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Interim Report Q2, 2021

On August 19, 2021 Calliditas Therapeutics reported that During the 2nd quarter we significantly ramped up our pre commercial activities in the US following the strengthening of the team announced in Q1 (Press release, Calliditas Therapeutics, AUG 19, 2021, View Source [SID1234586741]). We have added significant internal resources as well as entered into some key partnerships, in order to ensure that we are well positioned to initiate commercialization in Q4, subject to a positive outcome of the FDA approval process.

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During Q2 we also explored avenues to non-dilutive financing by way of a competitive process in order to provide the company with access to additional capital in advance of, as well as post a potential regulatory approval. In parallel we also ran a successful competitive process focused on securing a strong European commercial partner for Nefecon. The result of these processes which was announced in Q3 resulted in over $100m of non- dilutive capital potentially being available to the company, divided between approximately $50m available pre-approval with the remainder becoming available post FDA and EMA approvals and subsequent US commercialization. These processes, together with the accelerated book building procedure raising approximately gross $37m (SEK 324 million) which we completed in Q3, have significantly enhanced our financial strength after the close of Q2."

Renée Aguiar-Lucander, CEO

Summary of Q2 2021
April 1 – June 30, 2021

No net sales were recognized for the three months ended June 30, 2021 and 2020, respectively.
Operating loss amounted to SEK 159.4 million and SEK 66.6 million for the three months ended June 30, 2021 and 2020, respectively.
Loss before income tax amounted to SEK 165.2 million and SEK 61.3 million for the three months ended June 30, 2021 and 2020, respectively.
Loss per share before and after dilution amounted to SEK 3.20 and SEK 1.50 for the three months ended June 30, 2021 and 2020, respectively.
Cash amounted to SEK 709.3 million and SEK 1,459.6 million as of June 30, 2021 and 2020, respectively.
Significant events during Q2 2021, in summary
In April 2021, Calliditas was granted accelerated assessment procedure by the European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP) for Nefecon, reducing the maximum timeframe for review of the application for marketing authorization. If approved, Nefecon could be available to patients in Europe in first half of 2022.
In April 2021, Calliditas announced that the FDA accepted the submission and granted Priority Review for the NDA for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. Subject to approval, this would enable commercialization of Nefecon in the US in Q4, 2021.
In May 2021, Calliditas announced that the company submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon.
Significant events after the end of reporting period, in summary
In July 2021, Calliditas signed a loan facility of up to the EUR equivalent of $75 million with Kreos Capital.
In July 2021, Calliditas and STADA Arzneimittel AG entered into a license agreement to register and commercialize Nefecon in the European Economic Area (EEA) member states, Switzerland and the UK valued at a total of 97.5 million EUR ($115m) in initial upfront and potential milestone payments, plus royalties.
In August 2021, Calliditas received FDA fast track designation for setanaxib in PBC.
In August 2021, Calliditas completed an accelerated book building procedure and resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of SEK 324.0 million before transaction costs.
Investor presentation August 19, 14:30 CET
Audio cast with teleconference, Q2 2021, August 19, 2021, 14:30 (Europe/Stockholm)

Financial calendar
Interim Report for the period January 1 – September 30, 2021 November 18, 2021

Year-end Report for the period January 1 – December 31, 2021 February 24, 2022

Scandion Oncology A/S announces its results for the first half year of 2021

On August 19, 2021 Scandion Oncology reported its half year report for 2021 (Press release, Scandion Oncology, AUG 19, 2021, View Source,c3399288 [SID1234586740]). The following is taken from the report.

Bo Rode Hansen, President and CEO comments

"Positive interim CORIST results highlight an intensive quarter – The second quarter of 2021 was as busy and rewarding as the first three months. We reached several milestones both clinically and organizationally. Most importantly, we reported positive interim results from our Phase II
clinical study CORIST."

Highlights during Q2 2021

On 21 April, Scandion Oncology announced that Dr. Richard L. Schilsky, a seasoned and highly profiled international leader, was appointed as member of Scandion Oncology’s clinical advisory board
On 2 June, Scandion Oncology appointed Johnny Stilou as new CFO. He has long experience from both Danish and international listed companies.
On 24 June, Scandion Oncology reported positive results from the dose-finding part 1 of the CORIST Phase II study. A well tolerated dose of SCO-101 in combination with the chemotherapy regimen FOLFIRI had been determined and the SCO-101 treatment in the optimized combination resulted in notable potentiation of the biological activity of FOLFIRI. Furthermore, from the CORIST study the RAS oncogene has been identified as a predictive biomarker of optimal SCO-101 effect. This discovery will be used to optimize the inclusion of patients in part 2. These positive data have significantly de-risked the further development of SCO-101 and the company is now ready to advance to the proof-of-concept study (part 2) of CORIST.
On 30 June, Scandion Oncology announced promising preclinical data from the ongoing collaboration with Alligator Bioscience AB, exploring the anti-tumor effects on drug resistant cancer by combining Scandion Oncology’s drug candidate SCO-101 and Alligator Bioscience’s candidate drug mitazalimab together with chemotherapy.
Highlights after the end of the period

On 19 July, Scandion Oncology announced the date for the Scandion Oncology Capital Markets Day, which will take place on September 8, 2021.
The half year report 2021 is available on the Company’s website: www.scandiononcology.com.

Audiocast today, 19 August at 10:00 am CET

Today at 10:00 Scandion Oncology’s executive management will host a webcast and conference call presenting the results and a company update.

At the end of the presentation there will be a Q&A session.
This information is information that Scandion Oncology A/S is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, on 19 August 2021, at 8:30 CET

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, on 19 August 2021, at 8:30 CET

Beroni Initiates Manufacture of its Novel, Potential Anti-Cancer Drug PENAO

On August 18, 2021 Beroni Group (OTCQX: BNIGF; NSX: BTG) ("Beroni"), an Australia-based diversified biopharmaceutical enterprise, reported that PENAO Pty Ltd, its majority-owned, Sydney-based anti-cancer drug development company, has signed a drug manufacture contract with Aurigene Pharmaceutical Services, India, a subsidiary of Dr Reddy’s Laboratories Limited (NYSE: RDY; BSE: 500124) (Press release, Beroni Group, AUG 18, 2021, View Source [SID1234597999]).

This next-generation adenine nucleotide translocase (ANT) inhibitor, PENAO, was shown to be safe and well-tolerated in a phase I clinical trial conducted in Australia where encouraging efficacy data was observed. In a second clinical trial to commence H1 2022, PENAO is planned to be administered as twice-weekly injections to patients with advanced solid tumors. It is going to be a dose-finding study that also investigates anti-tumor effects using morphological assessments including radiological responses, molecular imaging surrogates, and anti-proliferative effects.

PENAO enjoys the support of a multi-national, high-quality management team including the drug’s co-creator Professor Phil Hogg, and minority shareholder the University of New South Wales, Sydney.

"I am pleased that we are making significant progress in the development of the anti-cancer drug PENAO. PENAO is a novel therapy targeting tumor cell mitochondria and could potentially have application in a wide range of cancers, including colorectal cancer, pancreatic cancer, ovarian cancer, liver cancer, etc.," said Jacky Zhang, CEO of Beroni Group. "It is a potential treatment for cancers that are unresponsive to standard treatment, or for which no standard treatment exists."

Coherus and Junshi Biosciences Announce Positive Interim Results of CHOICE-01, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer

On August 18, 2021 Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported positive interim results from the pivotal study "CHOICE-01" (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (NSCLC) (Press release, Coherus Biosciences, AUG 18, 2021, View Source [SID1234586739]). The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival (PFS) per RECIST v1.1 compared to chemotherapy alone.

The results will be summarized September 13 in an oral presentation by Professor Jie Wang, MD, PhD, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, during the Mini Oral Session at the 2021 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). The abstract is now available on the WCLC website.

"The CHOICE-01 study in patients with advanced non-small cell lung cancer has demonstrated the clinical benefit of toripalimab in yet another first-line setting, building on the evidence of efficacy in first-line studies in nasopharyngeal carcinoma and esophageal squamous cell carcinoma," said Dr. Patricia Keegan, Chief Medical Officer at Junshi Biosciences. "With an excellent clinical profile being established across multiple tumor types, we expect to pursue registration for toripalimab for a broad array of indications in China, the United States and other markets."

"The CHOICE-01 efficacy and safety data are compelling and demonstrate the potential for toripalimab to deliver the significant benefits of the PD-1 class of checkpoint inhibitor drugs to patients with non-small cell lung cancer," said Ildiko Csiki, MD, PhD, Chair of the Coherus Scientific Advisory Board and Chief Commercial Research and Development Officer at City of Hope, a comprehensive cancer center. "As data accumulate in the pivotal studies in the broad clinical development program, toripalimab is showing itself to be an excellent checkpoint inhibitor. We eagerly anticipate results from additional Phase 3 studies in esophageal, lung, liver, breast, kidney, bladder, stomach, and skin cancers."

About CHOICE-01
A total of 465 treatment-naive advanced NSCLC patients (220 squamous and 245 non-squamous) were randomized (2:1): 309 to the toripalimab plus chemotherapy arm and 156 to the placebo plus chemotherapy arm. The primary endpoint of PFS was assessed by the investigator. Secondary endpoints included PFS assessed by a blinded independent review committee (BIRC), overall survival (OS), objective response rate (ORR) and duration of response (DoR). Crossover to toripalimab was allowed for patients from the placebo plus chemotherapy arm upon disease progression.

As of November 17, 2020 (the data cut-off date of the interim analysis), 218 PFS events were observed, with a median follow-up of 7.1 and 7.0 months in the toripalimab arm and the placebo arm, respectively.
At the interim analysis, a significant improvement in PFS was detected for toripalimab over placebo [hazard ratio (HR)=0.58,95% confidence interval (CI): 0.44-0.77, P=0.0001] with median PFS of 8.3 vs. 5.6 months. The 1-year PFS rates for toripalimab and placebo arms were 32.6% and 13.1%, respectively.
This improvement in PFS was observed in both squamous [HR = 0.55 (95% CI: 0.38-0.83)] and non-squamous [HR=0.59 (95% CI: 0.40-0.87)] NSCLC and regardless of PD-L1 expression.
PFS assessed by BIRC showed similar results as PFS assessed by the investigator.
Toripalimab in combination with chemotherapy, as compared with chemotherapy alone, resulted in better ORR (squamous NSCLC: 68.7% vs. 58.9%; non-squamous NSCLC: 58.6% versus 26.5%) and median DoR (squamous NSCLC: 6.9 months vs. 4.2 months; non-squamous NSCLC: 8.6 months vs. 5.1 months).
Patients in the placebo plus chemotherapy arm were actively crossed over to toripalimab treatment at the time of disease progression.
Overall survival data were not yet mature as of March 7, 2021. There was a trend favoring the toripalimab arm [median OS of 21.0 vs. 16.0 months, HR = 0.81 (95% CI: 0.57-1.17)].
The addition of toripalimab to standard first-line chemotherapy in patients with advanced NSCLC showed a manageable safety profile with no new safety signal observed. The incidence of Grade ≥3 adverse events (AEs) was 76.3% in the toripalimab arm vs. 80.1% in the control arm. AEs leading to discontinuation of toripalimab or placebo were 12.3% vs. 1.9%, respectively.
Junshi Biosciences and Coherus plan to meet with the United States Food and Drug Administration to discuss a potential submission of a biologics license application for toripalimab for first line treatment of advanced NSCLC.

About toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells.

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

In the United States, a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC") and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

Astellas Partners with LabCentral to Help Emerging Biotechs Accelerate Preclinical Scientific Research

On August 18, 2021 Astellas Venture Management LLC (President: Kazunori Maruyama, Ph.D., "AVM"), a wholly-owned venture capital subsidiary of Astellas Pharma Inc., and LabCentral, a launchpad for early-stage life-sciences startups, reported their collaboration on the "Future Innovator Prize" formerly known as the Astellas Golden Ticket Competition (Press release, Astellas, AUG 18, 2021, View Source [SID1234586737]). The Future Innovator Prize offers entrepreneurial scientists or emerging biotechnology start-ups one-year usage of LabCentral’s state-of-the-art lab facility in Cambridge, Massachusetts, as well as access to Astellas’ research and development (R&D) capabilities and business leaders.

Astellas’ sponsorship of the Future Innovator Prize follows AVM obtaining Gold Sponsorship of LabCentral in October of 2019. With a shared commitment to discovering and advancing innovative science for the potential future benefit of patients worldwide, Astellas and LabCentral are proud to support scientists and early stage companies to accelerate their novel therapeutic programs, modalities or platforms.

"External innovation is critically important in helping us achieve our VISION of turning innovative science into VALUE for patients," said Maruyama, President, AVM. "Combining our R&D capabilities and expertise with LabCentral’s established network and launchpad in the Boston area, we look to bring hope to patients worldwide by partnering with emerging biotechnology companies and transforming their ideas into reality."

"We are extremely pleased to be working with Astellas to foster life-science innovation in the Boston area," said Johannes Fruehauf, LabCentral Co-founder and President. "Our labs offer a fertile environment in which biotechnology visionaries can thrive by providing them with the space and resources they need to test out, challenge, and nurture early ideas. We are excited that Astellas has chosen to create the Future Innovator Prize program to supplement their external innovation initiatives."

About the Future Innovator Prize at LabCentral
Astellas is offering up to two Future Innovator Prizes for pioneering scientists with innovative research that complements Astellas’ areas of interest that fit with the Astellas Focus Area Approach and pipeline, including oncology, immunology, neuroscience including neuromuscular and sensory disorders.

Companies awarded an Astellas Future Innovator Prize will gain one year’s priority admission or renewal to LabCentral’s state-of-the-art laboratory as well as access to Astellas’ R&D scientists and leaders. Time for submitting applications for the competition is from Wednesday August 18, 2021 to Monday September 20, 2021. Entrepreneurial scientists, emerging life-science or biotech start-ups are encouraged to apply and can learn more about the opportunity at View Source The decision to award any Future Innovator Prize, and the assessments underlying such decision, are solely the judgment of Astellas and LabCentral, and are not subject to objection or appeal.