On April 20, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported the closing of the sale of Coherus common stock to Junshi Biosciences. Under the terms of the February 2, 2021 stock purchase agreement, Coherus has received $50 million from Junshi Biosciences’ acquisition of 2,491,988 shares at a price per share of $20.06 (Press release, Coherus Biosciences, APR 20, 2021, View Source [SID1234578234]). The collaboration agreement between the companies for the development and commercialization in the United States and Canada of toripalimab, Junshi Biosciences’ PD-1 antibody, became effective in March.

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"This collaboration is a tremendous opportunity for Junshi Biosciences given Coherus’ commercial expertise and track record in bringing affordable high-quality medicines to patients," said Dr. Ning LI, CEO of Junshi Biosciences. "Since the collaboration was announced two months ago, we have already made progress toward the introduction of toripalimab in the United States with the initiation of the rolling submission of the Biologics License Application (BLA) for treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC)."

"It is an honor to welcome Junshi Biosciences as both collaborators and investors as we build on our oncology biosimilar success with the expansion of our mission into immuno-oncology. This investment speaks volumes about Junshi Biosciences’ commitment to our partnership," said Denny Lanfear, Chief Executive Officer of Coherus. "Our teams are already making excellent progress with the NPC BLA submission and are working together closely on the registration strategy for additional toripalimab indications."

About the Exclusive License and Commercialization Agreement
Under the terms of the collaboration agreement, Coherus paid $150 million upfront for exclusive rights to toripalimab in the United States and Canada, options in these territories to Junshi Biosciences’ anti-TIGIT antibody and next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates. Coherus will also pay Junshi Biosciences a 20% royalty on net sales of toripalimab and up to an aggregate $380 million in one-time payments for the achievement of various milestones. The option exercise fee for each of the anti-TIGIT antibody and the IL-2 cytokine is $35 million per program. Additionally, for each option program, Coherus will pay Junshi Biosciences an 18% royalty on net sales and up to an aggregate $255 million for the achievement of various milestones. The Companies will collaborate in the development of toripalimab and other licensed compounds, and Coherus will pay for a portion of these co-development activities up to a maximum of $25 million per licensed compound per year.

On April 20, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the initiation of the process of seeking marketing approval from the U.S. Food and Drug Administration (US FDA) for its lead product candidate eryaspase in patients with acute lymphoblastic leukemia (ALL) who developed hypersensitivity reactions to PEG-asparaginase based on the positive results of the NOPHO-sponsored Phase 2 clinical trial (Press release, ERYtech Pharma, APR 20, 2021, View Source [SID1234578232]).

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On April 20, 2021 Race Oncology Limited ("Race") reported the appointment of Dr David Fuller as Chief Medical Officer (CMO) (Press release, Race Oncology, APR 20, 2021, View Source [SID1234578231]). This appointment follows the announcement by Race on 19 February 2021 that the Company would be recruiting a full-time, Australian- based CMO to drive its three-pillar strategy forward.

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An internationally experienced biopharmaceutical executive and physician, Dr Fuller brings a deep understanding of the successful development & commercialisation of novel pharmaceuticals. His 30 years of R&D experience spans large, mid and small cap companies including pre-clinical and clinical development, medical and regulatory affairs, and commercialisation.

Dr Fuller will join Race Oncology on 1 July 2021 from Syneos Health Clinical Solutions, where he has been the Senior Vice President of Clinical Development in the Oncology Business Unit. Dr Fuller also currently serves as Chairman for EpiAxis Therapeutics, a privately owned epigenetic therapeutic and diagnostic company, and is a Non-Executive Director of the ASX- listed biotech company, AdAlta (ASX: 1AD).

Dr Fuller was formerly a Director at Linear Clinical Research, Chairman of Dimerix Bioscience, CMO/COO at Trident Clinical Research, CMO at Arana Therapeutics, and Vice-President Clinical at Genzyme Europe.

During his career, he has directly led successful major market drug approvals including Moraxen (UK), Busulfex (US Paediatrics and EU Adult indications), Xyrem (US) and Renagel (EU). He has also designed and executed multiple Phase I, II and III studies (US, EU, Asia) for both orphan and non-orphan drug products.

This is an important appointment for Race as David brings significant experience and capability. David has been successful in developing a number of pharmaceutical products across various international markets and we look forward to his future guidance in optimising plans for the execution of our Three Pillar strategy and maximising the significant opportunities we have ahead for Bisantrene.

Race Oncology CEO and Managing Director, Phil Lynch
I am honoured and excited to be joining Race at such a critical time in the Company’s evolution given the huge potential of Bisantrene as both a targeted precision oncology drug and a differentiated chemotherapeutic. I look forward to applying my experience and expertise to help Race successfully realise the objectives of its three-pillar strategy. And I am pleased to have a new opportunity to again work with Professor Borje Anderson after our successful prior collaboration on Busulfex.

Dr David Fuller
Dr Fuller holds a Bachelor of Medicine / Bachelor of Surgery degree, and a Bachelor of Pharmacy (First Class Honours in Pharmacology), both from University of Sydney. He is also a Member of the American Society Clinical Oncology (ASCO) (Free ASCO Whitepaper).

On April 19, 2021 NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology company, reported that it received clearance from the U.S. Food and Drug Administration (FDA) for the Company’s Investigational New Drug (IND) application for naptumomab estafenatox (NAP) (Press release, NeoTX, APR 19, 2021, View Source [SID1234640358]). NeoTX is developing targeted anticancer immunotherapies utilizing its proprietary Tumor Targeted Superantigen (TTS) platform. NAP, the company’s lead TTS molecule, binds a genetically engineered bacterial determinant to the tumor surface while simultaneously activating and expanding tumor specific immune cells. NAP has demonstrated preliminary safety and anti-tumor activity in early-stage clinical trials in solid tumors.

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"This FDA clearance is an exciting milestone for NeoTX," said Asher Nathan, Ph.D., chief executive officer of NeoTX. "Preclinical and preliminary clinical studies have demonstrated that NAP has potential in combination with other treatment modalities. Non-small cell lung cancer is one of the deadliest cancers, and we are looking forward to assessing NAP in the clinic in combination with chemotherapy as a potential new treatment option after failure of current standards of care."

The Phase 2a open label trial will evaluate NAP in combination with docetaxel in 35 patients with checkpoint inhibitor pretreated, advanced or metastatic non-small cell lung cancer. The primary endpoint is objective response rate as measured by RECIST 1.1 criteria. The trial will also evaluate safety, duration of response, progression free survival, overall survival, pharmacokinetics and pharmacodynamics.

On April 19, 2021 Epizyme reported that The protein EZH2 has long been known as a major driver of prostate cancer because of its ability to inactivate genes that would normally suppress tumor growth (Press release, Epizyme, APR 19, 2021, View Source [SID1234578328]). Now, a team at Cedars-Sinai Cancer has shown in preclinical models of the disease that blocking EZH2 reduces resistance to immune-boosting checkpoint inhibitors—and they did it with the help of Epizyme, which won FDA approval for the first EZH2 blocker last year.

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The Cedars-Sinai team inhibited EZH2 in preclinical prostate cancer models, activating interferon-stimulated genes in the immune system. The interferons then boosted the immune response and reversed resistance to drugs that inhibit the checkpoint PD-1, they reported in the journal Nature Cancer.

By inhibiting EZH2 either genetically or with a chemical inhibitor donated by Epizyme, the researchers used a technique called "viral mimicry" to "reopen" parts of the genome that are typically inactive, they explained in a statement. That signaled the immune system to respond to PD-1 inhibition.

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Cedars-Sinai is now planning a clinical trial of Epizyme’s EZH2 inhibitor, Tazverik (tazemetostat), in prostate cancer. The researchers believe combining checkpoint inhibitors with EZH2 blockers may be a viable strategy, they said.

RELATED: ESMO (Free ESMO Whitepaper): Early days, but Amgen’s BiTE drug in prostate cancer shows encouraging activity

Checkpoint inhibitors have been approved to treat several cancer types, but they’ve been largely disappointing in prostate cancer. Hence several research groups have been exploring combination strategies. They include the University of Texas MD Anderson Cancer Center, which published research in 2019 showing early evidence that combining checkpoint inhibition with anti-TGF-beta drug could be effective in prostate cancer.

More recently, bispecific antibodies have shown early promise in prostate cancer. Last September, Amgen presented data from a phase 1 study of AMG 160, a bispecific targeting PSMA and CD3 on T cells. The company said that 68.6% of patients experienced a decline in PSA, and eight out of 15 patients evaluated showed stable disease.

Regeneron is also developing a bispecific antibody for prostate cancer, targeting PSMA and CD28. The drug is being tested as a solo therapy and in combination with Regeneron’s PD-1 inhibitor Libtayo in a phase 1/2 clinical trial enrolling men with metastatic castration-resistant prostate cancer.

As for Epizyme’s EZH2 inhibitor, Tazverik, its path to market hasn’t been perfectly smooth. An advisory committee to the FDA questioned its efficacy and safety in its initial indication, metastatic or locally advanced epithelioid sarcoma. Still, the company got the go-ahead to market the drug in adult patients with the rare cancer last January. Then the FDA added follicular lymphoma to the label in June. The drug’s takeoff has been slower than expected, however, largely because the pandemic has prevented face-to-face interactions between the sales force and physicians.

The company is currently testing Tazverik in several other cancer types, including as a combination with standard-of-care treatments in castration-resistant prostate cancer.