On October 29, 2020 Sanofi reported that it has entered into an agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the U.S. and Canada) to conduct a Phase 2 clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of THOR-707, a highly differentiated non-alpha IL-2 candidate with a best-in-class profile, combined with or in sequenced administration with MSD’s KEYTRUDA (pembrolizumab) in patients with various cancers (Press release, Sanofi, OCT 29, 2020, View Source [SID1234569579]).

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Under the agreement, Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA.

"We believe that THOR-707 has the potential to become a foundation of the next generation of immuno-oncology therapies," said Peter Adamson, Global Head, Oncology Development and Pediatric Innovation, Sanofi. "This collaboration with MSD will enable us to explore whether THOR-707 can increase and expand the effectiveness of KEYTRUDA and improve the outcomes for patients with cancer."

THOR-707 is currently being evaluated by Sanofi in an ongoing Phase 1 open-label, multi-center, dose escalation and expansion trial. This study is designed to evaluate the safety and tolerability of THOR-707, and to determine its recommended Phase 2 dose alone and in combination with anti-PD-1 and anti-EGFR antibodies.

In addition to testing THOR-707 in combination with KEYTRUDA, Sanofi is separately evaluating the activity of this novel biologic in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors.

THOR-707 demonstrated in preclinical studies the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as single agent as well as in combination with an anti-PD1 mAb.

It is the first molecule from the Synthorin platform, Sanofi’s unique expanded genetic alphabet platform, which has the potential to create a new generation of precision medicines for oncology and autoimmune disease.

About THOR-707

THOR-707 has the potential to be a best-in-class IL-2 therapeutic for the treatment of many types of malignancies and may demonstrate improved pharmacology allowing for less frequent dosing. In pre-clinical experiments, THOR-707 shows striking synergy with anti-PD-1 therapeutics.

It is a precisely PEGylated engineered version of interleukin-2 (IL-2), where the PEG chain is attached at a location on IL-2 that prevents it from binding to immune receptors that cause drug toxicities (IL-2R-alpha, CD25) while preserving binding to immune receptors that selectively expand tumor-killing T effector and Natural Killer (NK) cells without the immunosuppressive effects of regulatory T cells or vascular leak syndrome (VLS) inducing eosinophils.

On October 29, 2020 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported a preclinical data update on IMA401, its lead T cell receptor (TCR) Bispecifics Program (Press release, Immatics Biotechnologies, OCT 29, 2020, View Source [SID1234569532]). IMA401 is the first product candidate from Immatics’ TCR Bispecifics pipeline, called TCER (T Cell Engaging Receptor), and directed against the cancer target MAGEA4/8. Immatics demonstrated specific targeting and T cell recruitment to target-positive tumors by its proprietary TCR Bispecific molecule, leading to complete remissions of human-derived tumors in xenograft mouse models. The data will be presented at the digital European Antibody Congress 2020 on November 2.

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Preclinical data highlights:

IMA401 TCER targets a peptide derived from the melanoma-associated antigen 4 or 8 ("MAGEA4/8"); the target peptide is highly prevalent in several solid tumor types including squamous non-small-cell lung carcinoma (sq NSCLC), head and neck squamous cell carcinoma (HNSCC) bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types
IMA401 TCER can kill tumor cells in vitro with MAGEA4/8 peptide levels similar to levels found in cancer patients
IMA401 TCER shows a minimum of 1,000-fold therapeutic window between normal tissue cell reactivity and tumor cell reactivity in vitro
IMA401 TCER demonstrates consistent tumor regression including complete responses in two tumor xenograft mouse studies (including patient-derived PDX models) treated once weekly at low doses
IMA401 TCER molecule shows favorable pharmacokinetics with terminal half-life of 10-11 days in mice and positive purity and stability characteristics with high production yields
IMA401 TCER targets an HLA-A*02-bound peptide, which is derived from two different cancer-associated proteins, MAGEA4 and MAGEA8 and shows a >5-fold higher peptide copy number per tumor cell than a commonly used MAGEA4 target peptide based on quantitative mass spectrometry data generated by Immatics´ XPRESIDENT platform
Carsten Reinhardt, MD, PhD, Chief Development Officer at Immatics, commented: "We continue to be enthusiastic about our first TCR Bispecific candidate and the preclinical proof-of-concept data we have generated. We look forward to advancing this novel treatment modality towards clinical development. This represents a new therapeutic opportunity in addition to our adoptive cell therapy programs for cancer patients at different disease stages and with different types of solid tumors."

For the IMA401 TCER program, Immatics is continuing the manufacturing development and the generation of the IND-enabling data package. Immatics expects to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) or the European Authorities for the IMA401 program by the end of 2021.

The full presentation will be available on Monday, November 2, 3:20pm CET on Immatics’ website using this link.

About TCER
Immatics’ TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. To do so, the proprietary biologics are engineered to have two binding regions. The first region contains an affinity- and stability-improved TCR that binds specifically to the cancer target on the cell surface presented by a human leukocyte antigen (HLA) molecule. The second region is derived from an antibody domain that recruits endogenous T cells to the tumor to become activated. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. In addition, the TCER molecule has a Fc-part conferring stability, half-life extension and manufacturability.

On October 29, 2020 Pacira BioSciences, Inc. (Nasdaq: PCRX), the leading provider of innovative non-opioid pain management options, reported financial results for the third quarter of 2020 (Press release, Pacira Pharmaceuticals, OCT 29, 2020, View Source;991.htm [SID1234569466]).

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"Throughout the third quarter, we continued to make meaningful progress in growing EXPAREL sales despite lingering challenges in the elective surgery market due to the COVID-19 pandemic. The ongoing transition from procedures in the inpatient setting to the 23-hour ambulatory surgical center setting has accelerated because of the pandemic and we expect this trend to continue. The recent opening of our state-of-the art Pacira Innovation and Training Facility in Tampa is expected to further drive the adoption of EXPAREL and iovera° by providing digital and educational tools that meet the needs of our physician customers, as they seek to improve patient care in a variety of surgical settings. Looking ahead, Pacira remains well-positioned as the leading provider of innovative non-opioid pain management solutions," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

Third Quarter 2020 Financial Results
•Total revenues were $117.5 million in the third quarter of 2020, a 12% increase versus the $104.7 million reported for the third quarter of 2019.
•EXPAREL net product sales were $113.7 million in the third quarter of 2020, a 12% increase versus the $101.5 million reported for the third quarter of 2019.
•Third quarter 2020 iovera° net product sales were $2.7 million, a 3% increase versus the $2.6 million reported for the third quarter of 2019.
•Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $0.4 million in the third quarter of 2020, compared to $0.3 million in the third quarter of 2019.
•Third quarter 2020 royalty revenues were $0.6 million, compared to $0.3 million in the third quarter of 2019.
•Total operating expenses were $99.9 million in the third quarter of 2020, compared to $102.3 million in the third quarter of 2019.
•Research and development (R&D) expenses were $14.7 million in the third quarter of 2020, compared to $20.3 million in the third quarter of 2019. R&D expenses include $5.6 million and $7.8 million of product development and manufacturing capacity expansion costs in the third quarters of 2020 and 2019, respectively.
•Selling, general and administrative (SG&A) expenses were $52.6 million in the third quarter of 2020, compared to $50.1 million in the third quarter of 2019.
•GAAP net income was $130.1 million, or $3.03 per share (basic) and $2.94 (diluted), in the third quarter of 2020, compared to a GAAP net loss of $6.1 million, or $(0.15) per share (basic and diluted), in the third quarter of 2019. Included in GAAP net income in the third quarter of 2020 was a $124.6 million income tax benefit related to the release of a valuation allowance on deferred tax assets.
•Non-GAAP net income was $29.9 million, or $0.70 per share (basic) and $0.68 (diluted), in the third quarter of 2020, compared to non-GAAP net income of $20.2 million, or $0.48 per share (basic and diluted), in the third quarter of 2019.
•Adjusted EBITDA was $34.2 million in the third quarter of 2020, versus adjusted EBITDA of $24.8 million in the third quarter of 2019.
•Pacira ended the third quarter of 2020 with cash, cash equivalents, short-term and long-term investments ("cash") of $576.2 million. Cash provided by operations was $39.8 million in the third quarter of 2020, compared to cash provided by operations of $18.4 million in the third quarter of 2019.
•Pacira had 42.9 million basic weighted average shares of common stock outstanding in the third quarter of 2020.
•Pacira had 44.3 million diluted weighted average shares of common stock outstanding in the third quarter of 2020.

See "Non-GAAP Financial Information" below.

Recent Highlights

•Launch of state-of-the-art training center dedicated to advancing best practice regional approaches to manage acute pain. In October 2020, Pacira announced the grand opening of the Pacira Innovation and Training Center of Tampa (the PITT). Designed to advance clinician understanding of the latest local, regional and field block approaches for managing pain, the PITT will provide an unparalleled training environment for healthcare providers working to reduce or eliminate patient exposure to opioids. The PITT is a fully adaptable environment constructed with guidance and input from leaders in the field of regional anesthesia, and is equipped with state-of-the-art technology and audio/visual capabilities to support a full range of educational events from didactic presentations to hands-on workshops.

•Preliminary net product sales for September 2020. In October 2020, Pacira reported preliminary unaudited net product sales of EXPAREL and iovera° of $39.5 million and $1.1 million, respectively, for the month of September 2020. In order to provide greater
transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19.

•Positive CHMP opinion for EXPAREL for the treatment of postsurgical pain. In September 2020, Pacira announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for EXPAREL for postsurgical analgesia. The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit. The CHMP positive opinion was based on the results of four pivotal Phase 3 studies that demonstrated improvements in pain reduction and opioid use.

•Collaboration with IPG to reduce postsurgical opioid prescribing and surgical procedure costs. In September 2020, IPG, the industry-leading provider of surgical cost management solutions, and Pacira announced a collaboration to reduce postsurgical opioid prescribing and surgical procedure costs across the IPG national health plan and provider network. Through this partnership, IPG will offer reimbursement for EXPAREL to its health plan provider clients across the country to further support its mission to bring high quality, cost-effective surgical solutions to the U.S. healthcare market. Pacira will work alongside IPG to provide education and training to ensure consistent, positive outcomes are achieved across procedures, clinicians, and provider facilities.

Today’s Conference Call and Webcast Reminder
The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, October 29, 2020, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 5997369. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 5997369. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

On October 29, 2020 Genecast (Beijing) Technology reorted that it completed a $149 million Series E financing to develop its second-generation sequencing technology and bioinformatics (Press release, Genecast Biotechnology, OCT 29, 2020, View Source [SID1234569465]). Founded in 2014, Genecast has developed a circulating tumor DNA detection technology to provide individualized cancer diagnoses. The E Round was led by China Structural Reform Fund, and joined by Taikang Asset Management, CCB Private Equity Investment Management, Hillhouse Capital’s VC unit GL Ventures and China Renaissance.

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On October 29, 2020 BioInvent Interim Reported that January 1 – September 30, 202 (Press release, BioInvent, OCT 29, 2020, View Source;september-30-2020-301162589.html [SID1234569462])

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China licensing agreement further validates technology and strategy

"The exclusive licensing agreement with CASI Pharmaceuticals for BI-1206 in China is an important validation of BioInvent’s technology, expertise and business model. It provides further impetus to our lead drug candidate and reinforces our financial position with $12 million upfront in cash and equity investment, plus potential future milestones and royalties."

Martin Welschof, CEO BioInvent

Financial information
Third quarter 2020

Net sales SEK 16.3 (18.1) million.
Loss after tax SEK -32.9 (-37.1) million.
Loss after tax per share before and after dilution SEK -0.04 (-0.07).
Cash flow from operating activities and investment activities SEK -33.1 (-25.0) million.
January – September 2020

Net sales SEK 48.6 (68.4) million.
Loss after tax SEK -104.9 (-97.7) million.
Loss after tax per share before and after dilution SEK -0.16 (-0.22).
Cash flow from operating activities and investment activities SEK -96.9 (-100.8) million. Liquid funds as of September 30, 2020: SEK 642.1 (183.9) million.
Events in the third quarter

BioInvent’s agreement with Pfizer Inc. was further extended until the end of 2020 to permit the companies to further identify and characterize new targets and antibodies binding to these targets.
The Extraordinary General Meeting on July 3 resolved to increase the Board of Directors with one member through new election of Dr. Thomas Hecht as a Board member. (R)
BioInvent’s Board of Directors resolved on a repair rights issue of a maximum of approximately SEK 139 million. It was completed in August and was heavily oversubscribed. The repair rights issue followed the successfully completed directed share issues of approximately SEK 487 million before transaction costs. (R)
Events after the reporting period

In October 2020, BioInvent licensed the anti-FcγRllB antibody BI-1206 to CASI Pharmaceuticals, Inc (NASDAQ: CASI) for the Greater China region. The collaboration accelerates and expands BioInvent’s global development plans for BI-1206. BioInvent is to receive $12 million upfront in combination of cash and equity investment and eligible to receive up to $83 million in milestone payments, plus tiered royalties. The equity investment is subject to the approval of an Extraordinary Shareholders’ Meeting (EGM) to be held on 27 November 2020. (R)
The Board of Directors has also proposed that the EGM approves the proposal on a reverse share split 1:25, a reduction of the share capital to adjust the share capital to the Company’s operations, and an updated authorization for the Board to decide on a new issue of shares comprising 109,378,025 new shares (corresponding to 4,375,121 shares after the reverse share split). (R)
BioInvent announced, in October 2020, regulatory authority approval of a clinical trial application (CTA) in Denmark for a Phase I/IIa, first-in-human study of BI-1808, as monotherapy and in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of solid tumors and CTCL.
In October 2020, BioInvent announced that it will receive a €2 million milestone payment under its collaboration with Daiichi Sankyo related to the initiation of a global Phase I clinical trial with a GARP directed antibody. (R)

(R)= Regulatory event

Comments from the CEO
BioInvent took a significant step forward with the signing of an exclusive licensing agreement with CASI Pharmaceuticals for the development and commercialization of our novel anti-FcγRIIB antibody, BI-1206, in mainland China, Taiwan, Hong Kong and Macau. It is an important validation of BioInvent’s technology, expertise and business model and provides further impetus to our lead drug candidate.

This agreement will further accelerate the development and commercialization preparations for BI-1206, based on CASI’s clinical and regulatory expertise and strong presence across this major market. Their established commercial infrastructure and medical marketing team, together with their wide access to a strong network of investigators across Greater China, make them an ideal partner to expand our global development footprint in this important region.

The agreement also further reinforces our financial position, as BioInvent receives $12 million upfront as a combination of cash and equity investment. We are eligible for up to $83 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of BI-1206.

In short this collaboration adds significant value to our overall BI-1206 program, through the leveraging of CASI’s capabilities in this major market and the financial terms.

The clinical development of BI-1206 in both hematological cancers and solid tumors is progressing well. A Phase I/IIa trial of BI-1206 in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) in solid tumors is continuing as planned, as is the Phase I/IIa trial of BI-1206 in combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL). With this exciting agreement with CASI now in place, we anticipate there could be further interest in similar partnerships for BI-1206 in other regional markets, or a license of the rest of the world.

Beyond BI-1206, BioInvent’s pipeline is expanding further based on the productivity of our proprietary n-CoDeR/F.I.R.S.TTM platforms and ability to generate antibodies to novel targets with potent anti-tumoral activity to address major unmet medical needs.

We have received regulatory authority approval of our clinical trial application in Denmark for a Phase I/IIa, first-in-human study of BI-1808, as monotherapy and in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of solid tumors and CTCL. BI-1808 will be the first anti-TNFR2 antibody to enter clinical development, and we believe this is a very promising approach for cancer therapy. We expect to enroll the first patient before the end of the year and to submit an investigational new drug (IND) application in the U.S. in the coming weeks. Together with our partner Transgene, we also continue to expect to initiate a Phase I clinical trial with the multifunctional oncolytic virus BT-001 before the end of 2020.

We continue our value-creating collaborations with various partners and most recently announced receipt of a €2 million milestone payment under our collaboration with Daiichi Sankyo, related to the initiation of a global Phase I clinical trial with a GARP directed antibody.

This all adds up to further substantial progress for BioInvent, across the pipeline, and I look forward to continuing to keep you up to date with further developments through the rest of 2020 and beyond.

As previously informed, BioInvent has taken necessary precautions with regards to the corona virus. Although we see an increase of cases, which is of course terrible for all those affected and their families, we still remain on track with our clinical trials and results. As the situation is still evolving, timelines are still subject to potential changes and we will provide updates as necessary.

With financing in place, a new partnering collaboration and the strong support of our investors, BioInvent is well positioned to continue to deliver on the promise of our pipeline.