sufficient quantities of vaccines and tests. The U.S. Food and Drug Administration has already approved JYNNEOS, a smallpox vaccine, for use to prevent monkeypox infection. The European Medicines Agency is considering the same for Imvanex, the same drug marketed under a different name, according to Health Policy Watch.

AHF issued a previous statement calling on the WHO to declare the monkeypox outbreak a public health emergency of international concern after the global health agency failed to do so at its meeting on June 25.

ADC Therapeutics Announces Exclusive License Agreement with Sobi to Develop and Commercialize ZYNLONTA (loncastuximab tesirine-lpyl) in Europe and Select International Territories

ADC Therapeutics SA (NYSE: ADCT) have announced that they have entered into an exclusive license agreement with Swedish Orphan Biovitrum AB (Sobi®) for the development and commercialization of ZYNLONTA® for all hematologic and solid tumor indications outside of the United States, greater China, Singapore and Japan. 

The Marketing Authorization Application (MAA) for ZYNLONTA was validated by the European Medicines Agency (EMA) at the end of October 2021, and orphan drug designation was granted for ZYNLONTA for the treatment of diffuse large B-cell lymphoma (DLBCL) in Europe. ADC Therapeutics and Sobi intend to make ZYNLONTA available following a regulatory decision that is expected by the first quarter of 2023.

Under the terms of the agreement, ADC Therapeutics will receive an upfront payment of $55 million, and is eligible to receive $50 million upon regulatory approval of ZYNLONTA in third-line DLBCL by the European Commission and up to approximately $330 million in additional regulatory and sales milestones. 

ADC Therapeutics will also receive a percentage of royalties ranging from the mid-teens to the mid-twenties based on net sales of ZYNLONTA in Sobi’s territories. Sobi will share a portion of select global ZYNLONTA clinical trial costs.

Oncology Merger and acquisitions in the last seven years

An interesting compilation of the mergers and acquisitions (M&A) in Oncology in the last seven years. 

source

Indian Pharma Market Sales - March 2022

Indian Pharma Market is at Rs. 14, 190 Crores (~142 Bn Rs) in March 2022 according to IQVIA.

While Cardiac and Gastro continue to be leading segments in the market, Anti-infectives segment has seen a decline by 6% in the month of month growth. Perhaps the first in the last two years.