On January 10, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported a corporate update and highlighted key milestones anticipated in 2022 (Press release, ALX Oncology, JAN 10, 2022, View Source [SID1234598498]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2021 was a year of substantial corporate and clinical accomplishments for ALX Oncology. We initiated numerous clinical trials, including two Phase 2 trials in head and neck squamous cell carcinoma ("HNSCC") and presented encouraging Phase 1b data from the ASPEN-01 trial in gastric/gastroesophageal junction ("GEJ") cancer and HNSCC, along with early Phase 1b data from the ASPEN-02 trial in myelodysplastic syndromes ("MDS")," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology.

"On the business development front, we collaborated with Tallac Therapeutics to jointly develop, manufacture, and commercialize a novel toll-like receptor nine agonist antibody conjugate, and late last year we acquired privately held ScalmiBio, giving us full access to their proprietary SHIELD platform for conditional activation of antibodies in the tumor microenvironment and proprietary cytotoxic payloads for antibody-drug conjugates. We expect 2022 to be an exciting and productive year with multiple clinical trial initiations and data readouts for evorpacept," Dr. Pons continued.

Accomplishments in 2021

Presented initial Phase 1a clinical data of evorpacept in combination with azacitidine in patients with MDS (ASPEN-02) at ASH (Free ASH Whitepaper). Accrual is ongoing in the Phase 1 dose expansion part of the study.
Presented updated Phase 1b clinical trial data of evorpacept in combination with pembrolizumab with and without chemotherapy in patients with HNSCC and evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel in patients with gastric/GEJ cancer (ASPEN-01) at SITC (Free SITC Whitepaper).
Initiated a Phase 1a clinical trial of evorpacept in combination with azacitidine and venetoclax in acute myeloid leukemia ("AML") (ASPEN-05).
Acquired privately held ScalmiBio, giving ALX Oncology full access to their proprietary SHIELD platform for conditional activation of antibodies in the tumor microenvironment and proprietary cytotoxic payloads for antibody drug conjugates.
Initiated a Phase 1b/2 clinical trial of evorpacept in combination with zanidatamab in patients with advanced HER2-positive breast cancer, HER2-low breast cancer and additional non-breast HER2-expressing solid tumors being conducted by Zymeworks (NYSE: ZYME).
Entered into a clinical trial collaboration and supply agreement with Eli Lilly (NYSE: LLY) to evaluate the combination of evorpacept and CYRAMZA (ramucirumab), Eli Lilly’s anti-VEGFR2 antibody, for the treatment of patients with HER2-positive gastric/GEJ cancer.
Initiated two randomized Phase 2 studies of evorpacept in combination with KEYTRUDA (pembrolizumab) in patients with HNSCC. The first study (ASPEN-03) evaluated the efficacy of evorpacept in combination with pembrolizumab for the first line treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC. The second study (ASPEN-04) evaluated evorpacept in combination with pembrolizumab and standard chemotherapy for the first line treatment of patients with metastatic or unresectable, recurrent HNSCC.
Entered into a collaboration with Tallac Therapeutics, a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer to jointly develop, manufacture and commercialize a novel class of cancer immunotherapeutics.
Anticipated Milestones in 2022

Initiation of a randomized Phase 2/3 clinical trial of evorpacept in combination with Herceptin (trastuzumab), Cyramza (ramucirumab) and paclitaxel in patients with 2nd line or greater gastric/GEJ cancer (ASPEN-06).
Dose optimization readout of a Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with MDS (ASPEN-02).
Add to and report on investigator sponsored clinical trials with evorpacept (non-Hodgkin’s lymphoma).
Report on ongoing collaboration with Zymeworks in HER2-expressing breast cancer and other solid tumors.
Select development candidate(s) from preclinical pipeline.
Cash Position and Financial Guidance

ALX Oncology ended the third quarter of 2021 with approximately $385.1 million in cash and cash equivalents. The Company expects that its cash and cash equivalents will be sufficient to fund its planned operations through mid-2024.

Upcoming Presentation at 40th Annual J.P. Morgan Healthcare Conference

ALX Oncology will present at the 40th Annual J.P. Morgan Conference on Tuesday, January 11, 2022 at 10:30 AM Eastern Time. A live webcast of the presentation is available here and can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcast will be archived for up to 30 days following the presentation date.

On January 10, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported that it will release its financial results for the fourth quarter and full year 2021 before the market opens on Thursday, February 10, 2022 (Press release, LabCorp, JAN 10, 2022, View Source [SID1234598497]). The company will host a conference call and webcast beginning at 9 a.m. ET that day to discuss the results. The earnings release and accompanying financial information will be posted on the Labcorp Investor Relations website.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Interested parties can access the conference call by dialing 1-877-825-4844 within the U.S. and Canada, or 1-631-813-4900 internationally, using the conference ID 1756959. In addition, a real-time webcast of the conference call will be available on the Labcorp Investor Relations website.

An audio replay of the conference call will be available from 1 p.m. ET on February 10, 2022, until 11:30 p.m. ET on February 24, 2022, by dialing 1-855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the conference ID 1756959. The webcast of the conference call will be archived and accessible through January 27, 2023, on the Labcorp Investor Relations website.

On January 10, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, IASO Biotherapeutics ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative medicines, and Innovent Biologics ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the companies entered into an agreement pursuant to which Sana obtained from IASO Bio and Innovent non-exclusive commercial rights to a clinically validated fully-human BCMA CAR construct for use in certain in vivo gene therapy and ex vivo hypoimmune cell therapy applications (Press release, Sana Biotechnology, JAN 10, 2022, View Source [SID1234598496]). IASO Bio and Innovent will receive an upfront payment and are entitled to receive up to approximately $204 million in potential development and regulatory milestone payments across up to six products, as well as royalties.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

B cell maturation antigen (BCMA) has been validated as a target for autologous CAR T therapy in relapsed and/or refractory multiple myeloma (RRMM). The BCMA CAR licensed from IASO Bio and Innovent to Sana is a key part of an autologous BCMA-directed CAR T cell therapy product (IASO Bio: CT103A, Innovent: IBI326) that has shown promising clinical safety and efficacy data in China.

The latest data from the phase 1/2 clinical study was jointly presented by IASO Bio and Innovent at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta (Abstract # 547). CT103A demonstrated an overall response rate of 94.9%, a minimal residual disease (MRD) negativity rate of 93.7%, and a complete response/stringent complete response (CR/sCR) rate of 58.2% in 79 RRMM patients. CT103A also demonstrated activity in patients who had previously received CAR T therapy: among 13 such patients, the ORR was 76.9%, with 61.5% of those patients achieving very good partial response (VGPR) or better and 46.2% achieving CR/sCR (Trial Registration# NCT05066646). In February 2021, CT103A was granted Breakthrough Therapy Designation by China’s National Medical Products Administration for the treatment of RRMM.

"Our commitment to address the unmet need for patients remains a priority as we move various multiple myeloma programs towards the clinic as early as next year," said Terry Fry, M.D., Sana’s Head of T Cell Therapeutics. "We are excited to have access to a fully-human BCMA CAR construct that has been validated in clinical trials. We are optimistic this agreement will accelerate Sana’s progress with our allogeneic BCMA-directed CAR T product candidate and in vivo CAR T product candidates using our fusogen platform."

"We are very pleased to enter a collaboration with Sana," said Dr. Wen (Maxwell) Wang, CEO and Chief Medical Officer of IASO Bio. "The potential of our fully-human BCMA CAR construct to treat patients with relapsed/refractory multiple myeloma has been validated in clinical trials of our BCMA autologous CAR T product candidate jointly developed by Innovent and us. We are excited to help maximize the value of CT103A by combining our CAR construct with Sana’s novel technologies and capabilities with the potential to benefit a broader patient population. We also have the potential to expand our product pipeline through a right of first negotiation to develop and commercialize Sana’s products targeting BCMA using the licensed CAR construct in the Greater China region."

"Innovent is pleased that the BCMA CAR construct, co-developed and clinically validated with IASO Bio, has been recognized by Sana for further investment," said Dr. Wei Xu, Innovent’s Vice President and R&D Head of Cell Therapy. "This license enables Sana to develop next generation products, using its proprietary technology, potentially benefiting even more relapsed/refractory multiple myeloma patients globally. We look forward to collaborating with Sana to address currently untreatable diseases."

About CT103A/IBI326 (BCMA CAR-T)
CT103A is an innovative therapy co-developed by IASO Bio and Innovent Biologics. Previous studies indicate subjects with relapsed/refractory multiple myeloma (RRMM) who received high-dose BCMA-targeting CAR T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR T cells will not be effective. To solve this dilemma, CT103A has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinge and transmembrane, and 4-1BB co-stimulatory and CD3ζ activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform and integrated in house manufacture process improvement, CT103A has shown promising efficacy data in China. In February 2021, CT103A was granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) for the treatment of RRMM. In addition to multiple myeloma, IASO Bio is investigating CT103A in patients with autoimmune diseases.

On January 10, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that Raul Rodriguez, the company’s president and chief executive officer, is scheduled to present a company overview at the 40th Annual J.P. Morgan Healthcare Conference at 10:30 a.m. ET on Wednesday, January 12, 2022 (Press release, Rigel, JAN 10, 2022, View Source [SID1234598494]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the live and subsequently archived webcast, go to the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

On January 10, 2022 Amgen (NASDAQ:AMGN) and BioLabs LA at the Lundquist Institute reported that Karma Biotechnologies has been awarded the second Amgen Golden Ticket in Southern California (Press release, Amgen, JAN 10, 2022, View Source [SID1234598493]). Karma Biotechnologies will receive one year of lab space at BioLabs LA at the Lundquist Institute (TLI) as well as additional facility benefits and connections to Amgen’s scientific and business leaders.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Amgen Golden Ticket winner was chosen by an internal team of Amgen scientific leaders at a virtual pitch event. Five finalists pitched their business plans before Amgen’s internal committee that evaluated the strength and novelty of their scientific rationale, subject matter expertise and business plan viability. This is the second of three Amgen Golden Tickets to be awarded through 2023 to help accelerate life science start-ups in Southern California.

Perspectives on announcement:

"Amgen’s partnership with BioLabs LA at the Lundquist Institute is contributing to the acceleration of bioscience innovation in the Los Angeles area, aligning with our vision to progress the development of breakthrough therapies to serve patients suffering from serious illness. We are enthusiastic about the Xavine platform being developed by Karma Biotechnologies, and look forward to engaging with the team as they advance novel therapies to treat autoimmune diseases." – Philip Tagari, vice president of Therapeutic Discovery at Amgen
"BioLabs LA at the Lundquist Institute is very pleased to participate in another successful Golden Ticket round with Amgen, a true pioneer in biotechnology. After seeing how well the first awardee is performing, under Amgen’s generous guidance, we are excited to see the innovation that spurs from this year’s winner, Karma Biotechnologies. It is such an honor to be a part of the collaborative network that is growing here in LA." – Lindsay Bourgeois, Site Director, BioLabs LA
"We are thrilled and deeply honored that the experts at Amgen see the value and novelty of our Xavine tolerogenic vaccine platform for treating and preventing autoimmunity and allergies. Having access to the phenomenal resources at BioLabs LA and Amgen’s clinical development expertise will rapidly accelerate Karma’s R&D, and help us make a difference in patients’ lives that much sooner. Collaborations such as these have fueled an explosion in the quality and quantity of biotech startups in the Los Angeles ecosystem in recent years, from therapeutics to biomanufacturing to agricultural technology. Karma is proud to be part of LA’s vibrant, collaborative and growing biotech ecosystem." – Andrew Gray, PhD, Co-founder and CEO, Karma Biotechnologies
Amgen supports life science start-ups through Golden Ticket awards and affiliated engagement in other Biotech Innovative hubs, including San Francisco, Boston and Toronto. Karma Biotechnologies is the 26th Golden Ticket winner since program inception in 2014.