On October 14, 2021 BeiGene reported that inked a deal with Celgene Logistics Sarl, which is now a subsidiary of Bristol Myers Squibb (Press release, BeiGene, OCT 14, 2021, View Source [SID1234591391]). The deal was a license and supply agreement giving BeiGene exclusive right to distribute and market Abraxane, Revlimid and Vidaza in China, excepting Hong Kong, Macau and Taiwan. Then, in March 2020, the Chinese National Medical Products Administration (NMPA) suspended importation, sales and use of Abraxane in China under the deal. BMS then initiated a recall of Abraxane in China. The entire suspension and recall were related to inspection findings at Bristol Myers Squibb-Celgene’s contract manufacturing plant in the U.S.

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On October 6, 2021, Bristol Myers Squibb and Celgene terminated the original deal related to Abraxane and gave BeiGene 180 days of notice that it was withdrawing Abraxane from the deal. The Notice stated:

"Indeed, as you are aware, due to the National Medical Products Association decision to suspend the importation, sale, or use of Abraxane in China on March 25, 2020, Celgene has been unable to manufacture Abraxane for China and, thus, has been unable to manufacture Abraxane on a global basis…"

The notice went on to say that after the NMPA suspended manufacturing at the facility in Illinois, the company shifted production to a facility in Phoenix, Arizona. In July 2021, there was a failure in media fill testing at that facility. After a root cause investigation and corrective actions, there was still rejection of additional vials. Celgene is working on the issue, but currently all manufacturing of Abraxane at the Phoenix facility has halted, and they have notified the U.S. Food and Drug Administration.

The Illinois site was run by contract drug manufacturing (CDMO) company Fresenius Kabi and the Phoenix site is owned by BMS.

BeiGene indicates they believe the "reasons stated in the Notice do not provide a valid basis for terminating the Agreement with respect to Abraxane, and that the Notice is a tactical maneuver on the part of BMS-Celgene to reduce its damages in the on-going arbitration proceedings described above. The Company intends to contest the purported termination vigorously."

On a little less threatening note, BeiGene also said that BMS and Celgene had not told them how long the manufacturing delays in Phoenix would last, but "would be happy to work with BMS-Celgene to help get the Phoenix manufacturing facility or another facility qualified to restore the supply of Abraxane for patients in China as soon as possible."

Abraxane is approved for use in advanced non-small cell lung cancer with carboplatin, in advanced pancreatic cancer with gemcitabine, and for advanced breast cancer.

The other drugs are Revlimid, which with dexamethasone is used to treat multiple myeloma, and Vidaza, a chemotherapy used to treat myelodysplastic syndrome (MDS). They do not appear to be part of the dispute.

At least one analyst, Andrew Berens, with SVB Leerink, suggests that the real issue is competition between BMS’s checkpoint inhibitor Opdivo and BeiGene and Novartis’s tislelizumab. Berns projected BeiGene would rake in $100 million in Abraxane sales in China next year once the marketing hold is resolved. Berns is taking that figure out of the equation, but believes that the BeiGene-BMS deal isn’t as important as it used to be, particularly now that BeiGene and Amgen have a strategic collaboration that initiated in January 2020.

That deal is to accelerate Amgen’s oncology presence in China. Amgen also has a 20.5% stake in BeiGene, which it paid $2.8 billion in cash for. Under that deal, BeiGene is commercializing Amgen’s XGEVA (denosumab), Kyprolis (carfilzomib) and Blincyto (blinatumomab) in China. Two of the drugs will revert to Amgen, one after five years and one after seven. After the commercialization period, BeiGene will keep the rights to one of the drugs and be eligible for royalties on sales in China for another five years on the drugs returned to Amgen. XGEVA was launched in China in September 2019.

The two companies are also collaborating on 20 drugs from Amgen’s oncology pipeline in China and globally.

Another hit against Abraxane occurred in August 2021. Roche had an accelerated approval for its Tecentriq (atezolizumab) in combination with Abraxane for adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1. After consulting with the FDA, Roche withdrew the accelerated approval. It only affected the mTNBC indication in the U.S. for that indication. It was granted accelerated approval in March 2019, the first immunotherapy to be approved for that setting. It was based on progression-free survival (PFS) in the Phase III IMpassion 130 study, but continued approval was

On October 14, 2021 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the third quarter ended August 31, 2021 and provided a corporate update (Press release, Nurix Therapeutics, OCT 14, 2021, View Source [SID1234591290]).

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"With the recent initiation of a Phase 1 trial for our lead E3 ligase inhibitor program NX-1607, we now have two wholly owned drug candidates in clinical development, both potentially addressing significant unmet needs in hematology and oncology," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "The remainder of 2021 promises to be an exciting time for Nurix as we prepare to deliver on our ambitious goal of initiating Phase 1 trials for two additional wholly owned and internally developed drug candidates."

Recent Business Highlights

Advanced NX-1607 into Phase 1 Clinical Development: Nurix initiated its Phase 1a/1b study to evaluate orally dosed small molecule NX-1607, a Casitas B-lineage lymphoma proto-oncogene (CBL-B) inhibitor at clinical sites in the United Kingdom. The multicenter, open-label Phase 1 dose escalation and expansion trial will evaluate the safety and tolerability of NX-1607 in adults with a variety of oncology indications.
Expanded the Board of Directors with Experienced Business Leaders: Nurix announced the appointments of Judith A. Reinsdorf and Paul M. Silva to its board of directors, effective October 1, 2021. Ms. Reinsdorf is the former executive vice president and general counsel of Johnson Controls International, and Mr. Silva is the former senior vice president, chief accounting officer at Vertex Pharmaceuticals Incorporated. Nurix previously announced the appointment of Clay Siegall, Ph.D., to its board, effective May 28, 2021. Dr. Siegall is the co-founder of Seagen Inc. (formerly Seattle Genetics, Inc.) and serves as its president, chief executive officer and chairman of the board.
Upcoming Program Highlights*

NX-2127: Nurix’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of BTK with immunomodulatory drug (IMiD) activity for the treatment of relapsed or refractory B-cell malignancies. Nurix is conducting its Phase 1 clinical trial of NX-2127 at multiple clinical sites. Initial pharmacokinetic (PK) and pharmacodynamic (PD) data from the dose escalation portion of the trial is anticipated by year-end 2021. Additional information on the clinical trial can be accessed at ClinicalTrials.gov (NCT04830137).
NX-1607: Nurix’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of CBL-B for immuno-oncology indications. Nurix recently initiated the dose escalation portion of its ongoing Phase 1 trial.
NX-5948: Nurix’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally bioavailable BTK degrader designed without IMiD activity for certain B-cell malignancies and autoimmune diseases. Nurix anticipates initiating a Phase 1 trial for NX-5948 in patients with hematologic malignancies in the second half of 2021 and is planning for the potential expansion of indications into selected autoimmune diseases in 2022.
DeTIL-0255: Nurix’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. Nurix anticipates initiating a Phase 1 trial for DeTIL-0255 in the second half of 2021.
* Expected timing of events throughout the press release are based on calendar year quarters.

Fiscal Third Quarter 2021 Financial Highlights

Collaboration revenue for the three months ended August 31, 2021 was $10.3 million compared to $4.1 million for the three months ended August 31, 2020. The increase was due to the continued scale up of internal resources and external spending for our collaborations with Sanofi and Gilead as compared to the prior period, resulting in a higher percentage of completion in the current period. The increase was also due to partial revenue recognized during the three months ended August 31, 2021 for the achievement of certain preclinical milestones under our collaborations with Gilead and Sanofi.

Research and development expenses for the three months ended August 31, 2021 were $30.9 million compared to $18.9 million for the three months ended August 31, 2020. The increase was primarily related to an increase of $4.1 million in compensation and related personnel costs attributable to an increase in headcount. There was also an increase of $1.6 million in non-cash stock-based compensation expense. In addition, there was an increase of $1.9 million in supplies and contract research and an increase of $1.8 million in preclinical activities and contract manufacturing attributable to increases in our preclinical development activities and drug discovery research and an increase of $1.5 million in clinical costs due to ongoing clinical trial startup and patient enrollment.

General and administrative expenses for the three months ended August 31, 2021 were $8.3 million compared to $4.3 million for the three months ended August 31, 2020. The increase was primarily related to an increase of $1.2 million in compensation related expenses attributable to a higher headcount and an increase of $1.6 million in non-cash stock-based compensation expense. There was also an increase of $0.9 million in consultant and other professional service expenses primarily related to becoming a public company.

Net loss for the three months ended August 31, 2021 was $28.8 million, or ($0.65) per share, compared to a net loss of $18.5 million for the three months ended August 31, 2020, or ($1.09) per share.

Cash, Cash Equivalents and Investments: As of August 31, 2021, Nurix had cash, cash equivalents and investments of $465.4 million compared to $372.0 million as of November 30, 2020. The increase was primarily attributable to the net proceeds of $150.2 million from Nurix’s follow-on offering in March 2021.

On October 14, 2021 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that it will release its third quarter 2021 financial results on Thursday, October 28, 2021 (Press release, Insmed, OCT 14, 2021, View Source [SID1234591262]).

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Thursday, October 28, 2021 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (844) 200-6205 (U.S. toll free), (646) 904-5544 (U.S. local), or +44-208-0682-558 (international) and referencing access code 594997. The call will also be webcast live on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through November 26, 2021 by dialing (866) 813-9403 (U.S. toll free), (929) 458-6194 (U.S. local), or +44-204-525-0658 (international) and referencing access code 963633. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.

On October 14, 2021 ViewRay, Inc. (Nasdaq: VRAY) reported details relating to the release of its third quarter 2021 financial results (Press release, ViewRay, OCT 14, 2021, View Source [SID1234591261]).

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ViewRay will hold a conference call to discuss results on Thursday, November 4, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The confirmation number is 5970168. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until November 11, 2021. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 5970168.

On October 14, 2021 DarwinHealth, Inc. reported a scientific research collaboration using its biomarker enrichment strategies for trials ( BEST platform ) to find new biomarkers to guide trajectories translational of several oncological molecules developed by Prelude Therapeutics (Press release, Prelude Therapeutics, OCT 14, 2021, View Source [SID1234591260]).

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As part of this collaboration, DarwinHealth will use its proprietary, quantitative, systems biology-based algorithms, CLIA-approved technologies, and validated principal regulator (MR) protein and tumor checkpoint approaches to identify novel protein-based biomarkers that will add significant precision to the selection of the patient cohort for clinical trials to be conducted at Prelude’s discretion in hematologic and solid tumors.

"The goal of this biomarker-focused collaboration," explained Professor Andrea Califano , Clyde Chair and Helen Wu , Chair of the Department of Systems Biology at Columbia University.and co-founder of DarwinHealth, "is to assess and characterize the global and tumor-specific mechanisms of action of molecules in the Prelude pipeline in order to identify new biomarkers likely to associate these agents with reactive patient cohorts. In addition, the collaboration will mechanically characterize the potential therapeutic opportunities for molecules in the Prelude pipeline targeting various oncogenic pathways in several hematologic malignancies and solid tumor subtypes, as selected by Prelude Therapeutics. The study will be based on the VIPER algorithm to characterize the activity of these various compounds against key protein modules (tumor checkpoints) of the primary regulator (MR) necessary for the viability of subtype-specific tumors. "

"The BEST initiative will provide precise and actionable compound and tumor information to assess the potential of molecules in the Prelude pipeline to reverse the activity of subtype-specific tumor checkpoints," explains Dr. Mariano Alvarez , Scientific Director of DarwinHealth. "The aim of these studies is to generate a range of validated compound / tumor subtype / biomarker alignments that represent evidence-based and mechanism-based roadmaps for biomarker development and patient selection to potentially speed up clinical studies. "

As part of the BEST initiative, DarwinHealth will provide a comprehensive read on the potential clinical value of certain molecules in the Prelude pipeline in a range of tumor types. Through quantitative modeling and biomarker-centric translational pathways, DarwinHealth will also help design in vivo validation studies to take advantage of key opportunities that may not be apparent with conventional technologies.

"The collaboration with BEST addresses one of the critical unmet needs of the biotechnology and biopharmaceutical spaces focused on cancer drug discovery, namely the development of biomarkers that are highly predictive of clinical response to compounds, whose efficacy final may be the result of an incompletely decipherable range of drug effects both on and off target directed at multiple targets of the regulatory programs that underlie cancer addictions "noted Dr Gideon Bosker, CEO and Co-Founder of DarwinHealth. "These uncertainties lend themselves to the extension of the concept of biomarker beyond the primary (ie high affinity) target of a drug, to multiprotein classifiers identified by our computational and integrative experimental methodologies. "

In particular, new multiprotein classifiers identified by the BEST platform have already been reported by DarwinHealth for multiple myeloma (N Engl J Med 2019; 381: 727-38. View Source NEJMoa1903455 ) and diffuse large B cell lymphoma (DBLC) (British Journal of Haematology; August 02, 2021, View Source ).

These technologies are ideally suited for identifying mechanistic alignments between drug candidates and cancer patients, based on the ability of the drugs to inactivate patient-specific MR proteins that are necessary to maintain tumor status. Importantly, these findings can be quickly transformed into precision human, biomarker-based clinical trials and commercial development.